Prevention of Malaria Transmission and Clinical MalariaPhase 2NCT07147400
Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults
A Phase 2 study testing 10µg of R21 with 50µg Matrix-M1, 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation and RABIVAX-S in people with Prevention of Malaria Transmission and Clinical Malaria, run by Serum Institute of India Pvt. Ltd. at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Malaria Transmission and Clinical Malaria
- What is being tested?
- 10µg of R21 with 50µg Matrix-M1, 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation and RABIVAX-S
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteMali
- Study dates
- 22 Aug 2025to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
- 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.
- 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.
- 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.
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- Current or planned participation in an investigational product study until the time period of the last required study visit under this protocol.
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- 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.
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
Mali1 site
University of Science, Technique and Technology of Bamako (Usttb)
Bamako
About this study
Official title: Phase 2 Randomized, Double-blind, Controlled Study of Pfs230D1-CRM197 With R21 in Matrix-M1 in Healthy African School Children and Adults
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.
Read the detailed description
Participants aged 9 - 17 years in the immunobridging cohort (n=540) will be randomized to one of the study arms ( 2:2:1:1) to receive 10μg R21 alone in 50μg of Matrix-M1, control vaccine (RABIVAX-S), or 6μg Pfs230D1-CRM197 with 10μg R21 in 50μg of Matrix-M1 as either a bedside mixture or a single-vial coformulation.
Participants in the main cohort who are aged 9-17 years will be randomized to one of the study arms (1:1:1) to receive 10μg R21 alone in 50μg of Matrix-M1, control vaccine (RABIVAX-S), or 6μg Pfs230D1-CRM197 with 10 μg R21 in 50μg of Matrix-M1 single-vial coformulation. Enrollment of participants aged 9-17 years in the main cohort will be done after DSMB reviews the 7-day safety data post dose 1 from the immunobridging cohort.
Participants in the main cohort who are aged 18 - 50 years will be randomized to one of the study arms (1:1:1) to receive either 10μg R21 alone in 50μg of Matrix-M1, control vaccine (RABIVAX-S), or 6μg Pfs230D1-CRM197 with 10μg R21 in 50μg of Matrix-M1 single-vial coformulation.
Enrollment of adult participants aged 18 -50 years in the main cohort (n=300) will be done from the start of the study and will be independent of enrollment into of the pediatric cohort (9-17 years).
All vaccines will be administered as an intramuscular (IM) injection on a 0, 28, 56 day schedule with an option for additional follow-up for a subsequent malaria transmission season with or without a fourth dose approximately 52 weeks after the third vaccine dose (based on year 1 results).
Initial enrollment will be staggered over time for safety, but all participants will be analyzed together for primary, secondary, and exploratory endpoints.
A total 1200 participants will be randomized into the study as below:
Immunobridging cohort (Participants 9-17 years of age, n = 540) (2:2:1:1 randomization)
- Arm 1a (n = 180): 10µg of R21 with 50µg Matrix-M1 on study day 0, 28, 56 +/- 392
- Arm 2a (n = 180): Control vaccine (rabies vaccine) on study day 0, 28, 56 +/- 392
- Arm 3a (n = 90): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation on study day 0, 28, 56 +/- 392
- Arm 4a (n = 90): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 bedside mix on study day 0, 28, 56 +/- 392
Main cohort:
Participants 9-17 years of age (n = 360) (1:1:1 randomization):
- Arm 1b (n=120): 10µg of R21 with 50µg Matrix-M1 on study day 0, 28, 56 +/- 392
- Arm 2b (n = 120): Control vaccine (rabies vaccine) on study day 0, 28, 56 +/- 392
- Arm 3b (n = 120): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation on study day 0, 28, 56 +/- 392
Participants 18-50 years of age (n = 300) (1:1:1 randomization):
- Arm 1c (n=100): 10µg of R21 with 50µg Matrix-M1 on study day 0, 28, 56 +/- 392
- Arm 2c (n = 100): Control vaccine (rabies vaccine) on study day 0, 28, 56 +/- 392
- Arm 3c (n = 100): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation on study day 0, 28, 56 +/- 392
- Being tested
- 10µg of R21 with 50µg Matrix-M1, 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation, RABIVAX-S, Conjugated Pfs230D1 Vaccine (Pfs230D1-CRM197) For Bedside Mixing, R21 Malaria Vaccine (Recombinant) For Bedside Mixing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10µg of R21 with 50µg Matrix-M1Biological
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. Matrix-M1 (Adjuvanted) is cGMP manufactured by Serum Institute of India, PVD, LTD (SIIPL), Pune.
6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulationBiological
R21 Malaria antigen is expressed in a recombinant high expressing Hansenula polymorpha production strain. The R21 Malaria drug substance lots/batches were cGMP manufactured at SIIPL, India.
Recombinant CRM197 is a recombinant protein, and its drug substance lots/batches cGMP manufactured using Pseudomonas fluorescens production strain at SIIPL, India.
Recombinant Pfs230D1M drug substance lots/batches of cGMP were manufactured using Hansenula Polymorpha and manufactured at the SIIPL.
A single vial coformulation containing 10µg R21 and 6µg Pfs230D1-CRM197 conjugate mixed with 50µg Matrix-M1 has been developed and is manufactured by SIIPL.
RABIVAX-SBiological
Sterile, purified inactivated rabies vaccine prepared on vero cells, indicated for the prevention of rabies in children and adults.
Conjugated Pfs230D1 Vaccine (Pfs230D1-CRM197) For Bedside MixingBiological
Recombinant Pfs230D1M drug substance lots/batches cGMP manufactured using Pichia pastoris manufactured at the Pilot Bioproduction Facility, Walter Reed Army Institute of Research (Silver Spring, Maryland), and at SIIPL respectively.
Recombinant CRM197 is a recombinant protein and its drug substance lots/batches cGMP manufactured using Pseudomonas fluorescens production strain at SIIPL, India.
R21 Malaria Vaccine (Recombinant) For Bedside MixingBiological
R21 is a fusion protein of hepatitis B surface antigen (HBsAg) to the C-terminus and central repeats of the circumsporozoite (CS) protein of Plasmodium falciparum. R21 VLP, recombinant HBsAg spontaneously self-assembled \& formed a virus-like particle, wherein circumsporozoite protein (CSP) from Plasmodium falciparum is presented on the VLP of recombinant HBsAg particles. R21 Malaria antigen expressed in recombinant high expressing Hansenula polymorpha production strain. The R21 Malaria drug substance lots/batches were cGMP manufactured at SIIPL, India.
MATRIX-M1 (Adjuvant) For Bedside MixingBiological
active ingredient in Matrix-M1 are saponin-based fractions. Matrix-M1 has a ratio of Matrix-A and Matrix-C of 85:15 (by weight). Both Matrix-A and Matrix-C are individual fractions (separated by chromatography) derived from extracts from the Quillaja saponaria tree. Matrix-M1 (Adjuvanted) is cGMP manufactured by Serum Institute of India, PVD, LTD (SIIPL), Pune.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1a (n=180), 9-17 years of age, Immunobridging cohort | Experimental | 10µg of R21 with 50µg Matrix-M1 Receives: Biological: 10µg of R21 with 50µg Matrix-M1 |
| Arm 2a (n=180), 9-17 years of age, Immunobridging cohort | Experimental | Control vaccine (rabies vaccine) Receives: Biological: RABIVAX-S |
| Arm 3a (n=90), 9-17 years of age, Immunobridging cohort | Experimental | 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation Receives: Biological: 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation |
| Arm 4a (n=90), 9-17 years of age, Immunobridging cohort | Experimental | 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 bedside mix Receives: Biological: Conjugated Pfs230D1 Vaccine (Pfs230D1-CRM197) For Bedside Mixing; Biological: R21 Malaria Vaccine (Recombinant) For Bedside Mixing; Biological: MATRIX-M1 (Adjuvant) For Bedside Mixing |
| Arm 1b (n=120), 9-17 years of age, main cohort | Experimental | 10µg of R21 with 50µg Matrix-M1 Receives: Biological: 10µg of R21 with 50µg Matrix-M1 |
| Arm 2b (n=120), 9-17 years of age, main cohort | Experimental | Control vaccine (rabies vaccine) Receives: Biological: RABIVAX-S |
| Arm 3b (n=120), 9-17 years of age, main cohort | Experimental | 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation Receives: Biological: 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation |
| Arm 1c (n=100), 18-50 years of age, main cohort | Experimental | 10µg of R21 with 50µg Matrix-M1 Receives: Biological: 10µg of R21 with 50µg Matrix-M1 |
| Arm 2c (n=100), 18-50 years of age, main cohort | Experimental | Control vaccine (rabies vaccine) Receives: Biological: RABIVAX-S |
| Arm 3c (n=100), 18-50 years of age, main cohort | Experimental | 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation Receives: Biological: 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Immediate adverse events in all participants
Occurrence of immediate adverse events
Measured: Up to 30-minutes following each dose
Number of Participants with solicited local adverse events in reactogenicity group
Occurrence of solicited local adverse events
Measured: Up to 7 days following each dose
Number of Participants with Solicited systemic adverse events in reactogenicity group
Occurrence of solicited systemic adverse events
Measured: Up to 7 days following each dose
Number of Participants with Unsolicited adverse events in all participants
Occurrence of unsolicited adverse events
Measured: Up to 28 days following each vaccination
Number of Participants with Serious adverse events in all participants
Occurrence of serious adverse events
Measured: Through the whole study duration, 24 months post dose 3 or 12 months post dose 4
Number of Participants with Abnormal Laboratory Values post-vaccination in laboratory safety group
Laboratory adverse events
Measured: at 7 days following each vaccination
Anti-NANP IgG antibodies
Antibody responses to NANP IgG antibodies
Measured: at 4 weeks post dose 3
Anti-Pfs230D1 IgG antibodies
Antibody responses to Pfs230D1 IgG antibodies
Measured: at 4 weeks post dose 3
Secondary outcomes (5)
To assess vaccine functional activity against transmission by DSF
Proportion reduction in proportion of infected mosquitoes (among those dissected)
Measured: from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster
To assess vaccine functional activity against transmission by DSF
Proportion reduction in DSFs with at least one infected mosquito
Measured: from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster
humoral immunogenicity time trends and durability
Antibody responses to Pfs230D1
Measured: at baseline, 28 days after each dose and through study completion, at an average of 1 month
humoral immunogenicity time trends and durability
Antibody responses to NANP
Measured: at baseline, 28 days after each dose and through study completion, at an average of 1 month
To assess the protective efficacy against clinical malaria caused by Pf
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
Measured: At 24 and 52 weeks after completion of the primary and booster vaccine course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start22 Aug 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Malaria Transmission and Clinical MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1200 Healthy male and non-pregnant female participants of age 9-50 years will be enrolled in VIMT002 study in Bancoumana, Mali and surrounding villages. Participants aged 9 - 17 years in the immunobridging cohort (n=540) will be randomized to one of the study arms (2:2:1:1) to receive 10µg R21 in 50µg of Matrix-M1 single vial formulation, control vaccine (RABIVAX-S), or 6µg Pfs230D1-CRM197 with 10µg R21 in 50µg of Matrix-M1 as either a bedside mixture or a single-vial coformulation. Participants in the main cohort will be randomized to one of the study arms (1:1:1) to receive 10µg R21 in 50µg of Matrix-M1, control vaccine (RABIVAX-S), or 6µg Pfs230D1-CRM197 with 10 µg R21 in 50µg of Matrix-M1 single-vial coformulation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147400
- Sponsor's protocol ID
- VIMT 002
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Double-blind, Controlled Study of Pfs230D1-CRM197 With R21 in Matrix-M1 in Healthy African School Children and Adults
- ClinicalTrials.gov ID
- NCT07147400
- Acronym / sponsor ID
- VIMT 002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants aged 9 - 17 years in the immunobridging cohort (n=540) will be randomized to one of the study arms ( 2:2:1:1) to receive 10μg R21 alone in 50μg of Matrix-M1, control vaccine (RABIVAX-S), or 6μg Pfs230D1-CRM197 with 10μg R21 in 50μg of Matrix-M1 as either a bedside mixture or a single-vial coformulation.
