A Phase 2 interventional study of R21 Matrix-M (R21/MM) Malaria Vaccine and Placebo in Malaria Vaccines and Malaria (Plasmodium Falciparum), sponsored by PATH. Active, not recruiting at 2 sites in Burkina Faso. Open to participants aged 42 Days to 49 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by PATH · Phase 2, Interventional, and Prevention
Among 52 studies in Malaria, Falciparum with a site in Burkina Faso — 6 open to participants now, 11 under way, none of them phase 3. Malaria, Falciparum · Burkina Faso.
Among the 52 studies in Malaria, Falciparum with a site in Burkina Faso, this one is the 13th largest by enrollment of the 46 interventional ones that give a count, is one of 8 that started in 2025, is one of 15 in phase 2, reaches primary completion later than 9 of the 10 other live ones, and was the 42nd registered.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
Browse Malaria, Falciparum studies →6 of the 52 studies in Malaria, Falciparum with a site in Burkina Faso are open now. Recruiting first, the newest first:
Clinton Health Access Initiative Inc. · Sites in Burkina Faso, Uganda
Sanaria Inc. · Sites in Burkina Faso
Novartis Pharmaceuticals · Sites in Burkina Faso, Côte D'Ivoire, Gabon and 4 more countries
Serum Institute of India Pvt. Ltd. · Sites in Burkina Faso, Côte D'Ivoire, Nigeria and 1 more country
Novartis Pharmaceuticals · Sites in Burkina Faso, Côte D'Ivoire, Gabon and 3 more countries
A study can be open while its sites in Burkina Faso have not opened yet or have stopped. Only those recruiting at a site in Burkina Faso →
Of the 21 Malaria, Falciparum studies recruiting now, 5 (24%) set no upper age limit and 15 (71%) stop at 75 or younger; 14 take children under 18; 9 take healthy volunteers.
This study: 42 Days to 49 Days · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 23 · Phase 3 17 · Phase 4 2
First in 2002; this study’s year is marked. 8 started in 2025.
This study's enrollment of 975 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Median enrollment 360 across the 46 interventional studies, 658 across the 6 observational. Of the 39 that completed or were terminated, 18 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 52 have an industry lead sponsor. The 10 most frequent:
PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
PATH has 6 studies filed under Malaria, Falciparum — fewer than ten, so there is no comparison to draw.
7 of the studies in Malaria, Falciparum with a site in Burkina Faso that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07385287Sanaria Inc.Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults | 2027-02 |
| NCT07811908Novartis PharmaceuticalsPlatform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2) | 2027-02-04 |
| NCT06958198University of OxfordA Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine) | 2027-03 |
| NCT07183371University of OxfordA Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M | 2027-03 |
| NCT07074665University of OxfordDose Finding Trial of R21/Matrix-M in School Children | 2027-03 |
Among the 52 studies in Malaria, Falciparum with a site in Burkina Faso, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.
The R21/Matrix-M (R21/MM) vaccine has been recommended by the World Health Organization (WHO) to prevent clinical malaria in young children living in moderate to high transmission areas of Sub-Saharan Africa. R21/MM is based on the circumsporozoite protein (CSP) targeting the pre-erythrocytic stage of Plasmodium falciparum. R21/MM elicits high levels of antibodies against the central repeat (Asn-Ala-Asn-Pro [NANP]) of the circumsporozoite protein (CSP) which has been shown to correlate with protection. Currently, R21/MM is recommended to be delivered to young children starting at 5-6 months of age with 3 doses given at monthly intervals, however, there are no existing Essential Programme on Immunization (EPI) vaccine visits scheduled at these ages.
We plan to evaluate, using the R21/MM malaria vaccine as a model system, how age at first vaccine dose and time intervals between doses modify the immunogenicity of the vaccine.
Healthy male or female infants 6 to 7 weeks of age will be randomized to one of three different immunization schedule cohorts: a) a "compressed" conventional schedule at 6-10-14 weeks of age; b) a "relaxed" schedule at 2-4-6 months of age; c) a "relaxed" schedule at 3-6-9 months of age.
In the original study design (Part A of the study), participants in each immunization schedule cohort were randomized in a ratio of 3:1 to receive either R21/MM or placebo - up until September 1, 2025, where upon confirmation of R21/MM rollout into the EPI schedule in the study districts, all participants already enrolled in the "relaxed" 2-4-6 month and "relaxed" 3-6-9 month schedules who had not yet received the first study vaccination, were assigned automatically to receive open-label R21/MM. Recruitment into the study was also paused while the protocol amendment with the revised study design was being developed. At the time of the recruitment being paused, the study had enrolled 644 participants.
All study participants enrolled during Part A of the study were unblinded as they approached 5 months of age and those who were randomized to the placebo arms had all study procedures discontinued, and were referred to local EPI clinics to receive R21/MM vaccinations and withdrawn from the study. Participants who had been randomized and who had received R21/MM at their first study vaccination, were kept on study and continued to receive open-label R21/MM, as per the protocol.
In Part B of the study, as per the revised study design, an additional 320 infants will be enrolled and randomized to the "compressed" 6-10-14 weeks (Cohort 1), "relaxed" 2-4-6 month (Cohort 2) and "relaxed" 3-6-9 month (Cohort 3) immunization schedules initially in a 2:1:1 ratio. Participants enrolled into Cohorts 2 and 3 will all be assigned to receive open-label R21/MM, while those enrolled into Cohort 1 will be randomized (blinded) 1:1 to receive 3 doses of either R21/MM or placebo. Once participants in Cohort 1 complete their 28 day post-3rd dose visit, they will be unblinded. Participants randomized to placebo will rollover to a new cohort, Cohort 4, to receive 3 doses of R21/MM on a 5-6-7-month schedule, aligning with WHO guidelines. Participants randomized into the "relaxed" 2-4-6 month schedule (Cohort 2) and "relaxed" 3-6-9 month schedule (Cohort 3) will receive 3 doses of open-label R21/MM; no placebo participants will be enrolled into Cohorts 2 and 3.
Infants randomized to the respective immunization schedule categories will receive co-administered routine EPI vaccines and participants in all cohorts will receive a 4th dose of R21/MM at Month 15.
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:
(Note: In case of acute disease, participants may be re-assessed by a study physician for resolution of the condition and enrolled if eligible and still within the visit window).
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.
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.
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).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
Participants will receive R21/MM malaria vaccination at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, pneumococcal conjugate vaccine (PCV), and oral rotavirus vaccine (RV). At 9 months of age participants will receive measles-rubella (MR) vaccine, yellow fever (YF) vaccine, and typhoid conjugate vaccine (TCV). Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (MenFive) and the 2nd dose of MR vaccine.
Biological: R21 Matrix-M (R21/MM) Malaria Vaccine · Biological: Hexavalent Vaccine · Biological: Pneumococcal Polysaccharide Conjugate Vaccine · Biological: Rotavirus, Live Attenuated (Oral) Vaccine · Biological: Measles and Rubella Vaccine · Biological: Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine · Biological: Yellow Fever vaccine · Biological: Typhoid Conjugate vaccine
Participants will receive placebo at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, PCV, and oral RV. After completion of the 28 day post-Dose 3 visit, these participants will rollover to Cohort 4 (Group 7) to then receive open-label R21/MM vaccine as per the "recommended" schedule at 5-6-7 months of age. At 9 months of age participants will receive MR and YF vaccines and TCV. Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the MenFive vaccine and the 2nd dose of MR vaccine.
Biological: R21 Matrix-M (R21/MM) Malaria Vaccine · Biological: Placebo · Biological: Hexavalent Vaccine · Biological: Pneumococcal Polysaccharide Conjugate Vaccine · Biological: Rotavirus, Live Attenuated (Oral) Vaccine · Biological: Measles and Rubella Vaccine · Biological: Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine · Biological: Yellow Fever vaccine · Biological: Typhoid Conjugate vaccine
Participants will receive R21/MM malaria vaccination at 2, 4, and 6 months of age co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines and TCV. Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the MenFive vaccine and the 2nd dose of MR vaccine.
Biological: R21 Matrix-M (R21/MM) Malaria Vaccine · Biological: Hexavalent Vaccine · Biological: Pneumococcal Polysaccharide Conjugate Vaccine · Biological: Rotavirus, Live Attenuated (Oral) Vaccine · Biological: Measles and Rubella Vaccine · Biological: Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine · Biological: Yellow Fever vaccine · Biological: Typhoid Conjugate vaccine
Participants will receive R21/MM malaria vaccination at 3, 6, and 9 months of age. Participants will receive the hexavalent vaccine, PCV, and oral RV at 6 weeks, 10 weeks, and 14 weeks of age. At 9 months of age participants will receive MR and YF vaccines and TCV. Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the MenFive vaccine and the 2nd dose of MR vaccine.
