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OpenTrials
Completed

NCT Number: NCT00004579

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Walter Reed Army Institute of Research

Rockville, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gp160 MN/LAI-2

Biological

ALVAC-HIV MN120TMG (vCP205)

Biological

Sponsors and collaborators

Lead sponsor

Walter Reed Army Institute of Research (WRAIR)

Fed

Registry information

Official study 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

Important dates

Study start
1998
First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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