NCT04870021: HepB-BirD

Hepatitis B Birth Dose for Newborns

Completed Phase 4 Last updated 3 May 2021

What this trial tests

Phase 4 trial testing recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm), in Hepatitis B in 218 participants. Completed in 30 June 2016.

Timeline

15 March 2015

Primary endpoint
30 November 2015

30 June 2016

Quick facts

Lead sponsor	Quaid-e-Azam University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	218
Start date	15 March 2015
Primary completion	30 November 2015
Estimated completion	30 June 2016
Sites	1 location across Pakistan

Drugs / interventions tested

• recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm), — full drug profile →
• Short text messages and calls to parents for compliance to routine immunization schedule

Conditions studied

• Hepatitis B — all drugs for Hepatitis B →
• Immunization; Infection — all drugs for Immunization; Infection →

Sponsor

Quaid-e-Azam University

Who can join

Adults 12 Hours to 8 Months, any sex, with Hepatitis B or Immunization; Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Gorar ZA, Butt ZA. · · 2024 · cited 2× · PMID 37712585 · DOI 10.1080/23744235.2023.2258208