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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496989
• Other study ID #: IAVI B004
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2011
• Last updated: August 30, 2013
• Start date: December 2011

Study information

• Verified date: August 2013
• Source: International AIDS Vaccine Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRwanda: Rwanda National Ethics CommitteeRwanda:Ministry of HealthKenya: Kenyatta National Hospital/University of Nairobi Ethics and Research CommitteeKenya: Ministry of HealthKenya: Pharmacy and Poisons Board, Ministry of Medical ServicesUganda: Uganda Virus Research Institute Science and Ethics CommitteeUganda: National Drug AuthorityUganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• 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

Locations

Country	Name	City	State
Kenya	Kenya AIDS Vaccine Initiative, Kangemi	Nairobi
Rwanda	Projet San Francisco	Kigali
Uganda	Uganda Virus Research Institute-IAVI	Entebbe

Sponsors (3)

Lead Sponsor	Collaborator
International AIDS Vaccine Initiative	Ichor Medical Systems Incorporated, Profectus BioSciences, Inc.

Countries where clinical trial is conducted

Kenya,  Rwanda,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability	To evaluate the safety and tolerability of HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens.	13 months approximately	Yes
Secondary	Immunogenicity	To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.	12 months	No

External Links

•   Ichor Medical Systems, Inc.
•   International AIDS Vaccine Initiative
•   Profectus Biosciences, Inc.