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

Primary Purpose

HIV/AIDS

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
REMUNE
Sponsored by
Immune Response BioPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring HIV/AIDS, Pediatric, Vaccine, HIV-1 Immunogen

Eligibility Criteria

3 Months - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Clinical Site TBA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

REMUNE

REMUNE Low Dose

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
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
HIV-1 immunogen on viral replication in children with HIV-1 infection
The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE
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

Full Information

First Posted
November 6, 2014
Last Updated
February 22, 2016
Sponsor
Immune Response BioPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02291809
Brief Title
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Official Title
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Response BioPharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, Pediatric, Vaccine, HIV-1 Immunogen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REMUNE
Arm Type
Experimental
Arm 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.
Arm Title
REMUNE Low Dose
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
REMUNE
Other Intervention Name(s)
HIV-1 Immunogen
Intervention Description
Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine
Primary Outcome Measure Information:
Title
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
Description
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) at Week 52
Time Frame
52 Weeks
Title
The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
Description
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
Secondary Outcome Measure Information:
Title
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
Description
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
Time Frame
52
Title
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
Description
HIV-1 immunogen on viral replication in children with HIV-1 infection
Time Frame
52 Weeks
Title
The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE
Description
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
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard M Bartholomew, PhD
Phone
(858) 414-4664
Email
richardmbartholomew@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Bartholomew, PhD
Organizational Affiliation
Immune Response BioPharma, Inc. Chief R&D Officer
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site TBA
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard M Bartholomew, PhD
Phone
858-414-4664
Email
richardmbartholomew@gmail.com

12. IPD Sharing Statement

Links:
URL
http://www.immuneresponse.net
Description
Immune Response BioPharma, Inc.

Learn more about this trial

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

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