A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

gp160 MN/LAI-2

ALVAC-HIV MN120TMG (vCP205)

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Viral Vaccines, HIV-1, Dose-Response Relationship, Drug, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, Immunization, HIV Envelope Protein gp120, Recombination, Genetic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Volunteers may be eligible for this study if they: Are HIV-negative. Are in good health. Are between ages 18 and 55. Are available for at least 1 year. Are a resident of the United States of America. Agree to practice sexual abstinence or use birth control. Exclusion Criteria Volunteers will not be eligible for this study if they: Have ever been given an HIV vaccine or certain other vaccines. (However, rabies vaccines are allowed.) Participate in activities that place them at high-risk for HIV infection, such as injection drug use or unprotected sex with someone who has HIV infection. Have certain psychiatric, medical, or substance abuse problems. Are allergic to eggs or other vaccines. Are an employee at a participating site and have access to study information. Are taking certain medications. Have received blood transfusions within 3 months before entering this study. Are pregnant or breast-feeding.

Sites / Locations

Walter Reed Army Institute of Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004579

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Walter Reed Army Institute of Research (WRAIR)

1. Study Identification

Unique Protocol Identification Number

NCT00004579

Brief Title

A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection

Official Title

A Phase I, Dose-Ranging Trial of the Pasteur Merieux Connaught (PMC) Oligomeric HIV-1 gp160MN/LAI-2 Vaccine Alone or Primed With Live Recombinant ALVAC-HIV (vCP205) in HIV Seronegative Adults

Study Type

Interventional

2. Study Status

Record Verification Date

June 2003

Overall Recruitment Status

Completed

Study Start Date

April 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Walter Reed Army Institute of Research (WRAIR)

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.

Detailed Description

This study consists of 2 parts: Part A: Dose-escalation protocol using oligomeric gp160MN/LAI-2. Part B: Placebo-controlled, randomized, double-blind (within arm) study of vCP205 priming with gp160MN/LAI-2 boosting. Volunteers are followed for at least 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, HIV Seronegativity

Keywords

Vaccines, Synthetic, Viral Vaccines, HIV-1, Dose-Response Relationship, Drug, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, Immunization, HIV Envelope Protein gp120, Recombination, Genetic

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Masking

Double

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

gp160 MN/LAI-2

Intervention Type

Biological

Intervention Name(s)

ALVAC-HIV MN120TMG (vCP205)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Volunteers may be eligible for this study if they: Are HIV-negative. Are in good health. Are between ages 18 and 55. Are available for at least 1 year. Are a resident of the United States of America. Agree to practice sexual abstinence or use birth control. Exclusion Criteria Volunteers will not be eligible for this study if they: Have ever been given an HIV vaccine or certain other vaccines. (However, rabies vaccines are allowed.) Participate in activities that place them at high-risk for HIV infection, such as injection drug use or unprotected sex with someone who has HIV infection. Have certain psychiatric, medical, or substance abuse problems. Are allergic to eggs or other vaccines. Are an employee at a participating site and have access to study information. Are taking certain medications. Have received blood transfusions within 3 months before entering this study. Are pregnant or breast-feeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerome H. Kim

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed Army Institute of Research

City

Rockville

State/Province

Maryland

Country

United States

12. IPD Sharing Statement

Citations:

Citation

Kim J, Robb M, Cox J, Ratto-Kim S, Vancott T, Zahwa H, Malia J, Chaddic C, El Habib R, Caudrelier P, Klein M, Excler JL, Birx D, McNeil J. Humoral and cellular HIV-specific responses induced by the prime-boost combination of Aventis-Pasteur ALVAC-HIV (vCP205) and oligomeric HIV-1 gp160MN/LAI-2 in HIV-uninfected adults. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 179)

Results Reference

background

PubMed Identifier

26908741

Citation

O'Connell RJ, Excler JL, Polonis VR, Ratto-Kim S, Cox J, Jagodzinski LL, Liu M, Wieczorek L, McNeil JG, El-Habib R, Michael NL, Gilliam BL, Paris R, VanCott TC, Tomaras GD, Birx DL, Robb ML, Kim JH. Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene. J Infect Dis. 2016 Jun 15;213(12):1946-54. doi: 10.1093/infdis/jiw059. Epub 2016 Feb 11.

Results Reference

derived

HIV Infections, HIV Seronegativity

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial