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

NCT ID: NCT02291809

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

REMUNE

Intervention Type BIOLOGICAL

Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine

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.

Group Type PLACEBO_COMPARATOR

REMUNE

Intervention Type BIOLOGICAL

Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine

Interventions

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REMUNE

Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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HIV-1 Immunogen

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immune Response BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard M Bartholomew, PhD

Role: STUDY_DIRECTOR

Immune Response BioPharma, Inc. Chief R&D Officer

Locations

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Clinical Site TBA

San Diego, California, United States

Site Status

Countries

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United States

Central Contacts

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Richard M Bartholomew, PhD

Role: CONTACT

(858) 414-4664

Facility Contacts

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Richard M Bartholomew, PhD

Role: primary

858-414-4664

Related Links

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http://www.immuneresponse.net

Immune Response BioPharma, Inc.

Other Identifiers

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IR-HIV-007

Identifier Type: -

Identifier Source: org_study_id

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