HIV Vaccine Trial in Thai Adults

NCT00223080 | Completed Phase 3 Results DMC

• 2 other identifiers: RV144HSRRB A-11048
• Study Type: interventional
• Target: 16,402
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

HIV Infection

Keywords

HIV Seronegativity

Outcome Measures

Primary Outcomes (4)

• Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population

  HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.

  42 Months

• Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population

  Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.

  42 Months

• Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population

  Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.

  42 months

• Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population

  Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.

  42 months

Secondary Outcomes (3)

• Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population

  42 weeks

• Safety Assessment (SAE's and AEs)

  Dose Interval 1: week 0, Dose Interval 2: Week 4, Dose Interval 3: Week 12, and Dose Interval 4: Week 24; every 6 months during 3 year f/u period

• Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)

  Week 182

Study Arms (2)

Vaccine

ACTIVE COMPARATOR

ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.

Biological: ALVAC-HIV vCP1521 + AIDSVAX

Placebo

PLACEBO COMPARATOR

ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.

Other: ALVAC Placebo + AIDSVAX Placebo

Interventions

ALVAC-HIV vCP1521 + AIDSVAX BIOLOGICAL

Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL

Also known as: ALVAC-HIV (vCP1521) >106 CCID50 per 1 mL dose, AIDSVAX® B/E, Bivalent HIV gp120 vaccine subtype B (MN), and E (A244)

Vaccine

ALVAC Placebo + AIDSVAX Placebo OTHER

ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection

Also known as: ALVAC carrier lyophilized product without virus, Aluminum hydroxide adjuvant

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Possession of the 13-digit Thai National ID card
• years of age (inclusive), male or female
• For women, a negative urine pregnancy test on the day of enrollment, as well as assurance that adequate birth control measures would be applied during the course of the injections and the 3 months after the last injection.
• Absence of systemic disease or immunodeficiency as determined by medical history and directed physical examination.
• Negative serology for HIV-1 infection within 45 days prior to enrollment.
• Availability and commitment for 3.5 years of participation.
• Able to understand the study (shown by receiving a passing score on the Test of Understanding administered under the screening protocol) and gave written informed consent.
• Enrollment in and referral from screening protocol, RV148

You may not qualify if:

• Previous participation in any HIV vaccine trial (unless the volunteer could provide documentation that he/she received placebo).
• Active tuberculosis, other systemic disease process, or immunodeficiency as detected by medical history and directed physical examination that would, in the opinion of the investigator, impede compliance with study requirements or complicate the interpretation of adverse events.
• Any significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study or might interfere with the volunteer's ability to successfully complete the study.
• Occupational or other responsibilities that would prevent completion of 3.5 years of participation in the study.
• History of anaphylaxis or other serious adverse reactions to vaccines, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including egg products and neomycin.
• Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the 9-month window between study enrollment and 3-months after the last vaccination visit.
• Study site employees who were involved in the protocol and may have had direct access to trial-related data.
• Chronic use of therapies which may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of \> 20 mg prednisone equivalent for periods exceeding 10 days), and use of experimental drugs or vaccines.
• Receipt of a non-HIV vaccine or immune globulins within 14 days.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• United States Army Medical Materiel Development Activity: collaborator
• Armed Forces Research Institute of Medical Sciences, Thailand: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• MCM Vaccines B.V.: collaborator
• VaxGen: collaborator
• The Emmes Company, LLC: collaborator
• Ministry of Health, Thailand: collaborator
• Mahidol University: collaborator
• Royal Thai Army Medical Department: collaborator
• Tripler Army Medical Center: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (8)

Ban Lamung District Hospital

Ban Lamung District, Changwat Chon Buri, Thailand

Location

Phan Tong District Hospital

Phan Tong District, Changwat Chon Buri, 20160, Thailand

Location

Sattahip District Hospital

Sattahip District, Changwat Chon Buri, 20180, Thailand

Location

Ao Udom Hospital

Sri Racha District, Changwat Chon Buri, 20230, Thailand

Location

Ban Chang District Hospital

Ban Chang District, Changwat Rayong, Thailand

Location

Ban Khai District Hospital

Ban Khai District, Changwat Rayong, Thailand

Location

Klaeng District Hospital

Klaeng District, Changwat Rayong, Thailand

Location

Provincial Health Office

Muang District, Changwat Rayong, 21000, Thailand

Location

Related Publications (13)

• 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. doi: 10.1086/422258. Epub 2004 Jul 20.

  PMID: 15272397 BACKGROUND

• 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. doi: 10.1016/j.vaccine.2004.10.028.

  PMID: 15752839 BACKGROUND

• 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. doi: 10.7205/milmed.169.8.588.

  PMID: 15379068 BACKGROUND

• Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7.

  PMID: 40190112 DERIVED

• Williams LD, Shen X, Sawant SS, Akapirat S, Dahora LC, Tay MZ, Stanfield-Oakley S, Wills S, Goodman D, Tenney D, Spreng RL, Zhang L, Yates NL, Montefiori DC, Eller MA, Easterhoff D, Hope TJ, Rerks-Ngarm S, Pittisuttithum P, Nitayaphan S, Excler JL, Kim JH, Michael NL, Robb ML, O'Connell RJ, Karasavvas N, Vasan S, Ferrari G, Tomaras GD; RV305 study team. Viral vector delivered immunogen focuses HIV-1 antibody specificity and increases durability of the circulating antibody recall response. PLoS Pathog. 2023 May 31;19(5):e1011359. doi: 10.1371/journal.ppat.1011359. eCollection 2023 May.

