TETANUS Antibody Detection in Saliva Study
ConditionTetanus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-45
SponsorUniversity of Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able and willing to provide informed consent to take part in the study; either directly or from a parent/guardian, where appropriate
[Group A] Aged 5-10 years inclusive, and determined as healthy by a member of the study team
[Group B] Aged 18-25yrs inclusive, and determined as healthy by a member of the study team
[Group C] Currently pregnant at any stage of pregnancy, prior to receipt of a tetanus booster vaccine in pregnancy, and determined as healthy by a member of the study team and safe to provide a blood sample
Disqualifiers
Participants or parents/guardians unwilling or unable to provide informed consent to take part
Unwilling or unable to comply with study procedures
Have a bleeding disorder deemed significant by study doctor
[Groups A, B and C only] Any health condition which, in the opinion of a study physician which could
Trial design
Design model
Single group
Treatments tested in this trial
Point of care, saliva-based lateral flow test
Diagnostic testMeasurement of anti-tetanus toxoid antibody concentration in saliva
Blood based immunoassay
Diagnostic testMeasurement of anti-tetanus toxoid antibody concentration in blood
Treatment groups
390 Participants
are divided into 1 treatment groupGroup A: All participantsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
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 according to the saliva-based lateral flow test. Any pigment on the test line will be interpreted as immune.
Time frame
Day 12
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 1Secondary outcomes
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 12
Serum anti-tetanus toxoid antibody concentration
Serum anti-tetanus toxoid antibody concentration as measured by bead-based multiplex assay.
Time frame
Day 13
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 14
Vaccination history
Vaccination history either by electronic healthcare records, vaccination card or maternal recall.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Birmingham
Lead sponsor
Rwanda Biomedical Centre
Collaborator
Center for Family Health Research/Projet San Francisco
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: