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NCT00001037 · ClinicalTrials.gov registry record · Phase 1

A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
22
Enrollment target

NCT00001037 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 22 participants.

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The verdict

NCT00001037, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection (i.e., at month 17). A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.

Interventions

  • BIOLOGICAL gp160 Vaccine (Immuno-AG)

Trial Details

FieldValue
Enrollment Target 22 participants
Est. Completion 1995-05
Phase Phase 1

What the Registry Record Tells You About NCT00001037

The ClinicalTrials.gov registry entry for NCT00001037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 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 1 intervention - of which gp160 Vaccine (Immuno-AG) is the first listed.

NCT00001037 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00001037 about?

NCT00001037 is a clinical study titled "A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules". To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 mon...

What is the current status of trial NCT00001037?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. Estimated completion is 1995-05.

What interventions are being tested in trial NCT00001037?

The interventions under investigation include: gp160 Vaccine (Immuno-AG) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00001037?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.