HIV Vaccine Trial in Thai Adults

The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.

A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts to control the HIV pandemic. In this phase III efficacy trial, a 'prime-boost' vaccine strategy is evaluated for prevention of infection and ameliorationn of disease course. ALVAC-HIV (vCP1521) from sanofi pasteur is given as the 'prime' vaccine at months 0, 1, 3 and 6; AIDSVAX gp120 B/E from VaxGen is given as the 'boost' at months 3 and 6. This regimen will be given to 8,000 adult Thai subjects, while another 8,000 will be given placebos in a double-blinded, randomized manner. Following the completion of each subjects immunization phase, he/she will be followed for 3 years with clinic visits every 6 months with HIV testing, pre- and post-test counseling. Subjects who become HIV infected will be counseled, referred to HIV treatment facilities for management according to national guidelines, and offered enrollment in a protocol for extended follow-up.

• Biological: ALVAC-HIV vCP1521 + AIDSVAX

  1cc injected into left deltoid muscle at day 0,weeks 4, 12, 24

  Prime/Boost Vaccination

• Biological: ALVAC Placebo + AIDSVAX Placebo

  1cc ALVAC Placebo in left deltoid at day 0 and week 4

  1 cc ALVAC Placebo + AIDSVAX Placebo in left deltoid on weeks 12 and 24

• Active Comparator: II
  Intervention: Biological: ALVAC-HIV vCP1521 + AIDSVAX
• Placebo Comparator: I
  Intervention: Biological: ALVAC Placebo + AIDSVAX Placebo

• Nitayaphan S, Pitisuttithum P, Karnasuta C, Eamsila C, de Souza M, Morgan P, Polonis V, Benenson M, VanCott T, Ratto-Kim S, Kim J, Thapinta D, Garner R, Bussaratid V, Singharaj P, el-Habib R, Gurunathan S, Heyward W, Birx D, McNeil J, Brown AE; Thai AIDS Vaccine Evaluation Group. Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults. J Infect Dis. 2004 Aug 15;190(4):702-6. Epub 2004 Jul 20.
• Karnasuta C, Paris RM, Cox JH, Nitayaphan S, Pitisuttithum P, Thongcharoen P, Brown AE, Gurunathan S, Tartaglia J, Heyward WL, McNeil JG, Birx DL, de Souza MS; Thai AIDS Vaccine Evaluation Group, Thailand. Antibody-dependent cell-mediated cytotoxic responses in participants enrolled in a phase I/II ALVAC-HIV/AIDSVAX B/E prime-boost HIV-1 vaccine trial in Thailand. Vaccine. 2005 Mar 31;23(19):2522-9.
• Brown AE, Nitayaphan S. Foundations for a Phase III human immunodeficiency virus vaccine trial: A decade of Thai-U.S. Army collaborative research. Mil Med. 2004 Aug;169(8):588-93. Review.
• Pitisuttithum P, Rerks-Ngarm S, Bussaratid V, Dhitavat J, Maekanantawat W, Pungpak S, Suntharasamai P, Vanijanonta S, Nitayapan S, Kaewkungwal J, Benenson M, Morgan P, O'Connell RJ, Berenberg J, Gurunathan S, Francis DP, Paris R, Chiu J, Stablein D, Michael NL, Excler JL, Robb ML, Kim JH. Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand. PLoS One. 2011;6(12):e27837. Epub 2011 Dec 21.
• Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH; MOPH-TAVEG Investigators. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009 Dec 3;361(23):2209-20. Epub 2009 Oct 20.

Inclusion Criteria:

• Thai citizen, 18-30 years of age; either gender,
• Available for participation for 3.5 years,
• Able to understand study and give written informed consent, Completed enrollment in associated screening protocol

Exclusion Criteria:

• HIV positive,
• Participant in previous HIV vaccine trial,
• Active TB or other systemic disease; immunodeficiency or chronic use of immune modifying therapy,
• History of anaphylaxis or other serious adverse reactions to vaccines,
• For women, breast feeding or pregnant (or planning to become pregnant during the first 9 months after enrollment)

• United States Army Medical Materiel Development Activity
• Armed Forces Research Institute of Medical Sciences, Thailand
• Walter Reed Army Institute of Research (WRAIR)
• Sanofi Pasteur MSD
• VaxGen
• The EMMES Corporation
• Ministry of Health, Thailand
• Mahidol University
• Royal Thai Army Medical Department
• Tripler Army Medical Center
• Henry M Jackson Foundation