Prevention of Malaria Transmission and Clinical MalariaPhase 1NCT06507605
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
A Phase 1 study testing R21, Pfs230D1-CRM197 and Pfs230D1-EPA 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 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Malaria Transmission and Clinical Malaria
- What is being tested?
- R21, Pfs230D1-CRM197 and Pfs230D1-EPA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteMali
- Study dates
- 30 Aug 2024to 24 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 50 years old.
- Provides written informed consent.
- Able to understand and comply with planned study procedures and be available for the duration of the trial.
- In good general health and without clinically significant medical history in the opinion of the investigator.
- Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 1 and until 1 month after the last vaccination.
Who cannot join
- Pregnant and breastfeeding females.
- Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory-defined reference ranges.
- Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of reference range.
- Infected with HIV, hepatitis B, hepatitis C.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies.
- Current or planned participation in an investigational product study until the time period of the last required study visit under this protocol.
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- 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, Autoimmune or antibody-mediated disease, Immunodeficiency, Seizure disorder, Asplenia or functional asplenia, Use of chronic oral or intravenous corticosteroids (excluding topical or nasal), Sickle cell disease.
- Any other condition that in the opinion of the investigator might jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or might render the subject 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 1 Randomized, Double-blind Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in Healthy African Adults
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.
Read the detailed description
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
- Arm 1a (n=20): 6μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 1b (n=20): 6μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
- Arm 1c (n=20): 12μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 1d (n=20): 12μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
- Arm 1e (n=20): 5μg of R21 in 50μg Matrix-M
- Arm 1f (n=20): 10μg of R21 in 50μg Matrix-M
Followed by Cohort 2 (n=80); 1:1:1:1
- Arm 2a (n=20): 20μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 2b (n=20): 20μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
- Arm 2c (n=20): 20μg Pfs230D1-CRM197 in 50μg Matrix-M
- Arm 2d (n=20): 20μg Pfs230D1-EPA + 5μg of R21 in 50μg Matrix-M
Followed by Cohort 3 (n=40); 1:1
- Arm 3a (n=20): 40μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 3b (n=20): 40μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
- Being tested
- R21, Pfs230D1-CRM197, Pfs230D1-EPA, Matrix-M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R21Biological
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.
Pfs230D1-CRM197Biological
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.
Pfs230D1-EPABiological
Recombinant Pfs230D1 conjugated to a recombinant Pseudomonas aeruginosa ExoProtein A (EPA)
Matrix-MOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1a (n=20) | Experimental | 6μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 1b (n=20) | Experimental | 6μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 1c (n=20) | Experimental | 12μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 1d (n=20) | Experimental | 12μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 1e (n=20) | Active comparator | 5μg of R21 in 50μg Matrix-M Receives: Biological: R21; Other: Matrix-M |
| Arm 1f (n=20) | Active comparator | 10μg of R21 in 50μg Matrix-M Receives: Biological: R21; Other: Matrix-M |
| Arm 2a (n=20) | Experimental | 20μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 2b (n=20) | Experimental | 20μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 2c (n=20) | Experimental | 20μg Pfs230D1-CRM197 in 50μg Matrix-M Receives: Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 2d (n=20) | Experimental | 20μg Pfs230D1-EPA + 5μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-EPA; Other: Matrix-M |
| Arm 3a (n=20) | Experimental | 40μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
| Arm 3b (n=20) | Experimental | 40μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M Receives: Biological: R21; Biological: Pfs230D1-CRM197; Other: Matrix-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Immediate adverse events
Occurrence of immediate adverse events
Measured: within 30-minutes following each dose
Number of Participants with Solicited local adverse events
Occurrence of solicited local adverse events
Measured: for 7 days following each dose
Number of Participants with Solicited systemic adverse events
Occurrence of solicited systemic adverse events
Measured: for 7 days following each dose
Number of Participants with Unsolicited adverse events
Occurrence of all unsolicited adverse events
Measured: 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
Measured: within 7 days following each dose
Number of Participants with Serious adverse events
Occurrence of serious adverse events
Measured: Till 6 months post last dose
Secondary outcomes (2)
Anti-NANP IgG antibodies
Comparison of anti-NANP IgG antibodies
Measured: at 2 weeks post dose 3 in all treatment arms
Anti-Pfs230D1 IgG antibodies
Comparison of Anti-Pfs230D1 IgG antibodies
Measured: at 2 weeks post dose 3 in all treatment arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start30 Aug 2024
- Primary completion24 Jan 2026
- Study completion24 Jan 2026
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized by cohorts as 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 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
- NCT06507605
- Sponsor's protocol ID
- VIMT 001
- Status last verified
- Feb 2026
- First submitted
- 4 Jul 2024
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized, Double-blind Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in Healthy African Adults
- ClinicalTrials.gov ID
- NCT06507605
- Acronym / sponsor ID
- VIMT 001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 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
- 30 Aug 2024 (actual)
- Primary completion
- 24 Jan 2026 (actual)
- Study completion
- 24 Jan 2026 (actual)
- First posted
- 18 Jul 2024 (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 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.
Detailed description
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
- Arm 1a (n=20): 6μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 1b (n=20): 6μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
- Arm 1c (n=20): 12μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 1d (n=20): 12μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
- Arm 1e (n=20): 5μg of R21 in 50μg Matrix-M
- Arm 1f (n=20): 10μg of R21 in 50μg Matrix-M
Followed by Cohort 2 (n=80); 1:1:1:1
- Arm 2a (n=20): 20μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 2b (n=20): 20μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
- Arm 2c (n=20): 20μg Pfs230D1-CRM197 in 50μg Matrix-M
- Arm 2d (n=20): 20μg Pfs230D1-EPA + 5μg of R21 in 50μg Matrix-M
Followed by Cohort 3 (n=40); 1:1
- Arm 3a (n=20): 40μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M
- Arm 3b (n=20): 40μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
- Model description
- Participants will be randomized by cohorts as 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1a (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M6μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M |
| Arm 1b (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M6μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M |
| Arm 1c (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M12μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M |
| Arm 1d (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M12μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M |
| Arm 1e (n=20) | Active comparator | Biological: R21, Other: Matrix-M5μg of R21 in 50μg Matrix-M |
| Arm 1f (n=20) | Active comparator | Biological: R21, Other: Matrix-M10μg of R21 in 50μg Matrix-M |
| Arm 2a (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M20μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M |
| Arm 2b (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M20μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M |
| Arm 2c (n=20) | Experimental | Biological: Pfs230D1-CRM197, Other: Matrix-M20μg Pfs230D1-CRM197 in 50μg Matrix-M |
| Arm 2d (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-EPA, Other: Matrix-M20μg Pfs230D1-EPA + 5μg of R21 in 50μg Matrix-M |
| Arm 3a (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M40μg Pfs230D1-CRM197 + 5μg of R21 in 50μg Matrix-M |
| Arm 3b (n=20) | Experimental | Biological: R21, Biological: Pfs230D1-CRM197, Other: Matrix-M40μg Pfs230D1-CRM197 + 10μg of R21 in 50μg Matrix-M |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 to 50 years old.
- Provides written informed consent.
- Able to understand and comply with planned study procedures and be available for the duration of the trial.
- In good general health and without clinically significant medical history in the opinion of the investigator.
- Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 1 and until 1 month after the last vaccination.
Key exclusion criteria (10 listed)
- Pregnant and breastfeeding females.
- Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory-defined reference ranges.
- Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of reference range.
- Infected with HIV, hepatitis B, hepatitis C.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies.
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 |
|---|---|---|
| R21R21 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. | Biological | Arm 1a (n=20), Arm 1b (n=20), Arm 1c (n=20), Arm 1d (n=20), Arm 1e (n=20), Arm 1f (n=20), Arm 2a (n=20), Arm 2b (n=20), Arm 2d (n=20), Arm 3a (n=20), Arm 3b (n=20) |
| Pfs230D1-CRM197Recombinant 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. | Biological | Arm 1a (n=20), Arm 1b (n=20), Arm 1c (n=20), Arm 1d (n=20), Arm 2a (n=20), Arm 2b (n=20), Arm 2c (n=20), Arm 3a (n=20), Arm 3b (n=20) |
| Pfs230D1-EPARecombinant Pfs230D1 conjugated to a recombinant Pseudomonas aeruginosa ExoProtein A (EPA) | Biological | Arm 2d (n=20) |
| Matrix-MVaccine 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. | Other | Arm 1a (n=20), Arm 1b (n=20), Arm 1c (n=20), Arm 1d (n=20), Arm 1e (n=20), Arm 1f (n=20), Arm 2a (n=20), Arm 2b (n=20), Arm 2c (n=20), Arm 2d (n=20), Arm 3a (n=20), Arm 3b (n=20) |
Primary outcome
Number of Participants with Immediate adverse events
Time frame: within 30-minutes following each dose
Occurrence of immediate adverse events
Number of Participants with Solicited local adverse events
Time frame: for 7 days following each dose
Occurrence of solicited local adverse events
Number of Participants with Solicited systemic adverse events
Time frame: for 7 days following each dose
Occurrence of solicited systemic adverse events
Number of Participants with Unsolicited adverse events
Time frame: for 28 days following each dose
Occurrence of all unsolicited adverse events
Number of Participants with Abnormal Laboratory Values post-vaccination
Time frame: within 7 days following each dose
Any significant change from baseline for laboratory values defined as adverse events
Number of Participants with Serious adverse events
Time frame: Till 6 months post last dose
Occurrence of serious adverse events
2 secondary outcomes
Anti-NANP IgG antibodies
Time frame: at 2 weeks post dose 3 in all treatment arms
Anti-Pfs230D1 IgG antibodies
Time frame: at 2 weeks post dose 3 in all treatment arms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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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 1 study testing R21, Pfs230D1-CRM197 and Pfs230D1-EPA 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 10 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: within 30-minutes following each dose). The study lists 6 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 10 Feb 2026.