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

Abstract

Background

Despite presence of hyperendemic areas, the national immunisation schedule in Pakistan does not include a hepatitis B birth dose, placing newborns at an additional risk of acquiring hepatitis B. This study aimed to assess the impact of adding hepatitis B birth dose in existing national vaccination schedule.

Methods

An open label, randomised controlled non-inferiority trial enrolled 296 healthy near-term mothers to intervention and control groups. Newborns in the intervention group received a hepatitis B birth dose along with routine immunisation vaccines, while control group newborns received vaccinations under the national schedule. Seroprotection was measured and compared at birth and 8 weeks after administering the third dose of pentavalent vaccine. The risk ratio of seroprotection was computed and compared with the delta value set at 5%.

Results

The study found that 95.8% of infants in the intervention group achieved seroprotection, which was significantly higher than the control group’s 58.7%. The difference in risk ratio of seroprotection was 1.62 (CI₉₅: 1.37–1.93), with the upper limit of the CI below the delta margin, confirming non-inferiority. The time interval between birth and the first hepatitis B immunisation shot was a predictor of seroprotection, with an odds ratio of 1.79 (CI₉₅: 1.01–2.9).

Conclusion

Our study indicates that adding a hepatitis B birth dose to the immunisation schedule in Pakistan is non-inferior to the existing one. This can also contribute towards Pakistan’s achievement of the SDG target of reducing hepatitis B surface antigen seroprevalence in children under 5 years of age.

Trial Registration Number

NCT04870021

Keywords:

• Hepatitis B vaccine
• seroprotection
• non-inferiority vaccine trial
• immunization schedule

Acknowledgement

Authors acknowledge the support and faciiitation extended by Dr. Human Qureshi and Ms. Sakina Fazal

Disclosure statement

No potential conflict of interest was reported by the author(s).

Notes

1 Dipetheria, Pertussis, Tetanus, Hemophilus Influenza Type B and Hepatitis B.

2 (a). IICC (b). ICIC (c). CIIC, (d). CCII, (e). CICI, (f). ICCI.