THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-9
SponsorMenzies School of Health Research
About this trial
RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. The goal of this clinical trial is to evaluate whether routinely administering a single dose of respiratory syncytial virus (RSV)-specific monoclonal antibody, nirsevimab, from 6 months old, provides protection against RSV infections for Aboriginal and Torres Strait Islander children throughout in the first and second year of life.
In this study, participants will be randomly assigned to receive either a single dose of intra-muscular RSV-specific monoclonal antibody, nirsevimab, or standard care (no RSV-specific monoclonal antibody). The primary objective is to determine whether administration ofRSV-specific monoclonal antibody, nirsevimab reduces the occurrence of RSV infection over the subsequent 12 months. Secondary objectives include assessing whether nirsevimab reduces RSV-related hospital attendances, as well as respiratory and all-cause hospitalisations, over the following 6 and 12 months. An assessment of cost-effectiveness will also be undertaken.
Participants will receive the study intervention at 6 months of age (+90 days). Follow-up will be conducted through passive surveillance using electronic medical records and public health notification systems to capture relevant health outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aboriginal and/or Torres Strait Islander infant ≥ 6 calendar months old and < 9 calendar months old.
Parent/caregiver is willing for their infant to participate in the study and informed consent for the infant's participation in the study has been given.
Parent/caregiver is willing to comply with all study procedures outlined in the protocol, including review of maternal/ infant immunisation records, electronic medical records and public health notifications, for the duration of the study.
Disqualifiers
Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).
Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.
Previously enrolled in this trial.
Infants who have received a prior dose of RSV-SMA between ≥ 1 calendar months old and < 3 calendar months old will be excluded until at least 150 days have passed since their most recent dose. Randomisation can be delayed until participants meet this criterion.
Trial design
Design model
Parallel
Treatments tested in this trial
Nirsevimab (RSV-specific monoclonal antibody)
Biological/VaccineA single intramuscular dose of RSV-specific monoclonal antibody (RSV-SMA) - nirsevimab, will be administered from 6 months old (+ 90 days) to prevent RSV respiratory infections among Aboriginal and Torres Strait Islander children in the first and second year of life. Our randomised clinical trial will be among the first to evaluate the health and economic impact of routinely administering a dose of RSV-SMA from 6 months old in a year-round program for this high-risk population with less distinct RSV infection seasons.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Nirsevimab (RSV-specific monoclonal antibody)Experimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
RSV infection
RSV respiratory infection detected by reverse transcription polymerase chain reaction (RT-PCR) on a respiratory specimen from time of randomisation to before 6-months and before 12-months post-randomisation AND notified to the NT Notifiable Disease System. RSV infection before 12 months post-randomisation is the primary endpoint.
Time frame
Before 6-months and 12-months post randomisation dateSecondary outcomes
1
RSV hospital attendance
Any emergency department presentation or hospital admission at any time from time of randomisation to before 6-months and before 12- months post-randomisation, AND for which RSV is detected by RT-PCR of a respiratory specimen (regardless of notification) collected at any time from 120 hours before hospital presentation to 72 hours afterwards.
Time frame
Before 6-months and 12-months post randomisation date2
RSV hospitalisation
Subset of RSV hospital attendances resulting in admission to an inpatient service.
Time frame
Before 6-months and 12-months post randomisation date3
RSV hospitalisation - severe
Subset of RSV hospitalisations WITH any documented oxygen saturation \<90% at any point during the clinical presentation in accordance with the World Health Organization case definition, AND WITH documented receipt of supplemental oxygen.
Time frame
Before 6-months and 12-months post randomisation date.4
Respiratory hospitalisation
Any admission to an inpatient service from time of randomisation to before 6 -months and before 12-months post randomisation AND receiving a primary diagnosis consistent with any acute respiratory infection, including bronchiolitis, bronchitis, pneumonia, influenza, whooping cough, or chest/respiratory infection, OR RSV hospitalisation.
Time frame
Before 6-months and 12-months post randomisation dateSponsors and contacts
Click on the lead sponsor to view all of their trials.
Menzies School of Health Research
Lead sponsor
University of Sydney
Collaborator
Murdoch Childrens Research Institute
Collaborator
Source ClinicalTrials.gov