MedTrace Logo

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

NCT00002261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2007-09-26

No results posted yet for this 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

  • HIV Infections

Interventions

BIOLOGICAL

Smallpox Vaccine

BIOLOGICAL

HIVAC-1e

BIOLOGICAL

gp160 Vaccine (MicroGeneSys)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Purpose
PREVENTION

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002261 on ClinicalTrials.gov