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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers Clinical research trials and A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers. A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers clinical trial. Participants typically obtain the most effective healthcare available for their A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers  A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative volunteers. ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease.
Details: ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease. Volunteers are randomized to receive doses of ALVAC-HIV vCP205 or ALVAC-HIV vCP65 control or both according to varying schedules over 12 months (was 6 months, amended 11/17/95) with a 12 month follow up. [AS PER AMENDMENT 5/29/98: One additional follow-up visit is required at 30-36 months.]
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers must have: - Normal history and physical exam. - Negative ELISA and Western blot for HIV. - CD4 count >= 400 cells/mm3. - Normal urine dipstick with esterase and nitrite. - Occupational responsibilities that preclude compliance. Exclusion Criteria Co-existing Condition: Volunteers 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. - 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. - Allergy to egg products or neomycin. Volunteers 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. - Prior immunization against rabies. - History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-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. - Occupational responsibilities that preclude compliance. Prior Medication: Excluded: - Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations. - Experimental agents within 30 days prior to study entry. - Prior HIV vaccines. - Prior rabies immunization. Prior Treatment: Excluded: - Blood products or immunoglobulin within 6 months prior to study entry. Risk Behavior: Excluded: Identifiable high-risk behavior for HIV infection, such as: - injection drug use within past 12 months; higher- or intermediate-risk sexual behavior. - Occupational exposure to birds. Low risk sexual behavior.
Total Enrollment: 76
Location and Contact Information:
Overall Study Official:
CoreyL, Study Chair,
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 212051901
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
St Louis Univ School of Medicine
St. Louis, Missouri, 63104
United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
United States
Additional Information:
Study ID Numbers: AVEG 022;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001055
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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers
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