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1

Jauro, Solomon, Erica C. Larson, Pauline Maiello, et al. "Evaluation of the time needed for BCG to be alive to protect against tuberculosis in intravenously BCG vaccinated SIV+ macaques." Journal of Immunology 210, no. 1_Supplement (2023): 141.20. http://dx.doi.org/10.4049/jimmunol.210.supp.141.20.

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Abstract Effective means of improving Bacille Calmette-Guérin (BCG) immunogenicity to protect against pulmonary tuberculosis (TB) is needed, especially among people living with HIV. Intravenous (IV) administration of BCG previously showed significant enhancement of immune responses and conferred ~75% protection against TB. Using our SIV/M. tuberculosis (Mtb) coinfection model (to mimic HIV/Mtb coinfection) in Mauritius cynomolgus macaques (MCM), we evaluated the length of time necessary for live BCG to elicit a protective immune responses by varying the timing of anti-BCG drug (isoniazid, rifa
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2

Lehman, Chelsea C., Hannah A. King, Supriya Pokkali, et al. "Repetitive vaccination with intravenous BCG is safe and immunogenic in naïve and SIV-infected macaques." Journal of Immunology 210, no. 1_Supplement (2023): 141.16. http://dx.doi.org/10.4049/jimmunol.210.supp.141.16.

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Abstract Tuberculosis (TB) is the leading cause of death in people with HIV (PWH) on or off antiretroviral therapy (ART); thus, new TB vaccine candidates should be evaluated in the setting of HIV. Mycobacterium bovis Bacillus Calmette-Guerin (BCG), the live attenuated bacterial TB vaccine given intradermally (ID) at birth, is contraindicated in PWH. We recently demonstrated that intravenous (IV) delivery of BCG elicits superior immunity and protection compared to ID delivery against Mycobacterium tuberculosis (Mtb) challenge in rhesus macaques. To assess IV BCG in an animal model of HIV infect
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3

Morrison, Alexandra L., Charlotte Sarfas, Laura Sibley та ін. "IV BCG Vaccination and Aerosol BCG Revaccination Induce Mycobacteria-Responsive γδ T Cells Associated with Protective Efficacy against M. tb Challenge". Vaccines 11, № 10 (2023): 1604. http://dx.doi.org/10.3390/vaccines11101604.

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Intravenously (IV) delivered BCG provides superior tuberculosis (TB) protection compared with the intradermal (ID) route in non-human primates (NHPs). We examined how γδ T cell responses changed in vivo after IV BCG vaccination of NHPs, and whether these correlated with protection against aerosol M. tuberculosis challenge. In the circulation, Vδ2 T cell populations expanded after IV BCG vaccination, from a median of 1.5% (range: 0.8–2.3) of the CD3+ population at baseline, to 5.3% (range: 1.4–29.5) 4 weeks after M. tb, and were associated with TB protection. This protection was related to effe
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4

Byrne, Kristen A., Dana C. Hill, and Crystal L. Loving. "Innate Memory Following Intravenous BCG in Neonatal Pigs." Journal of Immunology 208, no. 1_Supplement (2022): 50.17. http://dx.doi.org/10.4049/jimmunol.208.supp.50.17.

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Abstract In adults and rodents, Bacillus Calmette-Guerin (BCG) inoculation alters innate immune cells via epigenetic and metabolic modifications resulting in heightened responses to subsequent microbial exposure (innate memory). Neonatal BCG vaccination can correlate to improved disease resistance in some human populations, but studies with human infants are extremely limited. Pigs are a relevant biomedical model for human disease and offer a path to directly asses neonatal innate memory to improve disease resilience. BCG administration in a weaned (3 week old) pig model elicited monocyte memo
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5

Byrne, Kristen A., and Crystal L. Loving. "Intravenous BCG Induction of Innate Memory in Young Pigs." Journal of Immunology 210, no. 1_Supplement (2023): 71.25. http://dx.doi.org/10.4049/jimmunol.210.supp.71.25.

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Abstract Exposure to vaccine strain of Mycobacterium bovis(M. bovis), Bacillus Calmette-Guerin (BCG), alters innate immune cells through epigenetic and metabolic modifications resulting in heightened responses to subsequent microbial insult (innate memory). As a biomedical model for human disease, pigs provide a critical space to study the role of innate memory in disease resistance. Young pigs were inoculated intravenous (IV) or intraperitoneal (IP) with either live or heat-inactivated BCG (IV-live, IP-live, IV-inactive, noBCG groups). At 2wks post BCG inoculation, monocyte production of IL-1
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6

Larson, Erica C., Mark A. Rodgers, Amy L. Ellis, et al. "Intravenous BCG protects SIV+ macaques from tuberculosis." Journal of Immunology 206, no. 1_Supplement (2021): 59.11. http://dx.doi.org/10.4049/jimmunol.206.supp.59.11.

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Abstract Tuberculosis is the most common cause of death due to infection in people living with HIV (PLHIV). BCG, a live attenuated Mycobacterium bovis strain given intradermally to infants, is the only licensed vaccine to prevent TB. However, intradermal BCG offers little protection from pulmonary TB in adults and safety concerns limit its use in PLHIV. Recently, intravenous (IV) BCG has been shown to provide striking protection from TB in rhesus macaques. Given this dramatic success, we tested whether IV BCG could protect macaques with a pre-existing SIV infection using our established model
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7

Bucsan, Allison N., Patricia A. Darrah, James D. Dahlvang, et al. "Visualizing the early immune response to Mycobacterium tuberculosisinfection in macaques immunized with intravenous BCG." Journal of Immunology 210, no. 1_Supplement (2023): 253.07. http://dx.doi.org/10.4049/jimmunol.210.supp.253.07.

