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

Conditions

HIV Infections

Keywords

HIV, AIDS, HIV vaccine, HIV prevention

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.

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.

Juliet Mpendo, Gaudensia Mutua, Annet Nanvubya, Omu Anzala, Julien Nyombayire et al. (13 authors)

PLoS ONE2020-05-2919 citations

10.1371/journal.pone.0233151

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

Juliet Mpendo, Gaudensia Mutua, Julien Nyombayire, Rosine Ingabire, Annet Nanvubya et al. (20 authors)

PLoS ONE2015-08-0743 citations

10.1371/journal.pone.0134287

A phase I double blind, placebo-controlled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults.

Keefer MC, Gilmour J, Hayes P, Gill D, Kopycinski J, Cheeseman H, Cashin-Cox M, Naarding M, Clark L, Fernandez N, Bunce CA, Hay CM, Welsh S, Komaroff W, Hachaambwa L, Tarragona-Fiol T, Sayeed E, Zachariah D, Ackland J, Loughran K, Barin B, Cormier E, Cox JH, Fast P, Excler JL.

2012-08-0369 citations

10.1371/journal.pone.0041936

Interventions

BIOLOGICALHIV-MAG (3,000mcg)

Delivered intramuscularly by in vivo electroporation

BIOLOGICALGENEVAX® IL-12 (100mcg)

Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation

BIOLOGICALGENEVAX® IL-12 (1000mcg)

Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation

BIOLOGICALAd35-GRIN/ENV

(2x10\^10vp) Delivered intramuscularly by standard needle injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events as a measure of safety and tolerability	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

Measure	Time frame	Description
Immunogenicity	12 months	To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.

Countries

Kenya, Rwanda, Uganda

Outcome results

None listed