TRAP VAC TRIAL

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2010020001771828
• Date of registration: 03/12/2009
• Primary sponsor: University of Oxford
• Public title: TRAP VAC TRIAL
• Scientific 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
• Date of first enrolment: 2010-06-10
• Target sample size: 30
• Recruitment status: Closed to recruitment: follow up complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010020001771828
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Screened participants will be allocated a sequential study ID number. That study ID number will correspond to the specific treatment allocation which will be randomly allocated to either group 1 as A1 or B1 or group 2 as A2 or B2. Block randomisation, computed in five blocks of six distributing subject into two groups at 1:2 ration (group 1 = 10 subject, group2 = 20 subject),; Sealed envelopes. Independent statistician will generate randomisation list and print onto allocation cards and sealed. Sealed envelopes labeled wtih sequential study ID will be opened by subjects when eligible,

Countries of recruitment

South Africa

Contacts

• Name: Philip Bejon
• Affiliation: Core- PI

• Name: Peninah Menza
• Affiliation: Study Coordinator

Key inclusion & exclusion criteria

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)

Age minimum: 18 Year
Age maximum: 50 Year
Gender: Male

Health Condition(s) or Problem(s) studied

Malaria
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Primary Outcome(s)

Clinical and biological safety

Secondary Outcome(s)

Immunogenicity

Reactogenicity of the vaccines

Source(s) of Monetary Support

EDCTP