Malaria, FalciparumEarly Phase 1NCT05385471
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M in Healthy UK Adults
A Early Phase 1 study testing Matrix M with R78C and/or RH5.1 in people with Malaria, Falciparum, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is an open-label, single-centre Phase I P. falciparum blood-stage vaccine trial to assess the safety and immunogenicity and efficacy of the candidate malaria vaccines R78C and RH5.1 formulated in adjuvant Matrix-M Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Matrix M with R78C and/or RH5.1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2023to 31 Mar 2026
- Phase
- Early Phase 1
- 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 18 to 45 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 adult aged 18 to 45 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 GP
- Participants of childbearing potential only: must practice continuous effective contraception until 3 months after the final study vaccination (see section 9.10)
- 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
- The volunteer may not enter the study if any of the following apply:
- 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
- Use of immunoglobulins or blood products (e.g. blood transfusion) in the last three months
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
Show all 23Show fewer
- Concurrent involvement in another clinical trial involving an investigational product or planned involvement during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
- 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
- Any history of anaphylaxis in reaction to vaccinations
- Pregnancy, lactation or 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 that may affect participation in the study
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol misuse as defined by an alcohol intake of greater than 25 standard UK units every week
- Suspected or known injecting drug use in the 5 years preceding enrolment
- Hepatitis B surface antigen (HBsAg) detected in serum
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV ribonucleic acid (RNA) PCR at screening for this study)
- Volunteers unable to be closely followed for social, geographic or psychological reasons.
- Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested.
- 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
1 site in 1 country.
United Kingdom1 site
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE
About this study
Official title: A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M, Both Alone and in Combination, in Healthy UK Adults
This is an open-label, single-centre Phase I P. falciparum blood-stage vaccine trial to assess the safety and immunogenicity and efficacy of the candidate malaria vaccines R78C and RH5.1 formulated in adjuvant Matrix-M
Read the detailed description
Volunteers will be recruited into one of four groups (n=8+1 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. Volunteers in groups 1, 2 and 4 will be followed up for a total of approximately 12 months. There will be 3 sentinel participants in each group (and for each successive vaccination), which will require an independent safety review prior to each successive vaccination. Group 3 is not a first-in-human group and so can be recruited at any time and participants will be followed up for a total of approximately 20 months from first vaccination. All volunteers will be given 10 µg R78C and/or 10 µg RH5.1 soluble protein in combination with 50 µg of Matrix-M via intramuscular (IM) injection in the deltoid region of the non-dominant arm.
- Conditions
- Malaria, Falciparum
- Being tested
- Matrix M with R78C and/or RH5.1
- Keywords
- R78C, RH5.1, Matrix-M
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix M with R78C and/or RH5.1Biological
50 µg of Matrix-M adjuvant with R78C and/or RH5.1 at different doses and timepoints
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 8+1 volunteers receiving three doses of 10 µg R78C with 50 µg of Matrix-M on days 0, 28 and 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix M with R78C and/or RH5.1 |
| Group 2 | Experimental | 8+1 volunteers receiving three doses of 10 µg R78C + 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix M with R78C and/or RH5.1 |
| Group 3 | Experimental | 8+1 volunteers receiving three doses of 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and 56 via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix M with R78C and/or RH5.1 |
| Group 4 | Experimental | 8+1 volunteers receiving two doses of 10 µg R78C + 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28, one dose of 10 µg R78C with 50 µg of Matrix-M on day 182 and one dose of 10 µg RH5.1 with 50 µg of Matrix-M on day 210, all administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix M with R78C and/or RH5.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.
Measured: 7 days following each vaccination
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.
Measured: 7 days following each vaccination
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of unsolicited adverse events for 28 days following the vaccination
Occurrence of unsolicited adverse events for 28 days following the vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.
Measured: 28 days following the vaccination
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination, assessed through the number of participants with abnormal laboratory test results
Occurrence of change from baseline laboratory tests
Measured: 28 days following vaccination
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination, assessed through the number of participants with serious adverse events
Occurrence of serious adverse events during the whole study duration. Haematological and biochemical laboratory values will be presented according to local grading scales.
Measured: Whole duration of the Study (up to day 600 depending on group)
Secondary outcomes (5)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M when administered to healthy volunteers alone and in combination assessing antigen-specific IgG antibody levels, with comparison before and after vaccination
Serum ELISA response, quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity, with comparison before and after vaccination
Measured: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy volunteers assessing antigen-specific antibody subclass/isotype measurement, with comparison before and after vaccination
Serum ELISA response, antigen-specific antibody subclass/isotype measurement, with comparison before and after vaccination
Measured: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy volunteers assessing antigen-specific antibody avidity measurement, with comparison before and after vaccination
Serum ELISA response, antigen-specific antibody avidity measurement, with comparison before and after vaccination
Measured: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M when administered to healthy volunteers alone and in combination assessing In vitro GIA, with comparison before and after vaccination
In vitro GIA against 3D7 clone P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay, with comparison before and after vaccination
Measured: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy volunteers assessing Purified IgG ELISA versus GIA titration "Quality Analysis", with comparison before and after vaccination
Purified IgG ELISA versus GIA titration "Quality Analysis"
Measured: From a number of key timepoints, baseline up to day 600 (dependant on group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start13 Jan 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela M Minassian, DPhil FRCP, Principal investigator, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385471
- Sponsor's protocol ID
- VAC089
- Status last verified
- Mar 2025
- First submitted
- 17 May 2022
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M, Both Alone and in Combination, in Healthy UK Adults
- ClinicalTrials.gov ID
- NCT05385471
- Acronym / sponsor ID
- VAC089
- Conditions
- Malaria, Falciparum
- Keywords
- R78C, RH5.1, Matrix-M
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 23 May 2022 (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 an open-label, single-centre Phase I P. falciparum blood-stage vaccine trial to assess the safety and immunogenicity and efficacy of the candidate malaria vaccines R78C and RH5.1 formulated in adjuvant Matrix-M
Detailed description
Volunteers will be recruited into one of four groups (n=8+1 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. Volunteers in groups 1, 2 and 4 will be followed up for a total of approximately 12 months. There will be 3 sentinel participants in each group (and for each successive vaccination), which will require an independent safety review prior to each successive vaccination. Group 3 is not a first-in-human group and so can be recruited at any time and participants will be followed up for a total of approximately 20 months from first vaccination. All volunteers will be given 10 µg R78C and/or 10 µg RH5.1 soluble protein in combination with 50 µg of Matrix-M via intramuscular (IM) injection in the deltoid region of the non-dominant arm.
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 | Experimental | Biological: Matrix M with R78C and/or RH5.18+1 volunteers receiving three doses of 10 µg R78C with 50 µg of Matrix-M on days 0, 28 and 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
| Group 2 | Experimental | Biological: Matrix M with R78C and/or RH5.18+1 volunteers receiving three doses of 10 µg R78C + 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
| Group 3 | Experimental | Biological: Matrix M with R78C and/or RH5.18+1 volunteers receiving three doses of 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and 56 via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
| Group 4 | Experimental | Biological: Matrix M with R78C and/or RH5.18+1 volunteers receiving two doses of 10 µg R78C + 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28, one dose of 10 µg R78C with 50 µg of Matrix-M on day 182 and one dose of 10 µg RH5.1 with 50 µg of Matrix-M on day 210, all administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult aged 18 to 45 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 GP
- Participants of childbearing potential only: must practice continuous effective contraception until 3 months after the final study vaccination (see section 9.10)
- Agreement to refrain from blood donation for the duration of the study
Key exclusion criteria (23 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
- Use of immunoglobulins or blood products (e.g. blood transfusion) in the last three months
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
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 |
|---|---|---|
| Matrix M with R78C and/or RH5.150 µg of Matrix-M adjuvant with R78C and/or RH5.1 at different doses and timepoints | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination
Time frame: 7 days following each vaccination
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination
Time frame: 7 days following each vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of unsolicited adverse events for 28 days following the vaccination
Time frame: 28 days following the vaccination
Occurrence of unsolicited adverse events for 28 days following the vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination, assessed through the number of participants with abnormal laboratory test results
Time frame: 28 days following vaccination
Occurrence of change from baseline laboratory tests
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination, assessed through the number of participants with serious adverse events
Time frame: Whole duration of the Study (up to day 600 depending on group)
Occurrence of serious adverse events during the whole study duration. Haematological and biochemical laboratory values will be presented according to local grading scales.
5 secondary outcomes
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M when administered to healthy volunteers alone and in combination assessing antigen-specific IgG antibody levels, with comparison before and after vaccination
Time frame: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy volunteers assessing antigen-specific antibody subclass/isotype measurement, with comparison before and after vaccination
Time frame: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy volunteers assessing antigen-specific antibody avidity measurement, with comparison before and after vaccination
Time frame: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M when administered to healthy volunteers alone and in combination assessing In vitro GIA, with comparison before and after vaccination
Time frame: From a number of key timepoints, baseline up to day 600 (dependant on group)
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy volunteers assessing Purified IgG ELISA versus GIA titration "Quality Analysis", with comparison before and after vaccination
Time frame: From a number of key timepoints, baseline up to day 600 (dependant on group)
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 1 Apr 2025.
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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.
Angela M Minassian, DPhil FRCP principal investigator
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Matrix M with R78C and/or RH5.1 in people with Malaria, Falciparum, run by University of Oxford at 1 site 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 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 1 Apr 2025. 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination (time frame: 7 days following each vaccination). The study lists 5 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 1 Apr 2025.