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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03829735
Acronym
NeoVac2S
Enrollment
0
Registered
2019-02-04
Start date
2020-11-01
Completion date
2021-08-30
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

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).

Interventions

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

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Months to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vaccination coverage of the vaccine at birth from the health record and health post registers9 to 12 months post-natal visitCollection of thedate of vaccination of children aged 9-12 months

Secondary

MeasureTime frameDescription
Positive HBsAg among mothers of children aged 9-12 months9 to 12 months post-natal visitHBsAg testing from capillary blood on site
Positive HBsAg among children aged 9-12 months9 to 12 months post-natal visitHBsAg testing from capillary blood on site

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026