Phase III HIV vaccine trial in Thailand: a step toward a protective vaccine for HIV

References

• Burton DR, Desrosiers RC, Doms RW et al. Public health. A sound rationale needed for Phase III HIV-1 vaccine trials. Science303(5656), 316 (2004).
   PubMed Web of Science ®Google Scholar
• Belshe R, Franchini G, Girard MP et al. Support for the RV144 HIV vaccine trial. Science305(5681), 177–180 (2004).
   PubMedGoogle Scholar
• Health MoP. National Plan for HIV/AIDS Vaccine Development and Evaluation. Department of Communicable Deases Control, Ministry of Public Health, Nonthaburi, Thailand (1993).
   Google Scholar
• UNAIDS. Report on the global AIDS epidemic. UNAIDS, Geneva, Switzerland (2008).
   Google Scholar
• Phanuphak P, Locharernkul C, Panmuong W, Wilde H. A report of three cases of AIDS in Thailand. Asian Pac. J. Allergy Immunol.3, 4 (1985).
   PubMed Web of Science ®Google Scholar
• Porapakkham Y, Pramarnpol S, Athicbhoddhi S, Bernhard R. The evolution of HIV/AIDS policy in Thailand: 1984–1994. AIDSCAP policy working paper series, WP5. Family Health International/AIDSCAP/USAID, Washington, DC, USA (1995).
   Google Scholar
• UNAIDS. Thailand HIV/AIDS health profile. USAID, Bangkok, Thailand (2008).
   Google Scholar
• Nitayaphn S, Brown AE. Preventive HIV vaccine development in Thailand. AIDS2(Suppl. B), 155–161 (1998).
   Google Scholar
• Pitisuttithum P. HIV vaccine research in Thailand: lessons learned. Expert Rev. Vaccines7(3), 311–317 (2008).
   PubMed Web of Science ®Google Scholar
• Benenson M, Sirisopana N, Amphaipit R et al. Cohort development for future HIV-1 vaccine trials: a community cohort, Chon Buri Province. Thailand. Presented at: AIDS Vaccine 2001. PA, USA, 5–8 September 2001.
   Google Scholar
• Markowitz LE, Sirisopana N, Charonwatanachokchai A et al. Feasibility of a preventive HIV-1 vaccine cohort among persons attending sexually transmitted disease clinics in Thailand. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol.20(5), 488–494 (1999).
   PubMedGoogle Scholar
• Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N. Engl. J. Med.361(23), 2209–2220 (2009).
   PubMed Web of Science ®Google Scholar
• Kitayaporn D, Vanichseni S, Mastro TD et al. Infection with HIV-1 subtypes B and E in injecting drug users screened for enrollment into a prospective cohort in Bangkok, Thailand. Syndr. Hum. Retrovirol.19, 6 (1998).
   PubMedGoogle Scholar
• Xiridou M, van Griensven F, Tappero JW et al. The spread of HIV-1 subtypes B and CRF01_AE among injecting drug users in Bangkok, Thailand. J. Acquir. Immune Defic. Syndr.45(4), 468–475 (2007).
   PubMed Web of Science ®Google Scholar
• VanCott T, Mascola J, Loomis-Price L et al. Cross-subtype neutralizing antibodies induced in baboons by a subtype E gp120 immunogen based on an r5 primary human immunodeficiency virus type 1 envelope. J. Virol.73(6), 10 (1999).
   Google Scholar
• Pitisuttithum P, Berman PW, Phonrat B et al. Phase I/II study of a candidate vaccine designed against the B and E subtypes of HIV-1. AIDS37, 5 (2004).
   Google Scholar
• Klein M. AIDS and HIV vaccines. Vaccines17(2), 5 (1999).
   Google Scholar
• Klein M. AIDS vaccines: are we ready for human efficacy trials? JAMA11, 10 (1997).
   Google Scholar
• Kim J, Robb M, Cox J et al. Humoral and cellular HIV-specific responses induced by the prime–boost combination of aventis- pasteur ALVAC-HIV (vCP205) and oligomeric HIV-1 GP160MN/LAI-2 in HIV-uninfected adults. In: Eighth Conference on Retroviruses and Opportunistic Infections. Chicago, IL, USA (2001)
   Google Scholar
• Pitisuttithum P, Gilbert P, Gurwith M et al. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. J. Infect. Dis.194(12), 10 (2006).
