An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV

A Phase I Safety and Immunogenicity Trial of a Combination Vaccine (NefTat and gp120w61d) Formulated With AS02A (GlaxoSmithKline Biologicals) Given Intramuscularly in HIV-1 Uninfected Adult Participants

The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines.

There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Biological: Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A; Biological: NefTat; Drug: AS02A Adjuvant; Biological: gp120W61D

Detailed Description

Despite recent advances in the treatment and prevention of HIV disease, the epidemic is worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world. An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a Phase III trial, underscoring the need for new vaccine strategies.

Prior to study entry, participants have their risk status for HIV infection determined by a series of questions. Further eligibility is determined by results of physical exam, laboratory tests, and further questions. Blood is drawn on each study visit. Participants are assigned randomly to 1 of 4 study groups:

Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group receives a different concentration of gp120.

All immunizations are admixed with AS02A adjuvant. Vaccinations are administered intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and immunogenicity are performed at designated time points; participants have about 11 clinic visits.

• Study Type: Interventional
• Enrollment: 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama Vaccine CRS
  • California
    • San Francisco, California, United States, 94102
      • San Francisco Vaccine and Prevention CRS
  • Maryland
    • Baltimore, Maryland, United States
      • Project Brave HIV Vaccine CRS
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hosp. CRS
    • Boston, Massachusetts, United States, 02115
      • Fenway Community Health Clinical Research Site (FCHCRS)
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis Univ. School of Medicine, HVTU
  • New York
    • Bronx, New York, United States, 10456
      • NY Blood Ctr./Bronx CRS
    • New York, New York, United States
      • HIV Prevention & Treatment CRS
    • New York, New York, United States, 10021
      • NY Blood Ctr./Union Square CRS
    • Rochester, New York, United States, 14642
      • Univ. of Rochester HVTN CRS
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Miriam Hospital's HVTU
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Vaccine CRS
  • Virginia
    • Annandale, Virginia, United States
      • Infectious Diseases Physicians, Inc.
  • Washington
    • Seattle, Washington, United States
      • FHCRC/UW Vaccine CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

Participants may be eligible for this study if they:

• Are between 18 and 60 years of age.
• Are in good general health and meet laboratory test requirements.
• Have a CD4 count of 400 or more cells/mm3.
• Agree to use at least 1 of the following methods of contraception for at least 21 days before enrollment until the last protocol visit: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, IUD, or hormonal-based therapy (applies to women who are able to have children).
• Have access to a participating site and are willing to have follow-up for the entire study (12 months).
• Answer questions about their understanding of the study.
• Do not have hepatitis B or C.
• Are HIV-uninfected.

Exclusion Criteria

Participants may not be eligible for this study if they:

• Are pregnant or breast-feeding.
• Have recently received a vaccine.
• Have used experimental agents within 30 days before enrollment.
• Have received HIV vaccines or placebo in a previous HIV vaccine study.
• Have received blood products 120 days before HIV screening.
• Have received immunoglobulin (antibodies) 60 days before HIV screening.
• Have serious reactions to vaccines.
• Have problems with their immune system.
• Have cancer.
• Have used drugs that affect the immune system within the past 6 months.
• Have diabetes.
• Have a thyroid disease.
• Have unstable asthma.
• Are taking anti-tuberculosis drugs.
• Have seizures.
• Have a bleeding disorder.
• Have had their spleen removed.
• Have angioedema (a certain type of body tissue swelling).
• Have active syphilis.
• Have high blood pressure (unless controlled by medication).
• Have mental or emotional problems that make them unsuitable for the study.
• Have any medical, mental, or social condition; job responsibilities; or other responsibility that, in the opinion of the doctor, would interfere with the study.
• Have reactions to components of the vaccines.
• Are at high risk for contracting HIV.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Masking: Double

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

General Publications

• Vaine M, Wang S, Liu Q, Arthos J, Montefiori D, Goepfert P, McElrath MJ, Lu S. Profiles of human serum antibody responses elicited by three leading HIV vaccines focusing on the induction of Env-specific antibodies. PLoS One. 2010 Nov 9;5(11):e13916. doi: 10.1371/journal.pone.0013916.

Study record dates

Study Major Dates

• Study Completion (Actual): June 1, 2003

Study Registration Dates

• First Submitted: December 4, 2001
• First Submitted That Met QC Criteria: December 4, 2001
• First Posted (Estimate): December 5, 2001

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV-1; AIDS Vaccines; HIV Preventive Vaccine; HIV Envelope Protein gp120; HIV Antibodies; Neutralization Tests; Injections, Intramuscular; Gene Products, tat; Vaccines, Combined; AIDS Seronegativity; Gene Products, nef
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: HVTN 041; 10196 (DAIDS ES Registry Number)