NCT03580824

A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants

A Phase 1b, Open-label, Age De-escalation, Dose-escalation Study to Evaluate the Safety and Immunogenicity of Different Doses of a Candidate Malaria Vaccine; Adjuvanted R21(R21/MM) in Adults, Young Children and Infants in Kilifi, Kenya

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 5 Months – 45 Years
• Healthy volunteers: Accepted

Summary

This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.

Detailed description

The study includes three age groups: Group 1: healthy adults (18-45 years) Group 2: young children (aged 1-5 years) Group 3: infants (aged 5- \<12 months of age) Each group will receive 3 vaccine doses which will be 4-weeks apart. A booster dose will be administered at 9-25 months post 3rd dose. The trial is funded by The European \& Developing Countries Clinical Trials Partnership (EDCTP), European Union, ref: RIA2016V-1649 MMVC

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	R21 in Matrix- M adjuvant vaccine	R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.

Timeline

• Start date: 2019-04-30
• Primary completion: 2022-06-14
• Completion: 2022-06-14
• First posted: 2018-07-09
• Last updated: 2023-08-03

Locations

1 site across 1 country: Kenya