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

This study has been completed.
Sponsor:
Collaborators:
Profectus Biosciences, Inc.
Ichor Medical Systems Incorporated
Information provided by (Responsible Party):
International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT01496989
First received: December 19, 2011
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by International AIDS Vaccine Initiative:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 13 months approximately ] [ Designated as safety issue: Yes ]
    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:
  • Immunogenicity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.


Estimated Enrollment: 75
Study Start Date: December 2011
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496989

Locations
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
Profectus Biosciences, Inc.
Ichor Medical Systems Incorporated
  More Information

Additional Information:
No publications provided

Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT01496989     History of Changes
Other Study ID Numbers: IAVI B004
Study First Received: December 19, 2011
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration
Rwanda: Rwanda National Ethics Committee
Rwanda:Ministry of Health
Kenya: Kenyatta National Hospital/University of Nairobi Ethics and Research Committee
Kenya: Ministry of Health
Kenya: Pharmacy and Poisons Board, Ministry of Medical Services
Uganda: Uganda Virus Research Institute Science and Ethics Committee
Uganda: National Drug Authority
Uganda: National Council for Science and Technology

Keywords provided by International AIDS Vaccine Initiative:
HIV
AIDS
HIV vaccine
HIV prevention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interleukin-12
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014