TRAP VAC TRIA

Not Applicable

• Conditions: Malaria; Paediatrics

• Registration Number: PACTR2010020001771828
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 30

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and biological safety

Secondary Outcome Measures

Name	Time	Method
Reactogenicity of the vaccines;Immunogenicity