Trial record 6 of 27 for:
" December 14, 2011":" January 13, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers
This study is ongoing, but not recruiting participants.
Sponsor:
International AIDS Vaccine Initiative
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: December 13, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Interleukin-12
U.S. FDA Resources
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 |
| Estimated Primary Completion Date: | April 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: | December 13, 2012 |
| 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 May 22, 2013