AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
This study is ongoing, but not recruiting participants.
Sponsor:
University of Oxford
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01450293
First received: October 3, 2011
Last updated: October 2, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Biological: AdCh63 ME-TRAP, MVA ME-TRAP Biological: AdCH63 ME-TRAP, MVA ME-TRAP |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Oxford:
Primary Outcome Measures:
- Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP [ Time Frame: Participants will be followed for the duration of the study, an expected average of 16 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: Participants will be followed for the duration of the study, an expected average of 16 months ] [ Designated as safety issue: No ]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
| Enrollment: | 72 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
|
Biological: AdCh63 ME-TRAP, MVA ME-TRAP
1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
|
|
Experimental: Group B
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
|
Biological: AdCH63 ME-TRAP, MVA ME-TRAP
5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
|
|
No Intervention: Group C
5 to 12 months old infants; no vaccination
|
|
|
Experimental: Group D
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
|
Biological: AdCh63 ME-TRAP, MVA ME-TRAP
1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
|
|
Experimental: Group E
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
|
Biological: AdCH63 ME-TRAP, MVA ME-TRAP
5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
|
|
No Intervention: Group F
10 week old babies; no vaccination
|
Eligibility| Ages Eligible for Study: | 10 Weeks to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450293
Locations
| Gambia | |
| Medical Research Council Laboratories | |
| Banjul, Gambia | |
Sponsors and Collaborators
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP)
Investigators
| Principal Investigator: | Kalifa Bojang | Medical Research Council PO Box 273, Banjul The Gambia |
More Information
No publications provided
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01450293 History of Changes |
| Other Study ID Numbers: | VAC042 |
| Study First Received: | October 3, 2011 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Gambia: MRC Ethics Committee |
Keywords provided by University of Oxford:
|
Immune response |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013