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. 2022 Jan 10:10:100137.
doi: 10.1016/j.jvacx.2021.100137. eCollection 2022 Apr.

Safety and immunogenicity of a hexavalent DTwP-IPV-HB-PRP∼T vaccine versus separate DTwP-HB-PRP∼T and IPV vaccines in healthy infants in India

S Mangarule  1 , S Palkar  2 , M Mitra  3 , M D Ravi  4 , A P Dubey  5 , A Moureau  6 , M V Jayanth  1 , D M Patel  7 , S Ravinuthala  1 , S R Jagga  1 , B N Patnaik  1 , E Jordanov  7 , F Noriega  7
Affiliations

Safety and immunogenicity of a hexavalent DTwP-IPV-HB-PRP∼T vaccine versus separate DTwP-HB-PRP∼T and IPV vaccines in healthy infants in India

S Mangarule et al. Vaccine X. .

Abstract

Background: Multivalent vaccines containing whole-cell pertussis (wP) antigens combined with established diphtheria (D), tetanus (T), hepatitis B (HB), Haemophilus influenzae type b (Hib), and inactivated poliomyelitis (IPV) antigens allow the provision of a high-quality, affordable DTwP-IPV-HB-PRP∼T vaccine.

Methods: Phase I/II, randomized, active-controlled, open-label study in healthy toddlers (Cohort I) and infants (Cohort II). Toddlers in Cohort I who had completed primary series D, T, P, HB, Hib, and polio vaccination received a booster dose of DTwP-IPV-HB-PRP∼T (N = 30) or DTwP-HB-PRP∼T + IPV (N = 15) vaccines at 15-18 months of age. After satisfactory review of safety data in Cohort I, infants in Cohort II received DTwP-IPV-HB-PRP∼T (N = 100) or DTwP-HB-PRP∼T + IPV (N = 50) at 6-8, 10-12, and 14-16 weeks of age. All infants in Cohort II had received previous oral polio and HB vaccines per country recommendations.

Results: Booster and primary series vaccinations were well tolerated with no clinically significant differences between vaccine groups. Most adverse events were mild and resolved spontaneously; there were no vaccine-related serious adverse events and no deaths. In both vaccine groups, anti-D, anti-T, anti-HB, anti-Hib, and anti-polio 1, 2, and 3 seroprotection was 100% post-booster and post-primary series. For the pertussis antigens, booster response rate was > 86% in both groups. For the primary series, vaccine response rate was slightly higher for DTwP-IPV-HB-PRP∼T than DTwP-HB-PRP∼T + IPV for anti-PT (80.2% and 70.8%) and anti-FHA (81.3% and 68.8%), slightly lower for anti-PRN (72.5% and 81.3%), and similar in each group for anti-FIM (95.6% and 97.9%).

Conclusions: This study demonstrated a good safety and immunogenicity profile of the hexavalent DTwP-IPV-HB-PRP∼T vaccine for infant primary series vaccination at 6-8, 10-12, and 14-16 weeks of age and booster vaccination at 15-18 months of age and supported progression to the next development phase.

Keywords: Booster; Hexavalent; Primary; Vaccine.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Clinical investigators involved in these studies (SP, MM, MDR, and APD) received fees from Sanofi Pasteur through their institutions for the conduct of these clinical studies, but did not receive any direct payment from Sanofi Pasteur in this regard. EJ, FN, and SM hold Sanofi stock. EJ, FN, and AM are employees of Sanofi Pasteur. DMP and EJ were employees of Sanofi Pasteur at the time of the study. BNP, SM, MVJ, SR, and SRJ are employees of Sanofi Healthcare India Private Ltd (SHIPL).

Figures

Fig. 1
Fig. 1
Disposition of study participants.
See this image and copyright information in PMC

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References

    1. Decker M., Edwards K., Bogaerts H. In: Vaccines. 7th ed. Plotkin S.A., Orenstein W.A., Offit P.A., Edwards K.M., editors. Elsevier; PA, USA: 2018. Combination vaccines; pp. 198–227.
    1. Obando-Pacheco P., Rivero-Calle I., Gómez-Rial J., Rodríguez-Tenreiro Sánchez C., Martinón-Torres F. New perspectives for hexavalent vaccines. Vaccine. 2018;36(36):5485–5494. - PubMed
    1. Global Polio Eradication Inititative. The polio endgame strategy 2019-2023: eradication, integration, containment and certification. Available from: https://polioeradication.org/who-we-are/polio-endgame-strategy-2019-2023/. Accessed 19 August 2021.
    1. Mahmood K., Pelkowski S., Atherly D., Sitrin R., Donnelly J.J. Hexavalent IPV-based combination vaccines for public-sector markets of low-resource countries. Hum Vacc Immunotherapeut. 2013;9(9):1894–1902. - PMC - PubMed
    1. Gandhi D.J., Dhaded S.M., Ravi M.D., Dubey A.P., Kundu R., Lalwani S.K., 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 Vacc Immunotherapeut. 2016;12(4):946–954. - PMC - PubMed

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