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

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1A

Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Group 1B

Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Group 2A

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later

Group 2B

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Group 2C

Children (2-6 years old) vaccinated with human diploid cell rabies vaccine

Group Type ACTIVE_COMPARATOR

HDCRV

Intervention Type BIOLOGICAL

HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Group 3A

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later

Group 3B

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Group Type EXPERIMENTAL

AdCh63 ME-TRAP, MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Group 3C

Children (2-6 years old) vaccinated with human diploid cell rabies vaccine

Group Type ACTIVE_COMPARATOR

HDCRV

Intervention Type BIOLOGICAL

HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Interventions

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AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Intervention Type BIOLOGICAL

HDCRV

HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

Intervention Type BIOLOGICAL

HDCRV

HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.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.
* 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes