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ALVAC-HIV vCP1452 Alone and Combined With MN rgp120

Primary Purpose

HIV Infections, HIV Seronegativity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALVAC(2)120(B,MN)GNP (vCP1452)
MN rgp120/HIV-1
ALVAC(2)120(B,MN)GNP (vCP1452) placebo
MN rgp120/HIV-1 placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Antibodies, HIV Antigens, HIV Envelope Protein gp120, AIDS Vaccines, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Neutralization Tests, Haiti, Brazil, Cytotoxicity, Immunologic, Epitopes, Viral Proteins, Trinidad and Tobago, Peru, HIV Preventive Vaccine, HIV Seronegativity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Volunteers may be eligible for this study if they: Are from Brazil (Rio de Janeiro), Haiti, Peru, or Trinidad and Tobago. Are 18 to 60 years old. Are HIV-negative. Have not developed a sexually transmitted disease in the last 6 months. Have had no more than 2 sexual partners in the last 6 months. Have not injected drugs or used crack cocaine in the last 6 months. Have not exchanged sex for money or drugs in the last 6 months. Have used an adequate birth control method for 1 month prior to study injections and intend to continue for the injection period (7 months). Are available for 18 months of follow-up. Have a normal history and physical examination. (The criteria for inclusion have been changed from the original.) Exclusion Criteria Volunteers will not be eligible for this study if they: Have had immune diseases, chronic illness, or cancer (unless cured by surgical removal), or have used medications affecting the immune system. Have a medical or mental condition, or job that interferes with the study requirements. Have a sexual partner who is HIV-infected, unless practicing abstinence or have always used condoms for the last 6 months. Have a sexual partner at high risk of HIV infection. Have received live vaccines or experimental agents within 30 days prior to planned vaccination. Have received blood products or immunoglobulin in the past 6 months. Have active tuberculosis. Have had a severe allergic reaction, including 1 requiring hospitalization or medical care, or a serious reaction to vaccines. Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial. Are pregnant or breast-feeding. Are allergic to egg products, thimerosal, or neomycin.

Sites / Locations

  • Projeto Praça Onze/Hesfa Crs
  • Les Centres GHESKIO CRS
  • Barranco CRS
  • CCPRI Med. Ctr. - Med. Research Foundation of Trinidad & Tobago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 and Months 3 and 6

Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6

Participants will receive ALVAC-HIV vCP1452 placebo at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6

Outcomes

Primary Outcome Measures

Immunogenicity and safety of two vaccine regimens

Secondary Outcome Measures

Full Information

First Posted
February 8, 2001
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00011037
Brief Title
ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
Official Title
A Multisite Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Seronegativity
Keywords
HIV Antibodies, HIV Antigens, HIV Envelope Protein gp120, AIDS Vaccines, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Neutralization Tests, Haiti, Brazil, Cytotoxicity, Immunologic, Epitopes, Viral Proteins, Trinidad and Tobago, Peru, HIV Preventive Vaccine, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 and Months 3 and 6
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Participants will receive ALVAC-HIV vCP1452 placebo at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6
Intervention Type
Biological
Intervention Name(s)
ALVAC(2)120(B,MN)GNP (vCP1452)
Intervention Description
1 x 10^ 7 TCID50 administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
MN rgp120/HIV-1
Intervention Description
0.6 mg administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
ALVAC(2)120(B,MN)GNP (vCP1452) placebo
Intervention Description
ALVAC placebo administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
MN rgp120/HIV-1 placebo
Intervention Description
Alum placebo administered intramuscularly
Primary Outcome Measure Information:
Title
Immunogenicity and safety of two vaccine regimens
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Volunteers may be eligible for this study if they: Are from Brazil (Rio de Janeiro), Haiti, Peru, or Trinidad and Tobago. Are 18 to 60 years old. Are HIV-negative. Have not developed a sexually transmitted disease in the last 6 months. Have had no more than 2 sexual partners in the last 6 months. Have not injected drugs or used crack cocaine in the last 6 months. Have not exchanged sex for money or drugs in the last 6 months. Have used an adequate birth control method for 1 month prior to study injections and intend to continue for the injection period (7 months). Are available for 18 months of follow-up. Have a normal history and physical examination. (The criteria for inclusion have been changed from the original.) Exclusion Criteria Volunteers will not be eligible for this study if they: Have had immune diseases, chronic illness, or cancer (unless cured by surgical removal), or have used medications affecting the immune system. Have a medical or mental condition, or job that interferes with the study requirements. Have a sexual partner who is HIV-infected, unless practicing abstinence or have always used condoms for the last 6 months. Have a sexual partner at high risk of HIV infection. Have received live vaccines or experimental agents within 30 days prior to planned vaccination. Have received blood products or immunoglobulin in the past 6 months. Have active tuberculosis. Have had a severe allergic reaction, including 1 requiring hospitalization or medical care, or a serious reaction to vaccines. Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial. Are pregnant or breast-feeding. Are allergic to egg products, thimerosal, or neomycin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wright
Official's Role
Study Chair
Facility Information:
Facility Name
Projeto Praça Onze/Hesfa Crs
City
Rio de Janeiro
Country
Brazil
Facility Name
Les Centres GHESKIO CRS
City
Port-au-Prince
Country
Haiti
Facility Name
Barranco CRS
City
Lima
Country
Peru
Facility Name
CCPRI Med. Ctr. - Med. Research Foundation of Trinidad & Tobago
City
Port of Spain
Country
Trinidad and Tobago

12. IPD Sharing Statement

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ALVAC-HIV vCP1452 Alone and Combined With MN rgp120

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