Phase 2 Randomized, Double-blind, Controlled Study of Pfs230D1-CRM197 With R21 in Matrix-M1 in Healthy African School Children and Adults
This is a Phase 2, randomized, double-blind, controlled study designed to evaluate the safety, tolerability, immunogenicity, vaccine efficacy, and functional activity of Pfs230D1-CRM197 conjugate vaccine with R21 nanoparticle vaccine formulated on Matrix-M1. Participants (9-50 years of age) will be drawn from Bancoumana, Mali and the surrounding areas.
• Age:\>/= 9 years old and \</= 50 years old.
• Provides written informed consent if \>/=18 years of age.
• Provides written informed consent of parent/guardian if \<18 years of age, with additional participant written assent obtained from children \> 12 years of age.
• Known resident or long-term resident (more than 1 year) of trial site or surrounding villages.
• Available for the duration of the trial.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• In good general health and without clinically significant medical history in the opinion of the investigator.
• Permission for long term storage of blood samples.
• • Note: If a participant withdraws consent or at the time of study completion or end of participation wishes to withdraw permission for long term storage of blood samples, this can be requested, and sample destruction will be documented.
• Females of reproductive potential aged 12 years and above who have attained menarche and are sexually active must be willing to use reliable contraception from 21 days prior to Study Day 1 and 21 days prior to Study Day 392 (booster dose) and until 1 month after the last vaccination in primary series and after booster dose.
⁃ A reliable method of birth control includes one of the following:
∙ Confirmed pharmacologic contraceptives (parenteral) delivery.
‣ Intrauterine or implantable device.
‣ Barrier methods.