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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A
NefTat
AS02A Adjuvant
gp120W61D
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine, Injections, Intramuscular, HIV Antibodies, HIV-1, HIV Envelope Protein gp120, Gene Products, tat, AIDS Vaccines, Neutralization Tests, Vaccines, Combined, AIDS Seronegativity, Gene Products, nef

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alabama Vaccine CRS
  • San Francisco Vaccine and Prevention CRS
  • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
  • Project Brave HIV Vaccine CRS
  • Brigham and Women's Hosp. CRS
  • Fenway Community Health Clinical Research Site (FCHCRS)
  • Saint Louis Univ. School of Medicine, HVTU
  • NY Blood Ctr./Bronx CRS
  • NY Blood Ctr./Union Square CRS
  • HIV Prevention & Treatment CRS
  • Univ. of Rochester HVTN CRS
  • Miriam Hospital's HVTU
  • Vanderbilt Vaccine CRS
  • Infectious Diseases Physicians, Inc.
  • FHCRC/UW Vaccine CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 4, 2001
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00027365
Brief Title
An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Seronegativity, HIV Preventive Vaccine, Injections, Intramuscular, HIV Antibodies, HIV-1, HIV Envelope Protein gp120, Gene Products, tat, AIDS Vaccines, Neutralization Tests, Vaccines, Combined, AIDS Seronegativity, Gene Products, nef

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
84 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A
Intervention Type
Biological
Intervention Name(s)
NefTat
Intervention Type
Drug
Intervention Name(s)
AS02A Adjuvant
Intervention Type
Biological
Intervention Name(s)
gp120W61D

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Evans
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Vaccine CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
San Francisco Vaccine and Prevention CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Project Brave HIV Vaccine CRS
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Brigham and Women's Hosp. CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Fenway Community Health Clinical Research Site (FCHCRS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Saint Louis Univ. School of Medicine, HVTU
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NY Blood Ctr./Bronx CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
NY Blood Ctr./Union Square CRS
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
HIV Prevention & Treatment CRS
City
New York
State/Province
New York
Country
United States
Facility Name
Univ. of Rochester HVTN CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Miriam Hospital's HVTU
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vanderbilt Vaccine CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Infectious Diseases Physicians, Inc.
City
Annandale
State/Province
Virginia
Country
United States
Facility Name
FHCRC/UW Vaccine CRS
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21085486
Citation
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.
Results Reference
result

Learn more about this trial

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

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