Safety, immunogenicity and efficacy against febrile malaria of the candidate vaccines FP9 ME-TRAP and MVA ME-TRAP for children in an endemic area

Safety, immunogenicity and efficacy against febrile malaria of the candidate vaccines FP9 ME-TRAP and MVA ME-TRAP for children in an endemic area: a randomised controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88335123

Enrollment

410

Registered

2005-10-14

Start date

2005-02-01

Completion date

Unknown

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile malaria Infections and Infestations Malaria

Interventions

This study will evaluate the efficacy of the regime of FP9:ME-TRAP (attenuated Fowlpox virus recombinant for ME-TRAP) followed by MVA:ME-TRAP (modified Vaccinia Ankara recombinant for ME-TRAP) in one

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged one to six years old, either sex 2. Resident in the study area

Exclusion criteria

Exclusion criteria: 1. Clinically significant skin disorder, allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, severe malnutrition (mid-upper arm circumference less than 11 cm) 2. History of splenectomy 3. Serum creatinine concentration above the age related normal range in Kilifi 4. Serum alanine aminotransferase (ALT) concentration above the normal range in Kilifi 5. Clinically significant anaemia (i.e. with symptoms of limited exercise capacity, or signs of a high cardiac output state; large volume pulse, heaving cardiac apex beat, resting tachycardia) 6. Blood transfusion within one month of the beginning of the study 7. History of vaccination with previous experimental malaria vaccines 8. Administration of any other vaccine or immunoglobulin within two weeks before vaccination 9. Current participation in another clinical trial, or within 12 weeks of this study 10. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial 11. Likelihood of travel away from the study area

Design outcomes

Primary

Measure	Time frame
1. Safety and immunogenicity data will be evaluated by clinical assessments and blood tests 2. Subsequent weekly follow up will allow blood film examinations for all febrile children 3. Rates of development of febrile malaria and proportions of children with episodes of febrile malaria will be compared between groups to determine efficacy	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026