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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 Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD 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 website dedicated 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 health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties 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 volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes 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. Human subjects frequently get the finest 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, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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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:
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2. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
3. Tolerability of Three Local Anesthetic Formulations in Conjunction with NGX-4010 for the Treatment of Neuropathic Pain
4. A Study of Trimetrexate Plus Leucovorin in Children with Pneumocystis Carinii Pneumonia
5. A Pilot/Dose-Finding Study of the Toxicity, Anti-Kaposi's Sarcoma (KS) Activity, and Immunologic Activity of Interleukin-12 Administered to Patients with AIDS-Associated KS
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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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