Malaria
Conditions
Interventions
PfSPZ placebo and chloroquine placebo
PfSPZ placebo and chloroquine
PfSPZ Vaccine
PfSPZ-CVac
Sponsors
Centre de Recherches Médicale de Lambaréné
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Recruited children will be healthy population with the following inclusion criteria: -Healthy children aged 1 to 12 years -Provision of written informed consent of a legal representative of age 18 or above and provision of informed assent by underage participants in concordance with Gabonese national guidelines. -Able and willing to comply with all study requirements -Residence in the area throughout the study period -Household member reachable by mobile phone during the immunization phase -Correct answers on the informed consent quiz for legal representatives
Exclusion criteria
Exclusion criteria: Children will not enter the study if any of the following apply: -Receipt of an investigational product in the 30 days preceding enrollment -Immunization with more than 3 other vaccines or at least one live vaccine within the past four weeks -Use of immunoglobulins or blood products within 3 months prior to enrolment -Known intolerance to, or contraindications to the use of chloroquine or clindamycin -Known or suspected HIV infection or any other immunosuppressive state -Positive for hepatitis B surface antigen (HBsantigen) -Seropositive for hepatitis C virus (antibodies to HCV) -A hemoglobin concentration <9 g/dl -History of non-febrile or atypical febrile seizures -Pregnancy or lactation -Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the child because of participation in the study or impair interpretation of the study data In case of inconclusive results in laboratory tests or other diagnostic procedures, the test will be repeated. If doubts about the results persist, volunteers will be considered ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Grade 3 adverse events and serious adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Grade 1-3 adverse events and serious adverse events;Proportion of volunteers who develop P. falciparum parasitemia;Proportion of volunteers who develop P. falciparum parasitemia;Time to P. falciparum parasitemia | — |
Countries
Gabon
Contacts
Public ContactBertrand Lell
Centre de Recherches Médicale de Lambaréné
Outcome results
None listed