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NCT00000746 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00000746 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants.
The verdict
NCT00000746, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters. Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone. In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.
Interventions
- BIOLOGICAL rgp120/HIV-1 SF-2
- BIOLOGICAL HIVAC-1e
- BIOLOGICAL gp160 Vaccine (MicroGeneSys)
- BIOLOGICAL Env 2-3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Est. Completion | 1994-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000746
The ClinicalTrials.gov registry entry for NCT00000746 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which rgp120/HIV-1 SF-2 is the first listed.
NCT00000746 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000746 about?
NCT00000746 is a clinical study titled "A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines". Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the ...
What is the current status of trial NCT00000746?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. Estimated completion is 1994-07.
What interventions are being tested in trial NCT00000746?
The interventions under investigation include: rgp120/HIV-1 SF-2 (BIOLOGICAL), HIVAC-1e (BIOLOGICAL), gp160 Vaccine (MicroGeneSys) (BIOLOGICAL), Env 2-3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000746?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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