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A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers Clinical research trials and A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers. A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers clinical trial. Human subjects often receive the most effective healthcare possible for their A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers  A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers
A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected 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 live recombinant canarypox ALVAC-HIV vCP205 in combination with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) at 80 microg and 250 microg. [AS PER AMENDMENT 4/30/99: To study the safety of following 4 ALVAC immunizations with a nucleic acid gag/pol HIV-1 immunogen (APL-400-047, Wyeth-Lederle). To assess the ability of this sequence of immunization to boost the LTL, T-helper cell, and antibody response.] ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols. Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candidate vaccine, volunteers have generated anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the majority, of volunteers, the geometric mean titers of these antibodies are modest, usually less than 50. This study will determine whether there is an increase in the anti-HIV antibody titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the kinetics and magnitude of the HIV-specific CTL response.
Details: ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols. Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candidate vaccine, volunteers have generated anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the majority, of volunteers, the geometric mean titers of these antibodies are modest, usually less than 50. This study will determine whether there is an increase in the anti-HIV antibody titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the kinetics and magnitude of the HIV-specific CTL response. In this randomized, placebo-controlled, double-blinded study volunteers receive ALVAC-HIV vCP205 at 10^6.3 TCID50 or placebo and GM-CSF or placebo by intramuscular injection at Months 0, 1, 3, and 6 as follows: Group A: vCP205 plus GM-CSF placebo (10 volunteers) Group B: vCP205 plus 80 microg GM-CSF (10 volunteers) Group C: vCP205 plus 250 microg GM-CSF (10 volunteers) Group D: vcP205 placebo plus GM-CSF placebo (6 volunteers). [AS PER AMENDMENT 04/30/99: Boosting with APL-400-047 HIV-1 gag/pol DNA is added for volunteers who have received all scheduled immunization in the original protocol. Volunteers in Groups A, B, and C will receive booster intramuscular injections of DNA vaccine at Months 0 and 1, those in Group D will receive DNA control (bupivacaine carrier alone) at Months 0 and 1].
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers must have: - Negative ELISA for HIV within 8 weeks prior to immunization. - CD4 count of 400 cells/mm3 or higher. - Normal history and physical examination. - Viable EBV line prior to initial immunization. [AS PER AMENDMENT 4/30/99: - Negative anti-dsDNA antibodies (for volunteers receiving booster vaccine).] Exclusion Criteria Co-existing Condition: Volunteers with the following conditions or symptoms are excluded: - Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol. - Recent suicidal ideation or psychosis. - Active syphilis. NOTE: - If the serology is documented to be a false positive or due to a remote (greater than 6 months) treated infection, the volunteer is eligible. - Active tuberculosis. NOTE: - Volunteers who have a positive PPD and a normal chest x-ray showing no evidence of TB and who do not require INH therapy are eligible. - Positive for hepatitis C antibody or hepatitis B surface antigen. - Allergy to eggs, neomycin, or thimerosal. [AS PER AMENDMENT 4/30/99: - Hypersensitivity to bupivacaine or other amide-type anesthetics (e.g., lidocaine, mepivacaine) for volunteers receiving booster vaccine).] Concurrent Medication: Excluded: Lithium or cimetidine. Volunteers with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, or autoimmune disease. - History of cancer unless there has been surgical excision with reasonable assurance of cure. - History of suicide attempts or past psychosis. - History of anaphylaxis or other serious adverse reactions to vaccines. - History of serious allergic reaction to any substance requiring hospitalization or emergent care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). [AS PER AMENDMENT 11/13/97: - History of cardiac disease or cardiac arrhythmias.] Prior Medication: Excluded: - Live attenuated vaccines within 60 days of study. NOTE: - Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations. - Experimental agents within 30 days prior to study. - Blood products or immunoglobulin in the past 6 months. - HIV-1 vaccines or placebo as part of a previous HIV vaccine trial. - Immunosuppressive medications. Risk Behavior: Excluded: Volunteers with an identifiable higher-risk behavior for HIV infection (i.e., AVEG Risk Group C or D), including a history of injection drug use within 12 months prior to enrollment or higher-risk sexual behavior as defined by the AVEG.
Total Enrollment: 36
Location and Contact Information:
Overall Study Official:
TEvans, Study Chair,
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
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
Additional Information:
Study ID Numbers: AVEG 033;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001090
Other Hiv Infections Studies:
1. Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
2. Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s)
3. Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV
4. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
5. The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients with Early HIV Infection
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A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers
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