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1

Fragapane, Elena, Roberto Gasparini, Francesco Schioppa, Franco Laghi-Pasini, Emanuele Montomoli, and Angelika Banzhoff. "A Heterologous MF59-Adjuvanted H5N1 Prepandemic Influenza Booster Vaccine Induces a Robust, Cross-Reactive Immune Response in Adults and the Elderly." Clinical and Vaccine Immunology 17, no. 11 (2010): 1817–19. http://dx.doi.org/10.1128/cvi.00461-09.

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ABSTRACT Immunogenicity and safety of a booster dose of an MF59-adjuvanted H5N1 vaccine containing 7.5 μg A/turkey/Turkey/1/2005-like (clade 2.2) H5N1 hemagglutinin, given approximately 18 months after primary vaccination with a heterologous strain, were evaluated. The booster vaccine was well tolerated and induced a robust, cross-reactive immune response.
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Bihari, Iván, Gyula Pánczél, Jozsef Kovacs, Jenny Beygo, and Elena Fragapane. "Assessment of Antigen-Specific and Cross-Reactive Antibody Responses to an MF59-Adjuvanted A/H5N1 Prepandemic Influenza Vaccine in Adult and Elderly Subjects." Clinical and Vaccine Immunology 19, no. 12 (2012): 1943–48. http://dx.doi.org/10.1128/cvi.00373-12.

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ABSTRACTPreparedness against an A/H5N1 influenza pandemic requires well-tolerated, effective vaccines which provide both vaccine strain-specific and heterologous, cross-clade protection. This study was conducted to assess the immunogenicity and safety profile of an MF59-adjuvanted, prepandemic influenza vaccine containing A/turkey/Turkey/01/2005 (H5N1) strain viral antigen. A total of 343 participants, 194 adults (18 to 60 years) and 149 elderly individuals (≥61 years), received two doses of the investigational vaccine given 3 weeks apart. Homologous and heterologous antibody responses were an
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Lopez, Pio, Yolanda Caicedo, Alexandra Sierra, Sandrine Tilman, Ralf Clemens, and Angelika Banzhoff. "Combined Administration of MF59-Adjuvanted A/H5N1 Prepandemic and Seasonal Influenza Vaccines: Long-Term Antibody Persistence and Robust Booster Responses 1 Year after a One-Dose Priming Schedule." Clinical and Vaccine Immunology 20, no. 5 (2013): 753–58. http://dx.doi.org/10.1128/cvi.00626-12.

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ABSTRACTHaving previously demonstrated the feasibility of administering A/H5N1 and seasonal influenza vaccine antigens in an MF59-adjuvanted tetravalent formulation, we now report on long-term antibody persistence and responses to a booster dose of a combined seasonal-pandemic, tetravalent influenza vaccine in adults. The primary objective was the evaluation of responses to a booster dose of tetravalent influenza vaccine containing seasonal (A/H1N1, A/H3N2, and B) and avian (A/H5N1, clade 2) influenza virus strains administered to 265 healthy 18- to 40-year-old volunteers 1 year after priming
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Chen, Wei, Yongxia Liu, Jinhua Yin, et al. "Cloning, Expression, and Immunogenicity of Fimbrial-F17A Subunit Vaccine againstEscherichia coliIsolated from Bovine Mastitis." BioMed Research International 2017 (2017): 1–10. http://dx.doi.org/10.1155/2017/3248483.

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There is a need to identify and select new promising immunodominant antigens that have the ability to provide protective immunity againstE. colicausing bovine mastitis. Recently we showed thatf17awas found to be the most prevalent and crucial virulent factor among the pathogenicE. coliisolated from bovine mastitis. Here, in this report, the recombinant F17A based subunit vaccine adjuvant with MF59 was tested for immunogenicity againstE. coliin a murine model. The vaccinated mice did not show any abnormal behavioral changes and histopathological lesions after vaccination. The specific antibody
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Del Giudice, Giuseppe, Elena Fragapane, Roberto Bugarini, et al. "Vaccines with the MF59 Adjuvant Do Not Stimulate Antibody Responses against Squalene." Clinical and Vaccine Immunology 13, no. 9 (2006): 1010–13. http://dx.doi.org/10.1128/cvi.00191-06.

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ABSTRACT Squalene is a naturally occurring oil which has been used in the development of vaccine adjuvants, such as the oil-in-water emulsion MF59. In past years, by use of noncontrolled and nonvalidated assays, a claim was made that antisqualene antibodies were detectable in the sera of individuals with the so-called Gulf War syndrome. Using a validated enzyme-linked immunosorbent assay for the quantitation of immunoglobulin G (IgG) and IgM antibodies against squalene, we demonstrated that antisqualene antibodies are frequently detectable at very low titers in the sera of subjects who were ne
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Chen, Chao-Hung, Yu-Jen Lin, Li-Ting Cheng, Chien-Hung Lin, and Guan-Ming Ke. "Poloxamer-188 Adjuvant Efficiently Maintains Adaptive Immunity of SARS-CoV-2 RBD Subunit Vaccination through Repressing p38MAPK Signaling." Vaccines 10, no. 5 (2022): 715. http://dx.doi.org/10.3390/vaccines10050715.

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Poloxamer-188 (P188) is a nonionic triblock linear copolymer that can be used as a pharmaceutical excipient because of its amphiphilic nature. This study investigated whether P188 can act as an adjuvant to improve the immunogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor binding domain (RBD) subunit vaccine. BALB/c mice were vaccinated twice with the RBD antigen alone or in combination with P188 or MF59 (a commercial adjuvant for comparison purposes). The resulting humoral and cellular immunity were assessed. Results showed that P188 helped elicit higher neutr
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Lai, Jesse D., Paul C. Moorehead, Kate Sponagle, et al. "Concurrent influenza vaccination reduces anti-FVIII antibody responses in murine hemophilia A." Blood 127, no. 26 (2016): 3439–49. http://dx.doi.org/10.1182/blood-2015-11-679282.

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Key Points Vaccination against influenza, with and without the adjuvant MF59, decreases the risk of inhibitor development in HA mice. Decreased FVIII immunogenicity may be attributed to antigenic competition via T-cell chemotaxis toward the site of vaccination.
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Giusti, Fabiola, Anja Seubert, Rocco Cantisani, et al. "Ultrastructural Visualization of Vaccine Adjuvant Uptake In Vitro and In Vivo." Microscopy and Microanalysis 21, no. 4 (2015): 791–95. http://dx.doi.org/10.1017/s1431927615013744.

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AbstractAdjuvants are substances that enhance adaptive immune responses when formulated in a vaccine. Alum and MF59 are two vaccine adjuvants licensed for human vaccination. Their mode of action has not been completely elucidated. Here we show the first ultrastructural visualization of Alum and MF59 interaction with immune cells in vitro and in vivo. We observed that Alum is engulfed by cells as inclusions of laminae that are detectable within draining lymph nodes. MF59 is instead engulfed by cells in vitro as low-electron-dense lipid-like inclusions that display a vesicle pattern, as confirme
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Ko, Eun-Ju, Young-Tae Lee, Ki-Hye Kim, et al. "Effects of MF59 Adjuvant on Induction of Isotype-Switched IgG Antibodies and Protection after Immunization with T-Dependent Influenza Virus Vaccine in the Absence of CD4+T Cells." Journal of Virology 90, no. 15 (2016): 6976–88. http://dx.doi.org/10.1128/jvi.00339-16.

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ABSTRACTCD4+T cells play a central role in orchestrating adaptive immunity. To better understand the roles of CD4+T cells in the effects of adjuvants, we investigated the efficacy of a T-dependent influenza virus split vaccine with MF59 or alum in CD4 knockout (CD4KO) and wild-type (WT) mice. CD4+T cells were required for the induction of IgG antibody responses to the split vaccine and the effects of alum adjuvant. In contrast, MF59 was found to be highly effective in raising isotype-switched IgG antibodies to a T-dependent influenza virus split vaccine in CD4KO mice or CD4-depleted WT mice eq
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Lin, Pin-Hung, and Hung-Chih Yang. "The adjuvant effects of MF59 on antigen-specific regulatory and effector T cells." Journal of Immunology 202, no. 1_Supplement (2019): 196.15. http://dx.doi.org/10.4049/jimmunol.202.supp.196.15.

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Abstract Peptide vaccines are an ideal strategy to induce cross-protective T cell immunity against a broad range of influenza virus strains, but they are subimmunogenic and tend to induce regulatory T (Treg) cells. Our previous study has shown that adjuvanted peptide vaccines can suppress the development of antigen-specific Treg cells. MF59 is the first oil-in-water adjuvant approved for protein-based influenza vaccine, which enhances humoral and Th2 cellular immune responses. However, the role of MF59 in peptide-based vaccines regarding the induction of T cell immunity is unknown. We thus inv
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Nelson, Cody S., Jennifer A. Jenks, Norbert Pardi, et al. "2772. HCMV gB Ectodomain Subunit and gB mRNA Vaccines Reduce AD-3 Immunodominance and Elicit More Durable Antibody Responses Than gB/MF59 Immunization." Open Forum Infectious Diseases 6, Supplement_2 (2019): S978. http://dx.doi.org/10.1093/ofid/ofz360.2449.

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Abstract Background A vaccine to prevent maternal acquisition of human cytomegalovirus (HCMV) during pregnancy is one potential strategy to reduce the incidence of congenital disease. The MF59-adjuvanted glycoprotein B (gB/MF59) protein subunit vaccine is the most efficacious tested to-date, though achieved only 50% efficacy in phase 2 trial. We previously identified that gB/MF59 vaccination elicited poor heterologous virus neutralization and an immunodominant response against non-neutralizing/cytosolic antigenic domain 3 (AD-3) (Figure 1). Thus, we sought novel gB vaccination strategies to im
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Tang, Pan, En-hui Cui, Wen-chi Chang, et al. "Nanoparticle-Based Bivalent Swine Influenza Virus Vaccine Induces Enhanced Immunity and Effective Protection against Drifted H1N1 and H3N2 Viruses in Mice." Viruses 14, no. 11 (2022): 2443. http://dx.doi.org/10.3390/v14112443.

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Swine influenza virus (SIV) circulates worldwide, posing substantial economic loss and disease burden to humans and animals. Vaccination remains the most effective way to prevent SIV infection and transmission. In this study, we evaluated the protective efficacy of a recombinant, baculovirus-insect cell system-expressed bivalent nanoparticle SIV vaccine in mice challenged with drifted swine influenza H1N1 and H3N2 viruses. After a prime-boost immunization, the bivalent nanoparticle vaccine (BNV) induced high levels of hemagglutination inhibition (HAI) antibodies, virus-neutralization (VN) anti
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Vono, M., M. Taccone, P. Caccin, et al. "The adjuvant MF59 induces ATP release from muscle that potentiates response to vaccination." Proceedings of the National Academy of Sciences 110, no. 52 (2013): 21095–100. http://dx.doi.org/10.1073/pnas.1319784110.

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Zhang, Shuxia, Jing Tang, Liqi Liu, et al. "Construction and Immune Strategy Optimization of a Vaccine Strain for Influenza A (H5N8) Subtype." Viruses 17, no. 4 (2025): 544. https://doi.org/10.3390/v17040544.

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Multiple subtypes of avian influenza virus (AIV), including H5N1, H5N6, and H5N8 viruses, are currently co-circulating in wild birds and poultry and causing sporadic human infections. Vaccine development is essential for pandemic preparedness. In this study, we constructed a candidate vaccine virus (CVV) using reverse genetics (RG) based on the sequence of the first human-infected H5N8 subtype AIV, A/Astrakhan/3212/2020 (H5N8). We evaluated the immunogenicity of the rH5N8/PR8 vaccine strain in combination with Alum, ISA51, and MF59 adjuvants, and we optimized immunization strategies including
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Nelson, Cody S., Tori Huffman, Jennifer A. Jenks, et al. "HCMV glycoprotein B subunit vaccine efficacy mediated by nonneutralizing antibody effector functions." Proceedings of the National Academy of Sciences 115, no. 24 (2018): 6267–72. http://dx.doi.org/10.1073/pnas.1800177115.

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Human cytomegalovirus (HCMV) is the most common congenital infection worldwide, frequently causing hearing loss and brain damage in afflicted infants. A vaccine to prevent maternal acquisition of HCMV during pregnancy is necessary to reduce the incidence of infant disease. The glycoprotein B (gB) + MF59 adjuvant subunit vaccine platform is the most successful HCMV vaccine tested to date, demonstrating ∼50% efficacy in preventing HCMV acquisition in multiple phase 2 trials. However, the mechanism of vaccine protection remains unknown. Plasma from 33 postpartum women gB/MF59 vaccinees at peak im
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Beatty, P. Robert, Susana Orozco, Sarah Killingbeck, Simona Zompi та Eva Harris. "Dengue virus nonstructural protein 1 vaccine protects against lethal challenge in interferon α/β receptor-deficient mice (P6348)". Journal of Immunology 190, № 1_Supplement (2013): 182.26. http://dx.doi.org/10.4049/jimmunol.190.supp.182.26.

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Abstract Dengue virus (DENV) is a flavivirus that infects 100 million people and causes severe disease in ~500,000 people annually. DENV nonstructural protein 1 (NS1) is secreted by infected cells and found at high levels in patient sera during the acute illness. To investigate the potential for NS1 as a vaccine candidate, we examined the protective efficacy of immunization with recombinant NS1 protein against lethal DENV infection in a mouse model. Interferon α/β receptor-deficient mice were injected intraperitoneally 3 times over an 8-week period with 20 ug recombinant NS1 with different adj
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Barnett, Susan W., Brian Burke, Yide Sun, et al. "Antibody-Mediated Protection against Mucosal Simian-Human Immunodeficiency Virus Challenge of Macaques Immunized with Alphavirus Replicon Particles and Boosted with Trimeric Envelope Glycoprotein in MF59 Adjuvant." Journal of Virology 84, no. 12 (2010): 5975–85. http://dx.doi.org/10.1128/jvi.02533-09.

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ABSTRACT We have previously shown that rhesus macaques were partially protected against high-dose intravenous challenge with simian-human immunodeficiency virus SHIVSF162P4 following sequential immunization with alphavirus replicon particles (VRP) of a chimeric recombinant VEE/SIN alphavirus (derived from Venezuelan equine encephalitis virus [VEE] and the Sindbis virus [SIN]) encoding human immunodeficiency virus type 1 HIV-1SF162 gp140ΔV2 envelope (Env) and trimeric Env protein in MF59 adjuvant (R. Xu, I. K. Srivastava, C. E. Greer, I. Zarkikh, Z. Kraft, L. Kuller, J. M. Polo, S. W. Barnett,
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Tang, Aimin, Fengsheng Li, Daniel C. Freed, et al. "Evaluation of HCMV vaccines in rhesus macaques by a novel micro-neutralization assay (113.4)." Journal of Immunology 188, no. 1_Supplement (2012): 113.4. http://dx.doi.org/10.4049/jimmunol.188.supp.113.4.

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Abstract Human cytogemalovirus (HCMV) causes wide-spread infection in adult human populations. Although no symptoms observed in healthy persons, HCMV infection can cause severe and even life-threatening diseases in immune-compromised individuals. There are lines of evidence that humoral immunity can provide protection against HCMV infection. We have tested several versions of HCMV vaccines based on laboratory strain AD169 with its epithelial tropism restored in rhesus macaques. Vaccines were administered intramuscularly three times. In comparison, recombinant HCMV gB protein vaccine, which sho
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Stephenson, Iain, Maria C. Zambon, Anna Rudin, et al. "Phase I Evaluation of Intranasal Trivalent Inactivated Influenza Vaccine with Nontoxigenic Escherichia coli Enterotoxin and Novel Biovector as Mucosal Adjuvants, Using Adult Volunteers." Journal of Virology 80, no. 10 (2006): 4962–70. http://dx.doi.org/10.1128/jvi.80.10.4962-4970.2006.

