HIV Vaccine Trial in Thai Adults

HIV Infection Clinical Trial

Official title:

A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223080
• Other study ID #: RV144
• Secondary ID: HSRRB A-11048
• Status: Completed
• Phase: Phase 3
• Start date: October 2003
• Est. completion date: June 2009

Study information

• Verified date: April 2019
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 amelioration 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16402
• Est. completion date: June 2009
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Possession of the 13-digit Thai National ID card

• 18-30 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Biological:
• ALVAC-HIV vCP1521 + AIDSVAX
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

Other:
• ALVAC Placebo + AIDSVAX Placebo
ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection

Locations

Country	Name	City	State
Thailand	Ban Chang District Hospital	Ban Chang District	Rayong
Thailand	Ban Khai District Hospital	Ban Khai District	Rayong
Thailand	Ban Lamung District Hospital	Ban Lamung District	Chon Buri
Thailand	Klaeng District Hospital	Klaeng District	Rayong
Thailand	Provincial Health Office	Muang District	Rayong
Thailand	Phan Tong District Hospital	Phan Tong District	Chon Buri
Thailand	Sattahip District Hospital	Sattahip District	Chon Buri
Thailand	Ao Udom Hospital	Sri Racha District	Chon Buri

Sponsors (12)

Lead Sponsor

Collaborator

U.S. Army Medical Research and Materiel Command

Armed Forces Research Institute of Medical Sciences, Thailand, Henry M. Jackson Foundation for the Advancement of Military Medicine, Mahidol University, MCM Vaccines B.V., Ministry of Health, Thailand, Royal Thai Army Medical Department, The EMMES Corporation, Tripler Army Medical Center, United States Army Medical Materiel Development Activity, VaxGen, Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population	Two CD4 cell counts were obtained (at the verification blood draw and the notification blood draw) and through the remainder of the follow-up period. Results were compared in vaccine and placebo recipients who became HIV-infected during the trial.	42 weeks
Secondary	Safety Assessment (SAE's and AEs)	The intent-to-treat population is used for analysis of AEs and treatment emergent events are reported. Participant AE rates for all AEs, SAEs and treatment-related AEs are summarized	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
Secondary	Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)	Self Report of Risk Behavior Status by Treatment and Time. Specifically, this is the responses to the question "Do you think that your everyday behavior puts you at risk for HIV infection?" Modified intent to treat population (MITT)	Week 182