Safety of and Immune Response to a DNA Vaccine and a Recombinant HIV-1-MVA Vaccine, Separately and in Combination, in Healthy Adults
NCT ID: NCT00428337
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2007-04-30
2008-08-31
Brief Summary
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Detailed Description
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The purpose of this study is to determine the safety of and immune response to two experimental vaccines for the prevention of HIV infection, individually and in combination, in healthy adults who have not been previously vaccinated against smallpox. Participants will be randomly assigned to one of three groups. All participants will receive injections at Days 0, 28, 84, and 168 of the study. Participants assigned to Group 1 will receive, on Day 0, one injection in each arm of EP-1233 or placebo and the same study product (EP-1233 or the DNA placebo) on Day 28. Thereafter, each Group 1 participant will receive one injection of MVA-mBN32 or placebo on Days 84 and 168. Groups 2 and 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 2 will receive only the DNA vaccine EP-1233 (or placebo) in each arm on all injection days. Participants in Group 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 3 will receive a consistent regimen of MVA-mBN32 (or placebo) on all injection days. Participants will be required to keep a symptom log for 3 days after each injection and attend clinical visits on Day 0, 14, 28, 42, 84, 98, 168, 182, 273, and 364 of the study. At each of the 10 visits, a physical exam, cardiac assessment, and HIV risk reduction and prevention counseling will occur. Blood collection will occur on Days 0, 14, 42, 98, 182, 273, and 364. Urine collection will occur on Days 14, 42, 98, and 182.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0 and 28 and one injection of MVA-mBN32 or placebo in each arm on Days 84 and 168
EP-1233
DNA-HIV-recombinant vaccine
MVA-mBN32
HIV-recombinant viral vaccine
2
Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0, 28, 84, and 168
EP-1233
DNA-HIV-recombinant vaccine
3
Participants will receive one injection of MVA-mBN32 or placebo in each arm on Days 0, 28, 84, and 168
MVA-mBN32
HIV-recombinant viral vaccine
Interventions
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EP-1233
DNA-HIV-recombinant vaccine
MVA-mBN32
HIV-recombinant viral vaccine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* HIV-infected
* Hepatitis B surface antigen positive
* Participation in prior HIV vaccination trial
* Immunosuppressive medications within 168 days prior to study entry
* Receipt of blood products within 120 days of study entry
* Receipt of live attenuated, medically indicated subunit, or killed (inactivated) vaccines within 30 days of study entry
* Certain abnormal lab values
* Pregnant or breastfeeding
18 Years
40 Years
ALL
Yes
Sponsors
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HIV Vaccine Trials Network
NETWORK
Pharmexa-Epimmune
UNKNOWN
Bavarian Nordic
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Geoffrey Gorse
Role: STUDY_CHAIR
Saint Louis University School of Medicine
Christine Mhorag Hay
Role: STUDY_CHAIR
University of Rochester
Locations
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San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
Univ. of Rochester HVTN CRS
Rochester, New York, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States
Countries
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References
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Dale CJ, Thomson S, De Rose R, Ranasinghe C, Medveczky CJ, Pamungkas J, Boyle DB, Ramshaw IA, Kent SJ. Prime-boost strategies in DNA vaccines. Methods Mol Med. 2006;127:171-97. doi: 10.1385/1-59745-168-1:171.
Ostrowski MA, Yu Q, Yue FY, Liu J, Jones B, Gu XX, Loutfy M, Kovacs CM, Halpenny R. Why can't the immune system control HIV-1? Defining HIV-1-specific CD4+ T cell immunity in order to develop strategies to enhance viral immunity. Immunol Res. 2006;35(1-2):89-102. doi: 10.1385/IR:35:1:89.
Rodriguez-Chavez IR, Allen M, Hill EL, Sheets RL, Pensiero M, Bradac JA, D'Souza MP. Current advances and challenges in HIV-1 vaccines. Curr HIV/AIDS Rep. 2006 Feb;3(1):39-47. doi: 10.1007/s11904-006-0007-0.
Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One. 2013;8(1):e54407. doi: 10.1371/journal.pone.0054407. Epub 2013 Jan 17.
Other Identifiers
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10394
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 067
Identifier Type: -
Identifier Source: org_study_id