Safety and immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in children in a malaria endemic area

niversity of Oxford0 sites36 target enrollmentFebruary 26, 2012

Overview

No summary available.

Registry

who.int

Start Date

February 26, 2012

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•¿A male or female between, and including, 2 and 6 years of age at the time of the first vaccination.
•¿Written informed consent obtained from the subject¿s parents.
•¿Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•¿Availability for the duration of the immunization and follow\-up period.

•¿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, defined as weight\-for\-height z\-score \<\-3 or oedema of both feet (WHO)
•¿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
•¿Serum creatinine concentration above \>130mmol/L
•¿Serum ALT concentration \>69 IU/L
•¿Blood transfusion within one month of enrolment.
•¿History of vaccination with previous experimental malaria vaccines.