A Study of MVA85A in Healthy Infants
This study has been completed.
Sponsor:
Aeras
Collaborators:
University of Oxford
University of Cape Town
Information provided by (Responsible Party):
Aeras
ClinicalTrials.gov Identifier:
NCT00953927
First received: July 31, 2009
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
This is a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in BCG vaccinated infants without tuberculosis or HIV infection. This study consists of 2784 infants (126 to 182 days of age) who will receive study vaccine or control and be followed for 18-24 months. The study is planned at a single site in South Africa.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis |
Biological: MVA85A/AERAS-485 Biological: Candida Skin Test Antigen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants |
Resource links provided by NLM:
Further study details as provided by Aeras:
Primary Outcome Measures:
- The primary objective of this study is to evaluate the safety profile of MVA85A/AERAS-485 in BCG-Vaccinated, HIV-negative Infants. [ Time Frame: AEs recorded 28 days post-vaccination; SAEs recorded for entire study period. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the efficacy of the MVA85A/AERAS-485 vaccine compared to controls in prevention of tuberculosis using an endpoint derived from epidemiological cohort surveys in BCG vaccinated infants. [ Time Frame: 18 to 24 months post-vaccination ] [ Designated as safety issue: No ]
- To evaluate the immunogenicity of the MVA85A/AERAS-485 vaccine compared to controls as described by flow cytometric intracellular cytokine staining of CD4 and CD8 T cells. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
- To evaluate the immunogenicity of the MVA85A/AERAS-485 vaccine compared to controls as described by the ex vivo ELISPOT test used in previous MVA85A/AERAS-485 human trials. [ Time Frame: 7 days post-vaccination ] [ Designated as safety issue: No ]
- To evaluate the immunogenicity of the MVA85A/AERAS-485 vaccine compared to controls as described by the University of Capetown (UCT) whole blood intracellular cytokine assay. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
- To discover correlates of protection from tuberculosis in infants vaccinated with MVA85A/AERAS-485. [ Time Frame: 18 to 24 months post-vaccination ] [ Designated as safety issue: No ]
- To evaluate the QuantiFERON conversion rate at final study assessment in MVA85A/AERAS-485 recipients compared to controls in subjects without a diagnosis of tuberculosis during the trial. [ Time Frame: 18 to 24 months post-vaccination ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2784 |
| Study Start Date: | July 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Investigational Vaccine
MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
|
Biological: MVA85A/AERAS-485
Attenuated virus MVA vector with insertion. Single dose vaccine, 1 x 10^8 pfu.
Other Name: Manufactured by IDT of Germany.
|
|
Placebo Comparator: Control Group
Candida Skin Test control; subset into cohorts to explore different safety and immunogenicity tests.
|
Biological: Candida Skin Test Antigen
1 test, administered once as a placebo control.
Other Names:
|
Eligibility| Ages Eligible for Study: | 126 Days to 182 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age of 126 through 182 days on the day of randomization (Study Day 0)
- Written informed consent obtained from the parents/guardian
- Weight: by chart >3rd percentile on Study Day 0
- BCG vaccination within 7 days of birth.
- Generally good health confirmed by medical history and physical examination within 35 days prior to Study Day 0
- Must have received age-appropriate doses of pneumococcal vaccine as recommended by the South African Department of Health but no injection within 28 day prior to Study Day 0
- Ability to complete follow-up period of up to 728 days as required by the protocol
- Completed simultaneous enrollment in the Aeras Vaccine Development Registry protocol
Exclusion Criteria:
- Acute illness on Study Day 0
- Fever >=37.5C on Study Day 0
- Evidence of significant active infection on Study Day 0
- Received a EPI immunization within 28 days prior to Study Day 0
- Historical or virological evidence of individual or maternal human immunodeficiency virus (HIV-1) infection
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
- Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the infant in the study
- Evidence of chronic hepatitis from any cause
- History or evidence of any systemic disease on physical examination or any acute, chronic or intercurrent illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine
- History of or known tuberculosis or treatment for tuberculosis
- Shared residence since birth with an individual with active tuberculosis or on anti-tuberculosis treatment for less than 2 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953927
Locations
| South Africa | |
| South African Tuberculosis Vaccine Initiative (Satellite) | |
| Ceres, South Africa, 6835 | |
| South African Tuberculosis Vaccine Initiative (Satellite) | |
| Robertson, South Africa, 6705 | |
| South African Tuberculosis Vaccine Initiative (Headquarters) | |
| Worcester, South Africa, 6850 | |
Sponsors and Collaborators
Aeras
University of Oxford
University of Cape Town
Investigators
| Principal Investigator: | Hassan Mahomed, MD | South African Tuberculosis Vaccine Initiative |
| Study Director: | Bernard Landry, MPH | Aeras |
| Study Chair: | Helen McShane, MD | University of Oxford; Centre for Vaccinology & Tropical Medicine |
More Information
No publications provided
| Responsible Party: | Aeras |
| ClinicalTrials.gov Identifier: | NCT00953927 History of Changes |
| Other Study ID Numbers: | C-020-485, Oxford TB020 |
| Study First Received: | July 31, 2009 |
| Last Updated: | February 25, 2013 |
| Health Authority: | South Africa: Medicines Control Council South Africa: Human Research Ethics Committee United Kingdom: Research Ethics Committee United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013