Plasmodium Falciparum MalariaPhase 4VAC100NCT07194668
R21/MM Dosing, Presentations, and Preservatives
A Phase 4 study testing 10μg R21/50μg Matrix-M, 5μg R21/50μg Matrix-M with adaptor preservative free and 5μg R21/50μg Matrix-M with 2PE preservative in people with Plasmodium Falciparum Malaria and Malaria, run by University of Oxford at 2 sites in Bangladesh.
Trial summary
This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies. Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria, Malaria, Vaccine Reaction
- What is being tested?
- 10μg R21/50μg Matrix-M, 5μg R21/50μg Matrix-M with adaptor preservative free and 5μg R21/50μg Matrix-M with 2PE preservative
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 2 sitesBangladesh
- Study dates
- 15 Aug 2026to 31 Dec 2026
- Phase
- Phase 4
- 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 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Residence in a study village for the study period, i.e. 12 months.
- Age 14 years to 60 years.
- Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).
Who cannot join
- Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.
- Acute illness requiring intervention.
- A history of an adverse reaction to study vaccine.
- Prior receipt of any other malaria vaccine.
- Enrolment in another intervention trial in the last month.
- Planned enrolment in another intervention trial in the coming 12 months.
- Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and/or planned for the coming 12 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh2 sites
Alikadam Upazila Health Complex
Bāndarban, Bāndarban, 4650
Mohammad Abul Faiz, +008801613008857, drmafaiz@gmail.com
Lama Upazila Health Complex
Lāma, Lama, 4641
Mohammad Abul Faiz, +008801613008857, drmafaiz@gmail.com
About this study
Official title: Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial
This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.
All participants will receive the same number of injections and will be randomly assigned to receive one of the followings:
Read more
- Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125).
- Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125)
- Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125)
Clinical procedure for participants:
- Standardized symptom questionnaire
- Physical examination:
Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential)
- Venous blood collection (Pre-vaccination) 3mL
- Vaccination
Read the detailed description
This study was funded by Hanako Foundation. The grant reference number: 001/2026.
- Conditions
- Plasmodium Falciparum Malaria, Malaria, Vaccine Reaction
- Being tested
- 10μg R21/50μg Matrix-M, 5μg R21/50μg Matrix-M with adaptor preservative free, 5μg R21/50μg Matrix-M with 2PE preservative
- Keywords
- Plasmodium Falciparum Malaria, Malaria Vaccine
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10μg R21/50μg Matrix-MBiological
Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)
5μg R21/50μg Matrix-M with adaptor preservative freeBiological
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125)
5μg R21/50μg Matrix-M with 2PE preservativeBiological
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)
| Study group | Role | What they receive |
|---|---|---|
| The standard adult vaccine dose | Active comparator | Adults and adolescents receiving the standard adult vaccine dose Receives: Biological: 10μg R21/50μg Matrix-M |
| A half of the standard adult vaccine dose with adaptor Preservative Free | Active comparator | Adults and adolescents receiving a half of the standard adult vaccine dose with adaptor Preservative Free (n=125) Receives: Biological: 5μg R21/50μg Matrix-M with adaptor preservative free |
| A half of the standard adult vaccine dose with 2PE Preservative | Active comparator | Adults and adolescents receiving a half of the standard adult vaccine dose with 2PE Preservative (n=125) Receives: Biological: 5μg R21/50μg Matrix-M with 2PE preservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody)
Measured: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti C-Term, and full length R21 total IgG antibody), in addition to total IgG against Hepatitis B surface antigen
Measured: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
Secondary outcomes (2)
Adverse event and severe adverse event reports for safety and tolerability assessment of the standard adult vaccine dose 10μg R21/50μg Matrix-M and a half of the standard adult dose 5μg R21/50μg Matrix-M
Measured: At Month 1, Month 2, Month 3, Month 11 and Month 12
Adverse event and severe adverse event reports for safety and tolerability assessment a half of the standard adult dose 5μg R21/50μg Matrix-M with 2PE preservative vs, without 2PE preservative.
