An interventional study of Point of care, saliva-based lateral flow test and Blood based immunoassay in Tetanus, sponsored by University of Birmingham. Not yet recruiting at 1 site in Rwanda. Open to participants aged 5 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by University of Birmingham · Not applicable, Interventional, and Diagnostic
This study aims to design, develop and optimise a non-invasive, saliva sample-based point-of-care lateral flow test for use in low and middle income settings that can return a qualitative result on whether an individual has or has not immunity to tetanus within 10-15mins. If successful, this approach would not require blood sampling or laboratory facilities, empower personalised decision making on vaccine needs and support the development of population level data-driven public health policies.
The development of non-invasive point-of-care (POC) diagnostic testing for the detection of protective immunity to tetanus would empower LMICs to identify immunity gaps and individuals who are a priority for vaccination and generate sero-epidemiology models for future public health decision around tetanus control. Given tetanus antigen is included as polyvalent vaccine formulations for infants as part of the WHO EPI schedule for LMICS, the absence of anti-tetanus toxoid antibody might also indicate missed vaccine doses that would have conferred protection to other infectious diseases.
This is a cross-sectional, non-interventional, biological sampling study. This study will be conducted at the Center for Family Health Research in Kigali, Rwanda, in collaboration with Rwanda Biomedical Centre, the national health implementation agency for Rwanda, and the University of Birmingham, United Kingdom. WHO/UNICEF estimates DTP3 coverage in Rwanda at 97% following extensive SIA activity after vaccination coverage dropped to 88% in 2021. Rwanda hosts a significant number of refugees (135,000 at the end of April 2024), nearly half of these are children and many are from the Democratic Republic of the Congo where only just over half of children are fully immunised.
The overall aim of this study is to assess the real-world performance and the diagnostic clinical accuracy of a novel, saliva-based, point-of-care lateral flow test in determining the immune status to tetanus for individuals in Rwanda.
Participants will be recruited from the following groups:
Exclusion Criteria:
[Groups A, B and C only] Any health condition which, in the opinion of a study physician which could
All participants will receive the same interventions.
Diagnostic Test: Point of care, saliva-based lateral flow test · Diagnostic Test: Blood based immunoassay
Measurement of anti-tetanus toxoid antibody concentration in saliva
Measurement of anti-tetanus toxoid antibody concentration in blood
The clinical diagnostic performance of the saliva-based lateral flow test in determining immune status as compared to bead-based multiplexed assay on serum.
Immune status according to the saliva-based lateral flow test. Any pigment on the test line will be interpreted as immune.
Time frame: Day 1
The clinical diagnostic performance of the saliva-based lateral flow test in determining immune status as compared to bead-based multiplexed assay on serum.
Immune status as measured on serum by bead-based multiplex assay. Antibody titres at or above the WHO antibody immune correlate for protection of 0.1 IU/mL will be classed as immune.
Time frame: Day 1
Perspectives of healthcare workers and the public
Perceptions and acceptability of this approach from healthcare workers and members of the public around using a novel salivary point-of-care lateral flow test for tetanus and vaccination decisions. This will be determined by thematic analysis of transcripts from focus groups of 5-15 people who have either been a participant in the study or helped with delivery of the study.
Time frame: Day 1
Serum anti-tetanus toxoid antibody concentration
Serum anti-tetanus toxoid antibody concentration as measured by bead-based multiplex assay.
Time frame: Day 1
Serum antibody titres to other EPI vaccine antigens
Serum antibody titres to diptheria, haemophilus influenzae, hepatitis B and measles as measured by multiplex assay or enzyme-linked immunosorbent assay.
Time frame: Day 1
Vaccination history
Vaccination history either by electronic healthcare records, vaccination card or maternal recall.
Time frame: Day 1
Plan to share: Yes — The data that support the findings of this study are not openly available to protect the confidentiality of study participants. Fully anonymised data are, however, available from the authors upon reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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