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Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults Clinical research trials and Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults. Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults clinical trial. Test subjects typically receive the most effective healthcare possible for their Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults  Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
For Condition: HIV Seronegativity,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.
Details: To date, adverse reactions to immunization with the various ALVAC-HIV candidate vaccines, including ALVAC-HIV (vCP1452), have been similar to those observed in healthy adults who have received other licensed vaccines of similar types. In a previous trial, even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised. In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors, the data demonstrated more robust immune responses with higher doses of ALVAC-HIV (vCP1452) in mice. It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte (CTL) response. As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection, the HVTN will utilize the highest dose that can be currently manufactured. All study products are to be administered intramuscularly. Participants will receive 1 of 3 injections. Group A will receive a high dose of vaccine, group B will receive a low dose of vaccine, and group C will receive a placebo. Participants are inoculated at 4 time points. Assessment of product safety includes clinical observation, monitoring of hematological, chemical, and immunologic parameters, and a social harms questionnaire. Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial. Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Participants may be eligible for this study if they: - Are between the ages of 18 and 60. - Are in good general health. - Have a CD4 count of 400 or more cells/mm3. - Do not have hepatitis C or active hepatitis B. - Have had a negative HIV blood test within 8 weeks prior to enrollment. - Use approved methods of contraception. - Have access to a participating site and are available for follow-up for 18 months. - Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment. - Give written informed consent. Exclusion Criteria Participants may not be eligible for this study if they: - Are pregnant or breast-feeding. - Have received a live vaccine within 30 days prior to enrollment. - Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine. - Have used experimental research agents within 30 days prior to enrollment. - Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial. - Have received blood products 120 days before HIV screening. - Have received immunoglobulin 60 days before HIV screening. - Have a history of serious harmful reactions to vaccines. - Have a history of disease of the immune system. - Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period. - Are using or have used (within past 6 months) drugs that interfere with the immune system. - Have a history of type I or type II diabetes. - Have thyroid disease. - Have unstable asthma. - Are currently taking preventive anti-TB therapy. - Have a seizure disorder. - Have a bleeding disorder that was diagnosed by a physician. - Have had their spleen removed. - Have angioedema with serious episodes. - Have active syphilis. - Have hypertension. - Have mental problems that would interfere with the protocol. - Have any other problems that, in the judgment of the investigator, would interfere with the study. - Have a body mass index less than 20. - Are allergic or sensitive to egg products. - Have active tuberculosis.
Total Enrollment: 110
Location and Contact Information:
Overall Study Official:
PaulGoepfert, Study Chair,
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Columbia Univ
New York City, New York, 10032
United States
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, 212011192
United States
Fred Hutchinson Cancer Research Ctr
Seattle, Washington, 98109
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Johns Hopkins Bloomberg School of Public Health
Washington D.C., District of Columbia, 20037
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
United States
New York Blood Center
New York City, New York, 10021
United States
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
United States
Fenway Community Health
Boston, Massachusetts, 02115
United States
Univ of Marlyand / Infectious Diseases Physicians
Fairfax, Virginia,
United States
Harvard University / Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
Saint Louis Univ Health Sciences Ctr
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: HVTN 039;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027261
Other Hiv Seronegativity Studies:
1. Increasing HAART-Induced Immune Restoration with Cyclosporine
2. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
3. Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
4. A Comparison of Two Tests for Anti-HIV Drug Resistance
5. Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma
Related Studies:
Other HIV Seronegativity Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
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