Participants in the main cohort who are aged 9-17 years will be randomized to one of the study arms (1:1:1) to receive 10μg R21 alone in 50μg of Matrix-M1, control vaccine (RABIVAX-S), or 6μg Pfs230D1-CRM197 with 10 μg R21 in 50μg of Matrix-M1 single-vial coformulation. Enrollment of participants aged 9-17 years in the main cohort will be done after DSMB reviews the 7-day safety data post dose 1 from the immunobridging cohort.
Participants in the main cohort who are aged 18 - 50 years will be randomized to one of the study arms (1:1:1) to receive either 10μg R21 alone in 50μg of Matrix-M1, control vaccine (RABIVAX-S), or 6μg Pfs230D1-CRM197 with 10μg R21 in 50μg of Matrix-M1 single-vial coformulation.
Enrollment of adult participants aged 18 -50 years in the main cohort (n=300) will be done from the start of the study and will be independent of enrollment into of the pediatric cohort (9-17 years).
All vaccines will be administered as an intramuscular (IM) injection on a 0, 28, 56 day schedule with an option for additional follow-up for a subsequent malaria transmission season with or without a fourth dose approximately 52 weeks after the third vaccine dose (based on year 1 results).
Initial enrollment will be staggered over time for safety, but all participants will be analyzed together for primary, secondary, and exploratory endpoints.
A total 1200 participants will be randomized into the study as below:
Immunobridging cohort (Participants 9-17 years of age, n = 540) (2:2:1:1 randomization)
- Arm 1a (n = 180): 10µg of R21 with 50µg Matrix-M1 on study day 0, 28, 56 +/- 392
- Arm 2a (n = 180): Control vaccine (rabies vaccine) on study day 0, 28, 56 +/- 392
- Arm 3a (n = 90): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation on study day 0, 28, 56 +/- 392
- Arm 4a (n = 90): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 bedside mix on study day 0, 28, 56 +/- 392
Main cohort:
Participants 9-17 years of age (n = 360) (1:1:1 randomization):
- Arm 1b (n=120): 10µg of R21 with 50µg Matrix-M1 on study day 0, 28, 56 +/- 392
- Arm 2b (n = 120): Control vaccine (rabies vaccine) on study day 0, 28, 56 +/- 392
- Arm 3b (n = 120): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation on study day 0, 28, 56 +/- 392
Participants 18-50 years of age (n = 300) (1:1:1 randomization):
- Arm 1c (n=100): 10µg of R21 with 50µg Matrix-M1 on study day 0, 28, 56 +/- 392
- Arm 2c (n = 100): Control vaccine (rabies vaccine) on study day 0, 28, 56 +/- 392
- Arm 3c (n = 100): 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation on study day 0, 28, 56 +/- 392
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
- Model description
- 1200 Healthy male and non-pregnant female participants of age 9-50 years will be enrolled in VIMT002 study in Bancoumana, Mali and surrounding villages. Participants aged 9 - 17 years in the immunobridging cohort (n=540) will be randomized to one of the study arms (2:2:1:1) to receive 10µg R21 in 50µg of Matrix-M1 single vial formulation, control vaccine (RABIVAX-S), or 6µg Pfs230D1-CRM197 with 10µg R21 in 50µg of Matrix-M1 as either a bedside mixture or a single-vial coformulation. Participants in the main cohort will be randomized to one of the study arms (1:1:1) to receive 10µg R21 in 50µg of Matrix-M1, control vaccine (RABIVAX-S), or 6µg Pfs230D1-CRM197 with 10 µg R21 in 50µg of Matrix-M1 single-vial coformulation.