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Abstract Tuberculosis (TB) causes 1.6 million deaths annually and the standard human vaccine, intradermal (ID) Bacille-Calmette Guérin (BCG), does not prevent pulmonary TB. Previously, we showed that intravenous (IV) BCG immunization elicited robust TB-specific lung-resident T cell responses compared to ID BCG in rhesus macaques (RMs). Following Mycobacterium tuberculosis (Mtb) challenge, 6 out of 10 RMs had no detectable disease as demonstrated by bacterial burden, granuloma formation, and primary Mtb-specific immune responses. Together, these data suggest that Mtb is cleared rapidly from the
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8

Robertson, Molly A., Chelsea C. Lehman, Allison N. Buscan, et al. "Immunogenicity of intravenous irradiated or auxotrophic BCG immunization in macaques." Journal of Immunology 210, no. 1_Supplement (2023): 141.14. http://dx.doi.org/10.4049/jimmunol.210.supp.141.14.

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Abstract Tuberculosis (TB), caused by the bacillus Mycobacterium tuberculosis (Mtb), is a leading cause of death worldwide, particularly in people with HIV. The current vaccine against TB, BCG, is a live-attenuated strain of M. bovis that is administered intradermally at birth in endemic countries. BCG protects children against disseminated TB but fails to protect adolescents and adults against pulmonary TB, the most transmissible form. Thus, more effective TB vaccines are urgently needed. We previously demonstrated that delivering BCG intravenously (IV) elicits a high number of Mtb-specific T
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9

Smith, Alexander A., Mark A. Rodgers, Carolyn M. Bigbee, Dirk Schnappinger, Sabine Ehrt, and JoAnne L. Flynn. "Does intravenous vaccination with self-killing BCG lead to development of an immune response that protects against Mycobacterium tuberculosis?" Journal of Immunology 210, no. 1_Supplement (2023): 141.15. http://dx.doi.org/10.4049/jimmunol.210.supp.141.15.

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Abstract The use of intradermal BCG offers limited protection against tuberculosis. Intravenous (IV) administration of BCG has shown to produce robust protection against infection in a non-human primate model of tuberculosis. However, the duration of exposure and time required to elicit an efficacious, protective response is unknown and safety of IV administration of live BCG remains a concern. Here we investigated whether a self-limiting strain of BCG (killswitchBCG; ksBCG) could induce protective responses in macaques. ksBCG uses two transcriptionally repressible lysins; the inducer doxycycl
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10

Zeppa, Joseph John, Patricia A. Darrah, Supriya Pokkali, et al. "Intravenous Bacille Calmette-Guerin provides protection across a dose spectrum in a Rhesus macaque model of tuberculosis." Journal of Immunology 202, no. 1_Supplement (2019): 139.3. http://dx.doi.org/10.4049/jimmunol.202.supp.139.3.

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Abstract Our laboratory has demonstrated that intravenous (IV) vaccination with Bacille Calmette-Guerin (BCG; 5x107CFU) provides remarkably robust protection against low-dose Mycobacterium tuberculosis (Mtb) infection in Rhesus macaques (9/10 animals protected [<50 thoracic Mtb CFU]; 100,000-fold reduction compared to intradermal [ID] BCG). IV BCG also resulted in a 100-fold increase in mycobacterium-specific T cells in the bronchoalveolar lavage (BAL) of animals compared to other routes of administration (ID or aerosol). These results led us to hypothesize that significant protection c
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11

Grossman, Arielle, Aline Atallah, Tiziana Cotechini, Jean-Francois Pare, Robert Siemens, and Charles H. Graham. "Abstract 2058: Effect of route of Bacillus-Calmette Guerin administration on systemic immune responses in a murine model of non-muscle invasive bladder cancer." Cancer Research 82, no. 12_Supplement (2022): 2058. http://dx.doi.org/10.1158/1538-7445.am2022-2058.

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Abstract Background: Bladder cancer is the 5th most common cancer worldwide, with the most common type being non-muscle invasive bladder cancer (NMIBC). Treatment for high grade NMIBC includes resection of the bladder tumor followed by repeated intravesical administration of Bacillus-Calmette Guérin (BCG), the live-attenuated form of Mycobacterium bovis. Unfortunately, 60-70% of patients will experience disease recurrence. Our current understanding is that BCG acts within the local bladder tumor microenvironment and draining lymph nodes, leading to the activation of a systemic immune response.
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12

Atallah, Aline, Arielle Grossman, Jean-Francois Pare, Robert Siemens, Tiziana Cotechini, and Charles H. Graham. "Abstract 3540: Effect of route of Bacillus Calmette Guerin administration on the immune microenvironment and growth of bladder tumors." Cancer Research 82, no. 12_Supplement (2022): 3540. http://dx.doi.org/10.1158/1538-7445.am2022-3540.

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Abstract Background: Bladder cancer is the fifth most common cancer in North America. The standard of care for high-risk non-muscle invasive bladder cancer (NMIBC) involves intravesical immunotherapy with Bacillus Calmette Guérin (BCG). However, it is possible that the efficacy of this modality of BCG administration is suboptimal, as most patients do not respond fully to this immunotherapy. Furthermore, our current understanding of the immunotherapeutic effect of BCG is incomplete. Using a mouse model of NMIBC, we compared the tumor immune microenvironment (TiME) following intravesical versus
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13

Singh, Alok K., Kara Lombardo, Monali Praharaj, et al. "Abstract 3511: Varying Treatment outcomes of small molecule STING Agonist ADU-S100 in intratumoral and intravesical treatment regimens in syngeneic murine MB49 and in the N-methyl-N-nitrosourea (MNU) rat Model of urothelial carcinoma." Cancer Research 82, no. 12_Supplement (2022): 3511. http://dx.doi.org/10.1158/1538-7445.am2022-3511.

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Abstract Introduction: Intratumoral (IT) delivery of STING agonist ADU-S100 shows strong CD8+T cells-mediated antitumor immunity. However, rapid absorption from IT sites, short terminal half-life and adverse outcomes caused withdrawal of ADU-S100 from clinical trials. We reported development of BCG-STING, a preclinical candidate for non-muscle invasive bladder cancer (NMIBC) that overexpresses a bioactive STING agonist (c-di-AMP) and shows enhanced antitumor efficacy over BCG-WT by increasing tumor infiltrating CD4+ and CD8+ T cells and inflammatory macrophages. The similar mechanism of action
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14

Tran, Kim, and Maziar Divangahi. "BCG vaccination provides cross-protection against influenza infection through trained adaptive immunity." Journal of Immunology 206, no. 1_Supplement (2021): 110.18. http://dx.doi.org/10.4049/jimmunol.206.supp.110.18.

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Abstract The ongoing COVID-19 pandemic highlights the threat emerging viruses pose to the world. While the development of a new vaccine can take at least 1–2 years, alternative approaches are urgently needed to alleviate the burden of rapid transmission. The Bacillus Calmette-Guerin (BCG) vaccine is currently used worldwide to prevent tuberculosis but has also been shown to protect against a wide range of infections. Several studies have attributed this broad protection to trained immunity. While innate immune cells usually act in a non-specific manner, in the context of trained immunity, thes
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15

Morton, Donald L., Nicola Mozzillo, Mohammed Kashani-Sabet, et al. "Long-term cure after complete resection and adjuvant immunotherapy for distant melanoma metastases." Journal of Clinical Oncology 30, no. 15_suppl (2012): 8534. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.8534.

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8534 Background: In phase II trials, postoperative therapy with Canvaxin allogeneic melanoma cell vaccine plus Bacillus Calmette-Guerin (BCG) improved the survival of patients with stage IV melanoma. A multicenter, phase III placebo-controlled study was undertaken to investigate the vaccine’s efficacy. Methods: After complete resection of melanoma involving up to 5 distant sites, patients were randomized to treatment with BCG plus Canvaxin (BCG-Canvaxin) or BCG plus placebo (BCG-placebo). The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS) and s
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16

Kaufmann, Eva, Nargis Khan, Clinton S. Robbins, Luis B. Barreiro, and Maziar Divangahi. "Systemic BCG Vaccination in “Dirty Mice” induces Protective Trained Immunity against TB." Journal of Immunology 204, no. 1_Supplement (2020): 168.6. http://dx.doi.org/10.4049/jimmunol.204.supp.168.6.

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Abstract After a century of discovery of Bacille Calmette-Guerin (BCG), our understanding of its protective mechanism(s) against TB or other pathogens is very limited. We have recently demonstrated that systemic BCG vaccination (intravenously, iv) in specific pathogen-free (SPF) mice imprints hematopoietic stem cells (HSCs) to generate macrophages with a unique protective program against pulmonary M. tuberculosis (Mtb) infection. While this proof of concept study was an important step to determine how we can harness the power of innate (trained) immunity in vaccination against TB, the translat
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17

Zeppa, Joseph John, Patricia A. Darrah, Matthew Sutton, et al. "Vaccine-Elicited T cells are Important for Intravenous BCG Mediated Protection in a Rhesus macaque Model of Tuberculosis." Journal of Immunology 204, no. 1_Supplement (2020): 168.4. http://dx.doi.org/10.4049/jimmunol.204.supp.168.4.

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Abstract Our laboratories have shown that intravenous (IV) vaccination with Bacille Calmette-Guerin (BCG; 5×107 CFU) provides robust protection against low-dose Mycobacterium tuberculosis (Mtb) infection in rhesus macaques (9/10 protected [<50 thoracic Mtb CFU]; 100,000-fold reduction compared to intradermal [ID] BCG). IV BCG also resulted in a 100-fold increase in mycobacterium--specific T cells in the airways of animals compared to ID or aerosol administration. To investigate the role of T cells in this protective model, we employed two methodologies: 1. Vaccination with decreasing do
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18

Loving, Crystal L., Dana Hill, and Kristen Byrne. "Neonatal bacilllus Calmette-Guerin (BCG) administration did not limit influenza A virus replication or clinical disease in pigs." Journal of Immunology 210, no. 1_Supplement (2023): 73.09. http://dx.doi.org/10.4049/jimmunol.210.supp.73.09.

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Abstract A potential immunomodulation mechanism for improving disease resilience is innate training, which relies on epigenetic modifications of immune cells for a heightened (ie, trained) response upon repeated microbial stimulation. Prior experiences indicate bacillus Calmette-Guerin (BCG) exposure increases cytokine production upon secondary exposure to microbe-associated molecular patterns, and epidemiological data suggest improved disease resistance in humans administered neonatal BCG. Neonatal piglets received BCG or mock inoculum via intravenous (IV) route and were subsequently exposed
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19

Kamat, Ashish M., Shahrokh Shariat, Gary D. Steinberg, et al. "Randomized comparator-controlled study evaluating efficacy and safety of pembrolizumab plus Bacillus Calmette-Guérin (BCG) in patients with high-risk nonmuscle-invasive bladder cancer (HR NMIBC): KEYNOTE-676 cohort B." Journal of Clinical Oncology 40, no. 6_suppl (2022): TPS597. http://dx.doi.org/10.1200/jco.2022.40.6_suppl.tps597.

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TPS597 Background: Cohort A of the phase 2 KEYNOTE-057 study showed that pembrolizumab monotherapy provided effective antitumor activity and acceptable safety in patients with BCG-unresponsive HR NMIBC with carcinoma in situ (CIS). Pembrolizumab in combination with BCG at earlier stages of HR NMIBC might provide benefit superior to that of BCG monotherapy. The open-label, comparator-controlled, phase 3 KEYNOTE-676 study (NCT03711032) will be conducted to investigate the efficacy and safety of pembrolizumab + BCG versus BCG monotherapy in patients with HR NMIBC. Cohort A will enroll patients wi
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20

Ravaud, A., H. Eghbali, M. Trojani, G. Hoerni-Simon, P. Soubeyran, and B. Hoerni. "Adjuvant bacillus Calmette-Guérin therapy in non-Hodgkin's malignant lymphomas: long-term results of a randomized trial in a single institution." Journal of Clinical Oncology 8, no. 4 (1990): 608–14. http://dx.doi.org/10.1200/jco.1990.8.4.608.