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ABSTRACT Trivalent influenza virus A/Duck/Singapore (H5N3), A/Panama (H3N2), and B/Guandong vaccine preparations were used in a randomized, controlled, dose-ranging phase I study. The vaccines were prepared from highly purified hemagglutinin and neuraminidase from influenza viruses propagated in embryonated chicken eggs and inactivated with formaldehyde. We assigned 100 participants to six vaccine groups, as follows. Three intranasally vaccinated groups received 7.5-μg doses of hemagglutinin from each virus strain with either 3, 10, or 30 μg of heat-labile Escherichia coli enterotoxin (LTK63)
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DRULAK, MURRAY W., FRANK J. MALINOSKI, STEVEN A. FULLER, et al. "Vaccination of Seropositive Subjects with CHIRON CMV gB Subunit Vaccine Combined with MF59 Adjuvant for Production of CMV Immune Globulin." Viral Immunology 13, no. 1 (2000): 49–56. http://dx.doi.org/10.1089/vim.2000.13.49.

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Spearman, Paul, Georgia D. Tomaras, David C. Montefiori, et al. "Rapid Boosting of HIV-1 Neutralizing Antibody Responses in Humans Following a Prolonged Immunologic Rest Period." Journal of Infectious Diseases 219, no. 11 (2019): 1755–65. http://dx.doi.org/10.1093/infdis/jiz008.

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Abstract Background The durability and breadth of human immunodeficiency virus type 1 (HIV-1)–specific immune responses elicited through vaccination are important considerations in the development of an effective HIV-1 vaccine. Responses to HIV-1 envelope subunit protein (Env) immunization in humans are often described as short-lived. Methods We enrolled 16 healthy volunteers who had received priming with an HIV-1 subtype B Env vaccine given with MF59 adjuvant 5–17 years previously and 20 healthy unprimed volunteers. Three booster immunizations with a heterologous subtype C trimeric gp140 prot
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Baraniak, Ilona, Barbara Kropff, Lyn Ambrose, et al. "Protection from cytomegalovirus viremia following glycoprotein B vaccination is not dependent on neutralizing antibodies." Proceedings of the National Academy of Sciences 115, no. 24 (2018): 6273–78. http://dx.doi.org/10.1073/pnas.1800224115.

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Human cytomegalovirus (HCMV) is an important pathogen in transplant patients and in congenital infection. Previously, we demonstrated that vaccination with a recombinant viral glycoprotein B (gB)/MF59 adjuvant formulation before solid organ transplant reduced viral load parameters post transplant. Reduced posttransplant viremia was directly correlated with antibody titers against gB consistent with a humoral response against gB being important. Here we show that sera from the vaccinated seronegative patients displayed little evidence of a neutralizing antibody response against cell-free HCMV i
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Dai, MingRui, XueJian Feng, ZengShuo Mo та ін. "Stimulation Effects and Mechanisms of Different Adjuvants on a Norovirus P Particle-Based Active Amyloid-β Vaccine". Journal of Alzheimer's Disease 77, № 4 (2020): 1717–32. http://dx.doi.org/10.3233/jad-200351.

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Background: Adjuvants are important components of vaccines and effectively enhance the immune response of specific antigens. However, the role of adjuvants or combinations of adjuvants in stimulating immunogenicity of the amyloid-β (Aβ) vaccine, as well as molecular mechanisms underlying such stimulation still remain unclear. A previous study of ours developed a norovirus P particle-based active Aβ epitope vaccine, PP-3copy-Aβ1-6-loop123, which stimulates a high titer of Aβ-specific antibodies in mouse Alzheimer’s disease (AD) models. Objective: The most effective and safe adjuvant that maximi
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Kohli, Michele A., Michael Maschio, Shannon Cartier, Joaquin Mould-Quevedo, and Frank-Ulrich Fricke. "The Cost-Effectiveness of Vaccination of Older Adults with an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Other Available Quadrivalent Vaccines in Germany." Vaccines 10, no. 9 (2022): 1386. http://dx.doi.org/10.3390/vaccines10091386.

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Enhanced quadrivalent influenza vaccines that include an adjuvant (aQIV) or a high dose of antigen (QIV-HD), which stimulate a stronger immune response in older adults than the standard vaccine (QIVe), are now approved. The objective of this research is to compare available vaccines and determine the cost-effectiveness of immunizing persons aged 65 years and above with aQIV compared to QIVe and QIV-HD in Germany. A compartmental transmission model calibrated to outpatient visits for influenza in Germany was used to predict the number of medically attended infections using the three vaccines. T
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Middleton, Deborah, Steven Rockman, Martin Pearse, et al. "Evaluation of Vaccines for H5N1 Influenza Virus in Ferrets Reveals the Potential for Protective Single-Shot Immunization." Journal of Virology 83, no. 15 (2009): 7770–78. http://dx.doi.org/10.1128/jvi.00241-09.

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ABSTRACT As part of influenza pandemic preparedness, policy decisions need to be made about how best to utilize vaccines once they are manufactured. Since H5N1 avian influenza virus has the potential to initiate the next human pandemic, isolates of this subtype have been used for the production and testing of prepandemic vaccines. Clinical trials of such vaccines indicate that two injections of preparations containing adjuvant will be required to induce protective immunity. However, this is a working assumption based on classical serological measures only. Examined here are the dose of viral h
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Durando, P., D. Fenoglio, A. Boschini, et al. "Safety and Immunogenicity of Two Influenza Virus Subunit Vaccines, with or without MF59 Adjuvant, Administered to Human Immunodeficiency Virus Type 1-Seropositive and -Seronegative Adults." Clinical and Vaccine Immunology 15, no. 2 (2007): 253–59. http://dx.doi.org/10.1128/cvi.00316-07.

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ABSTRACT The objective of this study was to evaluate and compare both the safety and tolerability and the humoral and cell-mediated immune responses for two influenza virus subunit vaccines, one with MF59 adjuvant (Fluad) and one without an adjuvant (Agrippal), in healthy and in human immunodeficiency virus type 1 (HIV-1)-infected adult individuals. To achieve this aim, an open, randomized, comparative clinical trial was performed during the 2005-2006 season. A total of 256 subjects were enrolled to receive one dose of vaccine intramuscularly. Blood samples were taken at the time of vaccinatio
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Siriwattananon, Konlavat, Suwimon Manopwisedjaroen, Balamurugan Shanmugaraj, et al. "Immunogenicity Studies of Plant-Produced SARS-CoV-2 Receptor Binding Domain-Based Subunit Vaccine Candidate with Different Adjuvant Formulations." Vaccines 9, no. 7 (2021): 744. http://dx.doi.org/10.3390/vaccines9070744.

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Due to the rapid transmission of the coronavirus disease 2019 (COVID-19) causing serious public health problems and economic burden, the development of effective vaccines is a high priority for controlling the virus spread. Our group has previously demonstrated that the plant-produced receptor-binding domain (RBD) of SARS-CoV-2 fused with Fc of human IgG was capable of eliciting potent neutralizing antibody and cellular immune responses in animal studies, and the immunogenicity could be improved by the addition of an alum adjuvant. Here, we performed a head-to-head comparison of different comm
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Staats, Herman, Dorothy Jones, Massimo Maddaloni, et al. "A fusion protein containing the adenovirus type 2 fiber trimerizing and knob domains linked to HIV-1 gp120 exhibits increased nasal immunogenicity in rabbits (VAC8P.1046)." Journal of Immunology 194, no. 1_Supplement (2015): 144.2. http://dx.doi.org/10.4049/jimmunol.194.supp.144.2.

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Abstract We previously reported that the inclusion of the trimerizing and knob domains from adenovirus type 2 fiber (Ad2F) in protein immunogens enhanced their mucosal binding and immunogenicity when delivered nasally. This study was performed to determine if Ad2F would enhance the nasal immunogenicity of HIV-1 gp120 from the Clade C Env C.1086. A fusion protein with Ad2F at the C-terminus of HIV-1 gp120 was used as gp120-Ad2F. NZW rabbits were nasally immunized with 100, 200 or 300 µg of gp120 or equimolar doses of gp120-Ad2F fusion proteins adjuvanted with the cationic mast cell activating p
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Davies, Jenny E., Michael Hwang, Emmanuel Dollinger, et al. "Pandemic preparedness: Addition of TLR agonists CpG+MPLA to emulsified H5 confers protection against H5N1 challenge after a single dose." Journal of Immunology 210, no. 1_Supplement (2023): 223.23. http://dx.doi.org/10.4049/jimmunol.210.supp.223.23.

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Abstract H5N1 vaccines adjuvanted in the oil-in-water emulsion MF59 are maintained in the Strategic National Stockpile for pre-pandemic preparedness. The US population are currently naïve to H5 and a prime/boost regimen will likely be needed to engender a protective response. Ideally, a rapid response to pandemic influenza would benefit from being able to induce protection from a single dose of vaccine. Here, we have used a systems immunology approach in mice to examine the effect of formulating recombinant H5 in AddaVax alone or AddaVax with CpG+MPLA. AddaVax emulsion alone does not stimulate
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Gach, Johannes S., David Venzon, Monica Vaccari, Brandon F. Keele, Genoveffa Franchini, and Donald N. Forthal. "Relationship between Vaccine-Induced Antibody Capture of Infectious Virus and Infection Outcomes following Repeated Low-Dose Rectal Challenges with Simian Immunodeficiency Virus SIVmac251." Journal of Virology 90, no. 19 (2016): 8487–95. http://dx.doi.org/10.1128/jvi.00812-16.

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ABSTRACTAntibodies are known to enhancein vitroinfection by human immunodeficiency virus (HIV) and simian immunodeficiency virus (SIV). We measured the ability of antibodies induced by ALVAC-SIV/gp120 vaccination, given with alum or MF59 adjuvant, to capture infectious SIVmac251 and determined the association between capture and infection outcomes following low-dose, repeated rectal challenge of rhesus macaques. We found that capture correlated with the number of transmitted/founder (T/F) variants that established infection, such that animals whose plasma captured more virus were infected with
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Asai, Tadao, Walter J. Storkus, and Theresa L. Whiteside. "Evaluation of the Modified ELISPOT Assay for Gamma Interferon Production in Cancer Patients Receiving Antitumor Vaccines." Clinical Diagnostic Laboratory Immunology 7, no. 2 (2000): 145–54. http://dx.doi.org/10.1128/cdli.7.2.145-154.2000.

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ABSTRACT Frequencies of vaccine-responsive T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC) prior to and after administration of peptide-based vaccines in patients with cancer can be measured by limiting-dilution assays (LDA) or by ELISPOT assays. We have used a modified version of the ELISPOT assay to monitor changes in the frequency of gamma interferon (IFN-γ)-producing T cells in a population of lymphocytes responding to a relevant peptide or a nonspecific stimulator, such as phorbol myristate acetate-ionomycin. Prior to its use for monitoring of patient samples, the ass
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Mulligan, Mark J., David I. Bernstein, Sharon Frey, et al. "Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial." Open Forum Infectious Diseases 1, no. 3 (2014). http://dx.doi.org/10.1093/ofid/ofu102.

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Abstract Background. Avian influenza A/H5N1 has threatened human health for nearly 2 decades. Avian influenza A vaccine without adjuvant is poorly immunogenic. A flexible rapid tactic for mass vaccination will be needed if a pandemic occurs. Methods. A multicenter, randomized, blinded phase 1 clinical trial evaluated safety and antibody responses after point-of-use mixing of influenza A/Indonesia/05/2005 (H5N1) vaccine with MF59 adjuvant. Field-site pharmacies mixed 3.75, 7.5, or 15 mcg of antigen with or without MF59 adjuvant just prior to intramuscular administration on days 0 and 21 of heal
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Rashedi, Niloufar, Morteza Taghizadeh, Parisa Mohamadynejad, Mehdi Mahdavi, and Reza Jalalirad. "Evaluating the Immune Response of Recombinant H1N1 Hemagglutinin with MF59 Adjuvant in Animal Model as a Novel Alternative to the Influenza Vaccine." Iranian Journal of Allergy, Asthma and Immunology, October 27, 2020. http://dx.doi.org/10.18502/ijaai.v19i5.4465.

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The H1N1 influenza virus is known as a serious pandemic threat across the globe. Vaccination is one of the most effective methods of protection against this virus and the way to reduce the seasonal pandemic risk. The commercial vaccine does not adequately respond to pandemic strains. This study examines the potential function of formulated H1N1 hemagglutinin with MF59 adjuvant against A/PR/8/34 (H1N1). To this end, a recombinant hemagglutinin (rHA) gene of influenza A virus was designed and expressed in SF9 cell by the Baculovirus expression system. Four groups of mice were immunized by rHA in
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Nelson, Cody S., Jennifer A. Jenks, Norbert Pardi, et al. "Human Cytomegalovirus Glycoprotein B Nucleoside-Modified mRNA Vaccine Elicits Antibody Responses with Greater Durability and Breadth than MF59-Adjuvanted gB Protein Immunization." Journal of Virology 94, no. 9 (2020). http://dx.doi.org/10.1128/jvi.00186-20.

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ABSTRACT A vaccine to prevent maternal acquisition of human cytomegalovirus (HCMV) during pregnancy is a primary strategy to reduce the incidence of congenital disease. The MF59-adjuvanted glycoprotein B (gB) protein subunit vaccine (gB/MF59) is the most efficacious vaccine tested to date for this indication. We previously identified that gB/MF59 vaccination elicited poor neutralizing antibody responses and an immunodominant response against gB antigenic domain 3 (AD-3). Thus, we sought to test novel gB vaccines to improve functional antibody responses and reduce AD-3 immunodominance. Groups o
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Shalash, Ahmed O., Waleed M. Hussein, Ummey J. Nahar, et al. "Rational Development of a Novel Emulgel Adjuvant for Single‐Shot Effective Vaccination: A Multivariate Analysis Approach." Advanced Materials, June 3, 2025. https://doi.org/10.1002/adma.202506496.

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AbstractNanoemulsions, like MF59, are potent vaccine adjuvants due to their immunogenicity, scalability, stability, and generation of broad cross‐clade neutralizing immune responses, facilitating their feasibility for pandemic preparedness. However, they are unsuitable for single‐shot applications due to limited immunogenicity with subunit antigens, and need to be explored for key immunogenic formulation variables like surfactant type, antigen anchoring, oil‐globule solidification, hydrogel polymer trapping, or globule size. Here, a multivariate analysis approach is used for the first time in
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Wang, Yating, Shijia Liu, Boshuo Li, et al. "A novel CpG ODN compound adjuvant enhances immune response to spike subunit vaccines of porcine epidemic diarrhea virus." Frontiers in Immunology 15 (January 23, 2024). http://dx.doi.org/10.3389/fimmu.2024.1336239.

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CpG oligodeoxynucleotides (CpG ODNs) boost the humoral and cellular immune responses to antigens through interaction with Toll-like receptor 9 (TLR9). These CpG ODNs have been extensively utilized in human vaccines. In our study, we evaluated five B-type CpG ODNs that have stimulatory effects on pigs by measuring the proliferation of porcine peripheral blood mononuclear cells (PBMCs) and assessing interferon gamma (IFN-γ) secretion. Furthermore, this study examined the immunoenhancing effects of the MF59 and CpG ODNs compound adjuvant in mouse and piglet models of porcine epidemic diarrhea vir
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El Sahly, Hana M., Inci Yildirim, Sharon E. Frey, et al. "Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial." Journal of Infectious Diseases, July 19, 2023. http://dx.doi.org/10.1093/infdis/jiad276.

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Abstract Background Influenza A (H7N9) has caused multiple disease waves with evidence of strain diversification. Optimal influenza A (H7N9) prime-boost vaccine strategies are unknown. Methods We recruited participants who had received monovalent inactivated A/Shanghai/2/2013 (H7N9) vaccine (MIV) approximately 5 years earlier, as follows: MIV with MF59 (MF59 × 2 Group), MIV with AS03 (AS03 × 2 Group), unadjuvanted MIV (No Adj Group), MIV with MF59 or AS03 followed by unadjuvanted MIV (Adjx1 Group), and A/H7-naïve (Unprimed Group). Participants were randomized to receive one dose of AS03-adjuva
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Hayek, Haya, Lana Hasan, Justin Z. Amarin, et al. "Vaccine Adjuvants in the Immunocompromised Host: Science, Safety, and Efficacy." Transplant Infectious Disease, May 19, 2025. https://doi.org/10.1111/tid.70053.

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ABSTRACTVaccine adjuvants are essential for enhancing immune responses to vaccines, particularly in immunocompromised populations who typically demonstrate suboptimal responses to standard vaccination. This narrative review evaluates the safety and efficacy of approved and candidate adjuvants in immunocompromised hosts, with emphasis on solid organ and hematopoietic cell transplant recipients. We examine conventional aluminum‐based adjuvants alongside modern adjuvant systems such as AS01B, MF59, and AS04, analyzing their mechanisms of action and clinical applications. The review synthesizes cu
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Jangra, Sonia, Jeffrey J. Landers, Gabriel Laghlali, et al. "Multicomponent intranasal adjuvant for mucosal and durable systemic SARS-CoV-2 immunity in young and aged mice." npj Vaccines 8, no. 1 (2023). http://dx.doi.org/10.1038/s41541-023-00691-1.

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AbstractMultiple FDA-approved SARS-CoV-2 vaccines currently provide excellent protection against severe disease. Despite this, immunity can wane relatively fast, particularly in the elderly and novel viral variants capable of evading infection- and vaccination-induced immunity continue to emerge. Intranasal (IN) vaccination more effectively induces mucosal immune responses than parenteral vaccines, which would improve protection and reduce viral transmission. Here, we developed a rationally designed IN adjuvant consisting of a combined nanoemulsion (NE)-based adjuvant and an RNA-based RIG-I ag
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Luo, Kun, James T. Gordy, Fidel Zavala, and Richard B. Markham. "A chemokine-fusion vaccine targeting immature dendritic cells elicits elevated antibody responses to malaria sporozoites in infant macaques." Scientific Reports 11, no. 1 (2021). http://dx.doi.org/10.1038/s41598-020-79427-3.

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AbstractInfants and young children are the groups at greatest risk for severe disease resulting from Plasmodium falciparum infection. We previously demonstrated in mice that a protein vaccine composed of the chemokine macrophage inflammatory protein 3α genetically fused to the minimally truncated circumsporozoite protein of P. falciparum (MCSP) elicits high concentrations of specific antibody and significant reduction of liver sporozoite load in a mouse model system. In the current study, a squalene based adjuvant (AddaVax, InvivoGen, San Diego, Ca) equivalent to the clinically approved MF59 (
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Davis, Matthew, Craig Shapiro, Mark D. Adams, et al. "P-601. Safety and Immunogenicity of a Respiratory Syncytial Virus and Human Metapneumovirus Virus-like Particle Protein Subunit Combination Vaccine in 60–85-Year-Old Adults: Interim Results from a Phase 2a Clinical Trial." Open Forum Infectious Diseases 12, Supplement_1 (2025). https://doi.org/10.1093/ofid/ofae631.799.

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Abstract Background Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) often cause serious lower respiratory tract infections in older adults. In this phase 2a trial, we evaluate the safety and immunogenicity of an RSV/hMPV virus-like particle (VLP) subunit combination vaccine, IVX-A12, ± adjuvant in 60–85-year-olds (NCT05903183). We present interim data to Day 180 post vaccination.Figure.Geometric mean titers (GMTs) against RSV-A, RSV-B, hMPV-A, and hMPV-B at baseline and Days 28 and 180 post vaccination Methods Participants were randomized 2:2:1 to receive a single dose of IV
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Li, Zhuofan, Xinliang Kang, Ki-Hye Kim, et al. "Effective adjuvantation of nanograms of influenza vaccine and induction of cross-protective immunity by physical radiofrequency adjuvant." Scientific Reports 12, no. 1 (2022). http://dx.doi.org/10.1038/s41598-022-25605-4.

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AbstractNovel adjuvants are highly demanded to aid in development of improved or new vaccines against existing or emerging infectious diseases. Considering commonly used Alum and MF59 adjuvants induce tissue stress and release of endogenous danger signals to mediate their adjuvant effects, physical modalities may be used to induce tissue stress and endogenous danger signal release to enhance vaccine-induced immune responses. Furthermore, physical adjuvants are less likely to induce significant systemic adverse reactions due to their localized effects. Recently we found non-invasive radiofreque
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Chan, Janlin Ying Hui, Fiona Clow, Victoria Pearson, Ries J. Langley, John D. Fraser, and Fiona J. Radcliff. "Feasibility of using a combination of staphylococcal superantigen‐like proteins 3, 7 and 11 in a fusion vaccine for Staphylococcus aureus." Immunology & Cell Biology, April 4, 2024. http://dx.doi.org/10.1111/imcb.12745.

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AbstractStaphylococcus aureus is a significant bacterial pathogen in both community and hospital settings, and the escalation of antimicrobial‐resistant strains is of immense global concern. Vaccination is an inviting long‐term strategy to curb staphylococcal disease, but identification of an effective vaccine has proved to be challenging. Three well‐characterized, ubiquitous, secreted immune evasion factors from the staphylococcal superantigen‐like (SSL) protein family were selected for the development of a vaccine. Wild‐type SSL3, 7 and 11, which inhibit signaling through Toll‐like receptor
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Nelson, Cody S., Diana Vera Cruz, Melody Su, et al. "Intrahost Dynamics of Human Cytomegalovirus Variants Acquired by Seronegative Glycoprotein B Vaccinees." Journal of Virology 93, no. 5 (2018). http://dx.doi.org/10.1128/jvi.01695-18.

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ABSTRACTHuman cytomegalovirus (HCMV) is the most common congenital infection worldwide and a frequent cause of hearing loss and debilitating neurologic disease in newborn infants. Thus, a vaccine to prevent HCMV-associated congenital disease is a public health priority. One potential strategy is vaccination of women of child bearing age to prevent maternal HCMV acquisition during pregnancy. The glycoprotein B (gB) plus MF59 adjuvant subunit vaccine is the most efficacious tested clinically to date, demonstrating 50% protection against primary HCMV infection in a phase 2 clinical trial. Yet, th
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Gomes, A. C., I. A. Baraniak, A. Lankina, et al. "The cytomegalovirus gB/MF59 vaccine candidate induces antibodies against an antigenic domain controlling cell-to-cell spread." Nature Communications 14, no. 1 (2023). http://dx.doi.org/10.1038/s41467-023-36683-x.

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AbstractVaccination against human cytomegalovirus (CMV) infection remains high priority. A recombinant form of a protein essential for CMV entry, glycoprotein B (gB), demonstrated partial protection in a clinical trial (NCT00299260) when delivered with the MF59 adjuvant. Although the antibody titre against gB correlated with protection poor neutralising responses against the 5 known antigenic domains (AD) of gB were evident. Here, we show that vaccination of CMV seronegative patients induces an antibody response against a region of gB we term AD-6. Responses to the polypeptide AD-6 are detecte
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Valencia, Sarah M., Eric Rochat, Melissa J. Harnois, et al. "Vaccination with a replication-defective cytomegalovirus vaccine elicits a glycoprotein B-specific monoclonal antibody repertoire distinct from natural infection." npj Vaccines 8, no. 1 (2023). http://dx.doi.org/10.1038/s41541-023-00749-0.

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AbstractHuman Cytomegalovirus (HCMV) is the leading infectious congenital infection globally and the most common viral infection in transplant recipients, therefore identifying a vaccine for HCMV is a top priority. Humoral immunity is a correlate of protection for HCMV infection. The most effective vaccine tested to date, which achieved 50% reduction in acquisition of HCMV, was comprised of the glycoprotein B protein given with an oil-in-water emulsion adjuvant MF59. We characterize gB-specific monoclonal antibodies isolated from individuals vaccinated with a disabled infectious single cycle (
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He, Cai, Jingyun Yang, Weiqi Hong, et al. "A self-assembled trimeric protein vaccine induces protective immunity against Omicron variant." Nature Communications 13, no. 1 (2022). http://dx.doi.org/10.1038/s41467-022-33209-9.

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AbstractThe recently emerged Omicron (B.1.1.529) variant has rapidly surpassed Delta to become the predominant circulating SARS-CoV-2 variant, given the higher transmissibility rate and immune escape ability, resulting in breakthrough infections in vaccinated individuals. A new generation of SARS-CoV-2 vaccines targeting the Omicron variant are urgently needed. Here, we developed a subunit vaccine named RBD-HR/trimer by directly linking the sequence of RBD derived from the Delta variant (containing L452R and T478K) and HR1 and HR2 in SARS-CoV-2 S2 subunit in a tandem manner, which can self-ass
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Xu, Shiwei, Margaret C. Carpenter, Rachel L. Spreng, et al. "Impact of adjuvants on the biophysical and functional characteristics of HIV vaccine-elicited antibodies in humans." npj Vaccines 7, no. 1 (2022). http://dx.doi.org/10.1038/s41541-022-00514-9.

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AbstractAdjuvants can alter the magnitude, characteristics, and persistence of the humoral response to protein vaccination. HIV vaccination might benefit from tailored adjuvant choice as raising a durable and protective response to vaccination has been exceptionally challenging. Analysis of trials of partially effective HIV vaccines have identified features of the immune response that correlate with decreased risk, including high titers of V1V2-binding IgG and IgG3 responses with low titers of V1V2-binding IgA responses and enhanced Fc effector functions, notably antibody-dependent cellular cy
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Rosato, Antonio, Alessia Zoso, Gabriella Milan, et al. "Individual Analysis of Mice Vaccinated against a Weakly Immunogenic Self Tumor-Specific Antigen Reveals a Correlation between CD8 T Cell Response and Antitumor Efficacy." April 20, 2014. https://doi.org/10.4049/jimmunol.171.10.5172.

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Abstract The weakly immunogenic murine P1A Ag is a useful experimental model for the development of new vaccination strategies that could potentially be used against human tumors. An i.m. DNA-based immunization procedure, consisting of three inoculations with the P1A-coding pBKCMV-P1A plasmid at 10-day intervals, resulted in CTL generation in all treated BALB/c mice. Surprisingly, gene gun skin bombardment with the pBKCMV-P1A vector did not induce CTL, nor was it protective against a lethal challenge with the syngeneic P1A-positive J558 tumor cell line. To speed up the immunization procedure,
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Tang, Pan, Enhui Cui, Jinghua Cheng, et al. "A ferritin nanoparticle vaccine based on the hemagglutinin extracellular domain of swine influenza A (H1N1) virus elicits protective immune responses in mice and pigs." Frontiers in Immunology 15 (May 21, 2024). http://dx.doi.org/10.3389/fimmu.2024.1361323.

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IntroductionSwine influenza viruses (SIVs) pose significant economic losses to the pig industry and are a burden on global public health systems. The increasing complexity of the distribution and evolution of different serotypes of influenza strains in swine herds escalates the potential for the emergence of novel pandemic viruses, so it is essential to develop new vaccines based on swine influenza.MethodsHere, we constructed a self-assembling ferritin nanoparticle vaccine based on the hemagglutinin (HA) extracellular domain of swine influenza A (H1N1) virus using insect baculovirus expression
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