|
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B) Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B) Clinical research trials and A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B) medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B). A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B) Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B) clinical trial. Subjects typically recieve the finest healthcare available for their A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B) condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)  A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate, in healthy HIV-1 seronegative vaccinia-immune and vaccinia-naive volunteers, the safety and immunogenicity of an HIV-1 candidate vaccine (TBC-3B) consisting of a live recombinant vaccinia virus expressing the env, gag, and pol genes of HIV-1 IIIB strain. To evaluate the potential of boosting with one of a variety of HIV-1 recombinant subunit, peptide, or pseudovirion vaccines, if available, to augment the immune responses of the vaccinees. Antigenic drift, defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection, may confound attempts to achieve protective immunity using a vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability. A prime-boost immunization approach using a novel priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be attempted in this study.
Details: Antigenic drift, defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection, may confound attempts to achieve protective immunity using a vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability. A prime-boost immunization approach using a novel priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be attempted in this study. In Part I, vaccinia-immune volunteers are randomized to one of two regimens. Group A receives priming with TBC-3B on days 0 and 56, followed by boosting on day 224 (8 months) with one of the following: TBC-3B, an alternative immunogen such as pseudovirion particles or a recombinant HIV-1 subunit or peptide vaccine, or placebo. Group B receives priming with control vaccine (DryVax), followed by boosting with an appropriate placebo. At least 50 percent of subjects in Part I will be observed for a minimum of 8 weeks before subsequent volunteers are enrolled in Part II. PER 11/18/94 AMENDMENT, Part I boosting is given on day 392. PER 5/19/95 AMENDMENT, Part I boosting is given on day 756 if not available on day 392; if the appropriate product is not available then, the study will end on day 756. In Part II, vaccinia-naive volunteers are randomized to one of three regimens. Group C receives TBC-3B on day 0 and saline placebo on day 56. Group D receives TBC-3B on days 0 and 56. Both Group C and D receive boosting with TBC-3B or an alternative immunogen on day 224. Group E receives control vaccine (DryVax) on days 0 and 56, followed by appropriate placebo on day 224. Per 06/10/94 addendum, volunteers will be contacted once or twice per year for at least 5 years to check on health status. NOTE: Part I (Part A) of the protocol has closed to accrual.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Subjects must have: - Negative ELISA and Western blot for HIV-1 within 6 weeks prior to immunization. - Normal history and physical exam. - History of smallpox vaccination at least 5 years prior to study entry (Part I) OR no prior smallpox vaccination (Part II). - Absolute CD4 count >= 400 cells/mm3. - Normal urinalysis. NOTE: - No more than 10 percent of volunteers in both Parts I and II may be over 50 years of age. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: - Positive hepatitis B surface antigen. - Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance. - Occupational responsibilities that preclude compliance. - Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible. - Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. - Eczema. - Household contact with persons meeting any of the following criteria: - pregnancy, less than 12 months of age, eczema, immunodeficiency disease, or use of immunosuppressive medications. Subjects with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. - History of anaphylaxis or other serious adverse reactions to vaccines. - Eczema within the past year. - History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension). - Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance. - History of cancer unless there has been surgical excision that is considered to have achieved cure. Prior Medication: Excluded: - Prior HIV vaccines. - Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations. - Experimental agents within the past 30 days. Prior Treatment: Excluded: - Receipt of blood products or immunoglobulins within the past 6 months. It is STRONGLY RECOMMENDED that any activity that might expose subject to HIV (unprotected sex or needle sharing) be avoided.
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
KeeferM, Study Chair,
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
St Louis Univ School of Medicine
St. Louis, Missouri, 63104
United States
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 212051901
United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
United States
Additional Information:
Study ID Numbers: AVEG 014A/B;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000767
Other Hiv Infections Studies:
1. Vitamin A Therapy for Tuberculosis
2. A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
3. A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs
4. A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
5. Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
Related Studies:
Other HIV Infections Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
|
|
|
|
|
|
|
|
