REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
NCT ID: NCT02291809
Last Updated: 2016-02-23
Study Results
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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UNKNOWN
PHASE2
26 participants
INTERVENTIONAL
2017-11-30
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
REMUNE
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.
REMUNE
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs
Exclusion Criteria
* Triple cocktail HAART drugs
* Healthy subjects
3 Months
16 Years
ALL
No
Sponsors
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Immune Response BioPharma, Inc.
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Immune Response BioPharma, Inc.
Other Identifiers
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IR-HIV-007
Identifier Type: -
Identifier Source: org_study_id
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