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Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination 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 Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults Clinical research trials and Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults. Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults clinical trial. Test subjects typically receive the most expert healthcare available for their Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults  Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults
Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine formulations, rMVA-HIV and rFPV-HIV, alone and in combination, in HIV uninfected adults.
Details: Pox viruses are used for investigational vaccines in humans because they can accommodate large amounts of foreign DNA, can infect mammalian cells, and can access the cytotoxic T cell responses believed to be important in the control of HIV infection and disease. Two pairs of matching recombinant HIV vaccines have been developed for use in this study. One pair uses a modified vaccinia Ankara (MVA) vector and the other pair uses a fowlpox (FPV) vector. Each vaccine pair consists of one vaccine containing env/gag sequences and one vaccine containing modified tat/rev/nef-RT sequences. The HIV sequences are identical and are from a vertically transmitted pediatric primary isolate. The controls in this study are MVA and FPV vectors without the HIV genes. The study will evaluate the safety and immunogenicity of the vaccine pairs. There are two parts to this study. Participants in Part A will be randomly assigned to one of five different vaccination groups. Within each group, participants will be randomly assigned to receive either vaccine or control injections. Group 1 participants will receive the FPV vaccine pair or FPV control at each vaccine visit. Groups 2, 3, and 4 will receive one of three different doses of the MVA vaccine pair or MVA control at study entry and Month 1, then a fixed dose of the FPV vaccine pair or FPV control at Months 3, 5, and 7. Group 5 participants will receive the MVA vaccine pair or MVA control at maximum tolerated dose (MTD) at each vaccine visit. Groups 1 and 2 will enroll simultaneously; Groups 3, 4, and 5 will enroll as safety data from the previous groups become available. In Part B, participants will be randomly assigned to receive study vaccine or control vaccine in one of three vaccination groups. Group 6 participants will receive the FPV vaccine pair or FPV control at each vaccine visit. Group 7 participants will receive the MVA vaccine pair or MVA control at study entry and Month 1, then a fixed dose of the FPV vaccine pair or FPV control at Months 3, 5, and 7. Group 8 participants will receive the MVA vaccine pair at MTD or MVA control at each vaccine visit. Enrollment into Groups 6, 7, and 8 will begin simultaneously after the completion of the safety data evaluation of Groups 1 and 2. Study vaccinations will be given at study entry and at Months 1, 3, 5 and 7. Study visits will occur at screening, study entry, and at 11 visits over 13 months. Study visits will consist of a physical exam, risk reduction/pregnancy prevention counseling, and blood and urine collection. Women will have pregnancy tests at study entry and Months 1, 3, 5, 7, and 13.
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: - HIV uninfected within 8 weeks prior to first vaccination - Blood pressure 140/90 or less upon enrollment - Good general health - Willing to receive HIV test results - Understand the vaccination procedure - Negative for hepatitis B surface antigen - Negative for anti-hepatitis C virus antibodies (anti-HCV) or negative for HCV PCR if anti-HCV is positive - Agree to use acceptable forms of contraception - Willing to be followed for the duration of the study - Access to a participating HIV vaccine trial site Exclusion Criteria: - HIV vaccines or placebos in prior HIV vaccine trial - Previously received Avipox vaccine - Previously received Vaccinia vaccine - Immunosuppressive medications within 168 prior to first vaccination - Blood products within 120 days prior to first vaccination - Immunoglobulin within 60 days prior to first vaccination - Live attenuated vaccines within 30 days prior to first vaccination - Investigational research agents within 30 days prior to first vaccination - Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration, or allergy treatment with antigen injections within 30 days prior to first vaccination - Current tuberculosis prophylaxis or therapy - Hypersensitivity to egg products - Present or past active cardiac disease - Two or more of the following cardiac risk factors: history of fasting LDL greater than 160 mg/dl; first degree relative who had heart condition, excluding hypertension; cigarette smoking - Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. - Autoimmune disease or immunodeficiency - Unstable asthma - Diabetes mellitus Type 1 or Type 2 - Thyroid disease requiring treatment - Serious angioedema within the last 3 years - Bleeding disorder - Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period - Seizure disorder requiring medication within the past 3 years - Absence of the spleen - Mental illness that would interfere with the study - Other conditions that, in the judgement of the investigator, would interfere with the study - Pregnancy or breastfeeding
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
MichaelKeefer, Study Chair, University of Rochester
FHCRC/UW - Vaccine Trials Unit
Seattle, Washington, 98104
United States
David Berger 206-667-2344
New York Blood Center - Bronx
Bronx, New York, 10456
United States
Pamela Brown-Peterside 718-588-8900
Miriam Hospital
Providence, Rhode Island, 02906
United States
Patricia Morris 401-793-4932
Additional Information:
Study ID Numbers: HVTN 055;
Study Start Date: July 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083603
Other Hiv Infections Studies:
1. Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects
2. Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults
3. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
4. Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients with AIDS
5. 3TC (Lamivudine; GR109714X) Open-Label Program
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults
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