Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa

NCT ID: NCT03722615

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-06
• Study Completion Date: 2019-04-01

Brief Summary

The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV) infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent setting in Soweto, Johannesburg. A cross-sectional study will be conducted on mother-infant pairs, screening mothers for CMV infection and newborns for congenital CMV infection. Maternal CMV prevalence will be determined by testing for CMV specific antibodies in blood. Newborn congenital infection will be determined by polymerase chain reaction (PCR) tests on newborn saliva and urine within 3 weeks of birth. Various risk factors associated with congenital CMV such as HIV exposure, and gestational age will be assessed. The association between maternal vaginal CMV shedding postnatally with congenital CMV infection will be explored by swabbing maternal vaginal fluid and conducting quantitative CMV PCR analysis. Newborns confirmed with congenital CMV and a control group of uninfected newborns will form a cohort to be followed up until 12 months of age monitoring for various neurological sequelae such as hearing loss, neurodevelopmental impairment, ocular damage, cerebral damage and seizures.

A comparison of vaccine immune responses between cases of congenital CMV and the CMV uninfected infants to the primary series of vaccines in the National Expanded Programme on Immunisation will be compared. The contribution of CMV infection to neonatal death and stillbirths will be described by minimally invasive tissue sampling (MITS) for CMV on babies that die during the neonatal period and stillbirths.

Conditions

Cytomegalovirus Congenital; Hearing Loss; Neurodevelopmental Disorders; Immunogenicity; Neonatal Death; Stillbirth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Mother's age ≥18y
• Residing in Soweto and would be available for study follow-up
• Consents to enrol self and baby in study

Exclusion Criteria

• Mother not enrolled in V98_28OBTP (NCT02215226)

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: lead

Responsible Party

Jayani Pathirana

PhD Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shabir A Madhi

Role: STUDY_DIRECTOR

Univeristy of Witwatersrand, South Africa

Locations

Respiratory and Meningeal Pathogen Research Unit, Soweto

Johannesburg, , South Africa

Countries

South Africa

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

M151161

Identifier Type: -

Identifier Source: org_study_id