   Google Scholar
• Excler JL, Plotkin S. The prime–boost concept applied to HIV preventive vaccines. AIDS11(Suppl. A), 10 (1997).
   Google Scholar
• Clements-Man , Weinhold K, Matthews T et al. Immune responses to human immunodeficiency virus (HIV) type 1 induced by canarypox expressing HIV-1MN gp120, HIV-1SF2 recombinant gp120, or both vaccines in seronegative adults. J. Infect. Dis.177(5), 1230–1246 (1998).
   PubMed Web of Science ®Google Scholar
• Belshe R, Gorse G, Mulligan M et al. Induction of immune responses to HIV-1 by canarypox virus (ALVAC) HIV-1 and gp120 SF-2 recombinant vaccines in uninfected volunteers. NIAID AIDS Vaccine Evaluation Group. AIDS12(18), 2407–2415 (1998).
   PubMed Web of Science ®Google Scholar
• Sabbaj S, Mulligan MJ, Hsieh RH, Belshe RB, McGhee JR. Cytokine profiles in seronegative volunteers immunized with a recombinant canarypox and gp120 prime–boost HIV-1 vaccine. AIDS14(10), 1365–1374 (2000).
   PubMed Web of Science ®Google Scholar
• Gorse GJ, Patel GB, Belshe RB; National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network. HIV type 1 vaccine-induced T cell memory and cytotoxic T lymphocyte responses in HIV type 1-uninfected volunteers. AIDS Res. Hum. Retroviruses17(12), 1175–1189 (2001).
   PubMed Web of Science ®Google Scholar
• Belshe RB, Stevens C, Gorse GJ et al. Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus type 1 vaccine with or without gp120: a Phase 2 study in higher- and lower-risk volunteers. J. Infect. Dis.183(9), 1343–1352 (2001).
   PubMed Web of Science ®Google Scholar
• Nitayaphan S, Pitisuttithum P, Karnasuta C et al. Safety and immunogenicity of an HIV subtype B and E prime–boost vaccine combination in HIV negative Thai adults. J. Infect. Dis.190(4), 702–706 (2004).
   PubMed Web of Science ®Google Scholar
• Thongcharoen P, Suriyanon V, Paris RM et al. A Phase 1/2 comparative vaccine trial of the safety and immunogenicity of a CRF01_AE (subtype E) candidate vaccine: ALVAC-HIV (vCP1521) prime with oligomeric gp160 (92TH023/LAI-DID) or bivalent gp120 (CM235/SF2) boost. J. Acquir. Immune Defic. Syndr.46(1), 48–55 (2007).
   PubMed Web of Science ®Google Scholar
• Flynn NM, Harro CD, Judson FN, Mayer KH, Para MF; rgp120 HIV Vaccine Study Group. Placebo-controlled Phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J. Infect. Dis.191(5), 654–665 (2005).
   PubMed Web of Science ®Google Scholar
• Paoletti E, Tartaglia J, Taylor J. Safe and effective poxvirus vectors – NYVAC and ALVAC. Dev. Biol. Stand.82, 65–69 (1994).
   PubMedGoogle Scholar
• Paoletti E, Taylor J, Meignier B, Meric C, Tartaglia J. Highly attenuated poxvirus vectors: NYVAC, ALVAC and TROVAC. Dev. Biol. Stand.84, 159–163 (1995).
   PubMedGoogle Scholar
• Baxby D, Paoletti E. Potential use of non-replicting vectors as recombinant vaccines. Vaccine10(1), 8–9 (1992).
   PubMed Web of Science ®Google Scholar
• Plotkin SA, Cadoz M, Meignier B et al. The safety and use of canarypox vectored vaccines. Dev. Biol. Stand.84, 5 (1995).
   Google Scholar
• Franchini G, Benson J, Gallo R, Paoletti E, Tartaglia J. Attenuated poxvirus vectors as carriers in vaccines against human T cell leukemia-lymphoma virus type I. AIDS Res. Hum. Retroviruses12(5), 1 (1996).
