Phase 2
Completed N=2,797
A Study of MVA85A in Healthy Infants
Source: ClinicalTrials.gov NCT00953927 ↗Enrolled (actual)
2,797
Serious AEs
18.4%
Results posted
Dec 2013
Primary outcomePrimary: To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants. — 95.9; 83.7 percentage of all subjects vaccinated
Summary
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of age) who received study vaccine or control and were followed for 15 - 36 months. The study was conducted at a single site in South Africa.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants. |
95.9; 83.7 | — |
| SECONDARY 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. |
32; 39 | — |
| SECONDARY 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. |
0.012; 0.003; 0.007; 0.000 | — |
| SECONDARY To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials. |
143.000; 1.000 | — |
| SECONDARY 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. |
0.030; 0.001; 0.000; 0.000 | — |
| SECONDARY To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485. |
— | — |
| SECONDARY To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial. |
178; 171 | — |
Eligibility 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 or, if =37.5 degrees Celsius on Study Day 0
- Evidence of significant active infection on Study Day 0
- Received a Expanded Program of Immunization (EPI) within 14 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
Data sourced from ClinicalTrials.gov (NCT00953927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.