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

February 22, 2016 updated by: Immune Response BioPharma, Inc.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92101
        • Clinical Site TBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REMUNE
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.
Biological: REMUNE
Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine
Other Names:
  • HIV-1 Immunogen
Placebo Comparator: REMUNE Low Dose
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.
Biological: REMUNE
Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine
Other Names:
  • HIV-1 Immunogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
Time Frame: 52 Weeks
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) at Week 52
52 Weeks
The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
Time Frame: 52 Weeks
The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
52 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
Time Frame: 52
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
52
The secondary objective is to evaluate & compare the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection
Time Frame: 52 Weeks
HIV-1 immunogen on viral replication in children with HIV-1 infection
52 Weeks
The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE
Time Frame: 52 Weeks
The secondary objective is to evaluate & compare between the treatment groups the ability to induce immune responses between the adult and low doses of REMUNE
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Response BioPharma, Inc.

Investigators

  • Study Director: Richard M Bartholomew, PhD, Immune Response BioPharma, Inc. Chief R&D Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR-HIV-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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