Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal

NCT03829735 | Withdrawn

• 1 other identifier: 2017-048
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in sub-Saharan Africa (SSA). Prior to the introduction of the hepatitis B vaccine, main modes of transmission in SSA were perinatal transmission from mother-to-child (MTCT) (10%) and horizontal transmission during early childhood (90%). MTCT occurs through contact with maternal fluids during passage through the birth cana; transplacental transmission and transmission through breastfeeding are rare. In 2009, WHO recommended the administration of hepatitis B vaccination to all newborns within 24 hours of birth to prevent perinatal and early transmissions. In Senegal, the government introduced the monovalent vaccine that can be used within 24 hours after birth in the Expanded Program on Immunization (EPI) in March 2016. Here, we present a study protocol for a sero-epidemiological study of pairs of children aged 9 to 12 months and their mothers, identified through the demographic study, to assess the impact of monovalent vaccine introduced by the national program for prevention of mother-to-child transmission in Senegal. We will also assess the diagnostic performance of loop-mediated isothermal amplification assay (LAMP) to identify people with high viral replication (HBV DNA ≥200,000 IU/ml), compared to a conventional reference test (PCR).

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Vaccination coverage of the vaccine at birth from the health record and health post registers

  Collection of thedate of vaccination of children aged 9-12 months

  9 to 12 months post-natal visit

Secondary Outcomes (2)

• Positive HBsAg among mothers of children aged 9-12 months

  9 to 12 months post-natal visit

• Positive HBsAg among children aged 9-12 months

  9 to 12 months post-natal visit

Study Arms (1)

Children and their mothers

EXPERIMENTAL

Human biological samples from children aged 9 to 12 months and their mothers. Capillary and venous blood samples.

Other: Human biological samples

Interventions

Human biological samples OTHER

Collection of capillary blood for HbsAg testing. Collection of 12 mL of blood for HbsAg positive women and 1 mL for HbsAg positive children.

Children and their mothers

Eligibility Criteria

• Age: 9 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All mothers of children between 9 and 12 months of age registered in the SSDS of Niakhar, Bambey and Fatick, who accept a blood sample from her and their child.

You may not qualify if:

• A child without a mother identified for sampling
• Failure to sign informed consent to participate in the NeoVac 2 study

Sponsors & Collaborators

• Institut Pasteur: lead

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Fabien Taieb

  Institut Pasteur Dakar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: November 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 30, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share