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

NCT ID: NCT00002261

Last Updated: 2007-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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HIV Infections

Keywords

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Vaccines, Synthetic Vaccinia Virus Viral Vaccines Smallpox Vaccine HIV-1 AIDS Vaccines HIV Seronegativity

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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Smallpox Vaccine

Intervention Type BIOLOGICAL

HIVAC-1e

Intervention Type BIOLOGICAL

gp160 Vaccine (MicroGeneSys)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

* 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:

* 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.

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

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Bristol - Myers Squibb Co

Wallingford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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AI452-003001

Identifier Type: -

Identifier Source: secondary_id

063A

Identifier Type: -

Identifier Source: org_study_id