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Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults Clinical research trials and Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults. Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults clinical trial. Participants frequently obtain the most expert healthcare available for their Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults  Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.
Details: The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was developed to incorporate HIV genes from multiple virus clades, representing the viral subtypes responsible for about 90% of new HIV infections in the world. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV uninfected individuals. Participants will be randomly assigned to one of three groups and will be followed for one year. Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group 2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit, study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All participants will undergo physical exams, blood and urine tests to assess measures of health, and blood tests to assess HIV infection and immune response to the injections.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Understanding of vaccination procedure - Willing to receive HIV test results and provide informed consent - Good general health - HIV negative - Hepatitis B surface antigen negative - Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive - Not pregnant and agrees to use acceptable forms of contraception Exclusion Criteria - HIV vaccines or placebo in a prior HIV vaccine trial - Immunosuppressive medications within 168 days prior to study - Blood products within 120 days prior to study - Immunoglobulin within 60 days prior to study - Live attenuated vaccines within 30 days prior to study - Investigational research agents within 30 days prior to study - Medically indicated subunit or killed vaccines within 14 days prior to study - Current anti-tuberculosis prophylaxis or therapy - Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded - Autoimmune disease or immunodeficiency - Active syphilis infection - Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years) - Diabetes mellitus; a participant with past gestational diabetes is not excluded - Thyroid disease, including removal of thyroid and diagnoses requiring medication - Serious angioedema - Hypertension - Diagnosis of bleeding disorder - Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study - Seizure disorder requiring medication within the last 3 years - Absence of the spleen - Mental illness that would interfere with compliance with the protocol - Pregnant or breastfeeding - Two or more elevated liver function tests
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
JulieMcElrath, Study Chair, Fred Hutchinson Cancer Research Center / University of Washington
Vanderbilt University *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Kyle Rybczyk 615-322-5641
Additional Information:
Study ID Numbers: HVTN 052;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071851
Other Hiv Infections Studies:
1. Aerosols in the Treatment of Asymptomatic Pneumocystis Pneumonia: A Pilot Study Assessing the Effectiveness of Aerosolized Pentamidine as Treatment of Subclinical Pneumocystis Infection in Patients With No Clinical Symptoms
2. Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
3. A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
4. A Multi-Center, Open-Label, Ascending, Multiple Oral dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
5. Safety of and Immune Response to an HIV Vaccine (VRC-HIVDNA009-00-VP) Administered With Interleukin-2/Immunoglobulin (IL-2/Ig) DNA Adjuvant in Uninfected Adults
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Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
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