Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States.

Abstract

Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) can further reduce the number of injections in pediatric immunization schedules of countries currently using pentavalent DTaP combination vaccines. This open-label, randomized, multicenter study (NCT02096263) conducted in the United States evaluated the immunogenicity and safety of DTaP-HBV-IPV/Hib vaccine compared with concomitant administration of DTaP-HBV-IPV and HibA or DTaP-IPV/Hib and HBV vaccines. We randomized (1:1:1) infants to receive 3-dose priming with DTaP-HBV-IPV/Hib boosted with DTaP+ HibB, DTaP-HBV-IPV+ HibA boosted with DTaP+ HibA, or DTaP-IPV/Hib+ HBV boosted with DTaP-IPV/Hib, at 2, 4, 6, and 15-18 months of age. We enrolled and vaccinated 585 participants, 486 received a booster, and 476 completed the study. Of these, 466 participants were included in the primary and 408 in the booster according-to-protocol cohorts for immunogenicity. We demonstrated non-inferiority of DTaP-HBV-IPV/Hib vaccine to DTaP-HBV-IPV+ HibA co-administered vaccines in terms of geometric mean concentrations for pertussis antibodies post-primary vaccination. Post-primary vaccination, seroprotection/seropositivity rates for all vaccine antigens were similarly high between DTaP-HBV-IPV/Hib (≥ 94.8%), DTaP-HBV-IPV+ HibA (≥ 98.1%) or DTaP-IPV/Hib+ HBV (≥ 97.8%) groups. We observed robust immune responses post-booster, indicating effective priming by the 3 regimens. Reactogenicity was similar in the 3 groups. Twenty-eight serious adverse events were reported during the study; 3 were considered related to vaccination and resolved by the end of the study. These results confirm that DTaP-HBV-IPV/Hib could be a valuable additional source of pediatric DTaP, IPV, HBV, and Hib-containing vaccine in countries that currently use multivalent vaccines.

• Authors: Nicola P Klein, Remon Abu-Elyazeed, Brigitte Cheuvart, Winnie Janssens, Narcisa Mesaros
• Journal: Human vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 15 Issue 4 Pg. 809-821 ( 2019) ISSN: 2164-554X [Electronic] United States
• PMID: 30444673 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Hepatitis B Vaccines
• Poliovirus Vaccine, Inactivated
• Vaccines, Combined
• diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Topics

• Diphtheria (prevention & control)
• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage, adverse effects, immunology)
• Female
• Haemophilus Vaccines (administration & dosage, adverse effects, immunology)
• Hepatitis B (prevention & control)
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Humans
• Immunization Schedule
• Immunization, Secondary
• Immunogenicity, Vaccine
• Infant
• Male
• Poliomyelitis (prevention & control)
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects, immunology)
• Tetanus (prevention & control)
• United States
• Vaccines, Combined (administration & dosage, adverse effects, immunology)
• Whooping Cough (prevention & control)