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AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area

NCT ID: NCT01450293

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Keywords

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Immune response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

1x10\^10 vp AdCH63 ME-TRAP followed by 1x10\^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.

Group B

5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP

Group Type EXPERIMENTAL

AdCH63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

5x10\^10 vp AdCH63 ME-TRAP followed by 1x10\^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.

Group C

5 to 12 months old infants; no vaccination

Group Type NO_INTERVENTION

No interventions assigned to this group

Group D

10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

1x10\^10 vp AdCH63 ME-TRAP followed by 1x10\^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.

Group E

10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP

Group Type EXPERIMENTAL

AdCH63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

5x10\^10 vp AdCH63 ME-TRAP followed by 1x10\^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.

Group F

10 week old babies; no vaccination

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Weeks

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kalifa Bojang

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council PO Box 273, Banjul The Gambia

Locations

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Medical Research Council Laboratories

Banjul, , The Gambia

Site Status

Countries

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The Gambia

Other Identifiers

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VAC042

Identifier Type: -

Identifier Source: org_study_id