AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
Safety and Immunogenicity of Heterologous Prime-boost Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Infants in a Malaria- Endemic Area
1 other identifier
interventional
72
1 country
1
Brief Summary
Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2011
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
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 12, 2013
December 1, 2013
1.4 years
October 3, 2011
December 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by recording local and systemic solicited and unsolicited adverse events
Participants will be followed for the duration of the study, an expected average of 16 months
Secondary Outcomes (1)
Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
Participants will be followed for the duration of the study, an expected average of 16 months
Study Arms (6)
Group A
EXPERIMENTAL5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
Group B
EXPERIMENTAL5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
Group C
NO INTERVENTION5 to 12 months old infants; no vaccination
Group D
EXPERIMENTAL10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
Group E
EXPERIMENTAL10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
Group F
NO INTERVENTION10 week old babies; no vaccination
Interventions
1x10\^10 vp AdCH63 ME-TRAP followed by 1x10\^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Eligibility Criteria
You may qualify if:
- Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.
You may not qualify if:
- Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- Severe malnutrition.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
- History of splenectomy Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
- Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator
- Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
- Blood transfusion within one month of enrollment.
- History of vaccination with previous experimental malaria vaccines. -Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs Current participation in another clinical trial, or within 12 weeks of this study.
- Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
- Likelihood of travel away from the study area
- Maternal HIV infection Positive malaria antigen test at screening
- Failure to have received, prior to enrollment, the routine EPI vaccinations due according to the Gambian EPI schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Research Council Laboratories
Banjul, The Gambia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kalifa Bojang
Medical Research Council PO Box 273, Banjul The Gambia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 12, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
December 12, 2013
Record last verified: 2013-12