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NCT00001021 · ClinicalTrials.gov registry record · Phase 1
A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00001021: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001021 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001021, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X extension - in patients previously enrolled on VEU 009). ORIGINAL DESIGN: To evaluate the clinical and immunologic safety of MN rgp120/HIV-1 vaccine (MN rgp120 vaccine) given alone or concurrently with the IIIB rgp120/HIV-1 vaccine (IIIB rgp120 vaccine) in healthy HIV-1 seronegative adult subjects. To compare the immune response to MN rgp120 vaccine given at 100, 300, or 600 mcg. To determine the immune response to 300 mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently. Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA technology. Because the two vaccines are derived from distinct HIV-1 strains, they may elicit some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120 vaccine has not yet been evaluated in humans, although it is expected that the MN type will result in similar safety and immunogenicity as the IIIB type.
Interventions
- BIOLOGICAL rgp120/HIV-1MN
- BIOLOGICAL rgp120/HIV-1IIIB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Phase | Phase 1 |
What the finished NCT00001021 record still lists
NCT00001021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which rgp120/HIV-1MN is the first listed.
NCT00001021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001021 about?
NCT00001021 is a clinical study titled "A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)". AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X extension - in patients previously enrolled on VEU 009). ORIGINAL DESIGN: To evaluate the clinical and immunologic safe...
What is the current status of trial NCT00001021?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants.
What interventions are being tested in trial NCT00001021?
The interventions under investigation include: rgp120/HIV-1MN (BIOLOGICAL), rgp120/HIV-1IIIB (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001021?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001021's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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