Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)
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|ClinicalTrials.gov Identifier: NCT01151189|
Recruitment Status : Completed
First Posted : June 28, 2010
Results First Posted : August 26, 2015
Last Update Posted : May 24, 2016
This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults.
This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity analysis set).
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis HIV Infections||Biological: MVA85A/AERAS-485 Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Proof of Concept, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Protective Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in Healthy, HIV-infected Adults|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||September 2014|
Placebo Comparator: Placebo
The placebo is a licensed product manufactured by Allermed, Inc. and is used for evaluation of delayed-type of hypersensitivity reactions in adults.
Subjects received an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.
Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485.
- Percentage of Participants With Adverse Events [ Time Frame: Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination. ]The primary objective of this study is to evaluate the safety of MVA85A/AERAS-485 compared to placebo in HIV-infected, African adult subjects without active TB disease.
- Number of TB Cases [ Time Frame: For at least 6 months post second vaccination up to 33 months total follow-up. ]Efficacy of MVA85A/AERAS-485 in the prevention of TB disease compared to control subjects who received placebo in HIV-infected, African adult subjects without active TB disease.
- CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in Anti-retroviral Therapy Negative (ART -)Subjects [ Time Frame: Up to 6 months post second vaccination. ]
- CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Subjects [ Time Frame: Up to 6 months post second vaccination. ]
- HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART - Participants [ Time Frame: Up to 6 months post second vaccination. ]
- HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Participants. [ Time Frame: Up tp 6 months post second vaccination ]
- Counts of Spot-forming Units After Stimulation With AG85A Peptide Pool. [ Time Frame: 28 days post second vaccination. ]Immunogenicity of MVA85A/AERAS-485 compared to placebo as described by the ex vivo interferon (IFN)-γ enzyme linked immunospot (ELISpot).
- Immunogenicity of MVA85A/AERAS-485 Compared to Placebo as Described by Flow Cytometric Intracellular Cytokine Staining (ICS) of CD4+ and CD8+ T Cells After Stimulation With a Peptide Pool of Mycobacterial Antigens. [ Time Frame: 7 days post second vaccination. ]The antigen-specific negative control-subtracted response for any cytokine (Interferon gamma [INFγ] , Interleukin 2 [IL2], Interleukin 17 [IL17] and tumor necrosis factor [TNF]).
- QuantiFERON (QFN) Conversion Rate in MVA85A/AERAS-485 Recipients Compared to Control Subjects Without a Diagnosis of Tuberculosis During the Trial. [ Time Frame: For at least 6 months post second vaccination up to 33 months total follow-up. ]
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): NCT01151189
|Hopital Aristide Le Dantec|
|Dakar, Senegal, 7325|
|University of Cape Town|
|Cape Town, South Africa, 7925|
|Principal Investigator:||Souleymane Mboup||Hopital Aristide Le Dantec|
|Principal Investigator:||Robert Wilkinson||University of Cape Town|
|Study Director:||Bernard Landry||Aeras|