Respiratory Syncytial Virus (RSV) Clinical Trial
Official title:
Community-based RSV Surveillance in Infant Mortality: Minimally Invasive Tissue Sampling Study in Karachi, Pakistan
In order to assess the burden of respiratory syncytial virus on infant mortality in Pakistan, nasopharyngeal swab sampling and minimally invasive tissue sampling (MITS) will be conducted on deceased infants under 6 months of age. The specimens will be analysed by the microbiology and histopathology labs at Aga Khan University, Karachi, Pakistan. Verbal consent will be obtained from parents of deceased infants, and a cause of death lab report and grief counseling services will be offered to enrolled parents who gave consent for specimen collection. The study is funded by Bill & Melinda Gates Foundation in affiliation with Research Triangle Institute (RTI) MITS Surveillance Alliance.
Respiratory syncytial virus (RSV) is a respiratory pathogen with potentially high disease burden in Lower middle income country (LMIC). This pathogen is a potential target for maternal immunization strategies to prevent disease and early death in young infants. Majority of current studies estimate the burden of disease in terms of facility-based (e.g. hospital) deaths. There is a knowledge gap regarding the proportion of community-based deaths due to RSV. There are many challenges to generating evidence for the burden of RSV, such as lack of resources for hospital and community surveillance and diagnostics, and difficulty in obtaining specimens. Parent study: In January 2018, the Community-based Infant RSV Mortality Study was initiated in collaboration with Emory University, funded by the Bill and Melinda Gates Foundation. Following a formative phase involving interviews with community stakeholders, in August 2018 a pilot surveillance stage was initiated, in which upon receiving death alerts from key community partners about the recent death of an infant (<6 months) in the 4 catchment areas of Karachi, a team of nurses and health workers mobilize to identify and approach the household of the infant's primary caregivers. Upon obtaining verbal consent from the parents, the nurse obtains nasopharyngeal specimens from the left and right nostrils of the recently deceased infant. These specimens are tested for respiratory syncytial virus and Bordetella pertussis through real-time Polymerase chain reaction (PCR) testing, and lab results are reported to the parents along with verbal autopsy findings in a cause of death consultation. Enrolled bereaved parents are also offered grief support home visits and grief counseling services by the community health workers and study psychologist. The surveillance phase continued from August 2018 to March 2020, when specimen collection was paused due to coronavirus disease of 2019 (COVID-19) distancing measures. In 20 months, 490 nasopharyngeal specimens were collected out of 713 households approached upon death alerts. Of these 490, 14 tested positive for RSV and 1 positive for pertussis. Following a training on disinfection, personal protective equipment (PPE) protocols, distancing measures, as well as a study-specific training on mental health, communication, and counseling skills June-July 2020, surveillance and specimen collection is planned to resume from August 2020. Proposal for current study: While nasopharyngeal swab sampling with PCR testing is the gold standard for detection of RSV, little is understood about lung morphology in relation to upper respiratory tract infections in neonate and infant mortality. The objective of this study is to assess and analyze the burden and determinants of RSV mortality in infants in 2 peri-urban areas of Karachi Pakistan and to provide a cause of death consultation for the families of the recently deceased infants under 6 months of age in the catchment areas. The RSV-MITS Study will be merged with the ongoing parent study of Community-based Infant RSV Mortality. With the additional procedure and analysis of minimally invasive tissue sampling (MITS) of the lungs/thorax, we aim to examine lung morphology through microbiology and histology specimens. Designated staff (nurses) will require additional MITS training, and the nasopharyngeal swab specimens and lung/thorax MITS specimens will be collected in the designated study ambulance parked near the household or transported to the closest partner hospital. The target sample size is 150 lung/thorax MITS and nasopharyngeal specimens from deceased infants under 6 months of age; stillbirths and miscarriages excluded. This study will be conducted in 2 Health and Demographic Surveillance System (HDSS) catchment areas: Bhains Colony and Ali Akbar Shah Goth. The MITS Study is funded by the MITS Surveillance Alliance. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02593071 -
Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
|
Phase 2 | |
Completed |
NCT02282982 -
Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis
|
N/A | |
Completed |
NCT02266628 -
Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults
|
Phase 2 | |
Completed |
NCT01709019 -
RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
|
Phase 1 | |
Completed |
NCT01704365 -
RSV-F Vaccine Dose Ranging Study in Young Women
|
Phase 2 | |
Recruiting |
NCT06185647 -
Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis
|
||
Recruiting |
NCT04925310 -
Infection With Respiratory Syncytial Virus in Infants
|
||
Completed |
NCT02968173 -
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
|
Phase 3 | |
Active, not recruiting |
NCT06077149 -
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
|
Phase 4 | |
Completed |
NCT02608502 -
A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
|
Phase 3 | |
Terminated |
NCT04225897 -
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
|
Phase 2 | |
Recruiting |
NCT06216093 -
Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
|
Phase 1 | |
Not yet recruiting |
NCT06392451 -
LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
|
N/A | |
Completed |
NCT04927793 -
Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects
|
Phase 1 | |
Active, not recruiting |
NCT05443607 -
Transplacental Transmission of RSV (TTRSV)
|
||
Recruiting |
NCT04896853 -
Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®
|
Phase 1 | |
Completed |
NCT03916185 -
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
|
Phase 1/Phase 2 | |
Completed |
NCT05842967 -
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease
|
Phase 3 | |
Recruiting |
NCT04909021 -
Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
|
Phase 1 | |
Completed |
NCT05900154 -
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
|
Phase 1 |