Clinical trials and recent progress in HIV vaccine development

Ajbani S (2016a) HIV vaccine development: current scenario and future prospects. J AIDS Clin Res, 7(11), 626. DOI:https://doi.org/610.4172/2155-6113.1000626

Ajbani S (2016b) HIV vaccine development: current scenario and future prospects. J AIDS Clin Res, 7(11), 626.DOI: https://doi.org/610.4172/2155-6113.1000626

Andersen-Nissen E, Fiore-Gartland A, Ballweber Fleming L, Carpp LN, Naidoo AF, Harper MS, Voillet V, Grunenberg N, Laher F, Innes C (2021) Innate immune signatures to a partially-efficacious HIV vaccine predict correlates of HIV-1 infection risk. PLoS pathogens, 17(3), e1009363.https://doi.org/1009310.1001371/journal.ppat.1009363

Andrabi R, Bhiman JN, Burton DR (2018) Strategies for a multi-stage neutralizing antibody-based HIV vaccine. Curr Opin Immunol 53:143–151. https://doi.org/110.1016/j.coi.2018.1004.1025

Åsjö B, Stavang H, Sørensen B, Baksaas I, Nyhus J, Langeland N (2002) Phase I trial of a therapeutic HIV type 1 vaccine, Vacc-4x, in HIV type 1-infected individuals with or without antiretroviral therapy. AIDS Res Hum Retroviruses 18(18):1357–1365. https://doi.org/1310.1089/088922202320935438

Article  PubMed  Google Scholar 

Baden LR, Walsh SR, Seaman MS, Tucker RP, Krause KH, Patel A, Johnson JA, Kleinjan J, Yanosick KE, Perry J (2013) First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001). J Infect Dis 207(2):240–247. https://doi.org/210.1093/infdis/jis1670

Article  CAS  PubMed  Google Scholar 

Baden LR, Karita E, Mutua G, Bekker L-G, Gray G, Page-Shipp L, Walsh SR, Nyombayire J, Anzala O, Roux S (2016) Assessment of the safety and immunogenicity of 2 novel vaccine platforms for HIV-1 prevention: a randomized trial. Ann Intern Med 164(5):313–322. https://doi.org/310.7326/M7315-0880

Baden LR, Stieh DJ, Sarnecki M, Walsh SR, Tomaras GD, Kublin JG, McElrath MJ, Alter G, Ferrari G, Montefiori D (2020) Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study. The Lancet HIV, 7(10), e688-e698. DOI: https://doi.org/610.1016/S2352-3018(1020)30229-30220

Barouch DH, Santra S, Schmitz JE, Kuroda MJ, Fu T-M, Wagner W, Bilska M, Craiu A, Zheng XX, Krivulka GR (2000a) Control of viremia and prevention of clinical AIDS in rhesus monkeys by cytokine-augmented DNA vaccination. Science, 290(5491), 486–492. https://doi.org/410.4049/jimmunol.4164.4049.4968

Barouch DH, Santra S, Schmitz JE, Kuroda MJ, Fu T-M, Wagner W, Bilska M, Craiu A, Zheng XX, Krivulka GR (2000b) Control of viremia and prevention of clinical AIDS in rhesus monkeys by cytokine-augmented DNA vaccination. Science, 290(5491), 486–492.DOI: https://doi.org/410.1126/science.1290.5491.1486

Barouch DH, Liu J, Peter L, Abbink P, Iampietro MJ, Cheung A, Alter G, Chung A, Dugast A-S, Frahm N (2013) Characterization of humoral and cellular immune responses elicited by a recombinant adenovirus serotype 26 HIV-1 Env vaccine in healthy adults (IPCAVD 001). The Journal of infectious diseases, 207(2), 248–256. https://doi.org/210.1093/infdis/jis1671

Bekker L-G, Moodie Z, Grunenberg N, Laher F, Tomaras GD, Cohen KW, Allen M, Malahleha M, Mngadi K, Daniels B (2018) Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. The Lancet HIV, 5(7), e366-e378. DOI: https://doi.org/310.1016/S2352-3018(1018)30071-30077

Bontempo A, Garcia MM, Rivera N, Cayabyab MJ (2020) A systematic approach to HIV-1 vaccine immunogen selection. AIDS research and human retroviruses, 36(9), 762–770. https://doi.org/710.1089/aid.2019.0239

Burton DR (2019) Advancing an HIV vaccine; advancing vaccinology. Nat Rev Immunol 19(2):77–78. https://doi.org/10.1038/s41577-41018-40103-41576

Article  CAS  PubMed  PubMed Central  Google Scholar 

Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication‐defective recombinant adenovirus vector. J Infect Dis 194(12):1638–1649. 1610.1086/509258

Article  CAS  PubMed  Google Scholar 

Cooney E, Collier A, Greenberg P, Coombs R, Zarling J, Arditti D, Hoffman M, Hu S, Corey L (1991) Safety of and immunological response to a recombinant vaccinia virus vaccine expressing HIV envelope glycoprotein. The Lancet, 337(8741), 567–572. https://doi.org/510.1016/0140-6736(1091)91636-91639

de Parseval A, Bobardt MD, Chatterji A, Chatterji U, Elder JH, David G, Zolla-Pazner S, Farzan M, Lee T-H, Gallay PA (2005) A highly conserved arginine in gp120 governs HIV-1 binding to both syndecans and CCR5 via sulfated motifs. J Biol Chem 280(47):39493–39504. https://doi.org/39410.31074/jbc.M504233200

Article  CAS  PubMed  Google Scholar 

DeCamp AC, Rolland M, Edlefsen PT, Sanders-Buell E, Hall B, Magaret CA, Fiore-Gartland AJ, Juraska M, Carpp LN, Karuna ST (2017) Sieve analysis of breakthrough HIV-1 sequences in HVTN 505 identifies vaccine pressure targeting the CD4 binding site of Env-gp120. PloS one, 12(11), e0185959. https://doi.org/0185910.0181371/journal.pone.0185959

Derking R, Sanders RW (2021) Structure-guided envelope trimer design in HIV‐1 vaccine development: a narrative review. Journal of the International AIDS Society, 24, e25797. https://doi.org/25710.21002/jia25792.25797

Esparza J (2013) A brief history of the global effort to develop a preventive HIV vaccine. Vaccine, 31(35), 3502–3518. https://doi.org/3510.1016/j.vaccine.2013.3505.3018

Excler J-L, Kim JH (2019) Novel prime-boost vaccine strategies against HIV-1. Expert review of vaccines, 18(8), 765–779. https://doi.org/710.1080/14760584.14762019.11640117

Fong Y, Shen X, Ashley VC, Deal A, Seaton KE, Yu C, Grant SP, Ferrari G, deCamp AC, Bailer RT (2018) Modification of the association between T-cell immune responses and human immunodeficiency virus type 1 infection risk by vaccine-induced antibody responses in the HVTN 505 trial. The Journal of infectious diseases, 217(8), 1280–1288. https://doi.org/1210.1093/infdis/jiy1008

Gaudinski MR, Coates EE, Houser KV, Chen GL, Yamshchikov G, Saunders JG, Holman LA, Gordon I, Plummer S, Hendel CS (2018) Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults. PLoS medicine, 15(1), e1002493. https://doi.org/1002410.1001371/journal.pmed.1002493

Gómez CE, Nájera JL, Perdiguero B, García-Arriaza J, Sorzano COS, Jiménez V, González-Sanz R, Jiménez JL, Muñoz-Fernández MA (2011) & López Bernaldo de Quirós, J. C. The HIV/AIDS vaccine candidate MVA-B administered as a single immunogen in humans triggers robust, polyfunctional, and selective effector memory T cell responses to HIV-1 antigens. Journal of virology, 85(21), 11468–11478. DOI: https://doi.org/11410.11128/jvi.05165-11411

Gorse GJ, Frey SE, Patel G, Newman FK, Belshe RB, Network NAVCT (1994) Vaccine-induced antibodies to native and recombinant human immunodeficiency virus type 1 envelope glycoproteins. Vaccine, 12(10), 912–918. https://doi.org/910.1016/0264-1410X(1094)90034-90035

Gray GE, Allen M, Moodie Z, Churchyard G, Bekker L-G, Nchabeleng M, Mlisana K, Metch B, De Bruyn G, Latka MH (2011) Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study. The Lancet infectious diseases, 11(7), 507–515. DOI: https://doi.org/510.1016/S1473-3099(1011)70098-70096

Haut LH, Lin SW, Tatsis N, DiMenna LJ, Giles-Davis W, Pinto AR, Ertl HC (2010) Robust genital gag‐specific CD8 + T‐cell responses in mice upon intramuscular immunization with simian adenoviral vectors expressing HIV‐1‐gag. European journal of immunology, 40(12), 3426-3438. https://doi.org/3410.1002/eji.201040440

Haynes BF, Verkoczy L (2014) Host controls of HIV neutralizing antibodies. Science, 344(6184), 588–589. DOI: 510.1126/science.1254990

Hladik F, Bender S, Akridge RE, Hu Y, Galloway C, Francis D, McElrath MJ (2001) Recombinant HIV-1 glycoprotein 120 induces distinct types of delayed hypersensitivity in persons with or without pre-existing immunologic memory. The Journal of Immunology, 166(5), 3580–3588. https://doi.org/3510.4049/jimmunol.3166.3585.3580

Hopkins KL, Laher F, Otwombe K, Churchyard G, Bekker L-G, DeRosa S, Nchabeleng M, Mlisana K, Kublin J, Gray G (2014) Predictors of HVTN 503 MRK-AD5 HIV-1 gag/pol/nef vaccine induced immune responses. PloS one, 9(8), e103446. https://doi.org/103410.101371/journal.pone.0103446

Hsu DC, O’Connell RJ (2017) Progress in HIV vaccine development. Human vaccines & immunotherapeutics, 13(5), 1018–1030. https://doi.org/1010.1080/21645515.21642016.21276138

Julg B, Stephenson KE, Wagh K, Tan SC, Zash R, Walsh S, Ansel J, Kanjilal D, Nkolola J, Walker-Sperling VE (2022) Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial. Nature medicine, 28(6), 1288–1296. https://doi.org/1210.1038/s41591-41022-01815-41591

Kawamura T, Gatanaga H, Borris DL, Connors M, Mitsuya H, Blauvelt A (2003) Decreased stimulation of CD4 + T cell proliferation and IL-2 production by highly enriched populations of HIV-infected dendritic cells. The Journal of Immunology, 170(8), 4260–4266. https://doi.org/4210.4049/jimmunol.4170.4268.4260

Keefer MC, McElrath Grahambs, Matthews MJ, Stablein TJ, Lawrence Dmcoreylwrightpf, D., Fast, P. E., Weinhold K (1996) Safety and immunogenicity of Env 2–3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. AIDS research and human retroviruses, 12(8), 683–693. https://doi.org/610.1089/aid.1996.1012.1086

Kelsoe G, Haynes BF (2017) Host controls of HIV broadly neutralizing antibody development. Immunol Rev 275(1):79–88. https://doi.org/10.1111/imr.12508

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kim J, Vasan S, Kim JH, Ake JA (2021) Current approaches to HIV vaccine development: a narrative review. Journal of the International AIDS Society, 24, e25793. https://doi.org/25710.21002/jia25792.25793

Kirchhoff F (2010) Immune evasion and counteraction of restriction factors by HIV-1 and other primate lentiviruses. Cell Host Microbe 8(1):55–67. https://doi.org/10.1016/j.chom.2010.1006.1004

Article  CAS  PubMed  Google Scholar 

Korber B, Hraber P, Wagh K, Hahn BH (2017) Polyvalent vaccine approaches to combat HIV-1 diversity. Immunological reviews, 275(1), 230–244. https://doi.org/210.1111/imr.12516

Laher F, Bekker L-G, Garrett N, Lazarus EM, Gray GE (2020) Review of preventative HIV vaccine clinical trials in South Africa. Arch Virol 165:2439–2452. https://doi.org/2410.1007/s00705-00020-04777-00702

Article  CAS  PubMed  PubMed Central  Google Scholar 

Leggat DJ, Cohen KW, Willis JR, Fulp WJ, Decamp AC, Kalyuzhniy O, Cottrell CA, Menis S, Finak G, Ballweber-Fleming L (2022) Vaccination induces HIV broadly neutralizing antibody precursors in humans. Science, 378(6623), eadd6502. DOI: https://doi.org/6510.1126/science.add6502

Lemckert AA, Goudsmit J, Barouch Dh (2004) Challenges in the search for an HIV vaccine. European Journal of Epidemiology, 19, 513–516. https://doi.org/510.1023/B:EJEP.0000032423.0000087658.0000032468

Li D, Forrest BD, Li Z, Xue P, Hanson CV, Duan S, Cheng H, Li M, Koff WC (1997) International clinical trials of HIV vaccines: II. Phase I trial of an HIV-1 synthetic peptide vaccine evaluating an accelerated immunization schedule in Yunnan, China. Asian Pacific Journal of Allergy and Immunology, 15, 105–114.PMID: 9346275

Li B, Wang W, Zhao L, Li M, Yan D, Li X, Zhang J, Gao Q, Feng Y, Zheng J (2024) Aggregation-induced emission‐based macrophage‐like nanoparticles for targeted photothermal therapy and virus transmission blockage in Monkeypox. Advanced Materials, 36(9), 2305378. https://doi.org/2305310.2301002/adma.202305378

Liao H-X, Bonsignori M, Alam SM, McLellan JS, Tomaras GD, Moody MA, Kozink DM, Hwang K-K, Chen X, Tsao C-Y (2013) Vaccine induction of antibodies against a structurally heterogeneous site of immune pressure within HIV-1 envelope protein variable regions 1 and 2. Immunity, 38(1), 176–186. DOI: https://doi.org/110.1016/j.immuni.2012.1011.1011

Liu J, O’Brien KL, Lynch DM, Simmons NL, La Porte A, Riggs AM, Abbink P, Coffey RT, Grandpre LE, Seaman MS (2009) Immune control of an SIV challenge by a T-cell-based vaccine in rhesus monkeys. Nature, 457(7225), 87-91.10.1038/nature07469

Mahomed S, Garrett N, Capparelli EV, Osman F, Mkhize NN, Harkoo I, Gengiah TN, Mansoor LE, Baxter C, Archary D (2023) Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. The Lancet HIV, 10(4), e230-e243. DOI: https://doi.org/210.1016/S2352-3018(1023)00003-00006

Masci AM, Galgani M, Cassano S, De Simone S, Gallo A, De Rosa V, Zappacosta S, Racioppi L (2003) HIV-1 gp120 induces anergy in naive T lymphocytes through CD4-independent protein kinase-A-mediated signaling. Journal of Leucocyte Biology, 74(6), 1117–1124. https://doi.org/210.1016/S2352-3018(1023)00003-00006

Mascola JR, Lewis MG, Stiegler G, Harris D, VanCott TC, Hayes D, Louder MK, Brown CR, Sapan CV, Frankel SS (1999) Protection of macaques against pathogenic simian/human immunodeficiency virus 89.6 PD by passive transfer of neutralizing antibodies. Journal of virology, 73(5), 4009–4018. https://doi.org/4010.1128/jvi.4073.4005.4009-4018.1999

Mayer KH, Seaton KE, Huang Y, Grunenberg N, Isaacs A, Allen M, Ledgerwood JE, Frank I, Sobieszczyk ME, Baden LR (2017) Safety, pharmacokinetics, and immunological activities of multiple intravenous or subcutaneous doses of an anti-HIV monoclonal antibody, VRC01, administered to HIV-uninfected adults: Results of a phase 1 randomized trial. PLoS medicine, 14(11), e1002435. https://doi.org/1002410.1001371/journal.pmed.1002435

McElrath MJ, Corey L, Montefiori D, Wolff M, Elrath MJ, Keefer M, Belshe R (2000) A phase II study of two HIV type 1 envelope vaccines, comparing their immunogenicity in populations at risk for acquiring HIV type 1 infection. AIDS research and human retroviruses, 16(9), 907–919. https://doi.org/910.1089/08892220050042846

Moodie Z, Dintwe O, Sawant S, Grove D, Huang Y, Janes H, Heptinstall J, Omar FL, Cohen K, De Rosa SC (2022) Analysis of the HIV vaccine trials Network 702 phase 2b–3 HIV-1 vaccine trial in South Africa assessing RV144 antibody and T-cell correlates of HIV-1 acquisition risk. J Infect Dis 226(2):246–257

