Safety of Malaria vaccines in Gambian infants

Not Applicable

• Conditions: Malaria; Paediatrics

• Registration Number: PACTR201401000363170
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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.

Exclusion Criteria

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.
¿Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs
¿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
¿Maternal HIV infection
¿Positive malaria antigen test at screening
¿Failure to have received, prior to enrolment, the routine EPI vaccinations due according to the Gambian EPI schedule.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP

Secondary Outcome Measures

Name	Time	Method
To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP