Hepatitis B Birth Dose for Newborns

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

Interventions

BIOLOGICAL

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

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

BEHAVIORAL

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

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

Sponsors & Collaborators

• Medical Research Council, Pakistan

  collaborator OTHER

• Health Services Academy, Islamabad, Pakistan

  collaborator OTHER

• Quaid-e-Azam University

  lead OTHER

Principal Investigators

• Zulfikar A Gorar, MBBS, MPH · Health Services Academy, Islamabad, Pakistan

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Hours

Max Age

8 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-03-15

Primary Completion

2015-11-30

Completion

2016-06-30

FDA Drug

Yes

Countries

• Pakistan

Study Locations