Malaria
Conditions
Interventions
3 dose arm
Placebo
2 Dose arm
1 Dose arm
Sponsors
University of Toronto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Residents of Bo, Sierra Leone above the age of 18
Exclusion criteria
Exclusion criteria: 1. Known history of anaphylactic reaction or other forms of allergy to vaccine(s), food product(s), or drug(s). 2. Expected problems with follow-up (e.g., cannot be contacted by primary or secondary mobile phone numbers, planning to move out of sampling frame within the next year). 3. Known HIV infection. 4. Any medical condition that would preclude participation in the trial in the opinion of both surveyors at the household. 5. Women aged 18-49 years who are pregnant or planning to get pregnant within the next year or are breastfeeding or who may be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprevalence and trends in anti-NANP antibodies and anti-Pfs230 antibodies.;local and systemic adverse events and selected laboratory hematological variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| P. falciparum prevalence in adult participants, based on PCR DNA analysis, including quantification of parasite load (cycle threshold values).;Seroprevalence of anti-GEXP18 anti-Etramp 5 Ag1. These are proteins expressed by P. falciparum that play a role in the parasite's lifecycle or in interactions with the host immune system. Antibodies to these two proteins likely represent recent versus long past exposure.;Feasibility outcomes include the proportion of adults approached who consent to participate in the trial, the proportion of those enrolled who receive all doses of vaccine or placebo, and the proportion who achieve complete follow-up for clinical outcomes.;Reduction in clinical malaria (symptoms with relevant PCR result tested centrally after collection) within 4 weeks of each visit and during the 6-9 month visit. This is a secondary outcome as the number of such clinical events is expected to be small (approximately 25 in the placebo arm).;Reduction in P. falciparum infection in children below aged 5-18 years in study households. The assessment will be based on PCR DNA testing in a random subset of 150-200 children in each arm (with a sub-set comparing households with 1, 2, or more adults vaccinated). | — |
Countries
Sierra Leone
Contacts
Public ContactDickson Kargbo
Trial Coordinator
Outcome results
None listed