MalariaPhase 3SERVALNCT06578572
Seasonal R21 Mass Vaccination for Malaria Elimination
A Phase 3 study testing R21Matrix M in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
This is a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination. Read more about this study
- Who is it for?
- Ages 5 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- R21Matrix M
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 May 2024to 31 Dec 2025
- Phase
- Phase 3
- 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 5 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age≥ 5 months.
- Willingness to comply with trial procedures.
- Individual written informed consent obtained at the beginning of the study.
Who cannot join
- Pregnancy
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
- Any history of anaphylaxis in relation to vaccination.
- Known chronic illness.
- Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Trial locations and contacts
2 sites in 2 countries.
Anette Erhart, MD, MSs, PhD contact
2 sites in 2 countries
Burkina Faso1 site, 1 recruiting
- Recruiting
Clinical Research Unit of Nanoro, Burkina Faso
Nanoro
Magloire Natama, PhD
Halidou Tinto, PhD
The Gambia1 site, 1 recruiting
- Recruiting
MRC Unit The Gambia at LSHTM
Fajara, 273
Edgard Dabira, MD, MSc, PhD, Edgard.Dabira@lshtm.ac.uk
Umberto D'Alessandro, MD, MSc, PhD
About this study
This is a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination.
The primary objective is to compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after seasonal mass vaccination with R21 (3 monthly doses).
Read more
Secondary objectives are:
- To assess the safety and tolerability of R21 through spontaneously reported adverse events.
- To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following seasonal mass vaccination with R21 (3 monthly doses).
- To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses).
- To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21.
- To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following one booster dose of R21.
- To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21.
- To determine the coverage of seasonal mass vaccination with R21 (primary series of three vaccinations and booster) in intervention clusters and related socio-cultural factors
- To estimate the cost of seasonal mass vaccination with R21 administration.
- To estimate the cost-effectiveness of seasonal mass vaccination with R21 compared to standard malaria control measures.
The exploratory objective is to determine whether serological markers can detect changes in malaria transmission following mass vaccination with R21.
Read the detailed description
This is a cluster-randomized controlled trial. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination. Therefore,15 medium-sized (200-600 people) villages in The Gambia and 12 medium-sized (200-600 people) villages in Burkina Faso will receive the intervention. All study villages will receive standard control intervention, e.g., seasonal malaria chemoprevention, insecticide-treated bed nets, implemented by the National Malaria Control Program and according the National Strategic Plan for malaria control. Mass vaccination will be completed before the start of the malaria transmission season, i.e. July.
A cross-sectional survey to estimate malaria prevalence will be implemented at peak transmission, both following the mass vaccination with 3 doses (first year) and the booster dose (second year). A blood sample will be collected during the malaria transmission season from a cohort of randomly selected individuals to determine the incidence of malaria infection. A system of passive case detection to determine the incidence of clinical malaria will be set up throughout the study period, with special attention to the malaria transmission season (July-December).
- Conditions
- Malaria
- Being tested
- R21Matrix M
- Keywords
- Malaria, Malaria vaccine R21/Matrix M, Mass vaccination, The Gambia, Burkina Faso
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R21Matrix MBiological
A mixture of R21/Matrix M at a dose of 5 μg (for children up to 14 years of age) or 10 μg ( for individuals ≥ 15 years old) with 50 μg of Matrix-M will be administered monthly over 3 months (one dose per month over 3 months (May, June, and July 2024) plus a booster dose in June 2025.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Three monthly doses of R21/MM will be administered to all eligible residents in the 27 intervention villages (15 in The Gambia and 12 in Burkina Faso), starting from May 2024, with the aim of having completed the vaccination schedule by end of July 2024, before the malaria transmission season starts. A booster vaccine dose will be administered in June 2025 to all eligible individuals who received at least one vaccine dose the previous year. Residents who are eligible but not vaccinated in the previous year, will be offered a complete vaccination schedule, i.e. 3 monthly doses, starting from April. After each vaccination, the first 100 vaccinated individuals will be visited at home daily, for 3 consecutive days, and then at day 7 after the vaccination to collect local and systemic adverse events (AE). Vaccinated individuals (or their parents) will be asked to report to the nurse based in their study village any illness occurring during the 28 days after vaccination. Receives: Biological: R21Matrix M |
| Control Group | No intervention | Only standard malaria control measures ( Malaria Chemoprevention (SMC), Intermittent Preventive Treatment during pregnancy (IPTp), Insecticide-Treated bed Nets (ITN), prompt diagnosis and treatment of patients with uncomplicated malaria and Indoor Residual Spraying (IRS)) will be implemented in control villages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses.
A cross-sectional survey will be conducted at peak transmission in October -November 2024 to determine prevalence of malaria infection.
Measured: At 6 months ( October - November 2024) post first round of vaccination
Secondary outcomes (10)
Occurrence of Adverse Events (AEs) during follow up.
- Occurrence of solicited local and/or systemic reactogenicity
- Occurrence of unsolicited adverse events
- Occurrence of abnormal hematology and biochemistry parameters ( clinically significant values)
- Occurrence of serious adverse events ( throughout the trial)
Measured: Up to 28 days post vaccination
Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21
Incidence of malaria infection will be determined by molecular analyses (PCR) in a cohort of 20 individuals per village in Burkina Faso and 30 individuals per villages in The Gambia through monthly home visits ( following mass vaccination with R21).
Measured: Up to 6 months post the third vaccination round
Incidence of clinical malaria in all age groups following mass vaccination with R21.
A passive case detection of clinical malaria throughout the study period, with special attention to the malaria transmission season (July-December)
Measured: Up to 6 months post the third vaccination round
Prevalence of malaria infection by PCR in all age groups at peak transmission following the booster dose.
A cross-sectional survey will be conducted at peak transmission in October -November 2025 to determine prevalence of malaria infection.
Measured: At 6 months ( October - November 2025) post booster dose
Incidence of malaria infection in all age groups during the transmission season following the booster dose.
Incidence of malaria infection will be determined by molecular analyses (PCR) in a cohort of 20 individuals per village in Burkina Faso and 30 individuals per villages in The Gambia through monthly home visits ( following the booster dose).
Measured: Up to 6 months post booster dose
Incidence of clinical malaria in all age groups following the booster dose.
Passive detection of clinical malaria both at the community and at health facility level
Measured: Up to 6 months post the third vaccination round
Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses.
Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses.
Measured: Up to 4 weeks post the third vaccination round
Coverage of at least one vaccine dose administered during the mass vaccination with 3 doses
Coverage of at least one vaccine dose
Measured: Up to 4 weeks post the third vaccination round
Coverage of the booster dose
Coverage of the booster dose
Measured: Up to 4 weeks post booster dose
Cost of vaccine administration and cost effectiveness, both for the mass vaccination campaign with 3 doses and the booster dose.
A cross sectional survey will be carried out at the beginning of the project in both study arms to estimate the cost of seeking care among households and the costs supported by the health facility. Cost of mass vaccination will be collected for each round.
Measured: Up to 6 months post booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 May 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Malaria Control Programme, The Gambia
- Responsible party
- Sponsor
- Investigators
- Umberto D'Alessandro, MD, MSc, PhD, Principal investigator, MRCG at LSHTMHalidou Tinto, PhD, Principal investigator, Clinical Research Unit of NanoroEdgard Dabira, MD, MSc, PhD, Study director, MRCG at LSHTMMagloire Natama, PhD, Study director, Clinical Research Unit of Nanoro, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578572
- Sponsor's protocol ID
- LEO29834
- Acronym
- SERVAL
- Status last verified
- Aug 2024
- First submitted
- 27 Mar 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised IPD data will be made available from one month after trial publication and for a further 24 months
Publications
Dabira ED, Natama HM, Jaiteh F, Grietens KP, Bocoum FY, Ndiath MO, Mohammed N, Gibba B, Hill AVS, Ghani A, Erhart A, Tinto H, D'Alessandro U. Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised trial. Trials. 2025 Sep 29;26(1):382. doi: 10.1186/s13063-025-09048-6.
PubMed 41024138
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal R21 Mass Vaccination for Malaria Elimination
- ClinicalTrials.gov ID
- NCT06578572
- Acronym / sponsor ID
- SERVAL / LEO29834
- Conditions
- Malaria
- Keywords
- Malaria, Malaria vaccine R21/Matrix M, Mass vaccination, The Gambia, Burkina Faso
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,200 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Malaria Control Programme, The Gambia
- Study start
- 30 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 2024 (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 a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination.
The primary objective is to compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after seasonal mass vaccination with R21 (3 monthly doses).
Secondary objectives are:
- To assess the safety and tolerability of R21 through spontaneously reported adverse events.
- To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following seasonal mass vaccination with R21 (3 monthly doses).
- To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses).
- To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21.
- To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following one booster dose of R21.
- To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21.
- To determine the coverage of seasonal mass vaccination with R21 (primary series of three vaccinations and booster) in intervention clusters and related socio-cultural factors
- To estimate the cost of seasonal mass vaccination with R21 administration.
- To estimate the cost-effectiveness of seasonal mass vaccination with R21 compared to standard malaria control measures.
The exploratory objective is to determine whether serological markers can detect changes in malaria transmission following mass vaccination with R21.
Detailed description
This is a cluster-randomized controlled trial. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination. Therefore,15 medium-sized (200-600 people) villages in The Gambia and 12 medium-sized (200-600 people) villages in Burkina Faso will receive the intervention. All study villages will receive standard control intervention, e.g., seasonal malaria chemoprevention, insecticide-treated bed nets, implemented by the National Malaria Control Program and according the National Strategic Plan for malaria control. Mass vaccination will be completed before the start of the malaria transmission season, i.e. July.
A cross-sectional survey to estimate malaria prevalence will be implemented at peak transmission, both following the mass vaccination with 3 doses (first year) and the booster dose (second year). A blood sample will be collected during the malaria transmission season from a cohort of randomly selected individuals to determine the incidence of malaria infection. A system of passive case detection to determine the incidence of clinical malaria will be set up throughout the study period, with special attention to the malaria transmission season (July-December).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: R21Matrix MThree monthly doses of R21/MM will be administered to all eligible residents in the 27 intervention villages (15 in The Gambia and 12 in Burkina Faso), starting from May 2024, with the aim of having completed the vaccination schedule by end of July 2024, before the malaria transmission season starts. A booster vaccine dose will be administered in June 2025 to all eligible individuals who received at least one vaccine dose the previous year. Residents who are eligible but not vaccinated in the previous year, will be offered a complete vaccination schedule, i.e. 3 monthly doses, starting from April. After each vaccination, the first 100 vaccinated individuals will be visited at home daily, for 3 consecutive days, and then at day 7 after the vaccination to collect local and systemic adverse events (AE). Vaccinated individuals (or their parents) will be asked to report to the nurse based in their study village any illness occurring during the 28 days after vaccination. |
| Control Group | No intervention | –Only standard malaria control measures ( Malaria Chemoprevention (SMC), Intermittent Preventive Treatment during pregnancy (IPTp), Insecticide-Treated bed Nets (ITN), prompt diagnosis and treatment of patients with uncomplicated malaria and Indoor Residual Spraying (IRS)) will be implemented in control villages. |
Who may qualify
- Ages
- 5 months to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥ 5 months.
- Willingness to comply with trial procedures.
- Individual written informed consent obtained at the beginning of the study.
Key exclusion criteria (5 listed)
- Pregnancy
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
- Any history of anaphylaxis in relation to vaccination.
- Known chronic illness.
- Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
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 |
|---|---|---|
| R21Matrix MA mixture of R21/Matrix M at a dose of 5 μg (for children up to 14 years of age) or 10 μg ( for individuals ≥ 15 years old) with 50 μg of Matrix-M will be administered monthly over 3 months (one dose per month over 3 months (May, June, and July 2024) plus a booster dose in June 2025. | Biological | Experimental Group |
Primary outcome
Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses.
Time frame: At 6 months ( October - November 2024) post first round of vaccination
A cross-sectional survey will be conducted at peak transmission in October -November 2024 to determine prevalence of malaria infection.
10 secondary outcomes
Occurrence of Adverse Events (AEs) during follow up.
Time frame: Up to 28 days post vaccination
Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21
Time frame: Up to 6 months post the third vaccination round
Incidence of clinical malaria in all age groups following mass vaccination with R21.
Time frame: Up to 6 months post the third vaccination round
Prevalence of malaria infection by PCR in all age groups at peak transmission following the booster dose.
Time frame: At 6 months ( October - November 2025) post booster dose
Incidence of malaria infection in all age groups during the transmission season following the booster dose.
Time frame: Up to 6 months post booster dose
Incidence of clinical malaria in all age groups following the booster dose.
Time frame: Up to 6 months post the third vaccination round
Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses.
Time frame: Up to 4 weeks post the third vaccination round
Coverage of at least one vaccine dose administered during the mass vaccination with 3 doses
Time frame: Up to 4 weeks post the third vaccination round
Coverage of the booster dose
Time frame: Up to 4 weeks post booster dose
Cost of vaccine administration and cost effectiveness, both for the mass vaccination campaign with 3 doses and the booster dose.
Time frame: Up to 6 months post booster dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Derived from this study: PubMed 41024138Dabira ED, Natama HM, Jaiteh F, Grietens KP, Bocoum FY, Ndiath MO, Mohammed N, Gibba B, Hill AVS, Ghani A, Erhart A, Tinto H, D'Alessandro U. Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised trial. Trials. 2025 Sep 29;26(1):382. doi: 10.1186/s13063-025-09048-6.
- Individual participant dataSharing planned: Yes. Anonymised IPD data will be made available from one month after trial publication and for a further 24 months
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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.
Anette Erhart, MD, MSs, PhD contact
Umberto D'Alessandro, MD, MSc, PhD principal investigator
MRCG at LSHTM
Halidou Tinto, PhD principal investigator
Clinical Research Unit of Nanoro
Edgard Dabira, MD, MSc, PhD study director
MRCG at LSHTM
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing R21Matrix M in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. 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 Burkina Faso, The Gambia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto D'Alessandro, MD, DHTM, MSc, PhD (+220449544 ext. 4001, Umberto.Dalessandro@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses. (time frame: At 6 months ( October - November 2024) post first round of vaccination). 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 NCT06578572, 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 29 Aug 2024.