Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas

October 2, 2012 updated by: University of Oxford

Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults in a Malaria Endemic Area

The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.

The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kilifi, Kenya, PO Box 43640, 00100
        • KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Consenting adult males aged 18-50 years in good health.
  • Will remain resident in the study area for the study duration

Exclusion Criteria:

  • Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
  • History of splenectomy
  • Haemoglobin less than 9.0 g/dl
  • Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein).
  • Blood transfusion within one month of the beginning of the study
  • 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.
  • History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine, see the investigators brochure for details, attached)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Intramuscular arm
Biological: AdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
Biological: AdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal
Experimental: Group 2
Intradermal arm
Biological: AdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
Biological: AdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months
To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of vaccines
Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months
To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert.
Participants will be followed for the duration of the study, an expected average of 12 months
Immunogenicity of Vaccines
Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months
To compare the use of intra-muscular and intra-dermal MVA ME-TRAP
Participants will be followed for the duration of the study, an expected average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

European and Developing Countries Clinical Trials Partnership (EDCTP)
Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAC040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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