Back to resultsAdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
Gambia
Study Type
Interventional
Intervention
AdCh63 ME-TRAP, MVA ME-TRAP
AdCH63 ME-TRAP, MVA ME-TRAP
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Immune response
Eligibility Criteria
Inclusion Criteria:
- Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.
Exclusion Criteria:
- 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.
Sites / Locations
- Medical Research Council Laboratories
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
No Intervention
Experimental
Experimental
No Intervention
Arm Label
Group A
Group B
Group C
Group D
Group E
Group F
Arm Description
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
5 to 12 months old infants; no vaccination
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
10 week old babies; no vaccination
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
To assess the immunogenicity 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 assessing induced antibody and T cell response to the vaccine insert
Full Information
NCT ID
NCT01450293
First Posted
October 3, 2011
Last Updated
December 11, 2013
Sponsor
University of Oxford
Collaborators
European and Developing Countries Clinical Trials Partnership (EDCTP)
1. Study Identification
Unique Protocol Identification Number
NCT01450293
Brief Title
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
European and Developing Countries Clinical Trials Partnership (EDCTP)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Immune response
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
Arm Title
Group B
Arm Type
Experimental
Arm Description
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
Arm Title
Group C
Arm Type
No Intervention
Arm Description
5 to 12 months old infants; no vaccination
Arm Title
Group D
Arm Type
Experimental
Arm Description
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
Arm Title
Group E
Arm Type
Experimental
Arm Description
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
Arm Title
Group F
Arm Type
No Intervention
Arm Description
10 week old babies; no vaccination
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP, MVA ME-TRAP
Intervention Description
1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Intervention Type
Biological
Intervention Name(s)
AdCH63 ME-TRAP, MVA ME-TRAP
Intervention Description
5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Primary Outcome Measure Information:
Title
Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
Description
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
Time Frame
Participants will be followed for the duration of the study, an expected average of 16 months
Secondary Outcome Measure Information:
Title
Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
Description
To assess the immunogenicity 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 assessing induced antibody and T cell response to the vaccine insert
Time Frame
Participants will be followed for the duration of the study, an expected average of 16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalifa Bojang
Organizational Affiliation
Medical Research Council PO Box 273, Banjul The Gambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Council Laboratories
City
Banjul
Country
Gambia
12. IPD Sharing Statement
Learn more about this trial
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
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