Actively Recruiting
Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults
Led by Serum Institute of India Pvt. Ltd. · Updated on 2025-11-19
1200
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
S
Serum Institute of India Pvt. Ltd.
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 9 to 50 years old
- Provides written informed consent if 18 years or older
- Provides written parental/guardian consent if under 18 years, plus assent if over 12 years old
- Known or long-term resident (more than 1 year) of study site or nearby villages
- Available to participate for the full duration of the trial
- Able to provide proof of identity acceptable to the study clinician
- In good general health without significant medical history as judged by the investigator
- Agrees to long-term storage of blood samples with option to withdraw consent later
- Females aged 12 and above who are sexually active and have started menstruation must agree to use reliable contraception from 21 days before first dose until one month after last vaccination and booster dose if given
You will not qualify if you...
- Pregnant or breastfeeding females confirmed by pregnancy test
- Females under 12 years who are menstruating (to avoid cultural issues with assessing pregnancy potential)
- Behavioral, cognitive, or psychiatric conditions affecting understanding or compliance with the study
- Significant neurologic, cardiac, lung, liver, endocrine, rheumatologic, autoimmune, blood, cancer, or kidney diseases
- Current or planned participation in any other investigational product study during this study
- Alcohol or illicit drug problems in the past 12 months
- History of severe allergic reaction or anaphylaxis
- Severe asthma with recent urgent care or steroid use
- Autoimmune or antibody-mediated diseases like lupus or rheumatoid arthritis
- Immunodeficiency
- Seizure disorders except simple febrile seizures
- Absence or malfunction of the spleen
- Use of immunosuppressive corticosteroids or drugs recently
- Allergy to rabies vaccine
- Recent live vaccine (within 4 weeks) or killed vaccine (within 2 weeks)
- Immunoglobulin or blood products within past 3 months
- Previous malaria vaccine use
- Investigational product use in last 6 months
- Any other condition that may risk participant safety or study integrity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Science, Technique and Technology of Bamako (Usttb)
Bamako, Mali
Actively Recruiting
Research Team
P
Prasad S Kulkarni, MD
CONTACT
S
Sandesh M Bharati, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
10
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