HIV Vaccine Trial in Thai Adults | NCT00223080

NCT00223080

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
HSRRB A-11048	Other Identifier	USAMRMC HSRRB

Status Module

Name	Class
United States Army Medical Materiel Development Activity	FED
Armed Forces Research Institute of Medical Sciences, Thailand	OTHER_GOV
Walter Reed Army Institute of Research (WRAIR)	FED

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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	Vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Supachai Rerks-Ngarm, MD	Ministry of Health, Thailand	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ban Lamung District Hospital		Ban Lamung District	Changwat Chon Buri		Thailand
Phan Tong District Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15272397	Background	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.
15752839

Arm/Group Information

ID	Title	Description
FG000	Vaccine	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. 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
FG001	Placebo	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. 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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Vaccine	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. 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
BG001

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study

Posted

Number

95% Confidence Interval

Percetage of subjects

42 Months

ID	Title	Description
OG000	Vaccine	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. 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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vaccine	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. 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

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral