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

NCT ID: NCT03829735

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-08-30

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).

Detailed Description

Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in sub-Saharan Africa (SSA). Each year, about 61,000 people are estimated to die of hepatocellular carcinoma (HCC) or cirrhosis secondary to chronic infection with HBV. 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.

Despite a relatively low frequency of perinatal transmission in SSA, prevention of this type of transmission is important, because this mode of transmission results in higher risk of becoming chronic HBV carriers, and developing chronic liver disease, including HCC, than horizontal transmission.

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.

It is in this context that the NeoVac study started in 2016 in Senegal, Burkina Faso and Madagascar. The general objective is to develop a long-term strategy adapted to the local context to vaccinate newborns against hepatitis B in the first 24 hours of life.

The NeoVac 1, a population-based epidemiological survey to estimate the coverage of this newly introduced monovalent hepatitis B vaccine started in Senegal in 2018. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Children and their mothers

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

Group Type: EXPERIMENTAL

Human biological samples

Intervention Type: 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.

Interventions

Human biological samples

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Taieb

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur Dakar

Other Identifiers

2017-048

Identifier Type: -

Identifier Source: org_study_id