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Completed

NCT Number: NCT01379430

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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast

Kilifi, PO Box 43640, 00100, Kenya

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.
  • 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)

Treatment and study plan

AdCh63 ME-TRAP followed by MVA ME-TRAP

Biological

AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

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 in a Malaria Endemic Area

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 23, 2011
Registry last updated
Oct 3, 2012

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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