Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06578572

Seasonal R21 Mass Vaccination for Malaria Elimination

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:

1. To assess the safety and tolerability of R21 through spontaneously reported adverse events. 2. 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). 3. To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses). 4. To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21. 5. 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. 6. To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21. 7. 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 8. To estimate the cost of seasonal mass vaccination with R21 administration. 9. 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

5 month–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Unit of Nanoro, Burkina Faso, Nanoro, Burkina Faso

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥ 5 months.
  • Willingness to comply with trial procedures.
  • Individual written informed consent obtained at the beginning of the study.

Exclusion criteria

  • 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.

Treatment and study plan

R21Matrix M

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Occurrence of Adverse Events (AEs) during follow up.

    Time frame: Up to 28 days post vaccination

    • 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)

  2. 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 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).

  3. Incidence of clinical malaria in all age groups following mass vaccination with R21.

    Time frame: Up to 6 months post the third vaccination round

    A passive case detection of clinical malaria throughout the study period, with special attention to the malaria transmission season (July-December)

  4. 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

    A cross-sectional survey will be conducted at peak transmission in October -November 2025 to determine prevalence of malaria infection.

  5. 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 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).

  6. Incidence of clinical malaria in all age groups following the booster dose.

    Time frame: Up to 6 months post the third vaccination round

    Passive detection of clinical malaria both at the community and at health facility level

  7. 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 completed vaccination schedule (3 doses) during the mass vaccination with 3 doses.

  8. 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 at least one vaccine dose

  9. Coverage of the booster dose

    Time frame: Up to 4 weeks post booster dose

    Coverage of the booster dose

  10. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anette Erhart, MD, MSs, PhD

CONTACT

[email protected]

Umberto D'Alessandro, MD, DHTM, MSc, PhD

CONTACT

[email protected]

+220449544 ext. 4001

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • National Malaria Control Programme, The Gambia

Registry information

Acronym: SERVAL

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.