A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

This study has been completed.
Sponsor:
Collaborator:
Protein Sciences Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000745
First received: November 2, 1999
Last updated: May 23, 2012
Last verified: May 2012

November 2, 1999
May 23, 2012
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00000745 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.

Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B vaccine group will serve as an additional control for immunological evaluations. An optional fourth injection may be given 15-21 months following the initial inoculation.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
  • Biological: Hepatitis B Vaccine (Recombinant)
  • Biological: gp160 Vaccine (MicroGeneSys)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
May 1991
Not Provided

Inclusion Criteria

Subjects must have:

  • Normal history and physical exam.
  • Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
  • T4 count >= 800 cells/mm3.
  • Normal chest x-ray and urinalysis.
  • Negative surface antibody and core antibody for hepatitis B.
  • Negative hepatitis B surface antigen.
  • Negative HIV p24 antigen test.
  • Normal skin reactivity by Merieux test.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

  • Positive PPD.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).

Subjects with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
  • Prior hepatitis B vaccination.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Prior Medication:

Excluded:

  • Prior hepatitis B vaccine.

Prior Treatment:

Excluded:

  • Prior blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:

  • Any history of IV drug use.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
  • More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000745
AVEG 003, 10540
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Protein Sciences Corporation
Study Chair: Belshe R
Study Chair: Clements ML
Study Chair: Couch R
Study Chair: Dolin R
Study Chair: Levine M
Study Chair: Wright P
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP