NCT07446166

TETANUS Antibody Detection in Saliva Study

Development of Novel Diagnostics That Use Point-of-care Lateral Flow Testing Technology for Non-invasive, Individual Assessment of Antibody Protection to Tetanus and Vaccine Need

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 5 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: * Group A: Healthy children aged 5-10 years (n=250) * Group B: Healthy younger adults aged 18-25 years (n=35) * Group C: Healthy pregnant women (n=30) * Group D: Adults with known immune suppression (see table 1) aged 18-45 years (n=75)

Conditions

• Tetanus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Point of care, saliva-based lateral flow test	Measurement of anti-tetanus toxoid antibody concentration in saliva
DIAGNOSTIC_TEST	Blood based immunoassay	Measurement of anti-tetanus toxoid antibody concentration in blood

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-11-01
• Completion: 2028-02-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Rwanda