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

September 24, 2007 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Wallingford, Connecticut, United States, 064927600
        • Bristol - Myers Squibb Co

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • All drugs, medications, and therapy which, by virtue of direct pharmacologic action or possible drug interaction, could influence the intended effects of the study vaccine or mask its side effects may be concomitantly administered only by prescription by the Principal Investigator and must be documented on the case report form (CRF).
  • Any drug, even aspirin, which is administered after vaccination and during the follow up periods must be documented on the patient's CRF.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Failure to meet any criteria listed under Inclusion Criteria.
  • Development of active eczema or other skin condition which would increase the risk of secondary vaccinia lesions.
  • Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
  • Current evidence of clinically active viral infections such as Mononucleosis, Epstein-Barr Virus, or cytomegalovirus which may affect immunocompetence.
  • Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria.

Concurrent Medication:

Excluded:

  • All drugs, medications and therapy not prescribed by the Principal Investigator, and not documented on the case report form (CRF).
  • Any drug, even aspirin, which is administered after vaccination and during the follow up periods which is not documented on the patient's CRF.

Patients with the following are excluded:

  • Failure to meet any criteria listed under Inclusion Criteria.
  • Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
  • Current evidence of clinically active viral infections.
  • Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria.

Risk Behavior:

Patients who do not agree to behave sexually in a manner that will minimize the risk of HIV infection for the duration of the study are excluded.

Patients must:

  • Be HIV seronegative.
  • Have excellent general health.
  • Be unable to bear children.
  • Have no immediate household contacts, sex partners, intimate contacts.
  • Be free of clinical skin diseases.
  • Have signed an informed consent.
  • Control subjects receiving Smallpox vaccine will also be selected under the same inclusion criteria. They may be recruited from low risk behavior populations; from laboratory and hospital employees providing service to the study who would normally require Smallpox vaccination; and may be heterosexual, homosexual, or bisexual.

Patients must agree to behave sexually in a manner that will minimize the risk of HIV infection for the duration of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

September 26, 2007

Last Update Submitted That Met QC Criteria

September 24, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 063A
  • AI452-003001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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