Article  CAS  PubMed  PubMed Central  Google Scholar 

Moodie Z, Andersen-Nissen E, Grunenberg N, Dintwe OB, Omar FL, Kee JJ, Bekker L-G, Laher F, Naicker N, Jani I (2024) Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial. PLoS medicine, 21(3), e1004360. https://doi.org/1004310.1001093/infdis/jiac1004260

Ng’uni T, Ndhlovu ZM (2020) Major scientific hurdles in HIV vaccine development: historical perspective and future directions. Front Immunol 11:590780

Article  PubMed  PubMed Central  Google Scholar 

Ng’uni T, Chasara C, Ndhlovu ZM (2020) Major scientific hurdles in HIV vaccine development: historical perspective and future directions. Frontiers in immunology, 11, 590780. https://doi.org/590710.593389/fimmu.592020.590780

Nicholson O, DiCandilo F, Kublin J, Sun X, Quirk E, Miller M, Gray G, Pape J, Robertson MN, Mehrotra DV (2011) Safety and immunogenicity of the MRKAd5 gag HIV type 1 vaccine in a worldwide phase 1 study of healthy adults. AIDS research and human retroviruses, 27(5), 557–567. https://doi.org/510.1089/aid.2010.0151

Niu M-M, Guo H-X, Shang J-C, Meng X-C (2023) Structural characterization and immunomodulatory activity of a mannose-rich polysaccharide isolated from bifidobacterium breve H4–2. Journal of Agricultural and Food Chemistry, 71(49), 19791-19803.19710.11021/acs.jafc.19793c04916

Pan R, Gorny MK, Zolla-Pazner S, Kong X-P (2015) The V1V2 region of HIV-1 gp120 forms a five-stranded beta barrel. Journal of virology, 89(15), 8003-8010.8010.1128/jvi.00754 – 00715

Phanuphak P, Teeratakulpixam S, Sarangbin S, Nookhai S, Ubolyam S, Sirivichayakul S, Leesavan A, Forrest BD, Li M, Wang CY (1997) International clinical trials of HIV vaccines: I. Phase I trial of an HIV-1 synthetic peptide vaccine in Bangkok, Thailand. Asian Pac J Allergy Immunol 15(1):41

CAS  PubMed  Google Scholar 

Picker LJ, Hansen SG, Lifson JD (2012) New paradigms for HIV/AIDS vaccine development. Annual review of medicine, 63(1), 95–111. https://doi.org/110.1146/annurev-med-042010-085643

Pitisuttithum P, Rerks-Ngarm S, Bussaratid V, Dhitavat J, Maekanantawat W, Pungpak S, Suntharasamai P, Vanijanonta S, Nitayapan S, Kaewkungwal J (2011) Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand. PloS one, 6(12), e27837. https://doi.org/27810.21371/journal.pone.0027837

Pontesilli O, Guerra EC, Ammassari A, Tomino C, Carlesimo M, Antinori A, Tamburrini E, Prozzo A, Seeber AC, Vella S (1998) Phase II controlled trial of post-exposure immunization with recombinant gp160 versus antiretroviral therapy in asymptomatic HIV-1-infected adults. Aids 12(5):473–480

Article  CAS  PubMed  Google Scholar 

Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM (2008) Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clinical infectious diseases, 46(11), 1769–1781. https://doi.org/1710.1086/587993

Qureshi H, Ma Z-M, Huang Y, Hodge G, Thomas MA, DiPasquale J, DeSilva V, Fritts L, Bett AJ, Casimiro DR (2012) Low-dose penile SIVmac251 exposure of rhesus macaques infected with adenovirus type 5 (Ad5) and then immunized with a replication-defective Ad5-based SIV gag/pol/nef vaccine recapitulates the results of the phase IIb step trial of a similar HIV-1 vaccine. Journal of virology, 86(4), 2239-2250.2210.1128/JVI.06175 – 06111

Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, De Souza M, Adams E (2009) Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. New England Journal of Medicine, 361(23), 2209-2220.2210.1056/NEJMoa0908492

Riviére Y, McCHESNEY MB, Porrot F, Tanneau-Salvadori F, Sansonetti P, Lopez O, Pialoux G

Comments (0)

No login
gif