REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

Immune Response BioPharma

Status and phase: Unknown; Phase 2

Conditions: HIV/AIDS

Treatments: Biological: REMUNE

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291809

IR-HIV-007

Details and patient eligibility

About

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.

Full description

This is a 26 subject Multi Center double-blind randomized, Safety & Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection & immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.

Enrollment: 26 estimated patients

Sex: All

Ages: 3 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
• Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs

Exclusion criteria

• Truvada
• Triple cocktail HAART drugs
• Healthy subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

REMUNE

Experimental group

Description:

Remune vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 10 μg of p24 antigen in approximately 100 μg of total protein.

Treatment:

Biological: REMUNE

REMUNE Low Dose

Placebo Comparator group

Description:

Remune low dose vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 2.5 μg of p24 antigen in approximately 25 μg of total protein.

Treatment:

Biological: REMUNE