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
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∼...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-04-01
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| Series: | Vaccine: X |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590136221000541 |
| _version_ | 1818644888130945024 |
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| author | S. Mangarule S. Palkar M. Mitra M.D. Ravi A.P. Dubey A. Moureau M.V. Jayanth D.M. Patel S. Ravinuthala S.R. Jagga B.N. Patnaik E. Jordanov F. Noriega |
| author_facet | S. Mangarule S. Palkar M. Mitra M.D. Ravi A.P. Dubey A. Moureau M.V. Jayanth D.M. Patel S. Ravinuthala S.R. Jagga B.N. Patnaik E. Jordanov F. Noriega |
| author_sort | S. Mangarule |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T00:22:00Z |
| format | Article |
| id | doaj.art-e0d2bb8e5e0542bdaa094cb4a62bf181 |
| institution | Directory Open Access Journal |
| issn | 2590-1362 |
| language | English |
| last_indexed | 2024-12-17T00:22:00Z |
| publishDate | 2022-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Vaccine: X |
| spelling | doaj.art-e0d2bb8e5e0542bdaa094cb4a62bf1812022-12-21T22:10:33ZengElsevierVaccine: X2590-13622022-04-0110100137Safety and immunogenicity of a hexavalent DTwP-IPV-HB-PRP∼T vaccine versus separate DTwP-HB-PRP∼T and IPV vaccines in healthy infants in IndiaS. Mangarule0S. Palkar1M. Mitra2M.D. Ravi3A.P. Dubey4A. Moureau5M.V. Jayanth6D.M. Patel7S. Ravinuthala8S.R. Jagga9B.N. Patnaik10E. Jordanov11F. Noriega12Sanofi Healthcare India Private Ltd (SHIPL), Hyderabad, India; Corresponding author at: Sanofi Healthcare India Private Ltd (SHIPL), Vasantha Chambers, 5-10-173 Fateh Maidan Road, Hyderabad, 500004 Telangana, India.Bharati Vidyapeeth Deemed University Medical College, Pune, IndiaInstitute of Child Health, Kolkata, IndiaJSS Academy of Higher Education and Research, JSS Medical College and Hospital, Mysore, IndiaMaulana Azad Medical College, New Delhi, IndiaSanofi Pasteur, Marcy l’Etoile, FranceSanofi Healthcare India Private Ltd (SHIPL), Hyderabad, IndiaSanofi Pasteur, Swiftwater, PA, USASanofi Healthcare India Private Ltd (SHIPL), Hyderabad, IndiaSanofi Healthcare India Private Ltd (SHIPL), Hyderabad, IndiaSanofi Healthcare India Private Ltd (SHIPL), Hyderabad, IndiaSanofi Pasteur, Swiftwater, PA, USASanofi Pasteur, Swiftwater, PA, USABackground: 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.http://www.sciencedirect.com/science/article/pii/S2590136221000541HexavalentVaccinePrimaryBooster |
| spellingShingle | S. Mangarule S. Palkar M. Mitra M.D. Ravi A.P. Dubey A. Moureau M.V. Jayanth D.M. Patel S. Ravinuthala S.R. Jagga B.N. Patnaik E. Jordanov F. Noriega 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 Vaccine: X Hexavalent Vaccine Primary Booster |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Hexavalent Vaccine Primary Booster |
| url | http://www.sciencedirect.com/science/article/pii/S2590136221000541 |
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