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Seroprotection With Three Dose vs Four Dose Schedule for Hepatitis B Vaccination in Children Living With Human Immunodeficiency Virus: Follow-up Data at 36–42 Months From a Randomized Controlled Trial

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Abstract

Objective

To compare the long-term seroprotection (anti-HBs ≥10 IU/L) in children living with HIV (CLHIV) receiving a 3- or 4-dose double-strength (20 µg) recombinant Hepatitis B virus (rHBV) vaccination.

Methods

We present anti-retroviral therapy (ART) clinic based follow-up data collected from January, 2021 to August, 2022, from CLHIV who had received either 3-dose or 4-dose double-strength (20 µg) rHBV vaccination, after 36–42 months and assessed for anti-HBs titres, naïve and memory T-helper lymphocytes, CD4 counts and HIV viral load. Children found unprotected after primary immunization, were administered a single double-strength rHBV vaccine booster dose (20 µg) and seroprotection was reassessed after 4 and 12 weeks.

Results

Out of 50 children initially vaccinated, 45 were followed up 36–42 months after primary immunization; median (IQR) anti-HBs titres (IU/L) were 230 (80.5–305.7) in the 3-dose group (n=23) and 263.5 (47.1–332.9) in the 4-dose group (n=22) (P=0.33). 19 and 20 children in the 3-dose and 4-dose group, respectively, were seroprotected (P=0.24). Anti-HBs titres at 36–42 months correlated with CD4 counts at baseline, anti-HBs titres at 1 and 6 months after completion of primary immunization and percentage of memory T-helper lymphocytes. All the five children (3-dose group: 4; 4-dose group: 1) who received rHBV vaccine booster dose attained seroprotection one-month later.

Conclusion

Three-dose double strength rHBV vaccination schedule offers comparable seroprotection to a 4-dose double strength rHBV vaccination schedule in CLHIV receiving ART.

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Funding

Funding: Intramural research grant for post-graduate thesis (NY).

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Authors and Affiliations

  1. Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi O]110095, India

    Nisha Yadav, Pooja Dewan & Sunil Gomber

  2. Department of Microbiology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India

    Bineeta Kashyap

  3. Department of Pathology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India

    Richa Gupta

Authors
  1. Nisha Yadav
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  2. Pooja Dewan
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  3. Sunil Gomber
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  4. Bineeta Kashyap
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  5. Richa Gupta
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Contributions

Contributors: NY: data collection, analysis and interpretation, drafted the manuscript and revised it; PD: conceptualized the study, data analysis and interpretation, drafted the manuscript and provided critical inputs; SG: data interpretation, critical inputs in manuscript; BK, RG: laboratory methods, data collection and interpretation, provided critical inputs in the manuscript. All authors approved final manuscript and are accountable for the contents.

Corresponding author

Correspondence to Pooja Dewan.

Ethics declarations

Ethics clearance: Institutional Ethics Committee for Human Research of University College of Medical Sciences; No.: IECHR/2020/PG/68-R1 dated Dec 21, 2020.

Competing interest: None stated.

Additional information

Note: V Balagopal Raju Award (second prize) at the PEDICON 2023 of the Indian Academy of Pediatrics, Gujarat (NY).

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Yadav, N., Dewan, P., Gomber, S. et al. Seroprotection With Three Dose vs Four Dose Schedule for Hepatitis B Vaccination in Children Living With Human Immunodeficiency Virus: Follow-up Data at 36–42 Months From a Randomized Controlled Trial. Indian Pediatr 60, 935–938 (2023). https://doi.org/10.1007/s13312-023-3040-9

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  • DOI: https://doi.org/10.1007/s13312-023-3040-9

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