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A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn) Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn) Clinical research trials and A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn) health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn). A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn) Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn) clinical trial. Human subjects often get the best healthcare available for their A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn) condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn)



A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn)

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e). Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.
Details: Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration. Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.
Eligibility:
Study Type:  Interventional, Prevention, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Normal history and physical exam. - Negative ELISA for HIV. - Negative HIV p24 antigen test. - Normal urinalysis. Prior Medication: Required: - Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners. - History of immunodeficiency or chronic illness. - Hypersensitivity to insects. - Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol. Patients with the following prior conditions are excluded: - History of immunodeficiency or chronic illness. Prior Medication: Excluded: - Immunosuppressive medications. Prior Treatment: Excluded: - Blood or blood product transfusion within the past 6 months. Risk Behavior: Excluded: - Intravenous drug use. - More than 2 sexual partners.
Total Enrollment: 13

Location and Contact Information:

Overall Study Official:
CoreyL,  Study Chair, 

Children's Hospital & Medical Center / Seattle ACTU
Seattle,  Washington,  981050371
United States
 


Additional Information:
Study ID Numbers:  AVEG 002B; 
Study Start Date: 
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000631

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A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn)
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