Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers
NCT ID: NCT01496989
Last Updated: 2013-09-02
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
75 participants
INTERVENTIONAL
2011-12-31
Brief Summary
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Detailed Description
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Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration. It is anticipated that it will take approximately 3 months to enrol the study. Approximately 75 volunteers (60 vaccine/15 placebo recipients) will be included in the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 5: Ad35-GRIN/ENV followed by HIV-MAG+GENEVAX® IL-12
Ad35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3)
HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation
GENEVAX® IL-12 (1000mcg)
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation
Ad35-GRIN/ENV
(2x10\^10vp) Delivered intramuscularly by standard needle injection
Group 1: HIV-MAG followed by Ad35-GRIN/ENV
HIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3)
HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation
Ad35-GRIN/ENV
(2x10\^10vp) Delivered intramuscularly by standard needle injection
Group 2: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
HIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo=12/3)
HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation
GENEVAX® IL-12 (100mcg)
Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation
Ad35-GRIN/ENV
(2x10\^10vp) Delivered intramuscularly by standard needle injection
Group 3: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
HIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo= 12/3)
HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation
GENEVAX® IL-12 (1000mcg)
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation
Ad35-GRIN/ENV
(2x10\^10vp) Delivered intramuscularly by standard needle injection
Group 4: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3)
HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation
GENEVAX® IL-12 (1000mcg)
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation
Ad35-GRIN/ENV
(2x10\^10vp) Delivered intramuscularly by standard needle injection
Interventions
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HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation
GENEVAX® IL-12 (100mcg)
Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation
GENEVAX® IL-12 (1000mcg)
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation
Ad35-GRIN/ENV
(2x10\^10vp) Delivered intramuscularly by standard needle injection
Eligibility Criteria
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Inclusion Criteria
* 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),
* who do not report high-risk behaviour for HIV infection,
* who are available for the duration of the trial,
* who are willing to undergo HIV testing,
* use an effective method of contraception, and
* who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.
Exclusion Criteria
* pregnancy and lactation,
* significant acute or chronic disease,
* clinically significant laboratory abnormalities,
* recent vaccination or receipt of a blood product,
* previous receipt of an HIV vaccine, and
* previous severe local or systemic reactions to vaccination or history of severe allergic reactions.
18 Years
50 Years
ALL
Yes
Sponsors
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Auro Vaccines LLC
INDUSTRY
Ichor Medical Systems Incorporated
INDUSTRY
International AIDS Vaccine Initiative
NETWORK
Responsible Party
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Locations
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Kenya AIDS Vaccine Initiative, Kangemi
Nairobi, , Kenya
Projet San Francisco
Kigali, , Rwanda
Uganda Virus Research Institute-IAVI
Entebbe, , Uganda
Countries
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References
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Mpendo J, Mutua G, Nanvubya A, Anzala O, Nyombayire J, Karita E, Dally L, Hannaman D, Price M, Fast PE, Priddy F, Gelderblom HC, Hills NK. Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial. PLoS One. 2020 May 29;15(5):e0233151. doi: 10.1371/journal.pone.0233151. eCollection 2020.
Mpendo J, Mutua G, Nyombayire J, Ingabire R, Nanvubya A, Anzala O, Karita E, Hayes P, Kopycinski J, Dally L, Hannaman D, Egan MA, Eldridge JH, Syvertsen K, Lehrman J, Rasmussen B, Gilmour J, Cox JH, Fast PE, Schmidt C. A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of Electroporated HIV DNA with or without Interleukin 12 in Prime-Boost Combinations with an Ad35 HIV Vaccine in Healthy HIV-Seronegative African Adults. PLoS One. 2015 Aug 7;10(8):e0134287. doi: 10.1371/journal.pone.0134287. eCollection 2015.
Related Links
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International AIDS Vaccine Initiative
Ichor Medical Systems, Inc.
Other Identifiers
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IAVI B004
Identifier Type: -
Identifier Source: org_study_id