Measured: At Month 1, Month 2, Month 3, Month 11 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194668
- Sponsor's protocol ID
- MAL25005
- Acronym
- VAC100
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy (https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing/moru-tropical-network-policy-on-sharing-data-and-other-outputs)with data repositories such as the WorldWide Antimalarial Resistance Network (WWARN, terms of submission here: http://www.wwarn.org/tools-resources/terms-submission) or other researchers to use in the future. All personal information will be anonymised so that no individual can be identified from their treatment records, through interviews, or from mapping data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07194668
- Acronym / sponsor ID
- VAC100 / MAL25005
- Conditions
- Plasmodium Falciparum Malaria, Malaria, Vaccine Reaction
- Keywords
- Plasmodium Falciparum Malaria, Malaria Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Sep 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 single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.
All participants will receive the same number of injections and will be randomly assigned to receive one of the followings:
- Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125).
- Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125)
- Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125)
Clinical procedure for participants:
- Standardized symptom questionnaire
- Physical examination:
Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential)
- Venous blood collection (Pre-vaccination) 3mL
- Vaccination
Detailed description
This study was funded by Hanako Foundation. The grant reference number: 001/2026.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The standard adult vaccine dose | Active comparator | Biological: 10μg R21/50μg Matrix-MAdults and adolescents receiving the standard adult vaccine dose |
| A half of the standard adult vaccine dose with adaptor Preservative Free | Active comparator | Biological: 5μg R21/50μg Matrix-M with adaptor preservative freeAdults and adolescents receiving a half of the standard adult vaccine dose with adaptor Preservative Free (n=125) |
| A half of the standard adult vaccine dose with 2PE Preservative | Active comparator | Biological: 5μg R21/50μg Matrix-M with 2PE preservativeAdults and adolescents receiving a half of the standard adult vaccine dose with 2PE Preservative (n=125) |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Residence in a study village for the study period, i.e. 12 months.
- Age 14 years to 60 years.
- Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).
Key exclusion criteria (7 listed)
- Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.
- Acute illness requiring intervention.
- A history of an adverse reaction to study vaccine.
- Prior receipt of any other malaria vaccine.
- Enrolment in another intervention trial in the last month.
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 R21/50μg Matrix-MAdults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125) | Biological | The standard adult vaccine dose |
| 5μg R21/50μg Matrix-M with adaptor preservative freeAdults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125) | Biological | A half of the standard adult vaccine dose with adaptor Preservative Free |
| 5μg R21/50μg Matrix-M with 2PE preservativeAdults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125) | Biological | A half of the standard adult vaccine dose with 2PE Preservative |
Primary outcome
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody)
Time frame: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti C-Term, and full length R21 total IgG antibody), in addition to total IgG against Hepatitis B surface antigen
Time frame: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
2 secondary outcomes
Adverse event and severe adverse event reports for safety and tolerability assessment of the standard adult vaccine dose 10μg R21/50μg Matrix-M and a half of the standard adult dose 5μg R21/50μg Matrix-M
Time frame: At Month 1, Month 2, Month 3, Month 11 and Month 12
Adverse event and severe adverse event reports for safety and tolerability assessment a half of the standard adult dose 5μg R21/50μg Matrix-M with 2PE preservative vs, without 2PE preservative.
Time frame: At Month 1, Month 2, Month 3, Month 11 and Month 12
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes. With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy (https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing/moru-tropical-network-policy-on-sharing-data-and-other-outputs)with data repositories such as the WorldWide Antimalarial Resistance Network (WWARN, terms of submission here: http://www.wwarn.org/tools-resources/terms-submission) or other researchers to use in the future. All personal information will be anonymised so that no individual can be identified from their treatment records, through interviews, or from mapping data.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10μg R21/50μg Matrix-M, 5μg R21/50μg Matrix-M with adaptor preservative free and 5μg R21/50μg Matrix-M with 2PE preservative in people with Plasmodium Falciparum Malaria and Malaria, run by University of Oxford at 2 sites in Bangladesh.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Lorenz von Seidlein (+66926486322, Lorenz@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody) (time frame: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).). The study lists 2 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 4 Aug 2026.