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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00820846 |
Purpose
The purpose of this study is to evaluate the safety of and immune response to a two vaccine regimen in healthy, HIV-uninfected adults who never received an HIV preventive vaccine before.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: Vaccine Biological: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62, in Health, HIV Uninfected Vaccinia-naive Adult Participants |
| Estimated Enrollment: | 225 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Participants will receive the JS7 DNA and MVA/HIV62 vaccinations
|
Biological: Vaccine
Administered as an intramuscular injection four times over the course of 6 months
|
|
B: Placebo Comparator
Participants will receive the placebo equivalents of the JS7 DNA and MVA/HIV62 vaccines
|
Biological: Placebo
Administered as an intramuscular injection four times over the course of 6 months
|
Some of the first HIV vaccines were designed to trigger neutralizing antibody responses as a way to prevent HIV infection. Unfortunately, the first versions of these vaccines were not able to achieve their desired response. An alternative strategy to the antibody approach is the stimulation of HIV-specific CD8 T-lymphocyte (CTL) responses. CTL responses were previously demonstrated to play an important role in the control of simian immunodeficiency virus (SIV), the HIV equivalent seen in rhesus macaque monkeys. Additionally, other studies suggest CTLs play an important role in viral control during chronic infection. Based on this information, several groups have shifted their focus to the development of CTL-based vaccines, some of which have entered advanced clinical trials.
A DNA/rMVA vaccine strategy is structured to bring about both T cell and antibody responses. The primary vaccination is DNA based and will express only HIV proteins as a way to produce an HIV-focused immune response. A secondary, rMVA boost vaccination, which expresses both HIV and MVA proteins will ideally amplify the focused response of the initial vaccination. The DNA and rMVA are physically two different vaccinations given at separate times but together they make up one preventive regimen. Both vaccine components express non-infectious virus-like particles.
This study is a multicenter, randomized study, which is comprised of both vaccine and placebo recipients. Each vaccine is given twice, for a total of four injections over 6 months. The study will last for a total of 12 months for participants, including enrollment and follow-up.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Alabama Vaccine CRS | Recruiting |
| Birmingham, Alabama, United States, 35294-2050 | |
| Contact: Susan F. Duncan, CRNP, MSN 205-975-2840 sduncan@uab.edu | |
| Principal Investigator: Paul A. Goepfert, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hosp. CRS | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Lizanne C. Noble, MPH 617-732-5394 lnoble@partners.org | |
| Principal Investigator: Lindsey R. Baden, MD | |
| Fenway Community Health Clinical Research Site (FCHCRS) | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Marie Feldmannova 617-927-6075 Mfeldmannova@fenwayhealth.org | |
| Principal Investigator: Kenneth H. Mayer, MD | |
| United States, New York | |
| Univ. of Rochester HVTN CRS | Recruiting |
| Rochester, New York, United States, 14642-0001 | |
| Contact: Catherine A. Bunce, RN, MS, CCRC 585-275-5744 catherine_bunce@urmc.rochester.edu | |
| Principal Investigator: Michael C. Keefer, MD | |
| HIV Prevention & Treatment CRS | Not yet recruiting |
| New York, New York, United States, 10032 | |
| Contact: Steven Chang 212-305-1570 sc1286@columbia.edu | |
| Principal Investigator: Scott M. Hammer, MD | |
| NY Blood Ctr./Bronx CRS | Recruiting |
| Bronx, New York, United States, 10455 | |
| Contact: Debbie Lucy 718-402-0743 ext 309 dlucy@nybloodcenter.org | |
| Principal Investigator: Beryl Koblin, PhD | |
| NY Blood Ctr./Union Square CRS | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Krista Goodman 212-388-0008 ext 20 kgoodman@nybloodcenter.org | |
| Principal Investigator: Beryl Koblin, PhD | |
| United States, Tennessee | |
| Vanderbilt Vaccine CRS | Recruiting |
| Nashville, Tennessee, United States, 37232-2222 | |
| Contact: Kyle Rybzyk 615-322-5641 kyle.rybczyk@vanderbilt.edu | |
| Principal Investigator: Spyros A. Kalams, MD | |
| Peru, Maynas | |
| Asociacion Civil Selva Amazonica, CRS | Recruiting |
| Iquitos, Maynas, Peru | |
| Contact: Lilian Saavedra Sevillano 51-6-5236277 ext 107 lsaavedra@acsaperu.org | |
| South Africa | |
| CAPRISA eThekwini CRS | Not yet recruiting |
| Durban, South Africa, 4011 | |
| Contact: Munira Khan 27-031-260 1918 gengiahs@ukzn.ac.za | |
| Principal Investigator: Nesri Padayatchi, MD | |
| Study Chair: | Paul A Goepfert, M.D. | UAB, Div. of Infectious Diseases |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | HVTN 205 |
| Study First Received: | January 8, 2009 |
| Last Updated: | November 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00820846 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV Seronegativity HIV Preventive Vaccine |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |