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NCT00027261 · ClinicalTrials.gov registry record · Phase 1

Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

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

Completed
Registry status
Phase 1
Development phase
110
Enrollment target

NCT00027261 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 110 participants.

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The verdict

NCT00027261, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
110 participants
Enrollment target

Study Summary

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

Interventions

  • BIOLOGICAL ALVAC(2)120(B,MN)GNP (vCP1452)

Trial Details

FieldValue
Enrollment Target 110 participants
Est. Completion 2005-12
Phase Phase 1

What the Registry Record Tells You About NCT00027261

The ClinicalTrials.gov registry entry for NCT00027261 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 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 ALVAC(2)120(B,MN)GNP (vCP1452) is the first listed.

NCT00027261 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00027261 about?

NCT00027261 is a clinical study titled "Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults". The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, o...

What is the current status of trial NCT00027261?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. Estimated completion is 2005-12.

What interventions are being tested in trial NCT00027261?

The interventions under investigation include: ALVAC(2)120(B,MN)GNP (vCP1452) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00027261?

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

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