> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/pfs230d1-r21-in-matrix-m1-in-african-school-children-and-bfa1fe70-bf0f-47ae-987b-9d7dc8580556 > Record changed: 2026-10-13 # Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults NCT07147400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) Participants 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) Lead sponsor Serum Institute of India Pvt. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) Start date 2025-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Title and summary **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 and Donéguébougou, Mali and the surrounding areas. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Short title** Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Official title** Phase 2 Randomized, Double-blind, Controlled Study of Pfs230D1-CRM197 With R21 in Matrix-M1 in Healthy African School Children and Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Dates **Completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **First posted** 2025-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Registry last updated** 2026-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Primary completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Start date** 2025-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Size and sites **Actual participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Randomisation ratio** 2:2:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Lead sponsor** Serum Institute of India Pvt. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Identifiers **Registry ID** NCT07147400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **ClinicalTrials.gov ID** NCT07147400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** The study will be conducted with a double blind. Because there is some variation in vaccine volumes, the unblinded pharmacy team will cover all syringes (after vaccine preparation) with opaque tape to maintain blinding. The participants, the clinical staff, laboratory staff and the study team involved in study endpoint assessments will be blinded to study treatment allocation. An additional layer to be implemented to promote blinding is that designated clinical staff who administer the vaccinations will only participate in study product administration and will remain separate from the team of blinded investigators who conduct all subsequent follow-up study assessments. The pharmacy team at the study site where vaccine preparation and administration is taking place will be unblinded, and they are responsible for maintaining security of study treatment assignments. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Outcomes ### Primary outcomes 1. Number of Participants with Immediate adverse events in all participants Timeframe: Up to 30-minutes following each dose Occurrence of immediate adverse events 2. Number of Participants with solicited local adverse events in reactogenicity group Timeframe: Up to 7 days following each dose Occurrence of solicited local adverse events 3. Number of Participants with Solicited systemic adverse events in reactogenicity group Timeframe: Up to 7 days following each dose Occurrence of solicited systemic adverse events 4. Number of Participants with Unsolicited adverse events in all participants Timeframe: Up to 28 days following each vaccination Occurrence of unsolicited adverse events 5. Number of Participants with Serious adverse events in all participants Timeframe: Through the whole study duration, 24 months post dose 3 or 12 months post dose 4 Occurrence of serious adverse events 6. Number of Participants with Abnormal Laboratory Values post-vaccination in laboratory safety group Timeframe: at 7 days following each vaccination Laboratory adverse events 7. Anti-NANP IgG antibodies Timeframe: at 4 weeks post dose 3 Antibody responses to NANP IgG antibodies 8. Anti-Pfs230D1 IgG antibodies Timeframe: at 4 weeks post dose 3 Antibody responses to Pfs230D1 IgG antibodies ### Secondary outcomes 1. To assess vaccine functional activity against transmission by DSF Timeframe: from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster Proportion reduction in proportion of infected mosquitoes (among those dissected) 2. To assess vaccine functional activity against transmission by DSF Timeframe: from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster Proportion reduction in DSFs with at least one infected mosquito 3. humoral immunogenicity time trends and durability Timeframe: at baseline, 28 days after each dose and through study completion, at an average of 1 month Antibody responses to Pfs230D1 4. humoral immunogenicity time trends and durability Timeframe: at baseline, 28 days after each dose and through study completion, at an average of 1 month Antibody responses to NANP 5. To assess the protective efficacy against clinical malaria caused by Pf Timeframe: At 24 and 52 weeks after completion of the primary and booster vaccine course Efficacy against clinical malaria as defined by: presence of asexual P. falciparum parasitemia \\>0 parasites/µL and/or RDT positive with either an axillary temperature of ≥37.5 °C or one or more of the following symptoms: history of fever within the last 48 hours, headache, myalgia, arthralgia, malaise, nausea, dizziness, or abdominal pain Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 9 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Age:>/= 9 years old and /=18 years of age. 3. Provides written informed consent of parent/guardian if <18 years of age, with additional participant written assent obtained from children > 12 years of age. 4. Known resident or long-term resident (more than 1 year) of trial site or surrounding villages. 5. Available for the duration of the trial. 6. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 7. In good general health and without clinically significant medical history in the opinion of the investigator. 8. 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. 9. 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. ### Exclusion criteria 1. Pregnant and breastfeeding females. Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (βhCG) test. NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing 2. 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). NOTE: If a female less than 12 years of age starts menarche while on study it will not be exclusionary for them to continue participation, but will undergo pregnancy testing prior to each vaccination. 3. 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. 4. 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. 5. Current or planned participation in an investigational product study until the time period of the last required study visit under this protocol. 6. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. 7. History of a severe allergic reaction or anaphylaxis. 8. Known: - Severe asthma, defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years. - Autoimmune or antibody-mediated disease including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia. - Immunodeficiency. - Seizure disorder (exception: history of simple febrile seizures). - Asplenia or functional asplenia. - Use of chronic (≥14 days) oral or intravenous (IV) corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of enrollment. - Hypersensitivity reaction to rabies vaccine in the past. 9. Receipt of: - Live vaccine within 4 weeks prior to enrollment or a killed vaccine within 2 weeks prior to enrollment. - Immunoglobulins and/or blood products within the past 3 months. - Any malaria vaccine in the past. - Any investigational product in the last 6 months 10. Any other condition that in the opinion of the investigator might jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or might render the participant unable to comply with the protocol. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Sites - University of Science, Technique and Technology of Bamako (Usttb)Bamako, Mali Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147400) ## Related records ### Drugs (3) - [Autologous cultured chondrocytes](https://trialight.com/data/asset/autologous-cultured-chondrocytes-43258f87-47bc-41e2-b6a7-b6085ebf101f.md) - [Interferon alfa-2A](https://trialight.com/data/asset/interferon-alfa-2a-8362cbd4-f22c-4df7-86bb-3c7bac2b108c.md) - [Muramyl dipeptide](https://trialight.com/data/asset/muramyl-dipeptide-9831c7ba-8a15-402c-8de7-eef1bb5f5ed8.md) ### Collaborators (1) - National Institute of Allergy and Infectious Diseases (NIAID) ### Lead sponsors (1) - [Serum Institute of India Pvt. Ltd.](https://trialight.com/data/company/serum-institute-of-india-pvt-ltd-83f1638e-64f7-4ee9-9ca0-7ae346be8b28.md) ### Targets (2) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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