ALVAC-HIV vCP1452 Alone and Combined With MN rgp120

Phase 2

Completed

• Conditions: HIV Seronegativity; HIV Infections
• Interventions: Biological: ALVAC(2)120(B,MN)GNP (vCP1452); Biological: ALVAC(2)120(B,MN)GNP (vCP1452) placebo; Biological: MN rgp120/HIV-1 placebo; Biological: MN rgp120/HIV-1

• Registration Number: NCT00011037
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

The purpose of this study is to test how the body's immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120.

HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many worldwide populations cannot afford the antiviral treatments for infected people. HIV vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad and Tobago. The study will determine how volunteers' immune systems respond to the vaccines. (This protocol has been changed by adding new international sites.)

Detailed Description

There is no cure for HIV infection or AIDS in spite of recent advances in antiviral therapy. Furthermore, drug therapy is too expensive for most affected populations. For this reason, there is a commitment to the development of safe, effective vaccines to prevent HIV infection and AIDS worldwide. This study evaluates the immunogenicity and safety of candidate HIV-1 vaccines, based on the canarypox vector termed ALVAC, alone and combined with an MN rgp120 product, at 3 \[AS PER AMENDMENT 7/19/01: 5\] international sites.

\[AS PER AMENDMENT 7/19/01: Volunteers in Rio de Janeiro, Haiti, and Trinidad and Tobago comprise Part I; volunteers in Sao Paulo and Peru comprise Part II.\] Volunteers from Haiti, Brazil, \[AS PER AMENDMENT 7/19/01: Peru\] and Trinidad and Tobago are enrolled into 1 of 3 arms and followed for 18 months. Arm 1 volunteers receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months. Arm 2 volunteers receive ALVAC-HIV vCP1452 on the same schedule as Arm 1 and receive HIV-1 MN rgp120 subunit simultaneously with the 3-month and 6-month vaccine doses. Arm 3 volunteers receive a placebo. Blood and urine samples are collected for immunologic assays, virologic determinations, pregnancy testing, and safety assessments. Risk behavior and social harms are assessed every 6 months during follow-up \[AS PER AMENDMENT 7/19/01: Social harms are assessed every 3 months during follow-up and risk behavior every 6 months\]. At all clinic visits volunteers receive counseling on avoidance of HIV infection and pregnancy. Participants are tested for HIV-1 every 3 \[AS PER AMENDMENT 7/19/01: the following text has been deleted: to 6\] months. Counseling and follow-up for any needed medical care are provided.

Study Timeline

• Study First Submitted: 2001-02-08
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Study Completion: 2004-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ALVAC(2)120(B,MN)GNP (vCP1452)	Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 and Months 3 and 6
2	MN rgp120/HIV-1 placebo	Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6
3	MN rgp120/HIV-1 placebo	Participants will receive ALVAC-HIV vCP1452 placebo at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6
1	MN rgp120/HIV-1	Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 and Months 3 and 6
2	ALVAC(2)120(B,MN)GNP (vCP1452)	Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6
3	ALVAC(2)120(B,MN)GNP (vCP1452) placebo	Participants will receive ALVAC-HIV vCP1452 placebo at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6

Primary Outcome Measures

Name	Time	Method
Immunogenicity and safety of two vaccine regimens	Throughout study

Trial Locations

Locations (4)

Barranco CRS; 🇵🇪 Lima, Peru

Projeto Praça Onze/Hesfa Crs; 🇧🇷 Rio de Janeiro, Brazil

Les Centres GHESKIO CRS; 🇭🇹 Port-au-Prince, Haiti

CCPRI Med. Ctr. - Med. Research Foundation of Trinidad & Tobago; 🇹🇹 Port of Spain, Trinidad and Tobago