Phase 2 Randomized, Double-blind, Controlled Study of Pfs230D1-CRM197 With R21 in Matrix-M1 in Healthy African School Children and Adults

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Mali
University of Science, Technique and Technology of Bamako (Usttb)
RECRUITING
Bamako
Contact Information
Primary
Prasad S Kulkarni, MD
drpsk@seruminstitute.com
+91-20-71946820
Backup
Sandesh M Bharati, MD
sandesh.bharati@seruminstitute.com
+91-20-71946825
Time Frame
Start Date: 2025-08-22
Estimated Completion Date: 2027-11
Participants
Target number of participants: 1200
Treatments
Experimental: Arm 1a (n=180), 9-17 years of age, Immunobridging cohort
10µg of R21 with 50µg Matrix-M1
Experimental: Arm 2a (n=180), 9-17 years of age, Immunobridging cohort
Control vaccine (rabies vaccine)
Experimental: Arm 3a (n=90), 9-17 years of age, Immunobridging cohort
6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation
Experimental: Arm 4a (n=90), 9-17 years of age, Immunobridging cohort
6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 bedside mix
Experimental: Arm 1b (n=120), 9-17 years of age, main cohort
10µg of R21 with 50µg Matrix-M1
Experimental: Arm 2b (n=120), 9-17 years of age, main cohort
Control vaccine (rabies vaccine)
Experimental: Arm 3b (n=120), 9-17 years of age, main cohort
6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation
Experimental: Arm 1c (n=100), 18-50 years of age, main cohort
10µg of R21 with 50µg Matrix-M1
Experimental: Arm 2c (n=100), 18-50 years of age, main cohort
Control vaccine (rabies vaccine)
Experimental: Arm 3c (n=100), 18-50 years of age, main cohort
6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: Serum Institute of India Pvt. Ltd.

This content was sourced from clinicaltrials.gov

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