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

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ClinicalTrials.gov Identifier: NCT02291809
Recruitment Status : Not yet recruiting
First Posted : November 14, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Immune Response BioPharma, Inc.

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Biological: REMUNE Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Study Start Date : November 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: HIV-1 Immunogen




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291809


Contacts
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Contact: Richard M Bartholomew, PhD (858) 414-4664 richardmbartholomew@gmail.com

Locations
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United States, California
Clinical Site TBA Not yet recruiting
San Diego, California, United States, 92101
Contact: Richard M Bartholomew, PhD    858-414-4664    richardmbartholomew@gmail.com   
Sponsors and Collaborators
Immune Response BioPharma, Inc.
Investigators
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Study Director: Richard M Bartholomew, PhD Immune Response BioPharma, Inc. Chief R&D Officer

Additional Information:
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Responsible Party: Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02291809     History of Changes
Other Study ID Numbers: IR-HIV-007
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Immune Response BioPharma, Inc.:
HIV/AIDS
Pediatric
Vaccine
HIV-1 Immunogen

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs