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Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal (NeoVac2S)

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ClinicalTrials.gov Identifier: NCT03829735
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

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).


Condition or disease Intervention/treatment Phase
Hepatitis B Other: Human biological samples Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Children and their mothers
Human biological samples from children aged 9 to 12 months and their mothers. Capillary and venous blood samples.
Other: 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.




Primary Outcome Measures :
  1. Vaccination coverage of the vaccine at birth from the health record and health post registers [ Time Frame: 9 to 12 months post-natal visit ]
    Collection of thedate of vaccination of children aged 9-12 months


Secondary Outcome Measures :
  1. Positive HBsAg among mothers of children aged 9-12 months [ Time Frame: 9 to 12 months post-natal visit ]
    HBsAg testing from capillary blood on site

  2. Positive HBsAg among children aged 9-12 months [ Time Frame: 9 to 12 months post-natal visit ]
    HBsAg testing from capillary blood on site



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829735


Contacts
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Contact: Yusuke Shimakawa, MD, PhD +33140613887 yusuke.shimakawa@pasteur.fr

Sponsors and Collaborators
Institut Pasteur
Investigators
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Principal Investigator: Fabien Taieb Institut Pasteur Dakar
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03829735    
Other Study ID Numbers: 2017-048
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections