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NCT00002261 · ClinicalTrials.gov registry record · Phase 1

A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers

A Phase 1 study of HIV Infections, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
1
Study location

NCT00002261 is a Phase 1 study of HIV Infections that has completed, run by Bristol-Myers Squibb. The trial reports 1 study location across 1 state.

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The verdict

NCT00002261, a Phase 1 study of HIV Infections, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
1
Study location

Study Summary

To determine the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will include: 1. The course of physiological responses to vaccination, including (a) lesion development, progression, and resolution; (b) physiological changes such as temperature, malaise, itching at the site, etc. and (c) any observable AE. 2. The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus. 3. The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus. 4. The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site. 5. The safety, humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.

Conditions Studied

HIV Infections

Interventions

  • BIOLOGICAL Smallpox Vaccine
  • BIOLOGICAL HIVAC-1e
  • BIOLOGICAL gp160 Vaccine (MicroGeneSys)

Study Locations (1)

Connecticut

  • Bristol - Myers Squibb Co - Wallingford

Trial Details

FieldValue
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00002261

The ClinicalTrials.gov registry entry for NCT00002261 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Smallpox Vaccine is the first listed.

NCT00002261 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT00002261 about?

NCT00002261 is a clinical study titled "A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers". To determine the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will include: 1. The course of ...

What is the current status of trial NCT00002261?

This trial is currently completed. It is a Phase 1 study.

What conditions does trial NCT00002261 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002261?

The interventions under investigation include: Smallpox Vaccine (BIOLOGICAL), HIVAC-1e (BIOLOGICAL), gp160 Vaccine (MicroGeneSys) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00002261?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002261 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.