   PubMed Web of Science ®Google Scholar
• Taylor J, Meignier B, Tartaglia J et al. Biological and immunogenic properties of a canarypox-rabies recombinant, ALVAC-RG (vCP65) in non-avian species. Vaccine13(6), 539–549 (1995).
   PubMed Web of Science ®Google Scholar
• Egan MA, Pavlat WA, Tartaglia J et al. Induction of human immunodeficiency virus type 1 (HIV-1)-specific cytolytic T lymphocyte responses in seronegative adults by a nonreplicating, host-range-restricted canarypox vector (ALVAC) carrying the HIV-1MN env gene. J. Infect. Dis.171(6), 1623–1627 (1995).
   PubMed Web of Science ®Google Scholar
• Franchini G, Gurunathan S, Baglyos L, Plotkin S, Tartaglia J. Poxvirus-based vaccine candidates for HIV: two decades of experience with special emphasis on canarypox vectors. Expert Rev. Vaccines3(4 Suppl.), S75–S88 (2004).
   PubMed Web of Science ®Google Scholar
• Carroll MW, Moss B. Poxviruses as expression vectors. Curr. Opin. Biotechnol.8(5), 573 (1997).
   PubMed Web of Science ®Google Scholar
• Barré-Sinoussi F, Chermann JC, Rey F et al. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). Science220(4599), 868–871 (1983).
   PubMed Web of Science ®Google Scholar
• Wills JW, Craven RC. Form, function, and use of retroviral gag proteins. AIDS5(6), 639–654 (1991).
   PubMed Web of Science ®Google Scholar
• Haffar O, Garrigues J, Travis B, Moran P, Zarling J, Hu SL. Human immunodeficiency virus-like, nonreplicating, gag-env particles assemble in a recombinant vaccinia virus expression system. J. Virol.64(6), 2653–2659 (1990).
   PubMed Web of Science ®Google Scholar
• Hel Z, Nacsa J, Tsai WP et al. Equivalent immunogenicity of the highly attenuated poxvirus-based ALVAC-SIV and NYVAC-SIV vaccine candidates in SIVmac251-infected macaques. Virology304(1), 125–134 (2002).
   PubMed Web of Science ®Google Scholar
• Myagkikh M, Alipanah S, Markham PD et al. Multiple immunizations with attenuated poxvirus HIV type 2 recombinants and subunit boosts required for protection of rhesus macaques. AIDS Res. Hum. Retroviruses12(11), 985–992 (1996).
   PubMed Web of Science ®Google Scholar
• Nacsa J, Radaelli A, Edghill-Smith Y et al. Avipox-based simian immunodeficiency virus (SIV) vaccines elicit a high frequency of SIV-specific CD4+ and CD8+ T-cell responses in vaccinia-experienced SIVmac251-infected macaques. Vaccine22(5–6), 597–606 (2004).
   PubMed Web of Science ®Google Scholar
• Pal R, Venzon D, Letvin NL et al. ALVAC-SIV-gag-pol-env-based vaccination and macaque major histocompatibility complex class I (A*01) delay simian immunodeficiency virus SIVmac-induced immunodeficiency. J. Virol.76(1), 292–302 (2002).
   PubMed Web of Science ®Google Scholar
• Pal R, Venzon D, Santra S et al. Systemic immunization with an ALVAC-HIV-1/protein boost vaccine strategy protects rhesus macaques from CD4+ T-cell loss and reduces both systemic and mucosal simian-human immunodeficiency virus SHIVKU2 RNA levels. J. Virol.80(8), 3732 (2006).
   PubMed Web of Science ®Google Scholar
• Santra S, Schmitz JE, Kuroda MJ et al. Recombinant canarypox vaccine-elicited CTL specific for dominant and subdominant simian immunodeficiency virus epitopes in rhesus monkeys. J. Immunol.168(4), 1847–1853 (2002).
   PubMed Web of Science ®Google Scholar
• Andersson S, Makitalo B, Thorstensson R et al. Immunogenicity and protective efficacy of a human immunodeficiency virus type 2 recombinant canarypox (ALVAC) vaccine candidate in cynomolgus monkeys. J. Infect. Dis.174(5), 977–985 (1996).
   PubMed Web of Science ®Google Scholar
• Tubiana R, Gomard E, Fleury H et al. Vaccine therapy in early HIV-1 infection using a recombinant canarypox virus expressing gp160MN (ALVAC-HIV): a double-blind controlled randomized study of safety and immunogenicity. AIDS11(6), 819–820 (1997).
   PubMed Web of Science ®Google Scholar
• Kantakamalakul W, De Souza M, Karnasuta C et al. Enhanced sensitivity of detection of cytotoxic T lymphocyte responses to HIV type 1 proteins using an extended in vitro stimulation period for measuring effector function in volunteers enrolled in an ALVAC-HIV Phase I/II prime boost vaccine trial in Thailand. AIDS Res. Hum. Retroviruses20(6), 642–644 (2004).
   PubMed Web of Science ®Google Scholar
• Marovich MA. ALVAC-HIV vaccines: clinical trial experience focusing on progress in vaccine development. Expert Rev. Vaccines3(4 Suppl.), S99–S104 (2004).
   PubMedGoogle Scholar
• Lee D, Graham BS, Chiu YL et al. Breakthrough infections during Phase 1 and 2 prime–boost HIV-1 vaccine trials with canarypox vectors (ALVAC) and booster dose of recombinant gp120 or gp160. J. Infect. Dis.190(5), 903–907 (2004).
   PubMed Web of Science ®Google Scholar
• Paris R, Bejrachandra S, Karnasuta C et al. HLA class I serotypes and cytotoxic T-lymphocyte responses among human immunodeficiency virus-1-uninfected Thai volunteers immunized with ALVAC-HIV in combination with monomeric gp120 or oligomeric gp160 protein boosting. Tissue Antigens64(3), 251–256 (2004).
   PubMedGoogle Scholar
• Ratto-Kim S, Loomis-Price LD, Aronson N et al. Comparison between env-specific T-cell epitopic responses in HIV-1-uninfected adults immunized with combination of ALVAC-HIV(vCP205) plus or minus rgp160MN/LAI-2 and HIV-1-infected adults. J. Acquir. Immune Defic. Syndr.32(1), 9–17 (2003).
   PubMed Web of Science ®Google Scholar
• Pialoux G, Exler J, Rivière Y et al. A prime–boost approach to HIV preventive vaccine using a recombinant canarypox virus expressing glycoprotein 160 (MN) followed by a recombinant glycoprotein 160 (MN/LAI). The AGIS Group, and l’Agence Nationale de Recherche sur le SIDA. AIDS Res. Hum. Retroviruses11(3), 373–381 (1995).
   PubMed Web of Science ®Google Scholar
• Berman PW, Murthy KK, Wrin T et al. Protection of MN-rgpl20-immunized chimpanzees from heterologous infection with a primary isolate of human immunodeficiency virus type 1. J. Infect. Dis.173(1), 52–59 (1996).
   PubMed Web of Science ®Google Scholar
• Berman PW, Gregory T, Riddle L et al. Protection of chimpanzees from infection by HIV-1 after vaccination with recombinant glycoprotein gp120 but not gp160. Nature345, 622–625 (1990).
   PubMed Web of Science ®Google Scholar
• Belshe RB, Graham BS, Keefer MC et al. Neutralizing antibodies to HIV-1 in seronegative volunteers immunized with recombinant gp120 from the MN strain of HIV-1. NIAID AIDS Vaccine Clinical Trials Network. JAMA272(6), 5 (1994).
   Google Scholar
• el-Amad Z, Murthy KK, Higgins K et al. Resistance of chimpanzees immunized with recombinant gp120SF2 to challenge by HIV-1SF2. AIDS9(12), 1313–1322 (1995).
   PubMed Web of Science ®Google Scholar
• Francis DP. AIDSVAX is safe, but efficacy question remains. VaxGen founder discusses quest for AIDS vaccine. AIDS Alert16(11), 141–142, 147 (2001).
