Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-50
SponsorSerum Institute of India Pvt. Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Pregnant and breastfeeding females. Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (βhCG) test.
Menstruating females less than 12 years of age. (In order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group).
Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol at a level appropriate for the participant's age.
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
Trial design
Treatments tested in this trial
- 10µg of R21 with 50µg Matrix-M1
- 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation
- RABIVAX-S
- Conjugated Pfs230D1 Vaccine (Pfs230D1-CRM197) For Bedside Mixing
- R21 Malaria Vaccine (Recombinant) For Bedside Mixing
- MATRIX-M1 (Adjuvant) For Bedside Mixing
Treatment groups
1,200 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Serum Institute of India Pvt. Ltd.
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov