MalariaPhase 1NCT06141057
A Study to Compare Two Dosing Regimens for a New Malaria Vaccine
A Phase 1 study testing Matrix M with RH5.1 in people with Malaria and Malaria,Falciparum, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travellers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria,Falciparum, Protozoan Infections
- What is being tested?
- Matrix M with RH5.1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2023to Jul 2025
- Phase
- 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 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.
- 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 for the duration of the study (see section 9.9)
- 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 (CHMI) study
- 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
- Concurrent involvement in another clinical trial involving an investigational product or planned involvement during the study period
Show all 23Show fewer
- 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
- Pregnancy, lactation or intention to become pregnant during the study
- Body mass index of <18.5 or >35
- 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. Blood test abnormalities will be assessed as per the laboratory adverse event table in Appendix A (table 8). In the event of abnormal test results deemed to be clinically significant, confirmatory repeat tests may be requested. Procedures for identifying laboratory values meeting exclusion criteria are described in Appendix A.
- 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
Sheffield Teaching Hospitals, Royal Hallamshire Hospital
Sheffield, S10 2JF
About this study
Official title: Phase I Clinical Trial to Assess the Safety and Immunogenicity of the Malaria Vaccine Candidate RH5.1 Soluble Protein in Matrix-MTM Using Two Dosing Regimens
Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travellers. There is a great need for a safe, effective malaria vaccine.
This study is being done to evaluate an experimental malaria vaccine for its safety and also look at the body's immune response to the vaccine.
Read more
The vaccine tested in this study is called and "RH5.1". This is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination.
The aim is to use the vaccines and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess:
- The safety of the vaccines in healthy participants.
- The response of the human immune system to the vaccines.
This will be achieved by giving participants three doses of the RH5.1 vaccines at two different dose levels (10 micrograms and 50 micrograms). One group will have 3 doses of 10 micrograms given at 0, 1 and 6 months whilst the other will receive 2 doses of 50 micrograms (at 1 and 2 months) followed by a 10 microgram dose at 6 months- known as a 'delayed fractional dose'. Blood tests and information about any symptoms will be performed/collected that occur after vaccination.
Information from previous studies suggests that a delayed fractional dose improves the immune response to the vaccine, particularly in terms of the antibody response. Current prediction is that this improvement is due to the delay in dosing, rather than the reduction in dose, and this study will help to answer that. Having a vaccine at a single dose is important for efficient production and dosing for vaccines rolled out in national programs so being able to move away from 'delayed fractional dose' regimens to 'delayed final dose' regimens will be important for vaccine development.
- Conditions
- Malaria, Malaria,Falciparum, Protozoan Infections, Parasitic Disease, Infections, Vector Borne Diseases
- Being tested
- Matrix M with RH5.1
- Keywords
- RH5.1, Matrix-M
- Medical subject headings
- Malaria, Malaria, Falciparum, Protozoan Infections, Parasitic Diseases, Infections, Vector Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix M with RH5.1Biological
50 µg of Matrix-M adjuvant with RH5.1 at different doses on days 0 and 28.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Delayed regimen | Experimental | 12 volunteers receiving three doses of 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 RH5.1 |
| Group 2: Delayed Fractional Regimen | Experimental | 12 volunteers receiving two doses of 50 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and one dose of 10 µg RH5.1 with 50 µg of Matrix-M on day 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix M with RH5.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of solicited reactogenicity following each vaccinations
Occurrence of solicited local/systemic reactogenicity signs and symptoms for 7 days. following each vaccination. These will be tabulated, detailing frequency, duration and severity of signs and symptoms.
Measured: 7 days following each vaccination
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of unsolicited adverse events following each vaccinations
Occurrence of unsolicited adverse events for 28 days following the vaccination. These will be tabulated, detailing frequency, duration and severity of AEs.
Measured: 28 days following each vaccination
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by comparing safety laboratory measures following each vaccinations
Change from baseline for safety laboratory measures for 28 days following vaccination. Haematological and biochemical laboratory values will be presented according to local grading scales.
Measured: 28 days following each vaccination
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of serious adverse events
Occurrence of serious adverse events during the whole study duration. These will be tabulated, detailing frequency, duration and severity of SAEs.
Measured: During Whole study duration (547 days)
Secondary outcomes (3)
To assess the humoral immunogenicity of RH5.1 soluble protein with Matrix-M when administered to healthy volunteers at different doses.
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 547)
To compare the anti-RH5 serum IgG functional immunogenicity between the two groups receiving soluble RH5.1 at different doses by assessing purified IgG versus GIA titration (quality analysis)
Immunogenicity will be assessed to characterise quantity, quality and longevity of serum anti-RH5 IgG responses as measured by standardised ELISA. The growth inhibition activity will be used to determine functionality of these responses and allow quality analysis. Comparisons between two groups receiving soluble RH5.1 protein at different doses will be made post vaccination to determine how differing doses affect these responses.
Measured: After each vaccinations (D0, D28 and D182)
To compare differences in the innate immune responses following the first and third vaccinations and correlated these with adverse event data and adaptive immune responses
Innate immune cell analyses will include flow cytometry analyses and quantitative measurements of pro-inflammatory cytokines to phenotype innate immune cell populations primarily in the first 7 days following vaccination.
Measured: 7, 28 days following first and third vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start6 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06141057
- Sponsor's protocol ID
- BIO-002
- Status last verified
- Oct 2024
- First submitted
- 14 Jul 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Assess the Safety and Immunogenicity of the Malaria Vaccine Candidate RH5.1 Soluble Protein in Matrix-MTM Using Two Dosing Regimens
- ClinicalTrials.gov ID
- NCT06141057
- Acronym / sponsor ID
- BIO-002
- Conditions
- Malaria, Malaria,Falciparum, Protozoan Infections, Parasitic Disease, Infections, Vector Borne Diseases
- Keywords
- RH5.1, Matrix-M
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 21 Nov 2023 (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.
Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travellers. There is a great need for a safe, effective malaria vaccine.
This study is being done to evaluate an experimental malaria vaccine for its safety and also look at the body's immune response to the vaccine.
The vaccine tested in this study is called and "RH5.1". This is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination.
The aim is to use the vaccines and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess:
- The safety of the vaccines in healthy participants.
- The response of the human immune system to the vaccines.
This will be achieved by giving participants three doses of the RH5.1 vaccines at two different dose levels (10 micrograms and 50 micrograms). One group will have 3 doses of 10 micrograms given at 0, 1 and 6 months whilst the other will receive 2 doses of 50 micrograms (at 1 and 2 months) followed by a 10 microgram dose at 6 months- known as a 'delayed fractional dose'. Blood tests and information about any symptoms will be performed/collected that occur after vaccination.
Information from previous studies suggests that a delayed fractional dose improves the immune response to the vaccine, particularly in terms of the antibody response. Current prediction is that this improvement is due to the delay in dosing, rather than the reduction in dose, and this study will help to answer that. Having a vaccine at a single dose is important for efficient production and dosing for vaccines rolled out in national programs so being able to move away from 'delayed fractional dose' regimens to 'delayed final dose' regimens will be important for vaccine development.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Delayed regimen | Experimental | Biological: Matrix M with RH5.112 volunteers receiving three doses of 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 2: Delayed Fractional Regimen | Experimental | Biological: Matrix M with RH5.112 volunteers receiving two doses of 50 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and one dose of 10 µg RH5.1 with 50 µg of Matrix-M on day 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult 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 GP
- Participants of childbearing potential only: must practice continuous effective contraception for the duration of the study (see section 9.9)
- 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 (CHMI) study
- 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 RH5.150 µg of Matrix-M adjuvant with RH5.1 at different doses on days 0 and 28. | Biological | Group 1: Delayed regimen, Group 2: Delayed Fractional Regimen |
Primary outcome
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of solicited reactogenicity following each vaccinations
Time frame: 7 days following each vaccination
Occurrence of solicited local/systemic reactogenicity signs and symptoms for 7 days. following each vaccination. These will be tabulated, detailing frequency, duration and severity of signs and symptoms.
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of unsolicited adverse events following each vaccinations
Time frame: 28 days following each vaccination
Occurrence of unsolicited adverse events for 28 days following the vaccination. These will be tabulated, detailing frequency, duration and severity of AEs.
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by comparing safety laboratory measures following each vaccinations
Time frame: 28 days following each vaccination
Change from baseline for safety laboratory measures for 28 days following vaccination. Haematological and biochemical laboratory values will be presented according to local grading scales.
To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of serious adverse events
Time frame: During Whole study duration (547 days)
Occurrence of serious adverse events during the whole study duration. These will be tabulated, detailing frequency, duration and severity of SAEs.
3 secondary outcomes
To assess the humoral immunogenicity of RH5.1 soluble protein with Matrix-M when administered to healthy volunteers at different doses.
Time frame: From a number of key timepoints (Baseline up to day 547)
To compare the anti-RH5 serum IgG functional immunogenicity between the two groups receiving soluble RH5.1 at different doses by assessing purified IgG versus GIA titration (quality analysis)
Time frame: After each vaccinations (D0, D28 and D182)
To compare differences in the innate immune responses following the first and third vaccinations and correlated these with adverse event data and adaptive immune responses
Time frame: 7, 28 days following first and third vaccinations
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 Oct 2024.
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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 Matrix M with RH5.1 in people with Malaria and 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 6 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 4 Oct 2024. 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?
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?
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 RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of solicited reactogenicity following each vaccinations (time frame: 7 days following each 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 4 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.