Hepatitis B Birth Dose for Newborns

NCT04870021 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: F.No.3-107/2013-IERC/HSA
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

With 2.5% prevalence in general population, Pakistan is an intermediate endemicity country for hepatitis B. However, wide disparity exists across the country as disease prevalence in general population soars as high as 14% in hyper endemic areas. This hyper endemicity increases the risk of acquiring infection via vertical and horizontal routes of disease transmission. National immunization schedule in Pakistan administers the first vaccine against hepatitis B at 6th week after infant birth. Owing to this 6 week interlude the existing immunization schedule may not provide adequate protection to a newborn against the disease. A monovalent hepatitis B vaccination shot, administered within 12 hours of birth, is the preferred strategy for disease control in hyper endemic areas. The National Immunization Technical Advisory Groups around the world are expected to use rigorous scientific evidence and make changes in the immunization schedule and vaccine dosage, responding to the evolving epidemiology of childhood diseases. Such research on local evidence for hepatitis B vaccine in Pakistan is not available and our research fills this gap by This research studied the hepatitis B vaccine response, in two cohorts of healthy infants. An open labeled, randomized controlled, non-inferiority, vaccine trial methodology was used. Margin of non non-inferiority (Δ) was set at 5%. The trial administered hepatitis B birth dose as an intervention and vaccination done under the national immunization schedule was taken as standard of care.

Conditions

Hepatitis B; Immunization; Infection

Outcome Measures

Primary Outcomes (1)

• Sero-proetction Level

  The outcome of the study is the measurement of seroprotection correlates against hepatitis B, i.e., anti-hepatitis B surface antigen antibody titer

  8 weeks after third pentavalent vaccination

Secondary Outcomes (1)

• Adverse event

  96 hours after the administration of hepatitis B birth dose

Study Arms (2)

Intervention Arm

EXPERIMENTAL

After birth, one cc of intravenous blood was drawn from the peripheral veins of healthy newborn. The blood was immediately centrifuged, and serum was put in a plastic container, labeled with a unique identification number. The serum containers were frozen and then sent using a cold chain container, to Pakistan Medical Research Council laboratory at Jinnah Postgraduate Medical Center Karachi. The serum was tested for anti-hepatitis B surface antigen antibody on Enzyme Immunoassay (EIA) kit DS-EIA-Anti-HBsAg, manufactured by DSI S.r.I (Italy). After obtaining a blood sample, infants born to mothers in the intervention group were administered GSK's ® recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm), intramuscular in the anterolateral part of either of thighs. This birth dose of hepatitis B was followed by zero dose oral polio vaccine as per hospital policy. Infants born to mother in the control group were given oral polio vaccine as per the hospital policy.

Biological: recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm),; Behavioral: Short text messages and calls to parents for compliance to routine immunization schedule

Control Arm

OTHER

In this arm of the study, after birth, one cc of intravenous blood was drawn from the peripheral veins of healthy newborn. The blood was immediately centrifuged, and serum was put in a plastic container, labeled with a unique identification number. The serum containers were frozen and then sent using a cold chain container, to Pakistan Medical Research Council laboratory at Jinnah Postgraduate Medical Center Karachi. The serum was tested for anti-hepatitis B surface antigen antibody on Enzyme Immunoassay (EIA) kit DS-EIA-Anti-HBsAg, manufactured by DSI S.r.I (Italy). After obtaining a blood sample, infants born to mothers in the control group were given oral polio vaccine as per the hospital policy. Subsequent vaccinations were administered as per the expanded program on immunization schedule in Pakistan.

Behavioral: Short text messages and calls to parents for compliance to routine immunization schedule

Interventions

recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm), BIOLOGICAL

recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm), intramuscular in the anterolateral part of either of thighs

Intervention Arm

Short text messages and calls to parents for compliance to routine immunization schedule BEHAVIORAL

After the discharge of mothers from hospital, preformed, short text messages (SMS) were sent to parents, reminding them of the due date for as per the vaccination schedule. One day after the due date of the vaccine shot, a phone call was made to confirm the child was vaccinated or not

Control Arm; Intervention Arm

Eligibility Criteria

• Age: 12 Hours - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborn with weight more than 2000 grams
• Born to health mothers
• No sign of congenital disease

You may not qualify if:

• Low birth weight newborn
• Signs and Symptoms of febrile Illness/sepsis
• Congenital Malformation
• Signs of Cyanosis
• Difficulty in breathing

Sponsors & Collaborators

• Quaid-e-Azam University: lead
• Medical Research Council, Pakistan: collaborator
• Health Services Academy, Islamabad, Pakistan: collaborator

Study Sites (1)

Countess Dufferin Fund (CDF) Hospital

Hyderābād, Pakistan

Location

Related Publications (1)

• Gorar ZA, Butt ZA. Impact of hepatitis B birth dose on immune response in Pakistani children: an open-label, non-inferiority randomized controlled trial, implications for achieving SDG target. Infect Dis (Lond). 2024 Jan;56(1):1-10. doi: 10.1080/23744235.2023.2258208. Epub 2023 Sep 15.

  PMID: 37712585 DERIVED

MeSH Terms

Conditions

Hepatitis B; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Zulfikar A Gorar, MBBS, MPH

  Health Services Academy, Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph. D (Public Health Student)

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: March 15, 2015
• Primary Completion: November 30, 2015
• Study Completion: June 30, 2016
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available in May 2021
• Access Criteria: Everyone can share the data

Locations

PA (1)