A Study of MVA85A in Healthy Children and Infants
A Phase II Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Children and Infants After BCG Vaccination at Birth
2 other identifiers
interventional
168
1 country
1
Brief Summary
This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will vaccinate 24 children with 5 x 10\^7pfu of MVA85A and three groups of 36 infants with 2.5 x 10\^7, 5 x 10\^7 or 1 x 10\^8 pfu. Participants will be identified from the general population living in Worcester, Western Cape, South Africa
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 9, 2010
February 1, 2010
1.8 years
April 2, 2008
February 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of MVA85A. Both local and systemic adverse events will be monitored, including a daily diary card for the first week. Blood will be taken at day 7 and day 28 for biochemistry and haematology.
3 months
Secondary Outcomes (1)
Immunogenicity of MVA85A
3 months
Study Arms (5)
1
EXPERIMENTAL24 children (5 x 10\^7pfu)
2
EXPERIMENTAL36 infants (2.5 x 10\^7pfu)
3
EXPERIMENTAL36 infants (5 x 10\^7 pfu)
4
EXPERIMENTAL36 infants (1 x 10\^8pfu)
5
PLACEBO COMPARATOR36 infants (Prevenar vaccine)
Interventions
Eligibility Criteria
You may qualify if:
- Eligible subjects will be children or infants aged 6 months - 11 years.
- Subject's parent/guardian is willing and able to give written informed consent for participation in the study.
- Subject is BCG vaccinated within the first 4 weeks of life
- In addition, informed assent will be obtained from all children aged 7 years or older unless they are adjudged incapable of understanding the basic concepts covered in the informed assent form, and an attempt will be made to obtain informed assent from children aged younger than 7 years if they are judged capable of understanding the basic concepts covered in the informed assent form
- Subject is in good health
- Subject has clinically acceptable laboratory results from screening visit
- CXR normal with no evidence of active or past TB
- Subject's parent/legal guardian is willing to allow child to undergo an HIV test
- Parent/guardian and subject able (in the Investigators opinion) and willing to comply with all study requirements.
You may not qualify if:
- Subject is Mantoux (\>10 mm) and/or ELISPOT (\> 50 spots/million PBMC) positive for M tb (PPD, ESAT 6 and/or CFP10)
- Subject is HIV antibody positive
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/subject at risk because of participation in the study, or may influence the result of the study, or the patient/subject's ability to participate in the study.
- Patient/subjects/healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
- Patient/subjects previously enrolled into this study.
- Received a live vaccine (e.g. measles) in the previous 4 weeks or due to receive a live vaccine in the 4 weeks following enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- University of Cape Towncollaborator
Study Sites (1)
University Cape Town
Worcester, Western Cape, South Africa
Related Publications (1)
Scriba TJ, Tameris M, Mansoor N, Smit E, van der Merwe L, Mauff K, Hughes EJ, Moyo S, Brittain N, Lawrie A, Mulenga H, de Kock M, Gelderbloem S, Veldsman A, Hatherill M, Geldenhuys H, Hill AV, Hussey GD, Mahomed H, Hanekom WA, McShane H. Dose-finding study of the novel tuberculosis vaccine, MVA85A, in healthy BCG-vaccinated infants. J Infect Dis. 2011 Jun 15;203(12):1832-43. doi: 10.1093/infdis/jir195.
PMID: 21606542DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen McShane
University of Oxford
- PRINCIPAL INVESTIGATOR
Gregory Hussey
University of Cape Town
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 2, 2008
First Posted
May 16, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
February 9, 2010
Record last verified: 2010-02