Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study

Satoshi Iwata, Naohisa Kawamura, Haruo Kuroki, Yasunobu Tokoeda, Mitsunobu Miyazu, Asayuki Iwai, Tomohiro Oishi, Tomohide Sato, Akari Suyama, Nancy François, Fakrudeen Shafi, Javier Ruiz-Guiñazú, Dorota Borys

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3–4–5 months of age) and booster vaccination (17–19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children.

Original languageEnglish
Pages (from-to)826-837
Number of pages12
JournalHuman Vaccines and Immunotherapeutics
Volume11
Issue number4
DOIs
Publication statusPublished - 2015 Jan 1

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Conjugate Vaccines
Vaccines
Safety
Vaccination
Antibodies
Diphtheria-Tetanus-acellular Pertussis Vaccines
Haemophilus influenzae glpQ protein
Multicenter Studies
Japan
Proteins
Antigens
Control Groups

Keywords

  • Children
  • Co-administration
  • Immunogenicity
  • Japan
  • Pneumococcal conjugate vaccine
  • Safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children : A randomized, controlled study. / Iwata, Satoshi; Kawamura, Naohisa; Kuroki, Haruo; Tokoeda, Yasunobu; Miyazu, Mitsunobu; Iwai, Asayuki; Oishi, Tomohiro; Sato, Tomohide; Suyama, Akari; François, Nancy; Shafi, Fakrudeen; Ruiz-Guiñazú, Javier; Borys, Dorota.

In: Human Vaccines and Immunotherapeutics, Vol. 11, No. 4, 01.01.2015, p. 826-837.

Research output: Contribution to journalArticle

Iwata, Satoshi ; Kawamura, Naohisa ; Kuroki, Haruo ; Tokoeda, Yasunobu ; Miyazu, Mitsunobu ; Iwai, Asayuki ; Oishi, Tomohiro ; Sato, Tomohide ; Suyama, Akari ; François, Nancy ; Shafi, Fakrudeen ; Ruiz-Guiñazú, Javier ; Borys, Dorota. / Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children : A randomized, controlled study. In: Human Vaccines and Immunotherapeutics. 2015 ; Vol. 11, No. 4. pp. 826-837.
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AU - Iwata, Satoshi

AU - Kawamura, Naohisa

AU - Kuroki, Haruo

AU - Tokoeda, Yasunobu

AU - Miyazu, Mitsunobu

AU - Iwai, Asayuki

AU - Oishi, Tomohiro

AU - Sato, Tomohide

AU - Suyama, Akari

AU - François, Nancy

AU - Shafi, Fakrudeen

AU - Ruiz-Guiñazú, Javier

AU - Borys, Dorota

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N2 - This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3–4–5 months of age) and booster vaccination (17–19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children.

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