CVIA 108/PATH

PATH CVIA 108 PROJECT:

Infant Malaria Vaccine Schedule Optimization

 

Study Period: May 2024- December 2027

The CVIA 108 project is a Phase 2b multicenter randomized, placebo-controlled, double-blind, study evaluating the safety, immunogenicity and efficacy of R21/Matrix-M Malaria Vaccine (R21/MM)  in African infants with different immunization schedules. The project is implementated by Infectious Diseases Research Collaboration (IDRC) with funding from PATH Center for Vaccine Innovation and Access (Grant number: IDRC- Uganda_GAT.588511-01728256-PRE).

R21/MM vaccine has been recommended by the World Health Organisation to prevent clinical malaria in young children living in moderate to high transmission areas of Sub-Saharan Africa; with the first dose delivered at 5-6 months of age and two subsequent doses given monthly. The vaccine has not been evaluated for efficacy in younger groups. Thus, evidence about the safety, immunogenicity, and efficacy of R21/MM in younger infants is lacking.

The project will evaluate how age at first paediatric vaccine dose and time intervals between doses modify the immunogenicity of the vaccine and the efficacy in protecting infants against Plasmodium falciparum malaria clinical disease. We will compare the safety, immunogenicity, and efficacy of three doses of R21/MM in infants at 6 weeks of age at time of first vaccination in a conventional 6-10-14 week vaccine schedule (compressed schedule) and in infants at 8 weeks of age at time of first vaccination receiving three doses at 8-16-24 weeks (relaxed schedule). All infants will receive their routine paediatric vaccines on the same visits. Placebo arms will be included to evaluate both efficacy and potential interference of immune responses from co-administered routine vaccine.

 

Objectives

Primary objectives

1. Immunogenicity: To describe the anti-CS NANP antibody responses elicited following the primary 3-dose schedule of R21/MM for the “compressed” as compared to the “relaxed” immunization schedule categories.
2. Safety: To describe the reactogenicity, tolerability, and safety of R21/MM administered as a four-dose regimen to vaccine-naïve infants in two different vaccine immunization schedule categories (“compressed” and “relaxed”), with a booster dose (dose 4) at 15 months of age, when co-administered with routine immunizations

 

Secondary objectives

1. Immunogenicity: To describe the anti-CS NANP antibody responses elicited following the 4th dose of R21/MM for the “compressed” as compared to the “relaxed” immunization schedule categories.
2. Efficacy:
3. To evaluate the protective efficacy of R21/MM against clinical malaria disease caused by Plasmodium falciparum (Pf) by assessing time-to-first malaria episode in African infants randomized to either the “compressed” or “relaxed” immunization schedule category.
4. To evaluate the protective efficacy of R21/MM against all episodes of clinical malaria disease caused by Plasmodium falciparum by assessing the number of clinical malaria episodes in African infants randomized to either the “compressed” or “relaxed” immunization schedule category

 

Study Site:  IDRC Tororo study clinic

Principal Investigator: Dr. Joaniter I. Nankabirwa

Study Sponsor: PATH Center for Vaccine Innovation and Access