MalariaPhase 1/2NCT03970993
VAC 072-An Efficacy Study of R21/MM in Different Dose Schedules
A Phase 1/2 study testing R21 Matrix-M vaccination, R21 Matrix-M vaccination and CHMI and R21 Matrix-M vaccination booster in people with Malaria, run by University of Oxford at 4 sites in United Kingdom.
Trial summary
An open label, partially blinded clinical trial in which healthy volunteers will be administered experimental malaria vaccines. There will be seven experimental groups of volunteers, of which five receive vaccination with the novel malaria vaccine candidate, R21, in combination with the vaccine 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
- What is being tested?
- R21 Matrix-M vaccination, R21 Matrix-M vaccination and CHMI and R21 Matrix-M vaccination booster
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 17 Jun 2019to 24 Aug 2021
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 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 General Practitioner.
- Women only: Must practice continuous effective contraception for the duration of the study.
- Agreement to refrain from blood donation during the course of the study.
- Agree to refrain from blood donation for at least 3 years after the end of their involvement in the study.*
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- Written informed consent to participate in the trial.
- Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.*
- Willingness to take a curative anti-malaria regimen following CHMI.*
- For volunteers not living close to the malaria challenge follow-up site (CCVTM, Oxford) agreement to stay in a hotel room close to the trial centre during a part of the study (from at least day 6.5 post mosquito bite until anti-malarial treatment is completed).*
- Answer all questions on the informed consent quiz correctly.*
Who cannot join
- History of clinical malaria (any species).
- Travel to a clearly malaria endemic locality during the study period or within the preceding six months
- Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim- sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)*
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt 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).
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- Use of immunoglobulins or blood products within 3 months prior to enrolment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products) or malaria infection.
- Any history of anaphylaxis post vaccination.
- History of clinically significant contact dermatitis.
- History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait or any haematological condition that could affect susceptibility to malaria infection.
- Pregnancy, lactation or intention to become pregnant during the study.
- Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone*
- Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone*
- Any clinical condition known to prolong the QT interval and existing contraindication to the use of Malarone.*
- History of cardiac arrhythmia, including clinically relevant bradycardia and existing contraindication to the use of Malarone.*
- Clinically significant disturbances of electrolyte balance, eg, hypokalaemia or hypomagnesaemia
- Family history of congenital QT prolongation or sudden death and existing contraindication to the use of Malarone.*
- Contraindications to the use of both Riamet and Malarone*
- 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 abuse as defined by an alcohol intake of greater than 25 standard UK units every week.
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
- Positive family history in both 1st and 2nd degree relatives < 50 years old for cardiac disease.*
- 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. Procedures for identifying laboratory values meeting exclusion criteria are shown 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.
- Not applicable for volunteers who do not undergo CHMI (Groups 1, 4 and 5)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Imperial College Healthcare NHS Trust
London, W2 1NY
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
About this study
Official title: A Phase I/IIa Sporozoite Challenge Study to Assess the Safety, Immunogenicity and Protective Efficacy of Adjuvanted R21, Administered in Different Dose Schedules in Healthy UK Volunteers
An open label, partially blinded clinical trial in which healthy volunteers will be administered experimental malaria vaccines. There will be seven experimental groups of volunteers, of which five receive vaccination with the novel malaria vaccine candidate, R21, in combination with the vaccine adjuvant, Matrix M.
The study will assess the safety \& immune responses to vaccination, and the efficacy of the vaccine.
Read the detailed description
Arms 1a \& 1b receive vaccines at 3 vaccinations at 4 week intervals and a booster vaccination approximately 12 months after the first vaccination.
Arms 2a \& 2b receive 3 vaccinations at 0, 4 and 24 weeks. The protected volunteers in 2a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B.
Arms 3a and 3b receive 3 vaccinations at 0, 4 and 8 weeks. The protected volunteers in 3a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B.
Arms 4a and 4b will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination.
Group 5 will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination.
Groups 6 \& 7 are control groups and will receive controlled human malaria infection (CHMI)
Healthy volunteers will be recruited in England across four research sites in Oxford, London, and Southampton.
- Conditions
- Malaria
- Being tested
- R21 Matrix-M vaccination, R21 Matrix-M vaccination and CHMI, R21 Matrix-M vaccination booster
- Keywords
- Malaria challenge, Malaria vaccine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R21 Matrix-M vaccinationBiological
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
R21 Matrix-M vaccination and CHMIBiological
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
R21 Matrix-M vaccination boosterBiological
Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
| Study group | Role | What they receive |
|---|---|---|
| Group 1a | Experimental | Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart and an optional booster vaccination 12 months after the third dose Receives: Biological: R21 Matrix-M vaccination; Biological: R21 Matrix-M vaccination booster |
| Group 2a | Experimental | Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M at 0, 4 and 24 weeks, followed by CHMI by sporozoite challenge (mosquito bite) 4 weeks later. If protected from malaria, volunteers will receive an optional booster vaccination 28 days prior to malaria rechallenge Receives: Biological: R21 Matrix-M vaccination and CHMI; Biological: R21 Matrix-M vaccination booster |
| Group 3a | Experimental | Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart, followed by CHMI by sporozoite challenge (mosquito bite) 4 weeks later. If protected from malaria, volunteers will receive an optional booster vaccination 28 days prior to malaria rechallenge Receives: Biological: R21 Matrix-M vaccination and CHMI; Biological: R21 Matrix-M vaccination booster |
| Group 4a | Experimental | Volunteers will receive 2 doses of 50μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 10μg R21/50μg Matrix-M at 24 weeks. This is followed by optional CHMI by sporozoite challenge (mosquito bite) 4 weeks later Receives: Biological: R21 Matrix-M vaccination and CHMI |
| Group 5 | Experimental | Volunteers will receive 2 doses of 10μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 2μg R21/50μg Matrix-M at 24 weeks. This is followed by optional CHMI by sporozoite challenge (mosquito bite) 4 weeks later Receives: Biological: R21 Matrix-M vaccination and CHMI |
| Group 6 | No intervention | They are infectivity control volunteers for the sporozoite challenge procedures: these volunteers are not vaccinated. |
| Group 7 | No intervention | They are infectivity control volunteers for the sporozoite challenge procedures: these volunteers are not vaccinated. |
| Group 1b | Experimental | Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M, 4 weeks apart followed by an optional vaccination booster 12 months after the third dose. Receives: Biological: R21 Matrix-M vaccination; Biological: R21 Matrix-M vaccination booster |
| Group 2b | Experimental | Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M at 0, 4 and 24 weeks. Receives: Biological: R21 Matrix-M vaccination |
| Group 3b | Experimental | Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart. Receives: Biological: R21 Matrix-M vaccination |
| Group 4b | Experimental | Volunteers will receive 2 doses of 50μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 10μg R21/50μg Matrix-M at 24 weeks. Receives: Biological: R21 Matrix-M vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of adjuvanted R21 using different immunisation schedules in healthy malaria naïve volunteers
Occurrence of solicited and unsolicited local and systemic adverse events
Measured: Solicited AEs will be collected for 7 days and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period
The efficacy (prevention of occurrence of P. falciparum parasitemia) of adjuvanted R21 against malaria sporozoite challenge, in healthy malaria-naïve volunteers using two immunisation regimes
Assessed by PCR of adjuvanted R21 in two different vaccination regimes
Measured: Weeks 2 & 3 following malaria infection
Secondary outcomes (4)
To assess humoral immunogenicity generated in malaria-naïve individuals by adjuvanted R21 using different immunisation schedules in healthy malaria-naïve volunteers.
To document immunogenicity measures, capturing humoral and cellular immune responses to R21 as follows: Anti-CS antibody titers
Measured: Blood samples will be taken to assess immune responses at specified time points over the duration of the study
To assess the safety and tolerability of adjuvanted R21 using different immunisation schedules in healthy malaria-naïve volunteers following booster vaccination
Occurrence of solicited and unsolicited local and systemic adverse events
Measured: Solicited AEs will be collected for 7 days and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period
To assess the efficacy of adjuvanted R21 against malaria sporozoite challenge in healthy malaria-naïve volunteers following a booster vaccination.
To assess the efficacy (prevention of occurrence of P. falciparum parasitemia, assessed by PCR) of adjuvanted R21 against malaria sporozoite challenge, in healthy malaria-naïve volunteers following a booster vaccination.
Measured: Week 2 following malaria infection
To further assess the efficacy using different thresholds of adjuvanted R21 in two different vaccination regimes and compared to R21c against malaria sporozoite challenge, in healthy malaria-naïve volunteers.
To further assess the efficacy using different thresholds, measured as time to P. falciparum parasitemia, assessed by PCR of adjuvanted R21 in two different vaccination regimes and compared to R21c against malaria sporozoite challenge, in healthy malaria-naïve volunteers.
Measured: Weeks 2 & 3 following malaria infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start17 Jun 2019
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian V Hill, DPhill FRCP, Principal investigator, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970993
- Sponsor's protocol ID
- VAC072
- Status last verified
- Oct 2021
- First submitted
- 29 May 2019
- Last updated
- 13 Oct 2021
- 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 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Sporozoite Challenge Study to Assess the Safety, Immunogenicity and Protective Efficacy of Adjuvanted R21, Administered in Different Dose Schedules in Healthy UK Volunteers
- ClinicalTrials.gov ID
- NCT03970993
- Acronym / sponsor ID
- VAC072
- Conditions
- Malaria
- Keywords
- Malaria challenge, Malaria vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 3 Jun 2019 (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.
An open label, partially blinded clinical trial in which healthy volunteers will be administered experimental malaria vaccines. There will be seven experimental groups of volunteers, of which five receive vaccination with the novel malaria vaccine candidate, R21, in combination with the vaccine adjuvant, Matrix M.
The study will assess the safety \& immune responses to vaccination, and the efficacy of the vaccine.
Detailed description
Arms 1a \& 1b receive vaccines at 3 vaccinations at 4 week intervals and a booster vaccination approximately 12 months after the first vaccination.
Arms 2a \& 2b receive 3 vaccinations at 0, 4 and 24 weeks. The protected volunteers in 2a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B.
Arms 3a and 3b receive 3 vaccinations at 0, 4 and 8 weeks. The protected volunteers in 3a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B.
Arms 4a and 4b will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination.
Group 5 will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination.
Groups 6 \& 7 are control groups and will receive controlled human malaria infection (CHMI)
Healthy volunteers will be recruited in England across four research sites in Oxford, London, and Southampton.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Group 1a | Experimental | Biological: R21 Matrix-M vaccination, Biological: R21 Matrix-M vaccination boosterVolunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart and an optional booster vaccination 12 months after the third dose |
| Group 2a | Experimental | Biological: R21 Matrix-M vaccination and CHMI, Biological: R21 Matrix-M vaccination boosterVolunteers will receive 3 doses of 10μg R21/50μg Matrix-M at 0, 4 and 24 weeks, followed by CHMI by sporozoite challenge (mosquito bite) 4 weeks later. If protected from malaria, volunteers will receive an optional booster vaccination 28 days prior to malaria rechallenge |
| Group 3a | Experimental | Biological: R21 Matrix-M vaccination and CHMI, Biological: R21 Matrix-M vaccination boosterVolunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart, followed by CHMI by sporozoite challenge (mosquito bite) 4 weeks later. If protected from malaria, volunteers will receive an optional booster vaccination 28 days prior to malaria rechallenge |
| Group 4a | Experimental | Biological: R21 Matrix-M vaccination and CHMIVolunteers will receive 2 doses of 50μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 10μg R21/50μg Matrix-M at 24 weeks. This is followed by optional CHMI by sporozoite challenge (mosquito bite) 4 weeks later |
| Group 5 | Experimental | Biological: R21 Matrix-M vaccination and CHMIVolunteers will receive 2 doses of 10μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 2μg R21/50μg Matrix-M at 24 weeks. This is followed by optional CHMI by sporozoite challenge (mosquito bite) 4 weeks later |
| Group 6 | No intervention | –They are infectivity control volunteers for the sporozoite challenge procedures: these volunteers are not vaccinated. |
| Group 7 | No intervention | –They are infectivity control volunteers for the sporozoite challenge procedures: these volunteers are not vaccinated. |
| Group 1b | Experimental | Biological: R21 Matrix-M vaccination, Biological: R21 Matrix-M vaccination boosterVolunteers will receive 3 doses of 10μg R21/50μg Matrix-M, 4 weeks apart followed by an optional vaccination booster 12 months after the third dose. |
| Group 2b | Experimental | Biological: R21 Matrix-M vaccinationVolunteers will receive 3 doses of 10μg R21/50μg Matrix-M at 0, 4 and 24 weeks. |
| Group 3b | Experimental | Biological: R21 Matrix-M vaccinationVolunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart. |
| Group 4b | Experimental | Biological: R21 Matrix-M vaccinationVolunteers will receive 2 doses of 50μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 10μg R21/50μg Matrix-M at 24 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy adults 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 General Practitioner.
- Women only: Must practice continuous effective contraception for the duration of the study.
- Agreement to refrain from blood donation during the course of the study.
Key exclusion criteria (30 listed)
- History of clinical malaria (any species).
- Travel to a clearly malaria endemic locality during the study period or within the preceding six months
- Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim- sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)*
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data as assessed by the investigator.
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 vaccinationThree dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly | Biological | Group 1a, Group 1b, Group 2b, Group 3b, Group 4b |
| R21 Matrix-M vaccination and CHMIThree dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite | Biological | Group 2a, Group 3a, Group 4a, Group 5 |
| R21 Matrix-M vaccination boosterOptional R21 Matrix-M vaccination booster following a three dose vaccination schedule | Biological | Group 1a, Group 1b, Group 2a, Group 3a |
Primary outcome
The safety and tolerability of adjuvanted R21 using different immunisation schedules in healthy malaria naïve volunteers
Time frame: Solicited AEs will be collected for 7 days and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period
Occurrence of solicited and unsolicited local and systemic adverse events
The efficacy (prevention of occurrence of P. falciparum parasitemia) of adjuvanted R21 against malaria sporozoite challenge, in healthy malaria-naïve volunteers using two immunisation regimes
Time frame: Weeks 2 & 3 following malaria infection
Assessed by PCR of adjuvanted R21 in two different vaccination regimes
4 secondary outcomes
To assess humoral immunogenicity generated in malaria-naïve individuals by adjuvanted R21 using different immunisation schedules in healthy malaria-naïve volunteers.
Time frame: Blood samples will be taken to assess immune responses at specified time points over the duration of the study
To assess the safety and tolerability of adjuvanted R21 using different immunisation schedules in healthy malaria-naïve volunteers following booster vaccination
Time frame: Solicited AEs will be collected for 7 days and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period
To assess the efficacy of adjuvanted R21 against malaria sporozoite challenge in healthy malaria-naïve volunteers following a booster vaccination.
Time frame: Week 2 following malaria infection
To further assess the efficacy using different thresholds of adjuvanted R21 in two different vaccination regimes and compared to R21c against malaria sporozoite challenge, in healthy malaria-naïve volunteers.
Time frame: Weeks 2 & 3 following malaria infection
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 13 Oct 2021.
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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.
Adrian V Hill, DPhill FRCP principal investigator
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing R21 Matrix-M vaccination, R21 Matrix-M vaccination and CHMI and R21 Matrix-M vaccination booster in people with Malaria, run by University of Oxford at 4 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 11 inclusion and 30 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The safety and tolerability of adjuvanted R21 using different immunisation schedules in healthy malaria naïve volunteers (time frame: Solicited AEs will be collected for 7 days and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.