Infant RSV Immunity Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorUniversity of British Columbia
About this trial
Respiratory Syncytial Virus (RSV) is a main global cause of respiratory illness and death in infants. Previous infant vaccine trials have failed to demonstrate protection. Moreover, RSV infection during early infancy, particularly in infants younger than 4 months of age, is associated with more severe disease, reduced immune protection, and an increased risk of developing childhood asthma. This study aim to investigate the immunological and long-term health effects of a first exposure to RSV early (\<4 months) versus late (\>6-9 months) in infancy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Birthing parents who have a due date or delivery date in April, May or June 2026 (spring group/cohort) or September, October or November 2026 (fall group/cohort) with follow-up of the birthing parent and child during the 2026-2027, 2027-2028 and 2028-2029 RSV seasons. Children will be followed up to 3 years of age. The cohort will consist of 300 birthing parent-child pairs, with 150 in the spring cohort and 150 in the fall cohort. Birthing parents are recruited during antenatal care or shortly after delivery from the ultrasound clinic or delivery wards at BC Women's Hospital, patient lists from local maternity wards within the Vancouver Coastal Health Authority or advertisements at local prenatal care centres (obstetrician, physician and midwife clinics), community centres or on social media.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Fall group/cohort
Group B: Spring group/cohort
Trial outcomes
Primary outcomes
1
RSV antibody response
i) RSV neutralization titers (expressed as dilution titer to prevent 95% neutralization in vitro; NT95) ii) RSV F-specific antibody-mediated complement activation iii) RSV F-specific antibody-mediated phagocytosis
Time frame
Post-respiratory season 2027 (May 2027)2
Asthma symptoms
Children will be categorized as having low, moderate or high risk of asthma based on asthma-like symptoms defined using the Childhood Asthma Risk Tool (CHART)
Time frame
at age 3 years oldSecondary outcomes
1
Medically attended RSV infections
Incidence of RSV and Lower Respiratory Tract Infection hospitalizations and medically attended RSV infections
Time frame
At 1 year and 3 years of age2
Wheezing
Proportion of infants who develop persistent wheezing after their first RSV episode, and the number of wheezing days during season, and after each episode of RSV infection.
Time frame
During first RSV season (Sept to April), and each season, up to 3 years of age (for number of wheezing days during season).Other outcomes
1
Gut and upper airway microbiota
Characterization of gut and upper airway microbiota, with quantification of within- (α-diversity; Shannon index) and between-sample (β-diversity; Bray-Curtis or UniFrac) diversity.
Time frame
0, 3, 6, 9 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov