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
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
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| Enthalten in: |
Infectious diseases (London, England) - 56(2024), 1 vom: 13. Jan., Seite 1-10 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gorar, Zulfikar Ali [VerfasserIn] |
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| Links: |
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| Themen: |
Equivalence Trial |
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| Anmerkungen: |
Date Completed 11.01.2024 Date Revised 11.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT04870021 Citation Status MEDLINE |
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| doi: |
10.1080/23744235.2023.2258208 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM362097429 |
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| 500 | |a ClinicalTrials.gov: NCT04870021 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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% | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04870021 | ||
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| 650 | 4 | |a Journal Article | |
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