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A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers 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 II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 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 II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers Clinical research trials and A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers 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 II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers. A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers 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 II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers clinical trial. Human subjects often get the best healthcare available for their A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers 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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Home > "A" Clinical Trials Conditions > A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers  A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone.] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.]
Details: In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.] Volunteers are recruited and screened; those who are enrolled are then stratified by their risk status into 2 groups: individuals having lower-risk behavior for HIV and individuals having higher-risk behavior for HIV. Volunteers are then randomly assigned to arm A, B, or C and receive immunizations at months 0, 1, 3, and 6 as follows: Group A- ALVAC vCP205 plus SF-2 rgp120 in MF59. Group B- ALVAC vCP205 plus saline placebo. Group C- Placebo-ALVAC plus saline placebo. [AS PER AMENDMENT 7/2/98: Beginning 12-18 months after initial vaccination, then 2, 6, and 12 months later, 10 volunteers from group A receive saline placebo, while 50 volunteers each from groups B and C are rerandomized within their respective groups, and are treated as follows. Group B (subgroup 1) - AIDSVAX B/B. Group B (subgroup 2) - AIDSVAX B/E. Group B (subgroup 3) - alum placebo. Group C (subgroup 1) - AIDSVAX B/B. Group C (subgroup 2) - AIDSVAX B/E. Group C (subgroup 3) - alum placebo.] Volunteers are followed for 2 years and are tested for humoral immune response to HIV-1. Neutralizing activity to HIV-1 is performed on a subset of volunteers monitored for CTL response. [AS PER AMENDMENT 7/2/98: Volunteers receiving AIDSVAX B/B and AIDSVAX B/E will additionally be studied for formation of various neutralizing antibodies and parameters of cellular immunity.] [AS PER AMENDMENT 4/30/99: Because the subunit boosts that were added in version 3.0 are not available, the subunit boost portion of version 3.0 is cancelled.]
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Participants must have: - Negative ELISA for HIV within 8 weeks of immunization. - Normal history and physical examination. - Availability for follow-up for planned duration of at least 24 months and willing to have 2 brief evaluations at 36 and 48 months. Exclusion Criteria Co-existing Condition: Participants with the following symptoms or conditions are excluded: - Active syphilis. NOTE: - AS PER AMENDMENT 6/25/97: - Participant eligible if the serology is documented to be a false positive or due to adequately treated infection. - Active tuberculosis (TB). NOTE: - Participant eligible if positive purified protein derivative and normal chest x-ray shows no evidence of TB and does not require isoniazid therapy. Participants with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, malignancy, idiopathic anaphylaxis (AS PER AMENDMENT 6/25/97) or autoimmune disease. Participants with a history of cancer are excluded unless they have undergone surgery followed by a sufficient observation period to give a reasonable assurance of cure. - Any history of anaphylaxis or history of other serious adverse reactions to vaccines. - Immediate-type hypersensitivity reaction to egg products or neomycin (used to prepare ALVAC vaccines). Prior Medication: Excluded: - Immunosuppressive medications. - Live attenuated vaccines within 60 days of study. - Use of investigational agents within 30 days prior to study. - Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial. Prior Treatment: Excluded: - Receipt of blood products or immunoglobulin within past 6 months. Risk Behavior: Excluded: - Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol. Specifically excluded are persons with a history of suicide attempts within 3 years, recent suicidal ideation or who have past or present psychosis. - Medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, hepatitis A and B allowed provided administered more than 2 weeks from HIV study immunizations.
Total Enrollment: 420
Location and Contact Information:
Overall Study Official:
BelsheR, Study Chair,
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
United States
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
United States
Univ of Washington / Fred Hutchinson Cancer Rsch Cntr
Seattle, Washington, 98104
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Washington
Seattle, Washington, 98104
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Saint Louis Univ Health Sciences Ctr
St. Louis, Missouri, 63110
United States
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, 19104
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Denver Dept of Public Health / HIVNET
Denver, Colorado, 80204
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
Howard Brown Health Ctr / HIVNET
Chicago, Illinois, 60657
United States
New York Univ Med Ctr
New York City, New York, 100163240
United States
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, 80262
United States
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: AVEG 202; HIVNET 014
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000871
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2. Treatment of Acute HIV Infection to Preserve Immune Function
3. A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
4. Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing Nelfinavir
5. A Phase I/II Pilot Study of Simultaneously Administered rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
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A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
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