AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area
Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults and Children in a Malaria Endemic Area
1 other identifier
interventional
52
1 country
1
Brief Summary
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 and adult volunteers 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2010
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 14, 2013
March 1, 2013
1.5 years
June 14, 2011
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by recording local and systemic solicited and unsolicited adverse events
Participants will be followed for the duration of the study, an expected average of 12 months
Secondary Outcomes (1)
Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
Participants will be followed for the duration of the study, an expected average of 12 months
Study Arms (8)
Group 1A
EXPERIMENTALAdults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 1B
EXPERIMENTALAdults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP
Group 2A
EXPERIMENTALChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 2B
EXPERIMENTALChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 2C
ACTIVE COMPARATORChildren (2-6 years old) vaccinated with human diploid cell rabies vaccine
Group 3A
EXPERIMENTALChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 3B
EXPERIMENTALChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 3C
ACTIVE COMPARATORChildren (2-6 years old) vaccinated with human diploid cell rabies vaccine
Interventions
AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later
Eligibility Criteria
You may qualify if:
- Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.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.
- Hypersensitivity to HDCRV.
- 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 9.0 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 enrolment.
- History of vaccination with previous experimental malaria vaccines.
- Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
- 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.
- HIV positive.
- Positive malaria antigen test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Kalifa Bojang
Banjul, The Gambia
Related Publications (1)
Ogwang C, Afolabi M, Kimani D, Jagne YJ, Sheehy SH, Bliss CM, Duncan CJ, Collins KA, Garcia Knight MA, Kimani E, Anagnostou NA, Berrie E, Moyle S, Gilbert SC, Spencer AJ, Soipei P, Mueller J, Okebe J, Colloca S, Cortese R, Viebig NK, Roberts R, Gantlett K, Lawrie AM, Nicosia A, Imoukhuede EB, Bejon P, Urban BC, Flanagan KL, Ewer KJ, Chilengi R, Hill AV, Bojang K. Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults. PLoS One. 2013;8(3):e57726. doi: 10.1371/journal.pone.0057726. Epub 2013 Mar 19.
PMID: 23526949DERIVED
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
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 15, 2011
Study Start
June 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 14, 2013
Record last verified: 2013-03