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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002261
First received: November 2, 1999
Last updated: September 24, 2007
Last verified: September 2007
  Purpose

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.

Condition Intervention Phase
HIV Infections
Biological: Smallpox Vaccine
Biological: HIVAC-1e
Biological: gp160 Vaccine (MicroGeneSys)
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002261

Locations
United States, Connecticut
Bristol - Myers Squibb Co
Wallingford, Connecticut, United States, 064927600
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002261     History of Changes
Other Study ID Numbers: 063A, AI452-003001
Study First Received: November 2, 1999
Last Updated: September 24, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Vaccines, Synthetic
Vaccinia Virus
Viral Vaccines
Smallpox Vaccine
HIV-1
AIDS Vaccines
HIV Seronegativity

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
HIV Infections
Smallpox
Vaccinia
DNA Virus Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Poxviridae Infections
Retroviridae Infections
RNA Virus Infections
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014