| Arm | Type | Receives |
|---|---|---|
| Arm 1a (n=180), 9-17 years of age, Immunobridging cohort | Experimental | Biological: 10µg of R21 with 50µg Matrix-M110µg of R21 with 50µg Matrix-M1 |
| Arm 2a (n=180), 9-17 years of age, Immunobridging cohort | Experimental | Biological: RABIVAX-SControl vaccine (rabies vaccine) |
| Arm 3a (n=90), 9-17 years of age, Immunobridging cohort | Experimental | Biological: 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation |
| Arm 4a (n=90), 9-17 years of age, Immunobridging cohort | Experimental | Biological: Conjugated Pfs230D1 Vaccine (Pfs230D1-CRM197) For Bedside Mixing, Biological: R21 Malaria Vaccine (Recombinant) For Bedside Mixing, Biological: MATRIX-M1 (Adjuvant) For Bedside Mixing6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 bedside mix |
| Arm 1b (n=120), 9-17 years of age, main cohort | Experimental | Biological: 10µg of R21 with 50µg Matrix-M110µg of R21 with 50µg Matrix-M1 |
| Arm 2b (n=120), 9-17 years of age, main cohort | Experimental | Biological: RABIVAX-SControl vaccine (rabies vaccine) |
| Arm 3b (n=120), 9-17 years of age, main cohort | Experimental | Biological: 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation |
| Arm 1c (n=100), 18-50 years of age, main cohort | Experimental | Biological: 10µg of R21 with 50µg Matrix-M110µg of R21 with 50µg Matrix-M1 |
| Arm 2c (n=100), 18-50 years of age, main cohort | Experimental | Biological: RABIVAX-SControl vaccine (rabies vaccine) |
| Arm 3c (n=100), 18-50 years of age, main cohort | Experimental | Biological: 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation |
Who may qualify
- Ages
- 9 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10µg of R21 with 50µg Matrix-M1R21 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. Matrix-M1 (Adjuvanted) is cGMP manufactured by Serum Institute of India, PVD, LTD (SIIPL), Pune. | Biological | Arm 1a (n=180), 9-17 years of age, Immunobridging cohort, Arm 1b (n=120), 9-17 years of age, main cohort, Arm 1c (n=100), 18-50 years of age, main cohort |
| 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulationR21 Malaria antigen is expressed in a recombinant high expressing Hansenula polymorpha production strain. The R21 Malaria drug substance lots/batches were cGMP manufactured at SIIPL, India. Recombinant CRM197 is a recombinant protein, and its drug substance lots/batches cGMP manufactured using Pseudomonas fluorescens production strain at SIIPL, India. Recombinant Pfs230D1M drug substance lots/batches of cGMP were manufactured using Hansenula Polymorpha and manufactured at the SIIPL. A single vial coformulation containing 10µg R21 and 6µg Pfs230D1-CRM197 conjugate mixed with 50µg Matrix-M1 has been developed and is manufactured by SIIPL. | Biological | Arm 3a (n=90), 9-17 years of age, Immunobridging cohort, Arm 3b (n=120), 9-17 years of age, main cohort, Arm 3c (n=100), 18-50 years of age, main cohort |
| RABIVAX-SSterile, purified inactivated rabies vaccine prepared on vero cells, indicated for the prevention of rabies in children and adults. | Biological | Arm 2a (n=180), 9-17 years of age, Immunobridging cohort, Arm 2b (n=120), 9-17 years of age, main cohort, Arm 2c (n=100), 18-50 years of age, main cohort |
| Conjugated Pfs230D1 Vaccine (Pfs230D1-CRM197) For Bedside MixingRecombinant Pfs230D1M drug substance lots/batches cGMP manufactured using Pichia pastoris manufactured at the Pilot Bioproduction Facility, Walter Reed Army Institute of Research (Silver Spring, Maryland), and at SIIPL respectively. Recombinant CRM197 is a recombinant protein and its drug substance lots/batches cGMP manufactured using Pseudomonas fluorescens production strain at SIIPL, India. | Biological | Arm 4a (n=90), 9-17 years of age, Immunobridging cohort |