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Between 1973 and 1977, 48 patients less than 65 years old with non-Hodgkin's malignant lymphoma (NHML) of poor prognosis (+/- high grade malignancy, +/- clinical stages III or IV, +/- first or repeated relapse) were included in a prospective clinical trial. After complete remission (CR), obtained with chemotherapy and radiotherapy, patients were randomized to receive bacillus Calmette-Guérin (BCG) or no further therapy. BCG was administered in weekly scarifications up to 3 years. Forty-three patients are assessable. Twenty-four patients have relapsed: nine out of 21 in the BCG group, and 15 ou
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21

Morton, D. L., N. Mozzillo, J. F. Thompson, et al. "An international, randomized, phase III trial of bacillus Calmette-Guerin (BCG) plus allogeneic melanoma vaccine (MCV) or placebo after complete resection of melanoma metastatic to regional or distant sites." Journal of Clinical Oncology 25, no. 18_suppl (2007): 8508. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.8508.

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8508 Background: Active specific immunotherapy with BCG and an allogeneic, melanoma cell vaccine can induce antibody and T-lymphocyte immune responses to numerous antigens expressed by melanoma cells. This study compared overall and disease-free survival in patients receiving BCG plus placebo versus BCG plus MCV. Methods: Between June 1998 and November 2005, 1,656 patients without evidence of residual disease after resection of stage III (n = 1,160) or stage IV (n = 496) melanoma were randomly assigned to the two treatment arms (1:1). BCG was given as an immunologic adjuvant for the first two
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22

Abate, Getahun, Krystal A. Meza, Chase G. Colbert, Octavio Ramos-Espinosa, Nancy J. Phillips, and Christopher S. Eickhoff. "Immunity Against Mycobacterium avium Induced by DAR-901 and BCG." Vaccines 13, no. 6 (2025): 619. https://doi.org/10.3390/vaccines13060619.

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Background: The prevalence of pulmonary nontuberculous mycobacteria (NTM) is increasing in Europe and North America. Most pulmonary NTM cases are caused by Mycobacterium avium complex (MAC). The treatment of pulmonary MAC is suboptimal with failure rates ranging from 30% to 40% and there is a need to develop new vaccines. Methods: We tested the ability of two whole-cell vaccines, DAR-901 (heat-killed M. obuense) and BCG (live-attenuated M. bovis), to induce MAC cross-reactive immunity by first immunizing BALB/c mice and then performing IFN-γ ELISPOT assays after overnight stimulation of spleno
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23

Octavini, Nanda Andreas, Weni Yunisa Adriani, Nopi Yana, and Rolando Mandela. "ANALISIS BOSTON CONSULTING GROUP (BCG) PADA PORTOFOLIO PRODUK UNILEVER." Journal Of Economic And Business Retail 2, no. 1 (2023): 8. http://dx.doi.org/10.69769/jebr.v2i1.86.

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Tujuan dalam penelitian ini adalah untuk menganalisis matriks Boston Consulting Group (BCG) pada portofolio produk Unilever dan merumuskan strategi pemasaran yang tepat berdasarkan analisis matriks Boston Consulting Group (BCG). Teknik pengumpulan data yang digunakan dalam penelitian ini yaitu studi pustaka dan wawancara. Metode analisis yang digunakan adalah matriks Boston Consulting Group (BCG). Berdasarkan hasil pemetaan pada matriks Boston Consulting Group (BCG) dapat dijelaskan bahwa kesepuluh produk Unilever menempati kuadran (posisi) yang berbeda-beda yaitu : pada kuadran I atau Questio
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24

Larsson, LO, M. Magnusson, BE Skoogh, and A. Lind. "Sensitivity to sensitins and tuberculin in Swedish children. IV. The influence of BCG-vaccination." European Respiratory Journal 5, no. 5 (1992): 584–86. http://dx.doi.org/10.1183/09031936.93.05050584.

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BCG-vaccinated schoolchildren, 8-9 yrs of age, were simultaneously tested on separate arms with tuberculin and a sensitin. Using the 6 mm cut-off they reacted in 49% to two tuberculin units purified protein derivative (PPD RT23), in 67% to 0.1 micrograms Mycobacterium avium sensitin RS10, and in 58% to 0.1 micrograms M. scrofulaceum sensitin RS95. The corresponding figures for non-BCG-vaccinated schoolchildren of the same age tested at the same time were 3, 25 and 32%, respectively. The results indicate a stimulating influence of BCG-vaccination on tuberculin and sensitin reactivity. Since the
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25

Condori Bustillos, Rocio, María Rebeca De la Fuente Olmos, María Elena Villacastín Ruiz, and Marta Alvarez Garcia. "Sepsis con afectación peritoneal por BCG: A propósito de un caso." Revista Medica 28, no. 1 (2023): 70–73. http://dx.doi.org/10.58296/rm.v28i1.77.

