A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study Extended ONLY for Subjects Who Have Previously Received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover Study)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001020
First received: November 2, 1999
Last updated: May 16, 2012
Last verified: May 2012

November 2, 1999
May 16, 2012
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Complete list of historical versions of study NCT00001020 on ClinicalTrials.gov Archive Site
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A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study Extended ONLY for Subjects Who Have Previously Received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover Study)
A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study Extended ONLY for Subjects Who Have Previously Received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover Study)

AMENDED 11/17/93: To determine whether the pattern of response to MN rgp120 vaccine is altered by pre-exposure to IIIB rgp120.

ORIGINAL DESIGN: To evaluate the safety (clinical and immunologic) of rgp120/HIV-1IIIB vaccine (gp120 vaccine) immunization in healthy HIV-1 seronegative adult subjects. To compare the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine. To determine whether gp120 vaccine immunization causes a significant immune response as defined by specific parameters (e.g., induction of neutralizing antibodies to the IIIB isolate of HIV-1, gp120 antigen-specific lymphocytic proliferation).

Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species.

Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species.

AMENDED 11/17/93: Selected subjects from VEU 006 or VEU 006 Rollover study will receive two injections of MN rgp120 vaccine, administered 28 days apart beginning 10-16 months after their last injection. Eight additional clinic visits will be required. Subjects are followed for at least 6 months.

ORIGINAL DESIGN: Twenty-eight subjects will be randomized to receive 100 or 300 mcg rgp120/HIV-1IIIB vaccine (gp120 vaccine) or matching placebo. For each dose level, 10 subjects will receive vaccine and four subjects will receive matching placebo. Injections are given intramuscularly at 0, 4, and 32 weeks. Each subject receiving treatment at the lower dose level must be monitored for unacceptable toxicity for at least 2 weeks following the initial immunization before his or her second dose is administered and before treatment at the higher dose level begins. Subjects are followed for at least 12 months.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
  • Biological: rgp120/HIV-1IIIB
  • Biological: rgp120/HIV-1MN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 1995
Not Provided

Inclusion Criteria

Patients must have:

  • Documented HIV seronegativity.
  • Good general health.
  • No high-risk behavior for HIV infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Postive PPD (unless a chest x-ray is negative and there is no suggestion of active or old pulmonary tuberculosis).
  • Positive VDRL or HBsAG.
  • No febrile illness within 1 week of study.

Concurrent Medication:

Excluded:

  • Concomitant corticosteroids or other known immunosuppressive drugs.
  • Other experimental agents.

Patients with the following prior conditions are excluded:

  • History of clinically significant cardiac, pulmonary, hepatic, renal, neurologic, or autoimmune disease.

Prior Medication:

Excluded:

  • Other immunization within 4 weeks prior to study entry.

Identifiable high-risk behavior for HIV infection.

Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001020
AVEG 006X, VEU 006, V0199g, 11537
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Genentech
Study Chair: Clements M
Study Chair: Belshe R
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