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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.
Study NCT00002261.   Last updated on September 24, 2007.   Information provided by Bristol-Myers Squibb

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Descriptive Information Fields
Brief Title  A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
Official Title  A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
Brief 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.
Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Prevention
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Biological: Smallpox Vaccine
Biological: HIVAC-1e
Biological: gp160 Vaccine (MicroGeneSys)
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility 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.

Gender Both
Ages 18 Years to 60 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002261
Organization ID 063A
Secondary IDs †† AI452-003001
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Study Director:     Bristol-Myers Squibb     Bristol-Myers Squibb    
Information Provided By Bristol-Myers Squibb
Verification Date September 2007
First Received Date  November 2, 1999
Last Updated Date September 24, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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