| R21 Malaria Vaccine (Recombinant) For Bedside MixingR21 is a fusion protein of hepatitis B surface antigen (HBsAg) to the C-terminus and central repeats of the circumsporozoite (CS) protein of Plasmodium falciparum. R21 VLP, recombinant HBsAg spontaneously self-assembled \& formed a virus-like particle, wherein circumsporozoite protein (CSP) from Plasmodium falciparum is presented on the VLP of recombinant HBsAg particles. R21 Malaria antigen expressed in recombinant high expressing Hansenula polymorpha production strain. The R21 Malaria drug substance lots/batches were cGMP manufactured at SIIPL, India. | Biological | Arm 4a (n=90), 9-17 years of age, Immunobridging cohort |
| MATRIX-M1 (Adjuvant) For Bedside Mixingactive ingredient in Matrix-M1 are saponin-based fractions. Matrix-M1 has a ratio of Matrix-A and Matrix-C of 85:15 (by weight). Both Matrix-A and Matrix-C are individual fractions (separated by chromatography) derived from extracts from the Quillaja saponaria tree. Matrix-M1 (Adjuvanted) is cGMP manufactured by Serum Institute of India, PVD, LTD (SIIPL), Pune. | Biological | Arm 4a (n=90), 9-17 years of age, Immunobridging cohort |
Primary outcome
Number of Participants with Immediate adverse events in all participants
Time frame: Up to 30-minutes following each dose
Occurrence of immediate adverse events
Number of Participants with solicited local adverse events in reactogenicity group
Time frame: Up to 7 days following each dose
Occurrence of solicited local adverse events
Number of Participants with Solicited systemic adverse events in reactogenicity group
Time frame: Up to 7 days following each dose
Occurrence of solicited systemic adverse events
Number of Participants with Unsolicited adverse events in all participants
Time frame: Up to 28 days following each vaccination
Occurrence of unsolicited adverse events
Number of Participants with Serious adverse events in all participants
Time frame: Through the whole study duration, 24 months post dose 3 or 12 months post dose 4
Occurrence of serious adverse events
Number of Participants with Abnormal Laboratory Values post-vaccination in laboratory safety group
Time frame: at 7 days following each vaccination
Laboratory adverse events
Anti-NANP IgG antibodies
Time frame: at 4 weeks post dose 3
Antibody responses to NANP IgG antibodies
Anti-Pfs230D1 IgG antibodies
Time frame: at 4 weeks post dose 3
Antibody responses to Pfs230D1 IgG antibodies
5 secondary outcomes
To assess vaccine functional activity against transmission by DSF
Time frame: from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster
To assess vaccine functional activity against transmission by DSF
Time frame: from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster
humoral immunogenicity time trends and durability
Time frame: at baseline, 28 days after each dose and through study completion, at an average of 1 month
humoral immunogenicity time trends and durability
Time frame: at baseline, 28 days after each dose and through study completion, at an average of 1 month
To assess the protective efficacy against clinical malaria caused by Pf
Time frame: At 24 and 52 weeks after completion of the primary and booster vaccine course
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10µg of R21 with 50µg Matrix-M1, 6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation and RABIVAX-S in people with Prevention of Malaria Transmission and Clinical Malaria, run by Serum Institute of India Pvt. Ltd. at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Immediate adverse events in all participants (time frame: Up to 30-minutes following each dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.