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Three vs Four Dose Schedule of Double Strength Recombinant Hepatitis-B Vaccine in HIV-infected Children: A Randomized Controlled Trial

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Abstract

Objectives

To compare seroprotection rates and the anti-HBs titers following primary immunization with double strength (20 µg) recombinant hepatitis B virus (rHBV) vaccine administered intramuscularly (IM) in a 3-dose (0, 1 and 6 months) vs 4-dose (0, 1, 2 and 6 months) schedule in HIV-infected children receiving antiretroviral therapy (ART). An accelerated 3-dose schedule (0, 1, 2 months) within the 4-dose group was also compared.

Design

Randomized controlled trial.

Setting

Pediatric ART clinic of a tertiary hospital in Delhi from November, 2017 to April, 2019.

Participants

Fifty (25 per group) HIV-infected children aged 18 months — 12 years receiving ART for at least 6 months who had not received any prior dose of HBV vaccine, and were anti-HBs negative.

Intervention

Group 1 received 20 µg of rHBV vaccine IM (in deltoid muscle) at 0, 1, and 6 months, and group 2 received 20 µg the same vaccine at 0, 1, 2 and 6 months.

Outcome variables

Anti-HBs titers and proportion of responders in 3-dose vs 4-dose group at seventh and twelfth month and at third month after an accelerated 3-dose schedule.

Result

Median (IQR) anti-HBs titers at the seventh month were significantly higher in group 2 [225.7 (151–300) IU/L] compared to group 1 [138.2 (35.2–250) IU/L], but were comparable at the 12th month. Seroprotection rates were comparable between group 2 and group 1 at 7th month (96% vs 80%; P=0.19) and 12th month (96% vs 88%; P=0.61). The proportion of good responders were also comparable between the groups at 7th month and 12th month (both P=0.29). Accelerated 3-dose schedule achieved comparable anti-HBs titers [179.9 (130.6–250) IU/L] and seroprotection rate (92%) one month after completion of schedule to the standard 3-dose schedule.

Conclusion

A 3-dose double strength recombinant HBV vaccine schedule offers comparable seroprotection to 4-dose schedule for HIV-infected children receiving ART.

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References

  1. Soriano V, Puoti M, Bonacini M, et al. Care of patients with chronic hepatitis B and HIV-coinfection: Recommendations from an HIV-HBV International Panel. AIDS. 2005;19:221–40.

    Article  Google Scholar 

  2. Laurence JC. Hepatitis A and B immunizations of individuals infected with human immunodeficiency virus. Am J Med. 2005;118:75S–83S.

    Article  Google Scholar 

  3. Van den Berg R, van Hoogstraten I, van Agtmael M. Non-responsiveness to hepatitis B vaccination in HIV seropositive patients; possible causes and solutions. AIDS Rev. 2009;11:157–64.

    PubMed  Google Scholar 

  4. Zuin G, Principi N, Tornaghi R, et al. Impaired response to hepatitis B vaccine in HIV infected children. Vaccine. 1992; 10:857–60.

    Article  CAS  Google Scholar 

  5. Potsch DV, Camacho LAB, Tuboi S, et al. Vaccination against hepatitis B with 4-double doses increases response rates and antibodies titers in HIV-infected adults. Vaccine. 2012;30:5973–7.

    Article  CAS  Google Scholar 

  6. Ni JD, Xiong YZ, Wang XJ, Xiu LC. Does increased hepatitis B vaccination dose lead to a better immune response in HIV-infected patients than standard dose vaccination: A meta-analysis. Int J STD AIDS. 2013;24: 117–22.

    Article  CAS  Google Scholar 

  7. Scolfaro C, Fiammengo P, Balbo L, Madon E, Tovo PA. Hepatitis B vaccination in HIV-1-infected children: Double efficacy doubling the paediatric dose. AIDS. 1996;10:1169–70.

    CAS  PubMed  Google Scholar 

  8. Launay O, van der Vliet D, Rosenberg AR, et al. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: A randomized controlled trial. JAMA. 2011;305:1–9.

    Article  Google Scholar 

  9. Potsch DV, Oliveira MLA, Ginuíno C, et al. High rates of serological response to a modified hepatitis B vaccination schedule in HIV-infected adults subjects. Vaccine. 2010;28:1447–50.

    Article  CAS  Google Scholar 

  10. Cruciani M, Mengoli C, Serpelloni G, et al. Serologic response to hepatitis B vaccine with high dose and increasing number of injections in HIV infected adult patients. Vaccine. 2009;27:17–22.

    Article  CAS  Google Scholar 

  11. Rey D, Krantz V, Partisani M, et al. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. Effects on HIV-1 viral load. Vaccine. 2000;18:1161–5.

    CAS  PubMed  Google Scholar 

  12. Flynn PM, Cunningham CK, Rudy B, et al. Hepatitis B vaccination in HIV-infected youth: A randomized trial of three regimens. J Acquir Immune Defic Syndr. 2011; 54:325–32.

    Article  Google Scholar 

  13. Cruciani M, Mengoli C, Serpelloni G, Mazzi R, Bosco O, Malena M. Granulocyte macrophage colony-stimulating factor as an adjuvant for hepatitis B vaccination: a meta-analysis. Vaccine. 2007;25:709–18.

    Article  CAS  Google Scholar 

  14. Aberg JA, Gallant JE, Ghanem KG, Emmanuel P, Zingman BS, Horberg MA; Infectious Diseases Society of America. Primary Care Guidelines for the Management of Persons Infected With HIV: 2013 Update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;58:1–10.

    Article  Google Scholar 

  15. AIDSinfo. Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-infected Adults and Adolescents. April 16, 2015. Accessed August 1, 2020. Available from: https://aidsinfo.nih.gov/guidelines/html/4/adultand-adolescent-oiprevention-and-treatment-guidelines/344/hbv

  16. Mast EE, Margolis HS, Fiore AE, et al; Advisory Committee on Immunization Practices (ACIP). A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part 1: Immunization of Infants, Children, and Adolescents. MMWR Recomm Rep. 2005;54:1–31.

    PubMed  Google Scholar 

  17. Shastri DD. Immunization in special circumstances. In: Balasubramanian S, Shastri DD, Shah AK, et al, editors. IAP Guide Book on Immunization 2018–2019: By Advisory Committee on Vaccines and Immunization Practices (ACVIP). 3rd ed: Jaypee Brothers Medical Publishers; 2020.p406.

  18. Hepatitis B vaccines: WHO position paper — July 2017. Wkly Epidemiol Rec. 2017;92:369–92.

  19. National AIDS Control Organization. Pediatric Anti-Retroviral Therapy Guidelines, 2013. Available from: http://naco.gov.in/sites/default/files/Pediatric_14-03-2014.pdf. Accessed April 28, 2020.

  20. Shokrgozar MA, Shokri F. Enumeration of hepatitis B surface antigen-specific B lymphocytes in responder and non-responder normal individuals vaccinated with recombinant hepatitis B surface antigen. Immunology. 2001;104:75–9.

    Article  CAS  Google Scholar 

  21. Bose D, Chandra J, Dutta R, et al. Immune response to double dose hepatitis-B vaccine using four dose schedule in HIV infected children. Indian J Pediatr. 2016;83:772–6.

    Article  Google Scholar 

  22. Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: A randomized, controlled trial. PLoS One. 2013;8:e80409.

    Article  CAS  Google Scholar 

  23. Siddiqui SA, Maurya M, Singh DK, Srivastava A, Rai R. Double dose versus standard dose hepatitis B vaccine in HIV-infected children: A randomized controlled trial. Indian Pediatr. 2017;54:1017–20.

    Article  Google Scholar 

  24. Cornejo-Suarez P, Volkow-Fernandez P, Escobedo-Lopez K, Vilar-Compte D, Ruiz-Palacios G, Soto-Ramirez LE. Randomized controlled trial of hepatitis B virus vaccine in HIV-1 infected patients comparing two different doses. AIDS Res Ther. 2006;3:9.

    Article  Google Scholar 

  25. Launay O, Rosenberg AR, Rey D, et al. Long-term immune response to hepatitis B virus vaccination regimens in adults with human immunodeficiency virus 1: Secondary analysis of a randomized clinical trial. JAMA Int Med. 2016;176:603–10.

    Article  Google Scholar 

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Author information

Authors and Affiliations

  1. Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, 110 095, India

    Prachi Jain, Pooja Dewan & Sunil Gomber

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

    Bineeta Kashyap

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

    Alpana Raizada

Authors
  1. Prachi Jain
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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. Alpana Raizada
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Corresponding author

Correspondence to Pooja Dewan.

Additional information

Ethics clearance

Institutional Ethics Committee, UCMS; No. IECHR/2017/32/100 dated 17 October, 2017.

Contributors

PD, PJ, SG, BK, AR: conceptualized the study; PJ, PD: data collection; BK: laboratory support; PD, PJ: drafted the manuscript; SG, BK, AR: critical input. All authors approved the final manuscript and are accountable for the manuscript.

Funding

Intramural grant, University College of Medical Sciences.

Competing interests

None stated.

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Jain, P., Dewan, P., Gomber, S. et al. Three vs Four Dose Schedule of Double Strength Recombinant Hepatitis-B Vaccine in HIV-infected Children: A Randomized Controlled Trial. Indian Pediatr 58, 224–228 (2021). https://doi.org/10.1007/s13312-021-2159-9

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  • DOI: https://doi.org/10.1007/s13312-021-2159-9

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