Biological: R21 Matrix-M (R21/MM) Malaria Vaccine · Biological: Hexavalent Vaccine · Biological: Pneumococcal Polysaccharide Conjugate Vaccine · Biological: Rotavirus, Live Attenuated (Oral) Vaccine · Biological: Measles and Rubella Vaccine · Biological: Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine · Biological: Yellow Fever vaccine · Biological: Typhoid Conjugate vaccine
Drug page: R21
Administered by intramuscular injection. Each 0.5 mL dose contains R21 Malaria Antigen (5 mcg) and Matrix-M1 (Adjuvant) (50 mcg).
Administered by intramuscular injection. Each dose (0.5 mL) contains Normal saline (0.9%).
Administered by intramuscular injection. Each dose of 0.5 mL contains: * Diphtheria Toxoid \> 30 IU * Tetanus Toxoid \> 40 IU * B. pertussis (whole cell) \> 4 IU * Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg * Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU * Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\]
Also known as: HEXASIIL
Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.
Also known as: PNEUMOSIL
Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \[G1, G2, G3, G4 and G9\], 5.6 focus-forming units (FFU) / serotype.
Also known as: ROTASIIL
Drug pages: Measles Vaccine · Rubella Vaccine
Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.
Administered by intramuscular injection. Each 0.5 mL dose contains 5 mcg of each Meningococcal A, C, Y, W, and X polysaccharide, 7.8 to 33.4 mcg of TT and 11.7 to 50.1 mcg of recombinant CRM197.
Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.
Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.
Geometric Mean Titers (GMTs) of Anti-circumsporozoite (CS) Immunoglobulin G (IgG) at Baseline and 28 Days after 3rd Vaccine Dose
The anti-CS antibody responses elicited following the primary 3-dose schedule of R21/MM will be assessed in the "compressed" (6-10-14 week) immunization schedule and the two "relaxed" (2-4-6 month and 3-6-9 month) immunization schedule cohorts.
Time frame: Baseline and 28 days after 3rd vaccine dose
Geometric Mean Fold Rise (GMFR) in Anti-CS IgG 28 Days after 3rd Vaccine Dose Compared to Baseline
The anti-CS antibody responses elicited following the primary 3-dose schedule of R21/MM will be assessed in the "compressed" (6-10-14 week) immunization schedule and the two "relaxed" (2-4-6 month and 3-6-9 month) immunization schedule cohorts.
Time frame: Baseline and 28 days after 3rd vaccine dose
Number of Participants with Solicited Adverse Events
Local (redness, swelling, and pain at the injection site) and systemic (fever, drowsiness, irritability, decreased appetite) reactions will be collected in a subset of participants (the first 40 participants in each immunization schedule category at each site).
Time frame: 7 days after each study vaccination
Number of Participants with Unsolicited Adverse Events
Time frame: 28 days after each study vaccination
Number of Participants with Serious Adverse Events
Time frame: Up to 28 days post 4th vaccine dose.
Number of Participants with Adverse Events of Special Interest
Time frame: Up to 28 days post 4th vaccine dose.
Geometric Mean Titers (GMTs) of Anti-CS IgG Before and 28 Days After 4th Vaccine Dose
The anti-CS antibody responses elicited following the 4th dose of R21/MM will be assessed in the "compressed" (6-10-14 week) immunization schedule and the two "relaxed" (2-4-6 month and 3-6-9 month) immunization schedule cohorts.
Time frame: Month 15 predose and 28 days after vaccination
GMFR in Anti-CS IgG Titer Post 4th Dose Compared to Pre-4th Dose
The anti-CS antibody responses elicited following the 4th dose of R21/MM will be assessed in the "compressed" (6-10-14 week) immunization schedule and the two "relaxed" (2-4-6 month and 3-6-9 month) immunization schedule cohorts.
Time frame: Month 15 predose and 28 days after 4th dose
Plan to share: Yes — PATH as the Sponsor of the Clinical Study will post the Clinical Trial Data in compliance with the Gates Foundation's Open Access policy and the WHO Joint Statement on Clinical Transparency. The Clinical Trial Data will contain no personally identifiable information (PII) and will be fully anonymized and de-identified.
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Oct 2027, 28 months after the start.
Of 39 phase 2 interventional studies under Malaria, Falciparum, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's planned 28 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Sep 2027 → Oct 2027 and completion Sep 2027 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: R21 · Vaccines, Combined · Measles Vaccine · Rubella Vaccine · Yellow Fever Vaccine