Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03829735 |
| Other study ID # |
2017-048 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2020 |
| Est. completion date |
August 30, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Institut Pasteur |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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).
