A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to < 22 Months of Age (Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers).

December 26, 2024| Ongoing Project | Reading time: 8 min

Introduction

Researchers at Kintampo Health Research Centre (KHRC), with funding from Sanofi Pasture Inc., are conducting this study to understand how Respiratory Syncytial Virus (RSV) affects young children in Ghana and beyond. Over a period of six months, the study will track how common RSV is among infants and toddlers aged six (6) to twenty-one (21) months and how the illness effects these children.

Investigators

Dr. Seyram Kaali, Dr. Samuel Harrison, Dr. Prince Darko Agyapong, Dr. Cynthia Yaa Bema, Dr. Felicia Serwah, Mr. Francis Mensah Kornu, Mr. Zakariah Buwah, Mr. Kingsley Kayan, Mr. Elisha Adeniji.

Background

Human Respiratory Syncytial Virus (RSV) is a ubiquitous virus and the most common cause of acute lower respiratory tract infection in children younger than five. The burden of infection is highest in children under 2 years age. In Ghana, the prevalence of RSV infection among hospitalized children under five years diagnosed with ALRTI is estimated to be about 23% with the highest burden in children below 1 year of age. RSV infection demonstrated significant seasonal variation with the highest burden occurring between June and December. RSV group B accounted for majority (61%) of cases. Risk factors for RSV infection include low birthweight, crowded living conditions, tobacco and air pollution exposure, day-care attendance, family history of asthma, congenital heart disease, chronic respiratory disease, and poor socio-economic status.

There is currently no vaccine to protect against RSV infection in children. The purpose is to generate seroprevalence data to estimate the proportion of infants and toddlers who had been previously exposed to RSV or RSV antibodies (monoclonal or maternal), to test the RSV illness definitions, and to evaluate the incidence of lower respiratory tract disease (LRTD) and ARD cases associated with reverse transcription polymerase chain reaction (RT- PCR) confirmed RSV in the targeted population (incidence over the study duration of approximately one RSV season), and the proportion of LRTD among ARD cases.

Objectives
This study has two main objectives:

· To assess how common RSV infections are both within our country and globally.

· To measure the number of positive RSV illness cases recorded during the study period.

Study Methodology
This was a multi-center, multi-national, prospective surveillance study to describe the baseline seroprevalence of RSV and incidence of RSV-related lower respiratory tract infection (LRTI) in children aged 6 to < 22 months. Following informed consent and screening, participants were followed up with active and passive surveillance for RSV-like respiratory tract infection. Active surveillance involved contacting participants through home visits and telephone calls once weekly throughout the follow-up duration.

Parents and caregivers were asked to contact the study team whenever their child showed signs of illness. If a child exhibited symptoms resembling RSV, they were referred to the study clinic for evaluation by a study clinician. During these visits, appropriate samples were collected in line with the study protocol. Additional follow-up visits were scheduled for children with RSV-like symptoms as required by the protocol. Each child participated in the study for a total duration of six months.

Expected Outcomes
The study is expected to produce a baseline data to determine the prevalence of RSV-A and RSV-B in Ghana and other part of the world and also expected to determine how often children develop serious infections in their lower respiratory track, caused by RSV.

Funder
Sanofi Pasture Inc.

Study Duration
Six (6) Months for Each Participant
Start Date: July 2022
End Date: January 2025