NCT00001136

Brief Summary

The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune system responds to this vaccine. Vaccines are given to people to try to resist infection or prevent disease. There are a number of different HIV vaccines that are currently being tested. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the immune system responds to it.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2000

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

January 25, 2000

Last Update Submit

October 28, 2021

Conditions

HIV InfectionsHIV Seronegativity

Keywords

Injections, IntramuscularHIV-1AIDS VaccinesCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesT-Lymphocytes, CytotoxicGene Products, gagHIV SeronegativityImmunologic MemoryAntibodies, ViralGenetic VectorsGene Products, envPoxviridaeHIV Preventive Vaccine

Interventions

ALVAC-HIV MN120TMG (vCP205)BIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • You may be eligible for this study if you:
  • Are 18-60 years old.
  • Are willing to use adequate birth control for 1 month before study entry and during the study.
  • Have a CD4 count of at least 400 cells/mm3.
  • Have a normal medical history and physical examination.
  • Are available for 3 months of follow-up.
  • Have participated in AVEG Protocol 014C or 022A and received all the scheduled vaccinations 24 or more months before this study, or have never participated in HIV-vaccine studies.
  • Are HIV-negative within 8 weeks of study entry.
  • Are negative for hepatitis B surface antigen.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Are pregnant or breast-feeding.
  • Have a history of an immune system problem, any long-term illness, or any autoimmune disease.
  • Have a history of using medications which affect your immune system.
  • Have a history of cancer, except if it has been removed with surgery and cure is most likely.
  • Have a medical or mental condition which interferes with the study.
  • Have a job or work which interferes with the study.
  • Have ever attempted suicide, thought of attempting suicide, or have a severe mental condition.
  • Have received vaccines within 60 days of study entry.
  • Have used experimental drugs within 30 days prior to study entry.
  • Have received any blood products, such as immunoglobulin, in the last 6 months.
  • Have active syphilis.
  • Have active tuberculosis.
  • Have any history of severe allergic reactions, including reactions to vaccines.
  • Have an allergy to egg products or neomycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UAB AVEG

Birmingham, Alabama, 35294, United States

Location

JHU AVEG

Baltimore, Maryland, 21205, United States

Location

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63110, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

UW - Seattle AVEG

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Thomas Evans

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2000

First Posted

August 31, 2001

Study Completion

May 1, 2001

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(6)