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)
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001020
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 28
- Expected to finish
- 1995-02-01
- Last updated by the study team
- 2012-05-18
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients must have:
- Documented HIV seronegativity.
- Good general health.
- No high-risk behavior for HIV infection.
You may not qualify if…
- 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.
Where it is running
- St Louis Univ School of Medicine — St Louis, Missouri, United States
- Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States
- Children's Hospital & Medical Center / Seattle ACTU — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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