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La instilacion intravesical de BCG es utilizado en el tratamiento del carcinoma vesical in situ, generalmente es bien tolerada y con raras complicaciones, sobre estas se ha descrito mecanismos por diseminación hematógena (con pruebas microbiológicas e histopatológicas positivas) o por hipersensibilidad tipo IV (Pruebas microbiológicas negativas, granulomas y buena respuesta a corticoides) o mixto. Presentamos el caso de un paciente con Carcinoma vesical en tratamiento con instilaciones intravesicales de BCG, con factores de riesgo de lesión de la barrera urotelial, comienza con fiebre hasta ll
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Roupret, Morgan, Yann Neuzillet, Aurelie Bertaut, et al. "ALBAN: An open label, randomized, phase III trial, evaluating efficacy of atezolizumab in addition to one year BCG (bacillus Calmette-Guerin) bladder instillation in BCG-naive patients with high-risk nonmuscle invasive bladder cancer (AFU-GETUG 37)." Journal of Clinical Oncology 37, no. 15_suppl (2019): TPS4589. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps4589.

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TPS4589 Background: The majority of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC). Trans-urethral resection of bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG) therapy is the standard of care for most patients with high-risk NMIBC, although clinical outcomes remain poor. Data from preclinical and clinical studies suggest that programmed death-ligand 1 PD-L1 inhibition may enhance antitumor activity of BCG therapy. Atezolizumab, an anti–PD-L1 monoclonal antibody, is approved in the United States and the European Union as monotherapy w
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27

Hahn, Noah M., Gary D. Steinberg, Kelly Lynn Stratton, et al. "Atezolizumab (atezo) with or without Bacille Calmette-Guérin (BCG) in patients (pts) with high-risk nonmuscle-invasive bladder cancer (NMIBC): Results from a phase Ib/II study." Journal of Clinical Oncology 40, no. 6_suppl (2022): 493. http://dx.doi.org/10.1200/jco.2022.40.6_suppl.493.

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493 Background: Standard treatment (tx) for high-risk NMIBC is transurethral resection of bladder tumor (TURBT) followed by BCG induction and maintenance. However, ≈50% of pts experience recurrence and/or progression after tx and may be ineligible for or refuse cystectomy. The PD-L1/PD-1 pathway may be involved with immune escape in NMIBC following BCG exposure. Here, we report results of atezo (anti–PD-L1) ± BCG in BCG-unresponsive, high-risk NMIBC. Methods: This multicenter study (NCT02792192) enrolled pts with BCG-unresponsive NMIBC with carcinoma in situ who had repeat TURBT. Cohort 1A and
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28

Hallworth, Pam, Anthony Eccleston, Brad Mason, et al. "Quantifying patient preferences for bacillus Calmette-Guérin (BCG) and PD-(L)1 inhibitors in high-risk non-muscle invasive bladder cancer (NMIBC): A discrete choice experiment." Journal of Clinical Oncology 43, no. 16_suppl (2025): 4579. https://doi.org/10.1200/jco.2025.43.16_suppl.4579.

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4579 Background: Intravesical Bacillus Calmette-Guerin (BCG) induction + maintenance (I+M) is the standard of care for high-risk NMIBC. Disease recurrence and progression is common. The studies investigating programmed cell death-1/programmed death-ligand 1 (PD-[L]1) inhibitors + BCG aim to enhance treatment outcomes and reduce burden in BCG naïve high-risk NMIBC. There is limited evidence on patient preferences for these combination regimens. Methods: A discrete choice experiment quantified preferences for attribute levels related to BCG and PD-(L)1 inhibitors. Attributes and levels were info
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29

Ramos, Romela Irene, Misa A. Shaw, Leland Foshag, et al. "Genetic Variants in Immune Related Genes as Predictors of Responsiveness to BCG Immunotherapy in Metastatic Melanoma Patients." Cancers 13, no. 1 (2020): 91. http://dx.doi.org/10.3390/cancers13010091.

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Adjuvant immunotherapy in melanoma patients improves clinical outcomes. However, success is unpredictable due to inherited heterogeneity of immune responses. Inherent immune genes associated with single nucleotide polymorphisms (SNPs) may influence anti-tumor immune responses. We assessed the predictive ability of 26 immune-gene SNPs genomic panels for a clinical response to adjuvant BCG (Bacillus Calmette-Guérin) immunotherapy, using melanoma patient cohorts derived from three phase III multicenter clinical trials: AJCC (American Joint Committee on Cancer) stage IV patients given adjuvant BCG
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30

Joseph-Munné, Joan, Milena Maya-Hoyos, Narcís Saubi, et al. "Recombinant Mycobacterium bovis BCG-Based HIV Vaccine: Failures and Promising Approaches for a Successful Vaccine Strategy." Vaccines 13, no. 6 (2025): 606. https://doi.org/10.3390/vaccines13060606.

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During 2022, AIDS claimed a life every minute and about 9.2 million HIV-infected people were not on treatment. In addition, a person living with HIV is estimated to be 20–30 times more susceptible to developing active tuberculosis. Every year, 130,000 infants are newly infected, with vertical transmission being the main cause of pediatric HIV infection. Thus, the development of an effective, safe, and accessible vaccine for neonates and/or adults is an urgent need to prevent or control HIV infection or progression to AIDS. An effective HIV vaccine should induce long-lasting mucosal immunity, b
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José Caetano de Lima, Igor, Moacir Cavalcante de Albuquerque Neto, Thomé Décio Pinheiro Barros Júnior, Fabio de Oliveira Vilar, José Weslley Silva Bezerra, and Danilo de Lima Cavalcanti. "Intravesical adjuvant therapy with gemcitabine for patients with high-risk non-muscle invasive bladder cancer: Experience from a public hospital in Brazil." Recet 11, no. 1 (2024): e00167. http://dx.doi.org/10.55825/recet.sbu.0167.