   PubMedGoogle Scholar
• Berman PW, Huang W, Lavon Riddle et al. Development of bivalent (B/E) vaccines able to neutralize CCR5-dependent viruses from the United States and Thailand. Virology265(1), 9 (1999).
   Google Scholar
• Francis DP, Gregory T, McElrath MJ et al. Advancing AIDSVAX to Phase 3. Safety, immunogenicity, and plans for Phase 3. AIDS Res. Hum. Retroviruses14(Suppl. 3), S325–S331 (1998).
   PubMed Web of Science ®Google Scholar
• Harro CD, Judson FN, Gorse GJ et al. VAX004 study group. Recruitment and baseline epidemiologic profile of participants in the first Phase 3 HIV vaccine efficacy trial. J. Acquir. Immune Defic. Syndr.37(3), 1385–1392 (2004).
   PubMed Web of Science ®Google Scholar
• Jones NG, DeCamp A, Gilbert P, Peterson ML, Gurwith M, Cao H. AIDSVAX immunization induces HIV-specific CD8+ T-cell responses in high-risk, HIV-negative volunteers who subsequently acquire HIV infection. Vaccine27(7), 1136–1140 (2009).
   PubMed Web of Science ®Google Scholar
• Van Rompay KK, Abel K, Lawson J et al. Attenuated poxvirus-based simian immunodeficiency virus (SIV) vaccines given in infancy partially protect infant and juvenile macaques against repeated oral challenge with virulent SIV. J. Acquir. Immune Defic. Syndr.38(2), 124–134 (2005).
   PubMed Web of Science ®Google Scholar
• Franchini G, Robert-Guroff M, Tartaglia J et al. Highly attenuated HIV type 2 recombinant poxviruses, but not HIV-2 recombinant Salmonella vaccines, induce long-lasting protection in rhesus macaques. AIDS Res. Hum. Retroviruses11(8), 909–920 (1995).
   PubMed Web of Science ®Google Scholar
• Morgan C, Marthas M, Miller C et al. The use of nonhuman primate models in HIV vaccine development. PLoS Med.5(8), e173 (2008).
   PubMed Web of Science ®Google Scholar
• Liang X, Schleif WA. Vectored Gag and Env but not Tat show efficacy against simian-human immunodeficiency virus 89.6P challenge in mamu-A*01-negative rhesus monkey. J. Virol.79(19), 12321–12331 (2005).
   PubMed Web of Science ®Google Scholar
• Buchbinder S, Mehrotra DV, Duerr A et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet372, 1881–1893 (2008).
   PubMed Web of Science ®Google Scholar
• Girard M, van der Ryst E, Barré-Sinoussi F et al. Challenge of chimpanzees immunized with a recombinant canarypox-HIV-1 virus. Virology232(1), 98–104 (1997).
   PubMed Web of Science ®Google Scholar
• Abimiku A, Franchini G, Tartaglia J et al. HIV-1 recombinant poxviruses vaccine induces cross-protection against HIV-2 challenge in rhesus macaques. Nat. Med.1, 321–329 (1995).
   PubMed Web of Science ®Google Scholar
• Evans TG, McElrath MJ, Matthews T et al. QS-21 promotes an adjuvant effect allowing for reduced antigen dose during HIV-1 envelope subunit immmunization in humans. Vaccine19(15–16), 2080–2091 (2001).
   PubMed Web of Science ®Google Scholar
• Gahéry-Ségard H, Pialoux G, Figueiredo S et al. Long-term specific immune responses induced in humans by a human immunodeficiency virus type 1 lipopeptide vaccine: characterization of CD8+-T-cell epitopes recognized. J. Virol.77(20), 11220–11231 (2003).
   PubMed Web of Science ®Google Scholar
• Mugyenyi P. The Uganda experience. Vaccine20, 1905–1908 (2002).
   PubMed Web of Science ®Google Scholar
• Perez-Losados M, Jobes DV, Sinangil F et al. Phylodynamics of HIV-1 from a Phase-III AIDS Vaccine Trial in North America. Mol. Biol. Evol.27(2), 417–425 (2010).
   PubMed Web of Science ®Google Scholar