NCT00002261

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. 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. 2.The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus.
  3. 3.The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus.
  4. 4.The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site.
  5. 5.The safety, humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

September 26, 2007

Status Verified

September 1, 2007

First QC Date

November 2, 1999

Last Update Submit

September 24, 2007

Conditions

HIV Infections

Keywords

Vaccines, SyntheticVaccinia VirusViral VaccinesSmallpox VaccineHIV-1AIDS VaccinesHIV Seronegativity

Interventions

Smallpox VaccineBIOLOGICAL
HIVAC-1eBIOLOGICAL
gp160 Vaccine (MicroGeneSys)BIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • 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.
  • 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:
  • Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
  • Current evidence of clinically active viral infections.
  • 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:
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol - Myers Squibb Co

Wallingford, Connecticut, 064927600, United States

Location

MeSH Terms

Conditions

HIV InfectionsVaccinia

Interventions

Smallpox VaccineHIVAC-1eVaxSyn HIV-1 (gp160) vaccine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPoxviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

September 26, 2007

Record last verified: 2007-09

Locations

US(1)