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Introdução: A terapia intravesical adjuvante é o tratamento de escolha para o câncer de bexiga não músculo-invasivo (CBNM) de alto risco, o que reduz a recorrência e a progressão da doença. O Bacilo Calmette-Guerin (BCG) é o principal fármaco utilizado, mas apresenta escassez mundial. Aqui, relatamos o uso de gencitabina intravesical (GEN-IV) em nosso hospital.
 Metodologia: Este estudo incluiu pacientes com diagnóstico histológico de NMIBC urotelial de alto risco. Os pacientes foram submetidos a uma segunda ressecção transuretral de tumor de bexiga (RTUB) até 6 semanas após o diagnóstico
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32

Sonpavde, Guru, Charles Joel Rosser, Chong-xian Pan, et al. "Phase I trial of ALT-801, a first-in-class T-cell receptor (TCR)-interleukin (IL)-2 fusion molecule, plus gemcitabine (G) for Bacillus Calmette Guerin (BCG)-resistant non-muscle-invasive bladder cancer (NMIBC)." Journal of Clinical Oncology 34, no. 2_suppl (2016): 451. http://dx.doi.org/10.1200/jco.2016.34.2_suppl.451.

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451 Background: Novel agents are necessary to treat BCG-resistant NMIBC to avoid radical cystectomy (RC). This phase I clinical trial evaluated the safety and activity of ALT-801, a recombinant humanized TCR-IL-2 fusion protein in BCG-resistant NMIBC. Methods: This is a Phase I trial using the 3+3 design to evaluate intravenous (IV) ALT-801 plus IV G 1000 mg/m2 in BCG-resistant high-risk NMIBC patients (pts) defined as high grade Ta, T1 or carcinoma in situ, size > 4 cm or multi-focal tumors. BCG-intolerant pts, those who refused or were unfit to undergo RC were also eligible. Initially, pa
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33

Chystiakov, R. S., F. I. Kostyev, V. V. Lysenko, O. V. Bondar, V. O. Varbanets, and E. M. Nareiko. "Effectiveness of hyperthermic intravesical chemotherapy in the combined treatment of patients with high-risk non-muscle-invasive bladder cancer." Urologiya 28, no. 1-4 (2024): 5–12. https://doi.org/10.26641/2307-5279.28.1-4.2024.322074.

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The aim of the study was to increase the effectiveness of treatment of patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) by using hyperthermic intravesical chemotherapy in the adjuvant mode after transurethral resection of the bladder (HIVEC-therapy group; n=53) and to compare the treatment results with patients in which adjuvant therapy was carried out with BCG vaccine (BCG therapy group; n=54). The frequency of recurrence and progression during the 36-month follow-up period differed significantly between the two groups – 22.6 and 42.6% and 7.5 and 20.4%, respectively. The
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OTSUKA, MORIO. "Re-emerging infectious disease, pulmonary tuberculosis. IV. Treatment. 3. Significance of BCG vaccination." Nihon Naika Gakkai Zasshi 89, no. 5 (2000): 916–20. http://dx.doi.org/10.2169/naika.89.916.

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35

Black, Peter C., Catherine Tangen, Parminder Singh, et al. "Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer: SWOG S1605 (NCT #02844816)." Journal of Clinical Oncology 38, no. 15_suppl (2020): 5022. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.5022.

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5022 Background: Radical cystectomy (RC) is the standard of care for patients with BCG-unresponsive high risk non-muscle invasive bladder cancer (NMIBC), but many patients are unfit for surgery or elect bladder preservation. Based on the reported efficacy of atezolizumab in metastatic urothelial carcinoma and the known expression of PD-L1 in NMIBC after BCG therapy, this trial was designed to evaluate the activity of atezolizumab in BCG-unresponsive high risk NMIBC. Methods: This single arm phase II registration trial testing systemic atezolizumab (1200 mg IV) every 3 weeks for one year aimed
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36

Black, Peter C., Tangen Catherine, Seth P. Lerner, et al. "S1605: Phase II trial of atezolizumab in BCG-unresponsive nonmuscle invasive bladder cancer." Journal of Clinical Oncology 36, no. 6_suppl (2018): TPS527. http://dx.doi.org/10.1200/jco.2018.36.6_suppl.tps527.

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TPS527 Background: Radical cystectomy is the standard of care for patients with BCG-unresponsive high risk non-muscle invasive bladder cancer (NMIBC). Based on the reported efficacy of atezolizumab in metastatic urothelial carcinoma and the known expression of PD-L1 expression in NMIBC after BCG therapy, this trial will evaluate the activity of atezolizumab in BCG-unresponsive high risk NMIBC. Methods: This is a single arm phase II trial testing systemic atezolizumab (1200 mg IV) every 3 weeks for one year in 135 patients with BCG-unresponsive high risk NMIBC. The study will enroll 70 patients
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Singh, Parminder, Tangen Catherine, Seth P. Lerner, et al. "S1605: Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer." Journal of Clinical Oncology 35, no. 15_suppl (2017): TPS4591. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.tps4591.

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TPS4591 Background: Radical cystectomy is the standard of care for patients with BCG-unresponsive high risk non-muscle invasive bladder cancer (NMIBC). Based on the reported efficacy of atezolizumab in metastatic urothelial carcinoma and the known expression of PD-L1 expression in NMIBC after BCG therapy, this trial will evaluate the activity of atezolizumab in BCG-unresponsive high risk NMIBC. Methods: This is a single arm phase II trial testing systemic atezolizumab (1200 mg IV) every 3 weeks for one year in 135 patients with BCG-unresponsive high risk NMIBC. The study will enroll 70 patient
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38

Li, Roger, Gary Steinberg, Paras Shah, et al. "Abstract CT036: CORE1: Phase 2, single arm study of CG0070 combined with pembrolizumab in patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG)." Cancer Research 82, no. 12_Supplement (2022): CT036. http://dx.doi.org/10.1158/1538-7445.am2022-ct036.

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Abstract Introduction: CG0070, is an Ad5-based oncolytic vaccine engineered to express GM-CSF and replicate selectively in tumor cells with mutated or deficient RB. The CG0070 mechanism of action includes cell lysis and immunogenic cell death which is enhanced in the presence of GM-CSF. In an open label ph. 2 study, an overall CR rate of 62% and a CR at 12 months (m) of 29% have been observed in patients with high risk NMIBC previously treated with BCG. IV pembrolizumab, was recently approved by the FDA for patients with BCG-unresponsive CIS (with or without papillary tumors) with an overall c
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Azim, Sidra, Sanna Fatima, Benjamin Chang, and Vijaya Ram. "ODP079 BCG-Osis, a Rare Cause of 1,25 Hydroxy Vitamin D Mediated Hypercalcemia." Journal of the Endocrine Society 6, Supplement_1 (2022): A158. http://dx.doi.org/10.1210/jendso/bvac150.323.

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Abstract Background Non-parathyroid hormone (PTH) mediated hypercalcemia is mostly related to malignancy and less commonly caused by granulomatous diseases. We report a rare case of severe hypercalcemia caused by systemic granulomatous disease after intravesical Bacillus Calmette-Guerin (BCG) treatment for bladder cancer (BCGosis). Clinical Case 74-year-old male with history of bladder cancer treated with intravesical BCG a year ago, was hospitalized with confusion, weakness, recurrent falls and polyuria for a few days. He had night sweats and 50 lb weight loss over 6 months. Lab evaluation sh
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Hidayah, Listiani, Nur Muflihah, Andhika Mayasari, and Fatma Ayu Nuning Farida Afiatna. "Perencanaan Strategi Pemasaran Untuk Meningkatkan Penjualan Produk Batik Khas Jombang di Era New Normal." Jurnal Ilmiah Universitas Batanghari Jambi 22, no. 3 (2022): 1857. http://dx.doi.org/10.33087/jiubj.v22i3.2707.

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UKM Batik Tulis New Colet Jombang produces three types of batik, namely hand-written batik, stamped batik, and semi-written batik. The problem occurs when batik sales decline due to the Covid-19, so it requires planning a marketing strategy to increase sales in the new normal era. The study aims to determine the internal and exsternal factor in UKM Batik Tulis New Colet Jombang, planning a marketing strategy using SWOT, BCG, and QSPM methods. Internal factors consist of strengths and weaknesses, while external factors consist of opportunities and threats. The results of the SWOT matrix can be
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41

Arora, Sunisha, K. Upasana, Dhwanee Thakkar, Anjali Yadav, Neha Rastogi, and Satya P. Yadav. "Fatal Severe Cytokine Release Syndrome Post-haploidentical Stem Cell Transplant With Post-transplant Cyclophosphamide in an Infant With Severe Combined Immunodeficiency and Disseminated Bacille Calmette-Guérin Infection." Journal of Pediatric Hematology/Oncology 45, no. 6 (2023): e773-e774. http://dx.doi.org/10.1097/mph.0000000000002700.

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Introduction: Severe Combined Immunodeficiency (SCID) is a primary immunodeficiency disorder characterized by absent or dysfunctional T lymphocytes, leading to defective cellular and humoral immunity requiring urgent hematopoietic stem cell transplantation (HSCT). We report a case of SCID with disseminated Bacille Calmette-Guérin (BCG) infection who developed cytokine release syndrome (CRS) and possible Immune reconstitution inflammatory syndrome (IRIS) after Haploidentical HSCT with post-transplant cyclophosphamide. Methods: Data were retrospectively retrieved from electronic medical records.
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Olson, Devra, Yen Lin Chia, Enaharo Iboi, et al. "Abstract LB246: Enfortumab vedotin, a nectin-4-directed antibody-drug conjugate, demonstrates compelling antitumor activity in non-muscle invasive bladder cancer models which predicts minimal systemic exposure when administered by intravesical instillation in patients." Cancer Research 83, no. 8_Supplement (2023): LB246. http://dx.doi.org/10.1158/1538-7445.am2023-lb246.

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Abstract Enfortumab vedotin (EV) is a monomethyl auristatin E (MMAE)-containing antibody-drug conjugate directed to Nectin-4, which is highly expressed in bladder cancers. Preclinically, EV has demonstrated tumor cell killing by direct cytotoxicity and bystander effect and can induce the hallmarks of immunogenic cell death. EV improves survival in adults with previously treated locally advanced or metastatic urothelial carcinoma (la/mUC) and is approved in the US, Europe, Japan, and others. Most newly diagnosed bladder cancer cases are non-muscle invasive (NMIBC). Standard treatment of high-ri
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Bellmunt, Joaquim, Alejo Rodríguez-Vida, Imanol Martinez, et al. "A phase II prospective, open-label, multi-center, single-arm study of sasanlimab plus sacituzumab govitecan in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) pts: SSANTROP (APRO07-2022)." Journal of Clinical Oncology 43, no. 16_suppl (2025): 4596. https://doi.org/10.1200/jco.2025.43.16_suppl.4596.

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4596 Background: Radical cystectomy (RC)is the standard treatment forBCG unresponsive high-risk (HR) NMIBC patients (pts). Pembrolizumab (Pem) was approved by the FDA based on Keynote-057 (41% complete response rate (CRR)) and offers a non-surgical option for pts who decline or are ineligible for RC. Nadofaregene firadenovec and Nogapendekin alfa inbakicept have been recently approved in this setting. Sacituzumab govitecan (SG) demonstrated encouraging efficacy and safety in metastatic urothelial cancer (mUC) in the TROPHY-U-01 trial. Combining ADCs with immunotherapy showed promising results
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Hoshimoto, S., T. Shingai, H. Wang, R. M. Elashhoff, D. L. Morton, and D. S. Hoon. "Validation of a multimarker blood assay for postoperative assessment of stage IV melanoma patients in a prospective international phase III trial." Journal of Clinical Oncology 27, no. 15_suppl (2009): 9045. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.9045.

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9045 Background: Currently there are no validated prognostic molecular biomarkers for assessment of outcome after complete resection of stage IV melanoma patients. To validate blood molecular biomarkers for prognostic value and monitoring of these patients, we evaluated the clinical utility of a multimarker quantitative reverse-transcription PCR (qRT-PCR) for detecting circulating tumor cells (CTC) of patients blood enrolled in a multicenter international (29 sites) phase III trial of postoperative adjuvant therapy. After complete metastasectomy, AJCC stage IV patients underwent immunotherapy
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Simonson, Andrew W., Allison N. Bucsan, Joseph J. Zeppa, et al. "The role of lymphocyte subsets in preventing tuberculosis following intravenous vaccination with BCG." Journal of Immunology 208, no. 1_Supplement (2022): 181.11. http://dx.doi.org/10.4049/jimmunol.208.supp.181.11.

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Abstract Background We previously demonstrated in non-human primates (NHP) that intravenous (IV) administration of BCG induces substantial T cell responses and often sterilizing immunity against Mycobacterium tuberculosis (Mtb) infection. Here, we investigated the role of T cell populations in this unmatched response in the context of necessary immune mechanisms for protection against tuberculosis (TB). Methods Beginning 20 weeks after vaccination and through the end of the study, rhesus macaques were infused with antibodies to deplete CD4, CD8α, or CD8β expressing T cells, or with control IgG
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Shore, Neal D., Shilpa Gupta, Girish S. Kulkarni, et al. "Phase 2 KEYNOTE-057 cohort C: Pembrolizumab (pembro) with vibostolimab or favezelimab for patients (pts) with high-risk (HR) bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC)." Journal of Clinical Oncology 41, no. 6_suppl (2023): TPS591. http://dx.doi.org/10.1200/jco.2023.41.6_suppl.tps591.

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TPS591 Background: The PD-1 inhibitor pembro showed antitumor activity in cohort A of the phase 2 KEYNOTE-057 study (NCT02625961), with 41% of pts with HR BCG-unresponsive carcinoma in situ (CIS) of the bladder ± papillary tumors achieving a CR at 3 months with a median DOR of 16.2 months. Based on these results, pembro was approved in the United States for treatment of pts with BCG-unresponsive HR NMIBC with CIS ± papillary tumors who are ineligible for or have elected not to undergo radical cystectomy (RC). However, novel combinations that improve the efficacy of pembro are needed. Immune ch
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47

Li, Roger, Gary Steinberg, Donald Lamm, et al. "955 CORE1: phase 2, single arm study of CG0070 combined with pembrolizumab in patients with non muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guerin (BCG)." Journal for ImmunoTherapy of Cancer 9, Suppl 2 (2021): A1005. http://dx.doi.org/10.1136/jitc-2021-sitc2021.955.

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BackgroundCG0070, an oncolytic vaccine available as an intravesical therapy, is a serotype 5 adenovirus engineered to express GM-CSF and replicate in tumor cells with mutated or deficient RB (which results in increased of the transcription factor E2F). The CG0070 mechanism of action includes direct cell lysis in conjunction with immunogenic cell death which is enhanced in the presence of GM-CSF. In an initial phase 1 study as well as a subsequent phase 2 study, an overall CR rate of ~62% and a CR at 12 months (m) of 29% have been observed in patients with high risk NMIBC previously treated wit
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48

Tambunan, Willy, Yudi Sukmono, and Luvita Okti Anggreani. "Analisis Strategi Pemasaran untuk Meningkatkan Volume Penjualan dan Daya Saing." Jurnal Optimalisasi 7, no. 1 (2021): 48. http://dx.doi.org/10.35308/jopt.v7i1.3419.

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UKM Roti H-34 is one of the Small and Medium Enterprises (UKM) in Samarinda City which is engaged in the culinary field that produces unyil bread. The superior product has decreased in sales. Based on this, this study aims to determine the best alternative marketing strategy solutions to increase sales volume and competitiveness based on internal and external factors that affect the company. Marketing strategy analysis is carried out in several stages, the first is using the IFE and EFE matrices. The results obtained on the IFE matrix is 3.779, while the EFE matrix is 2.905. The second stage i
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Hena, Zafar, Priya Kannu, and Prakash Jaiswal Bir. "Impact of Malnutrition on TB Development in BCG-Vaccinated Children Aged 2 Months to 12 Years." International Journal of Current Pharmaceutical Review and Research 16, no. 05 (2024): 228–32. https://doi.org/10.5281/zenodo.12785727.

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AbstractAim: The aim of the present study was to assess the influence of malnutrition in development of tuberculosis inBCG vaccinated children in age group of 2 months to 12 years.Methods: The Present study was a prospective study carried out at Nalanda Medical College and Hospital, Patna,Bihar, India. Study population was children in the age group of 2 months to 12 years with symptoms suggestiveof tuberculosis. In our study, we studied 100 patients.Results: Majority of the patients belong to 1 to 5 years (40%) followed by 6 to 10 years (26%). Patients less than1 year were 17%. In our study, p
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Kulkarni, Girish S., Kyle A. Richards, Peter C. Black, et al. "A phase II clinical study of intravesical photo dynamic therapy in patients with BCG-unresponsive NMIBC (interim analysis)." Journal of Clinical Oncology 41, no. 6_suppl (2023): 528. http://dx.doi.org/10.1200/jco.2023.41.6_suppl.528.

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528 Background: Novel therapies are required for BCG-unresponsive, high risk non-muscle invasive bladder cancer. We report the interim results of a Phase II Clinical Study of Intravesical Photo Dynamic Therapy (PDT) in patients with BCG-Unresponsive Carcinoma In-Situ (CIS) with or without papillary disease. Methods: Out of a planned 125 patients, 42 patients have been enrolled and treated with two Study Treatments (Day 0 and Day 180) consisting of an intravesical instillation of the photosensitizer TLD-1433 (0.70 mg/cm2) followed by activation with a 520 nm intravesical laser under general ane
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