Safety and immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in infants 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

•For Stage 1: Healthy male and female infants aged 5\-12 months at the time of enrolment with consenting parents.
•For Stage 2: Healthy male and female infants aged 10 weeks at the time of enrolment with consenting parents.

•Any of the following constitutes an exclusion criterion:
•¿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.
•¿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 8\.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.