MalariaPhase 1NCT02572388
A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1
A Phase 1 study testing R21 and Matrix-M1 in people with Malaria, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. The vaccine R21 will either be administered alone or in combination with the adjuvant vaccine Matrix-M1. All vaccinations will be administered intramuscularly. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- R21 and Matrix-M1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Oct 2015to 29 Aug 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The volunteer must satisfy all the following criteria to be eligible for the study:
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Who cannot join
- The volunteer may not enter the study if any of the following apply:
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Show all 20Show fewer
- Any history of anaphylaxis in relation to vaccination
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition likely to affect participation in the study
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- History of clinical malaria (any species)
- Travel to a malaria endemic region during the study period or within the previous six months
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NIHR Wellcome Trust Clinical Research Facility, Hammersmith Hospital
London, W12 0HS
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With and Without Matrix-M1 in Healthy UK Volunteers
This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. The vaccine R21 will either be administered alone or in combination with the adjuvant vaccine Matrix-M1.
All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total.
Read more
There are three different vaccine schedules:
Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.
Group 2 will receive 50µg of R21 on days 0, 28, and 56. .
Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.
The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.
Healthy adult volunteers will be recruited in Oxford and London, England.
- Conditions
- Malaria
- Being tested
- R21, Matrix-M1
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R21Biological
Matrix-M1Biological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. Receives: Biological: R21; Biological: Matrix-M1 |
| Group 2 | Active comparator | 50µg of R21 on days 0, 28, and 56. Receives: Biological: R21 |
| Group 3 | Active comparator | 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. Receives: Biological: R21; Biological: Matrix-M1 |
| Group 4 | Active comparator | 2µg of R21 mixed with 50µg of Matrix-M Receives: Biological: R21; Biological: Matrix-M1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).
Measured: Assessment of solicited AEs in the first 7 days post vaccination.
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.
Occurrence of unsolicited local and systemic adverse events.
Measured: Unsolicited AEs to be assessed up to 28 days post vaccination.
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.
Occurrence of serious adverse events collected from enrolment until the end of the follow-up period.
Measured: 6 months
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
Measured: At Day 0 (baseline), day 7 and day 28 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start15 Oct 2015
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572388
- Sponsor's protocol ID
- VAC053
- Status last verified
- Jan 2018
- First submitted
- 1 Oct 2015
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Venkatraman N, Tiono AB, Bowyer G, Bellamy DG, Stockdale LK, Powlson J, Collins KA, Coulibaly S, Datoo MS, Silman D, Ouedraogo A, Nebie I, Imoukhuede EB, Brod F, Folegatti P, Dickinson-Craig E, Jamieson S, Bougouma EC, Wright D, Diarra A, Bliss CM, Morter R, Glenn G, Fries LF, Reimer JM, Lovgren-Bengtsson K, Baker M, Poulton I, Moyle S, Berrie E, Green N, Mukhopadhyay E, Viebig NK, Angus B, Lawrie A, Roberts R, Gilbert SC, Lewis DJM, Sirima SB, Ewer KJ, Hill AVS. Evaluation of a novel malaria anti-sporozoite vaccine candidate, R21 in Matrix-M adjuvant, in the UK and Burkina Faso: two phase 1, first-in-human trials. Lancet Microbe. 2025 Mar;6(3):100868. doi: 10.1016/S2666-5247(24)00084-3. Epub 2025 Jan 10.
PubMed 39805302
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With and Without Matrix-M1 in Healthy UK Volunteers
- ClinicalTrials.gov ID
- NCT02572388
- Acronym / sponsor ID
- VAC053
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Posted 12 Nov 2019
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 clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. The vaccine R21 will either be administered alone or in combination with the adjuvant vaccine Matrix-M1.
All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total.
There are three different vaccine schedules:
Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.
Group 2 will receive 50µg of R21 on days 0, 28, and 56. .
Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.
The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.
Healthy adult volunteers will be recruited in Oxford and London, England.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: R21, Biological: Matrix-M110µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. |
| Group 2 | Active comparator | Biological: R2150µg of R21 on days 0, 28, and 56. |
| Group 3 | Active comparator | Biological: R21, Biological: Matrix-M150µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. |
| Group 4 | Active comparator | Biological: R21, Biological: Matrix-M12µg of R21 mixed with 50µg of Matrix-M |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (20 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
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 | Biological | Group 1, Group 2, Group 3, Group 4 |
| Matrix-M1 | Biological | Group 1, Group 3, Group 4 |
Primary outcome
Safety and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.
Time frame: Assessment of solicited AEs in the first 7 days post vaccination.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.
Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination.
Occurrence of unsolicited local and systemic adverse events.
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.
Time frame: 6 months
Occurrence of serious adverse events collected from enrolment until the end of the follow-up period.
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.
Time frame: At Day 0 (baseline), day 7 and day 28 post vaccination
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39805302Venkatraman N, Tiono AB, Bowyer G, Bellamy DG, Stockdale LK, Powlson J, Collins KA, Coulibaly S, Datoo MS, Silman D, Ouedraogo A, Nebie I, Imoukhuede EB, Brod F, Folegatti P, Dickinson-Craig E, Jamieson S, Bougouma EC, Wright D, Diarra A, Bliss CM, Morter R, Glenn G, Fries LF, Reimer JM, Lovgren-Bengtsson K, Baker M, Poulton I, Moyle S, Berrie E, Green N, Mukhopadhyay E, Viebig NK, Angus B, Lawrie A, Roberts R, Gilbert SC, Lewis DJM, Sirima SB, Ewer KJ, Hill AVS. Evaluation of a novel malaria anti-sporozoite vaccine candidate, R21 in Matrix-M adjuvant, in the UK and Burkina Faso: two phase 1, first-in-human trials. Lancet Microbe. 2025 Mar;6(3):100868. doi: 10.1016/S2666-5247(24)00084-3. Epub 2025 Jan 10.
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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.
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 and Matrix-M1 in people with Malaria, 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 7 inclusion and 20 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 12 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events. (time frame: Assessment of solicited AEs in the first 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?
On the ClinicalTrials.gov record for NCT02572388, which also lists 1 linked publication.
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 12 Nov 2019.