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Immunogenicity and Safety of Three WHO Prequalified (DTwP -HB-Hib) Pentavalent Combination Vaccines Administered As Per Iranian National Immunization Plan in Iranian Infants: A Randomized, Phase III Study

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Abstract

Background

The pentavalent vaccine Pentavac was officially introduced in the Iranian National Immunization Plan in November, 2014.

Objective

To compare the immunogenicity and safety of Pentavac vaccine (Serum Institute of India Ltd.) with two other pentavalent vaccines available in Iran, i.e., Pentabio (PT Bio Farma (Persero)) and Shan 5 (Shantha Biotechnics Ltd.).

Design

Randomized, phase III study.

Participants

900 infants attending the study sites to receive the vaccine at 2, 4, and 6 months of age.

Intervention

Infants were randomly assigned to one of the Pentavac, Pentabio, and Shan 5 vaccine groups.

Outcomes

The antibody titers were measured against five antigens, diphtheria, tetanus, pertussis, Haemophilus influenzae B, and hepatitis B before receiving the first dose and one month after the last dose. The adverse events following vaccination after each dose were recorded in the adverse events diary.

Results

All vaccines showed similar immunogenicity against four of the five antigens except pertussis. While vaccination with Shan 5 resulted in the highest immunogenicity against pertussis, Pentabio was significantly lower than the other two vaccines (P<0.001). The incidence of local adverse events significantly differed among the three vaccine brands (P<0.001), but the incidence of most of the evaluated systemic adverse events was similar (P>0.05).

Conclusion

Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile.

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References

  1. Gandhi DJ, Dhaded SM, Ravi MD, et al. Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwp-HepB-Hib vaccine in healthy Indian toddlers and infants. Hum Vaccin Immunother. 2016; 12:946–54.

    Article  Google Scholar 

  2. Arístegui J, Usonis V, Coovadia H, et al. Facilitating the WHO expanded program of immunization: The clinical profile of a combined diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type b vaccine. Int J Infect Dis. 2003;7:143–51.

    Article  Google Scholar 

  3. Karami M, Ameri P, Bathaei J, et al. Adverse events following immunization with pentavalent vaccine: Experiences of newly introduced vaccine in Iran. BMC Immunology. 2017;18:42.

    Article  Google Scholar 

  4. Arjmand R., Gholami M., Shirvani F, et al. Study of serologic response rate to pertussis after administration of the third dose of pentavalent vaccine in children 12 months old in Karaj city, Iran. Int J Pediatr. 2018;6:7023–31.

    Google Scholar 

  5. Arjmand R, Golami M, Shirvani F, et al. Hepatitis B seroconversion rate after primary immunization series with newly introduced pentavalent vaccine: A report of local study in Alborz province, Iran, 2016. Arch Pediatr Infect Dis. 2019;7:e83565.

    Google Scholar 

  6. Rusmil K, Gunardi H, Fadlyana E, et al. The immuno-genicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immuni-zation schedule. BMC Pediatr. 2015;15:219.

    Article  Google Scholar 

  7. Rao R, Dhingra MS, Bavdekar S, et al. A comparison of immunogenicity and safety of indigenously developed liquid (DTwPHB-Hib) pentavalent combination vaccine (SHAN 5) with Easyfive (Liq) and Tritanrix + Hiberix (Lyo) in Indian infants administered according to the EPI schedule. Hum Vaccin. 2009;5:425–9.

    Article  CAS  Google Scholar 

  8. Bachtiar N, Rusmil K, Sudigdoadi S, et al. The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine. PI. 2017:57:129–7.

    Google Scholar 

  9. Sharma HJ, Yadav S, Lalwani SK, et al. Immunogenicity and safety of an indigenously manufactured reconstituted pentavalent (DTwP-HBV+Hib) vaccine in comparison with a foreign competitor following primary and booster immunization in Indian children. Hum Vaccin. 2011;7:451–7.

    Article  CAS  Google Scholar 

  10. Chatterjee S, Rego SJ, D’Souza F, et al. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule. BMC Infect Dis. 2010; 10:298.

    Article  Google Scholar 

  11. Ali SS, Chandrashekar SR, Singh M, et al. A multicenter, prospective, open-label, non-comparative study to evaluate the immunogenicity and tolerance of a new, fully liquid pentavalent vaccine (DTwP-HepB-Hib vaccine). Hum Vaccine. 2007; 3:116–20.

