A Phase 1 interventional study of R21 and Pfs230D1-CRM197 in Prevention of Malaria Transmission and Clinical Malaria, sponsored by Serum Institute of India Pvt. Ltd.. Completed at 1 site in Mali. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Serum Institute of India Pvt. Ltd. · Phase 1, Interventional, and Prevention
This is a Phase 1, individually randomized, double-blind, dose escalating study designed to evaluate the safety, tolerability, and immunogenicity of Pfs230D1 conjugate vaccines, R21 nanoparticle vaccine, or their combination conjugate vaccines, formulated on Matrix-M in healthy African adults aged 18 to 50 years.
240 healthy adults (18-50 years of age) will be enrolled from Mali, Africa in a staggered manner by increasing Pfs230D1 dosing.
Participants will be randomized by cohorts as (detailed below) to one of the study arms to receive single antigen (Pfs230D1 or R21) or combination (Pfs230D1 + R21) with 50 μg of Matrix-M, all administered as an IM injection on a 1, 29, 57-day schedule. Participants will be followed for safety for 6 months post last dose with continued assessment for clinical malaria cases and immunogenicity up until 12 months post last dose.
Cohort 1 (n=120); 1:1:1:1:1:1
Followed by Cohort 2 (n=80); 1:1:1:1
Followed by Cohort 3 (n=40); 1:1
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 240 is close to the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Serum Institute of India Pvt. Ltd. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
6μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
12μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
12μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
5μg of R21 in 50μg Matrix-M
Biological: R21 · Other: Matrix-M
10μg of R21 in 50μg Matrix-M
Biological: R21 · Other: Matrix-M
20μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
20μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
20μg Pfs230D1-CRM197 in 50μg Matrix-M
Biological: Pfs230D1-CRM197 · Other: Matrix-M
20μg Pfs230D1-EPA + 5μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-EPA · Other: Matrix-M
40μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
40μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
Biological: R21 · Biological: Pfs230D1-CRM197 · Other: Matrix-M
R21 is a portion of Pf circumsporozoite protein fused with hepatitis B surface antigen in the form of non-infectious virus-like particles (VLPs) produced in yeast cells (Hansenula) by recombinant DNA technology.
Recombinant Pfs230 domain 1 (Pfs230D1; a subdomain of a surface antigen of gametocytes, gametes, and zygotes, in the mosquito stage of Pf conjugated to CRM197 and adjuvanted with 50μg of Matrix-M.
Recombinant Pfs230D1 conjugated to a recombinant Pseudomonas aeruginosa ExoProtein A (EPA)
Vaccine adjuvant that contains purified saponin (from Quillaja saponaria Molina) and cholesterol and phosphatidyl choline. Matrix-M will be used at a 50μg dose for vaccinations.
Number of Participants with Immediate adverse events
Occurrence of immediate adverse events
Time frame: within 30-minutes following each dose
Number of Participants with Solicited local adverse events
Occurrence of solicited local adverse events
Time frame: for 7 days following each dose
Number of Participants with Solicited systemic adverse events
Occurrence of solicited systemic adverse events
Time frame: for 7 days following each dose
Number of Participants with Unsolicited adverse events
Occurrence of all unsolicited adverse events
Time frame: for 28 days following each dose
Number of Participants with Abnormal Laboratory Values post-vaccination
Any significant change from baseline for laboratory values defined as adverse events
Time frame: within 7 days following each dose
Number of Participants with Serious adverse events
Occurrence of serious adverse events
Time frame: Till 6 months post last dose
Anti-NANP IgG antibodies
Comparison of anti-NANP IgG antibodies
Time frame: at 2 weeks post dose 3 in all treatment arms
Anti-Pfs230D1 IgG antibodies
Comparison of Anti-Pfs230D1 IgG antibodies
Time frame: at 2 weeks post dose 3 in all treatment arms
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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