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A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers Clinical research trials and A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers. A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers clinical trial. Participants frequently get the best healthcare available for their A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers  A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
For Condition: HIV Infections
Status: Completed
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Bristol - Myers Squibb Co
Wallingford, Connecticut, 064927600
United States
Additional Information:
Study ID Numbers: 063A; AI452-003001
Study Start Date:
Record last reviewed: July 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002261
Other Hiv Infections Studies:
1. A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
2. The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
3. Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection
4. A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
5. Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
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A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
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