    Article  CAS  Google Scholar 

  12. Bavdekar SB, Maiya PP, Subba Rao SD, et al. Immuno-genicity and safety of combined diphtheria tetanus whole cell pertussis hepatitis B/Haemophilus influenzae type b vaccine in Indian infants. Indian Pediatr. 2007;44:505–10.

    CAS  PubMed  Google Scholar 

  13. Prequalified vaccines. WHO — Prequalification of Medical Products (IVDs, Medicines, Vaccines. Accessed February 23, 2021. Available from: https://extranet.who.int/pqweb/vaccines/prequalified-vaccines/

  14. Saffar MJ, Ajami A, Khalilian AR, et al. Pertussis seroimmunity among mother-infant pairs and infant immune response to pertussis vaccination. Indian Pediatr. 2007;44: 916–18.

    CAS  PubMed  Google Scholar 

  15. Eregowda A, Lalwani S, Chatterjee S, et al. A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in Indian infants. Hum Vacc Immunother. 2013; 9: 1903–9.

    Article  CAS  Google Scholar 

  16. Sharma H, Yadav S, Lalwani S, et al. A phase III randomized, controlled study to assess the immunogenicity and tolera-bility of DTPw—HBV—Hib, a liquid pentavalent vaccine in Indian infants. Vaccine. 2011;29:2359–64.

    Article  CAS  Google Scholar 

  17. Edwards KM, Berbers GA. Immune responses to pertussis vaccines and disease. J Infect Dis. 2014;209:S10–5.

    Article  CAS  Google Scholar 

  18. Bar-On ES, Goldberg E, Fraser A, et al. Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diph-theria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB). Cochrane Database Syst Rev. 2009:CD005530.

  19. Dalvi S, Kulkarni PS, Phadke MA, et al. A comparative clinical study to assess safety and reactogenicity of a DTwP-Hep B+Hib vaccine. Human Vacc Immunother. 2015;11:901–7.

    Article  Google Scholar 

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Funding

Funding: Elite Researcher Grant Committee award (No. 940821) from the National Institutes for Medical Research Development (NIMAD), Tehran, Iran. Sanofi Company, India, and Bio Farma, Indonesia provided the Shan 5 and Pentabio vaccines on a complimentary basis.

Author information

Authors and Affiliations

  1. Pediatric Infections Research Center (PIRC), Research Institute for Children’s Health (RICH), Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Sedigheh Rafiei Tabatabaei, Abdollah Karimi, Leila Azimi, Fariba Shirvani & Maryam Rajabnejad

  2. Center for Communicable Diseases Control, Ministry of Health and Medical Education, Tehran, Iran

    Seyed Mohsen Zahraei & Sousan Mohammadi

  3. Research Center of Pediatric Infectious Diseases, Institute of Immunology and Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran

    Abdoulreza Esteghamati

  4. Research Centre for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran

    Ahmadreza Shamshiri

  5. Dental Research Center, Department of Pediatric Dentistry, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran

    Reyhaneh Faghihian

  6. Department of Pediatric Infectious Disease, Iran University of Medical Sciences, Tehran, Iran

    Eiman Faghihian

Authors
  1. Sedigheh Rafiei Tabatabaei
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  2. Abdollah Karimi
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  3. Seyed Mohsen Zahraei
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  4. Abdoulreza Esteghamati
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  5. Leila Azimi
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  6. Fariba Shirvani
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  7. Sousan Mohammadi
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  8. Maryam Rajabnejad
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  9. Ahmadreza Shamshiri
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  10. Reyhaneh Faghihian
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  11. Eiman Faghihian
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Contributions

Contributors: All authors approved the final version of manuscript, and are accountable for all aspects related to the study.

Corresponding author

Correspondence to Eiman Faghihian.

Ethics declarations

Ethics clearance: National Institutes for Medical Research Development; No. IR.NIMAD.REC.1395.002 dated: 4 April 2016.

Competing interest: None stated.

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Tabatabaei, S.R., Karimi, A., Zahraei, S.M. et al. Immunogenicity and Safety of Three WHO Prequalified (DTwP -HB-Hib) Pentavalent Combination Vaccines Administered As Per Iranian National Immunization Plan in Iranian Infants: A Randomized, Phase III Study. Indian Pediatr 58, 1131–1135 (2021). https://doi.org/10.1007/s13312-021-2393-1

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  • DOI: https://doi.org/10.1007/s13312-021-2393-1

Keywords

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