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Completed

NCT Number: NCT01373879

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

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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Key information

Age range

2 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Dr Kalifa Bojang

Banjul, The Gambia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AdCh63 ME-TRAP, MVA ME-TRAP

Biological

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

HDCRV

Biological

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

Primary outcomes

  1. Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP

    Time frame: Participants will be followed for the duration of the study, an expected average of 12 months

    To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by recording local and systemic solicited and unsolicited adverse events

Secondary outcomes

  1. Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP

    Time frame: Participants will be followed for the duration of the study, an expected average of 12 months

    To assess the immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by assessing induced antibody and T cell response to the vaccine insert.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2011
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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