  PMID: 37256916 DERIVED

• Zhao LP, Fiore-Gartland A, Carpp LN, Cohen KW, Rouphael N, Fleurs L, Dintwe O, Zhao M, Moodie Z, Fong Y, Garrett N, Huang Y, Innes C, Janes HE, Lazarus E, Michael NL, Nitayaphan S, Pitisuttithum P, Rerks-Ngarm S, Robb ML, De Rosa SC, Corey L, Gray GE, Seaton KE, Yates NL, McElrath MJ, Frahm N, Tomaras GD, Gilbert PB. Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans. PLoS One. 2020 Jan 30;15(1):e0226803. doi: 10.1371/journal.pone.0226803. eCollection 2020.

  PMID: 31999736 DERIVED

• Akapirat S, Karnasuta C, Vasan S, Rerks-Ngarm S, Pitisuttithum P, Madnote S, Savadsuk H, Rittiroongrad S, Puangkaew J, Phogat S, Tartaglia J, Sinangil F, de Souza MS, Excler JL, Kim JH, Robb ML, Michael NL, Ngauy V, O'Connell RJ, Karasavvas N; RV305 Study Group. Characterization of HIV-1 gp120 antibody specificities induced in anogenital secretions of RV144 vaccine recipients after late boost immunizations. PLoS One. 2018 Apr 27;13(4):e0196397. doi: 10.1371/journal.pone.0196397. eCollection 2018.

  PMID: 29702672 DERIVED

• Huang Y, Zhang L, Janes H, Frahm N, Isaacs A, Kim JH, Montefiori D, McElrath MJ, Tomaras GD, Gilbert PB. Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials. Vaccine. 2017 Feb 22;35(8):1184-1193. doi: 10.1016/j.vaccine.2016.09.053. Epub 2017 Jan 25.

  PMID: 28131393 DERIVED

• Dommaraju K, Kijak G, Carlson JM, Larsen BB, Tovanabutra S, Geraghty DE, Deng W, Maust BS, Edlefsen PT, Sanders-Buell E, Ratto-Kim S, deSouza MS, Rerks-Ngarm S, Nitayaphan S, Pitisuttihum P, Kaewkungwal J, O'Connell RJ, Robb ML, Michael NL, Mullins JI, Kim JH, Rolland M. CD8 and CD4 epitope predictions in RV144: no strong evidence of a T-cell driven sieve effect in HIV-1 breakthrough sequences from trial participants. PLoS One. 2014 Oct 28;9(10):e111334. doi: 10.1371/journal.pone.0111334. eCollection 2014.

  PMID: 25350851 DERIVED

• Gartland AJ, Li S, McNevin J, Tomaras GD, Gottardo R, Janes H, Fong Y, Morris D, Geraghty DE, Kijak GH, Edlefsen PT, Frahm N, Larsen BB, Tovanabutra S, Sanders-Buell E, deCamp AC, Magaret CA, Ahmed H, Goodridge JP, Chen L, Konopa P, Nariya S, Stoddard JN, Wong K, Zhao H, Deng W, Maust BS, Bose M, Howell S, Bates A, Lazzaro M, O'Sullivan A, Lei E, Bradfield A, Ibitamuno G, Assawadarachai V, O'Connell RJ, deSouza MS, Nitayaphan S, Rerks-Ngarm S, Robb ML, Sidney J, Sette A, Zolla-Pazner S, Montefiori D, McElrath MJ, Mullins JI, Kim JH, Gilbert PB, Hertz T. Analysis of HLA A*02 association with vaccine efficacy in the RV144 HIV-1 vaccine trial. J Virol. 2014 Aug;88(15):8242-55. doi: 10.1128/JVI.01164-14. Epub 2014 May 14.

  PMID: 24829343 DERIVED

• Zolla-Pazner S, deCamp A, Gilbert PB, Williams C, Yates NL, Williams WT, Howington R, Fong Y, Morris DE, Soderberg KA, Irene C, Reichman C, Pinter A, Parks R, Pitisuttithum P, Kaewkungwal J, Rerks-Ngarm S, Nitayaphan S, Andrews C, O'Connell RJ, Yang ZY, Nabel GJ, Kim JH, Michael NL, Montefiori DC, Liao HX, Haynes BF, Tomaras GD. Vaccine-induced IgG antibodies to V1V2 regions of multiple HIV-1 subtypes correlate with decreased risk of HIV-1 infection. PLoS One. 2014 Feb 4;9(2):e87572. doi: 10.1371/journal.pone.0087572. eCollection 2014.

  PMID: 24504509 DERIVED

• 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. doi: 10.1371/journal.pone.0027837. Epub 2011 Dec 21.

  PMID: 22205930 DERIVED

• 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. doi: 10.1056/NEJMoa0908492. Epub 2009 Oct 20.

  PMID: 19843557 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

AIDSVAX

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Supachai Rerks-Ngarm
• Organization: Department of Disease Control, Ministry of Public Health

supachai@health.moph.go.th

66-2-590-3006

Study Officials

• Supachai Rerks-Ngarm, MD

  Ministry of Health, Thailand

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: June 1, 2009
• Last Updated: April 24, 2019
• Results First Posted: October 19, 2018

Record last verified: 2019-04

Locations

TH (8)