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Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01496989
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : September 2, 2013
Sponsor:
Collaborators:
Auro Vaccines LLC
Ichor Medical Systems Incorporated
Information provided by (Responsible Party):
International AIDS Vaccine Initiative

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: HIV-MAG (3,000mcg) Biological: GENEVAX® IL-12 (100mcg) Biological: GENEVAX® IL-12 (1000mcg) Biological: Ad35-GRIN/ENV Phase 1

Detailed Description:

The study is a randomized, double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM) followed by Ad35-GRIN/ENV in each of four different regimens. An additional group will evaluate the safety and tolerability of Ad35-GRIN/ENV followed by HIV-MAG with co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM).

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Safety and Immunogenicity of a Multiantigen HIV (HIV-MAG) pDNA Vaccine With or Without Human IL-12 pDNA GENEVAX® IL-12) and Ad35-GRIN/ENV Vaccine in HIV-Uninfected, Healthy Volunteers
Study Start Date : December 2011
Actual Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Biological: HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation

Biological: Ad35-GRIN/ENV
(2x10^10vp) Delivered intramuscularly by standard needle injection
Experimental: 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)
 Biological: HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation

Biological: GENEVAX® IL-12 (100mcg)
Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation

Biological: Ad35-GRIN/ENV
(2x10^10vp) Delivered intramuscularly by standard needle injection
Experimental: 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)
 Biological: HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation

Biological: GENEVAX® IL-12 (1000mcg)
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation

Biological: Ad35-GRIN/ENV
(2x10^10vp) Delivered intramuscularly by standard needle injection
Experimental: 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)
 Biological: HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation

Biological: GENEVAX® IL-12 (1000mcg)
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation

Biological: Ad35-GRIN/ENV
(2x10^10vp) Delivered intramuscularly by standard needle injection
Experimental: 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)
 Biological: HIV-MAG (3,000mcg)
Delivered intramuscularly by in vivo electroporation

Biological: GENEVAX® IL-12 (1000mcg)
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation

Biological: Ad35-GRIN/ENV
(2x10^10vp) Delivered intramuscularly by standard needle injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 13 months approximately ]
    To evaluate the safety and tolerability of HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens.


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 12 months ]
    To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male or female adults,
  • 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.

Principal exclusion criteria:

  • confirmed HIV infection,
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496989


Locations
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Kenya
Kenya AIDS Vaccine Initiative, Kangemi
Nairobi, Kenya
Rwanda
Projet San Francisco
Kigali, Rwanda
Uganda
Uganda Virus Research Institute-IAVI
Entebbe, Uganda
Sponsors and Collaborators
International AIDS Vaccine Initiative
Auro Vaccines LLC
Ichor Medical Systems Incorporated
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT01496989    
Other Study ID Numbers: IAVI B004
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013
Keywords provided by International AIDS Vaccine Initiative:
HIV
AIDS
HIV vaccine
HIV prevention
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Interleukin-12
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents