A Phase 1/2 interventional study of R21/Matrix-M1 and Saline in Malaria, sponsored by University of Oxford. Completed at 1 site in Burkina Faso. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-06.
Sponsored by University of Oxford · Phase 1/2, Interventional, and Prevention
This is a study in which healthy adult volunteers will be given either an experimental Malaria vaccine or a saline control vaccine.
Each volunteer will receive three vaccinations in total. Volunteers will be randomly allocated to one of two groups:
Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will receive a saline solution on days 0, 28, and 56.
A randomised, controlled, single-blind clinical trial to evaluate the safety and immunogenicity of the malaria vaccine candidate regime of three (3) doses of R21/Matrix-M1 compared with placebo, in healthy West African adult volunteers living in a malaria-endemic area.
The study will take place at the Centre National de Recherche et de Formation sur la Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B). Trial participants will be drawn from the Banfora Health Demographic system, which covers a total population of 30, 000.
Community sensitisation will be undertaken to engage the community with the study and recruit volunteers for participation in the study. The CNRFP study team will hold local community meetings and explain the study to the potentially eligible adult volunteers. During these meetings the investigators will explain the following: the need for a vaccine; the current status of vaccine development (including the fact that this is likely to be a prolonged process); the study screening and informed consent procedure; risks of vaccination and the unproven benefits of vaccination. It will be stressed that these are experimental vaccine regimens and cannot be guaranteed to provide protection, and that it will therefore still be necessary to seek treatment for possible malaria even after vaccination and they should continue to use other protective measures such as bed nets. It will be explained that to aid identification, a photograph of the volunteer will be taken if they are eligible to be enrolled in the trial.
After this meeting, based on the list of adults of suitable age for participation in the trial drawn from the DSS database, volunteers will be asked to participate in a public lottery that is made to randomly select participants who will be invited for a screening visit. All proposed volunteers thus selected will be invited to the Banfora clinical trials centre for the screening visit.
The Volunteer Information Sheet (VIS) will contain detailed information about the study and will be distributed to the proposed volunteers. The investigators will endeavour to ensure that all volunteers fully understand the risks. Any volunteer who appears to have less than complete understanding will be considered unable to give consent. If unable to sign, the volunteer will be asked to thumbprint the consent form in the presence of an impartial witness who will be present during the screening procedures and will countersign the consent form. Fully consented volunteers will undergo the full screening procedures. This consists of medical history, physical examination, and blood sampling for screening tests.
Volunteers will be randomised to receive either three (3) doses of R21/ Matrix-M1 or placebo (normal saline) as control. Simple randomisation into the study groups will be done by an independent statistician based at the University of Oxford. A randomisation code list will be generated by the independent statistician and its use guided by a clear Standard Operating Procedure (SOP). Allocation concealment will be employed by use of opaque sealed envelopes. As this is a single-blind clinical trial design, the laboratory scientists will be blinded to vaccine allocation until the end of the study.
Each volunteer will be monitored for one hour (or longer if necessary) after each vaccination. Each volunteer will be visited at home daily for 6 days after each vaccination (Days 0, 28, and 56) by a field worker for assessment and recording of any solicited and unsolicited AEs in diary cards. If necessary the volunteer will continue to be seen regularly until any observed AEs have resolved or stabilised. Scheduled visits at the CNRFP will be on Days 0, 7, 28, 35, 56, 63, 84, and 140. All volunteers will be followed up to Day 140 post-first vaccination for adverse events.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 13 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The volunteer must satisfy all the following criteria to be eligible for the study:
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
10μg R21/Matrix-M1 on days 0, 28, and 56.
Biological: R21/Matrix-M1
50μg R21/Matrix-M1 on days 0, 28, and 56.
Biological: R21/Matrix-M1
Saline injection on days 0, 28, and 56.
Other: Saline
Safety and Tolerability of Administration of R21/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).
Time frame: Assessment of solicited AEs in the first 7 days post vaccination.
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.
Occurrence of unsolicited local and systemic adverse events. This will be done by recording the number of participants who experience unsolicited adverse events.
Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination.
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.
Occurrence of serious adverse events will be collected from enrolment until the end of the follow-up period.
Time frame: 6 months
Safety and Tolerability of R21/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.
Time frame: At Day 0 (baseline), day 7 and day 28 post vaccination.
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 8 | 5 |
| Completed | 8 | 4 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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).
| Number of adverse events | Group 1 | Group 2 |
|---|---|---|
| Safety and Tolerability of Administration of R21/Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events. | 10 | 0 |
Occurrence of unsolicited local and systemic adverse events. This will be done by recording the number of participants who experience unsolicited adverse events.
| participants | Group 1 | Group 2 |
|---|---|---|
| Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events. | 8 | 5 |
Occurrence of serious adverse events will be collected from enrolment until the end of the follow-up period.
| SAEs | Group 1 | Group 2 |
|---|---|---|
| Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Serious Adverse Events. | 0 | 0 |
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.
| Laboratory AEs | Group 1 | Group 2 |
|---|---|---|
| Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events. | 18 | 15 |
Collected over Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Group 2 | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Group 1 | Group 2 |
|---|---|---|
| NeutropaeniaBlood and lymphatic system disorders | 6/8 | 2/5 |
| NeutropaeniaBlood and lymphatic system disorders | 5/8 | 2/5 |
| NeutropaeniaBlood and lymphatic system disorders | 3/8 | 3/5 |
| EpigastralgiaGastrointestinal disorders | 1/8 | 2/5 |
| RhinitisRespiratory, thoracic and mediastinal disorders | 2/8 | 0/5 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 2/8 | 0/5 |
| SwellingSkin and subcutaneous tissue disorders | 2/8 | 0/5 |
| PainGeneral disorders | 2/8 | 0/5 |
| PainGeneral disorders | 2/8 | 0/5 |
| PainGeneral disorders | 2/8 | 0/5 |
| Age, Categorical(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 5 | 13 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 5 | 0 | 5 |
| Race and Ethnicity Not Collected(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Burkina Faso | 8 | 5 | 13 |
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