Completed

Evaluation of Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

MN rgp120/HIV-1 and GNE8 rgp120/HIV-1

+ MN rgp120/HIV-1 and A244 rgp120/HIV-1

+ Aluminum hydroxide

Biological
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorVaxGen
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months: Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant. Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant. Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization. An interim analysis is performed after all patients receive the second dose (at 1 month).

NCT00002402
Principal SponsorVaxGen
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

Patients must: Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Dr Frank Judson / Director of Public Health Dept

Denver, United StatesOpen Dr Frank Judson / Director of Public Health Dept in Google Maps

Johns Hopkins Bloomberg School of Public Health

Washington D.C., United States

Fenway Community Health Ctr

Boston, United States

Saint Louis Univ Health Sciences Ctr

St Louis, United States
Completed4 Study Centers