Phase 1/2b study of ChAd63 /MVA ME-TRAP in 5-17 month old Burkinabe infants and children

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201208000404131
• Date of registration: 17/08/2012
• Primary sponsor: University of Oxford
• Public title: Phase 1/2b study of ChAd63 /MVA ME-TRAP in 5-17 month old Burkinabe infants and children
• Scientific title: A Phase 1/2b double blind randomised controlled trial of the efficacy, safety and immunogenicity of heterologous prime-boost immunisation with the candidate malaria vaccines ChAd63 ME-TRAP and MVA ME-TRAP in 5-17 month old Burkinabe infants and children
• Date of first enrolment: 2012-11-15
• Target sample size: 730
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201208000404131
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation using a radomisation table created by a computer software program,; Sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Ou?draogo N. Issa
• Affiliation: Head Immunology Lab

• Name: Tiono Alfred B.
• Affiliation: Head Public Health Department, CNRFP

Key inclusion & exclusion criteria

Inclusion criteria: 1.Healthy infant/child aged 5-17 months at the time of first study vaccination
2.Informed consent of parent/guardian
3.Infant/child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up

Exclusion criteria: 1. Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
2. Weight-for-age Z score of less than ?3 or other clinical signs of malnutrition
3. History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation
4. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone.
5. Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
6. Serum Creatinine concentration greater than 70 ?mol/L, where judged to be clinically significant in the opinion of the investigator
7. Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
8. Blood transfusion within one month of enrolment
9. Previous vaccination with experimental malaria vaccines.
10. Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine.
11. Current participation in another clinical trial, or within 12 weeks of this study.
12. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data
13. Known maternal HIV infection (No testing will be done by the study team)
14. Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, b= 0.5mg/kg/day. Inhaled and topical steroids are allowed.)


Age minimum: 5 Month
Age maximum: 17 Month
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

Protective efficacy against clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area

Secondary Outcome(s)

Duration of Protective efficacy against clinical malaria

Efficacy against asymptomatic P. falciparum infection

Efficacy against secondary case definitions of clinical malaria

Safety and reactogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation

Secondary ID(s)

VAC050

Source(s) of Monetary Support

EDCTP