Malaria,FalciparumPhase 1NCT06320535
A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™
A Phase 1 study testing R21/Matrix M™ (Group 1), R21/Matrix M™ (Group 2) and R21/Matrix M™ (Group 3) in people with Malaria,Falciparum, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- R21/Matrix M™ (Group 1), R21/Matrix M™ (Group 2) and R21/Matrix M™ (Group 3)
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Mar 2024to 1 Sep 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
- Healthy adult aged 18 to 50 years.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Participants of childbearing potential only: must practice continuous effective contraception until the last study visit.
- Agreement to refrain from blood donation for the duration of the study.
- Able and willing to provide written informed consent to participate in the trial.
Who cannot join
- History of clinical malaria (any species) or previous participation in any malaria vaccine trial or controlled human malaria infection trial.
- Travel to a clearly malaria endemic locality during the study period or within the preceding six months, as per the CDC website: https://www.cdc.gov/malaria/travelers/country_table/a.html
- Participation in another research study involving receipt of an investigational medicinal product (IMP) in the 30 days preceding enrolment or 5 half-lives of the investigational medicinal product, whichever is longer, or planned participation during the study period.
- Prior receipt of an IMP likely to impact interpretation of the trial data, as assessed by the Investigator.
- Receipt of any vaccine within 30 days of a study vaccine, with the exception of COVID-19 vaccination.
- Receipt of oral or systemic immunosuppressant medication for more than 14 days in the six months preceding enrolment.
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- Receipt of immunoglobulins or blood products (e.g. blood transfusion) in the three months preceding enrolment.
- History of anaphylaxis to vaccination, or allergy likely to be exacerbated by any component of the vaccine or study procedures, including allergy to lidocaine
- Pregnancy, lactation or intention to become pregnant during the study.
- Clinically significant history of chronic disease, including cancer (except basal cell carcinoma or cervical carcinoma in situ), immunodeficiency (including HIV), autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease), psychiatric disorder, drug or alcohol abuse
- Positive Hepatitis B surface antigen (HBsAg), HIV antibodies or Hepatitis C (HCV) antibodies (except previous HCV vaccine study participants)
- HEMStop score > or = to 2(30) with abnormal coagulation screen or clinical concern regarding bleeding risk.
- Use of medications that increase the risk of bleeding, as assessed by the clinician, including: warfarin, oral antithrombin agents (e.g. Apixaban), low molecular weight heparin
- Any clinically significant abnormality of screening examination, blood or urine tests
- Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may put the volunteer at risk, affect the volunteer's ability to participate in the study or impair interpretation of the study data
- Participants unable to be closely followed for social, geographic or psychological reasons.
- Investigator inability to corroborate a participant's medical history via access to NHS electronic records and/or their GP.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS2 8HW
Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Phase 1 Study to Assess the Safety and Immunogenicity of R21/Matrix-M™ Administered in an Escalating Dose, Multi-prime Vaccination Schedule in Healthy Adults
This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.
Read the detailed description
This is a study to assess safety and immunogenicity of a novel dosing regimen for R21/ Matrix-M™, a leading Plasmodium falciparum malaria vaccine, in healthy, malaria-naïve adults. Participants in the study will receive either 6 escalating doses (groups 1 and 2) or 2 standard doses (group 3) of R21/ Matrix-M™, all delivered in the same arm. Up to 36 volunteers will be enrolled and followed up for 12-24 months after their first vaccine.
In addition to blood sampling throughout the follow-up period, participants will undergo fine needle aspiration of axillary lymph nodes twice during the study, to allow further characterisation of immune responses to this novel vaccine regimen.
- Conditions
- Malaria,Falciparum
- Being tested
- R21/Matrix M™ (Group 1), R21/Matrix M™ (Group 2), R21/Matrix M™ (Group 3), Fine needle aspiration (FNA)
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R21/Matrix M™ (Group 1)Biological
- 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0)
- 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3)
- 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7)
- 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10)
- 5 mcg R21 in 25 mcg Matrix-M™ (D14)
- 10 mcg R21 in 50 mcg Matrix-M™ (D56)
R21/Matrix M™ (Group 2)Biological
Group 2A:
- 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0)
- 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3)
- 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7)
- 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10)
- 5 mcg R21 in 25 mcg Matrix-M™ (D14)
- 10 mcg R21 in 50 mcg Matrix-M™(D168)
Group 2B:
- 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0)
- 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3)
- 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7)
- 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10)
- 5 mcg R21 in 25 mcg Matrix-M™ (D14)
- 10 mcg R21 in 50 mcg Matrix-M™(D280)
R21/Matrix M™ (Group 3)Biological
- 10 mcg R21 in 50 mcg Matrix-M™ (D0)
- 10 mcg R21 in 50 mcg Matrix-M™ (D56)
Fine needle aspiration (FNA)Procedure or surgery
Participants in all groups will undergo fine needle aspiration (FNA) of axillary lymph nodes draining vaccination site on Day 77 and Day 105 after initial vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Escalating dose R21/Matrix M™ | Experimental | 12 volunteers receiving escalating doses of R21/Matrix M™ adjuvant at days 0, 3, 7, 10, 14, and 56 via intramuscular (IM) injection in the deltoid region of the same arm Receives: Biological: R21/Matrix M™ (Group 1); Procedure: Fine needle aspiration (FNA) |
| Group 2: Escalating dose R21/Matrix M™ with delayed booster | Experimental | 12 volunteers receiving escalating doses of R21/Matrix M™ adjuvant at days 0, 3, 7, 10, 14, 168 (subgroup 2A)/280 (subgroup 2B) via intramuscular (IM) injection in the deltoid region of the same arm Receives: Biological: R21/Matrix M™ (Group 2); Procedure: Fine needle aspiration (FNA) |
| Group 3: Standard dose R21/Matrix-M™ | Experimental | 12 volunteers receiving two 10mcg doses of R21 in 50mcg of Matrix M™ adjuvant at days 0 and 56 via intramuscular (IM) injection in the deltoid region of the same arm Receives: Biological: R21/Matrix M™ (Group 3); Procedure: Fine needle aspiration (FNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of solicited adverse events in each group
Occurrence of solicited local and systemic reactogenicity signs and symptoms will be collected for 7 days following each vaccination. Solicited adverse event data will be tabulated, detailing frequency, duration and severity of the AEs.
Measured: 7 days post-vaccination
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of unsolicited adverse events and laboratory adverse events in each group
Occurrence of unsolicited adverse events and changes from baseline in laboratory safety measures will be collected for 28 days following each vaccination. Unsolicited AE data will be tabulated, detailing frequency, duration and severity of AEs. Hematological and biochemical laboratory values will be presented according to local grading scales.
Measured: 28 days post-vaccination.
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of serious adverse events in each group
Occurrence of serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawal due to AE(s)/SAE(s) will be described in detail.
Measured: For the follow-up period of the study, between 1-2 years
Humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule verus a standard prime-boost regimen in healthy UK adults
Antibody dynamics will be assessed by measuring NANP-IgG at baseline and various timepoints during the trial.
Measured: For the follow-up period of the study, between 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start25 Mar 2024
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who opt to receive the escalating dose regimen will be randomized to either Group 1 or Group 2. Recruitment to Groups 1 and 2 will be staggered, as these groups assess a novel administration regimen for R21/Matrix-M: * Two participants will be enrolled first, into Group 1 or 2, with a review of safety data collected up to Day 16 by the DSMC. * If reactogenicity is acceptable, the remaining participants may be enrolled into Groups 1 and Group 2. Participants may be recruited to Group 3 at any time. A second DSMC review will take place 16 days after 10 participants have been recruited in Groups 1 and 2 and 5 participants have been recruited in Group 3. Group 2 is divided into subgroups 2A and 2B, who receive their booster vaccinations at 6 months and 9 months post-first vaccination respectively.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University Hospitals Bristol and Weston NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Susanne Hodgson, DPhil FRCP, Principal investigator, Center for Clinical Vaccinology and Tropical Medicine, University of OxfordRajeka Lazarus, DPhil FRCP, Principal investigator, University Hospitals Bristol and Weston Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320535
- Sponsor's protocol ID
- VAC096
- Status last verified
- Jun 2025
- First submitted
- 12 Feb 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety and Immunogenicity of R21/Matrix-M™ Administered in an Escalating Dose, Multi-prime Vaccination Schedule in Healthy Adults
- ClinicalTrials.gov ID
- NCT06320535
- Acronym / sponsor ID
- VAC096
- Conditions
- Malaria,Falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University Hospitals Bristol and Weston NHS Foundation Trust
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 20 Mar 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 I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.
Detailed description
This is a study to assess safety and immunogenicity of a novel dosing regimen for R21/ Matrix-M™, a leading Plasmodium falciparum malaria vaccine, in healthy, malaria-naïve adults. Participants in the study will receive either 6 escalating doses (groups 1 and 2) or 2 standard doses (group 3) of R21/ Matrix-M™, all delivered in the same arm. Up to 36 volunteers will be enrolled and followed up for 12-24 months after their first vaccine.
In addition to blood sampling throughout the follow-up period, participants will undergo fine needle aspiration of axillary lymph nodes twice during the study, to allow further characterisation of immune responses to this novel vaccine regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants who opt to receive the escalating dose regimen will be randomized to either Group 1 or Group 2. Recruitment to Groups 1 and 2 will be staggered, as these groups assess a novel administration regimen for R21/Matrix-M: * Two participants will be enrolled first, into Group 1 or 2, with a review of safety data collected up to Day 16 by the DSMC. * If reactogenicity is acceptable, the remaining participants may be enrolled into Groups 1 and Group 2. Participants may be recruited to Group 3 at any time. A second DSMC review will take place 16 days after 10 participants have been recruited in Groups 1 and 2 and 5 participants have been recruited in Group 3. Group 2 is divided into subgroups 2A and 2B, who receive their booster vaccinations at 6 months and 9 months post-first vaccination respectively.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Escalating dose R21/Matrix M™ | Experimental | Biological: R21/Matrix M™ (Group 1), Procedure: Fine needle aspiration (FNA)12 volunteers receiving escalating doses of R21/Matrix M™ adjuvant at days 0, 3, 7, 10, 14, and 56 via intramuscular (IM) injection in the deltoid region of the same arm |
| Group 2: Escalating dose R21/Matrix M™ with delayed booster | Experimental | Biological: R21/Matrix M™ (Group 2), Procedure: Fine needle aspiration (FNA)12 volunteers receiving escalating doses of R21/Matrix M™ adjuvant at days 0, 3, 7, 10, 14, 168 (subgroup 2A)/280 (subgroup 2B) via intramuscular (IM) injection in the deltoid region of the same arm |
| Group 3: Standard dose R21/Matrix-M™ | Experimental | Biological: R21/Matrix M™ (Group 3), Procedure: Fine needle aspiration (FNA)12 volunteers receiving two 10mcg doses of R21 in 50mcg of Matrix M™ adjuvant at days 0 and 56 via intramuscular (IM) injection in the deltoid region of the same arm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult aged 18 to 50 years.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Participants of childbearing potential only: must practice continuous effective contraception until the last study visit.
- Agreement to refrain from blood donation for the duration of the study.
- Able and willing to provide written informed consent to participate in the trial.
Key exclusion criteria (17 listed)
- History of clinical malaria (any species) or previous participation in any malaria vaccine trial or controlled human malaria infection trial.
- Travel to a clearly malaria endemic locality during the study period or within the preceding six months, as per the CDC website: https://www.cdc.gov/malaria/travelers/country_table/a.html
- Participation in another research study involving receipt of an investigational medicinal product (IMP) in the 30 days preceding enrolment or 5 half-lives of the investigational medicinal product, whichever is longer, or planned participation during the study period.
- Prior receipt of an IMP likely to impact interpretation of the trial data, as assessed by the Investigator.
- Receipt of any vaccine within 30 days of a study vaccine, with the exception of COVID-19 vaccination.
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 |
|---|---|---|
| R21/Matrix M™ (Group 1)* 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0) * 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3) * 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7) * 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10) * 5 mcg R21 in 25 mcg Matrix-M™ (D14) * 10 mcg R21 in 50 mcg Matrix-M™ (D56) | Biological | Group 1: Escalating dose R21/Matrix M™ |
| R21/Matrix M™ (Group 2)Group 2A: * 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0) * 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3) * 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7) * 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10) * 5 mcg R21 in 25 mcg Matrix-M™ (D14) * 10 mcg R21 in 50 mcg Matrix-M™(D168) Group 2B: * 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0) * 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3) * 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7) * 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10) * 5 mcg R21 in 25 mcg Matrix-M™ (D14) * 10 mcg R21 in 50 mcg Matrix-M™(D280) | Biological | Group 2: Escalating dose R21/Matrix M™ with delayed booster |
| R21/Matrix M™ (Group 3)* 10 mcg R21 in 50 mcg Matrix-M™ (D0) * 10 mcg R21 in 50 mcg Matrix-M™ (D56) | Biological | Group 3: Standard dose R21/Matrix-M™ |
| Fine needle aspiration (FNA)Participants in all groups will undergo fine needle aspiration (FNA) of axillary lymph nodes draining vaccination site on Day 77 and Day 105 after initial vaccination. | Procedure or surgery | Group 1: Escalating dose R21/Matrix M™, Group 2: Escalating dose R21/Matrix M™ with delayed booster, Group 3: Standard dose R21/Matrix-M™ |
Primary outcome
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of solicited adverse events in each group
Time frame: 7 days post-vaccination
Occurrence of solicited local and systemic reactogenicity signs and symptoms will be collected for 7 days following each vaccination. Solicited adverse event data will be tabulated, detailing frequency, duration and severity of the AEs.
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of unsolicited adverse events and laboratory adverse events in each group
Time frame: 28 days post-vaccination.
Occurrence of unsolicited adverse events and changes from baseline in laboratory safety measures will be collected for 28 days following each vaccination. Unsolicited AE data will be tabulated, detailing frequency, duration and severity of AEs. Hematological and biochemical laboratory values will be presented according to local grading scales.
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of serious adverse events in each group
Time frame: For the follow-up period of the study, between 1-2 years
Occurrence of serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawal due to AE(s)/SAE(s) will be described in detail.
Humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule verus a standard prime-boost regimen in healthy UK adults
Time frame: For the follow-up period of the study, between 1-2 years
Antibody dynamics will be assessed by measuring NANP-IgG at baseline and various timepoints during the trial.
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 21 Oct 2026.
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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.
Susanne Hodgson, DPhil FRCP principal investigator
Center for Clinical Vaccinology and Tropical Medicine, University of Oxford
Rajeka Lazarus, DPhil FRCP principal investigator
University Hospitals Bristol and Weston Foundation Trust
2 sites 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/Matrix M™ (Group 1), R21/Matrix M™ (Group 2) and R21/Matrix M™ (Group 3) in people with Malaria,Falciparum, run by University of Oxford at 2 sites in United Kingdom.
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 17 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 21 Oct 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 United Kingdom. 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?
Safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule versus a standard prime-boost regimen in healthy UK adults, measured by the number of solicited adverse events in each group (time frame: 7 days post-vaccination). The study lists 4 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 21 Oct 2026.