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Vaccine. 2018 Mar 14;36(12):1528-1532. doi: 10.1016/j.vaccine.2018.02.011. Epub 2018 Feb 17.

Comparison of serum bactericidal and antibody titers induced by two Haemophilus influenzae type b conjugate vaccines: A phase III randomized double-blind study.

Author information

1
Research Institute for Microbial Diseases, Osaka University, Osaka, Japan; Department of Infection Control and Prevention, Osaka University Graduate School of Medicine, Osaka, Japan; Division of Infection Control and Prevention, Osaka University Hospital, Osaka, Japan. Electronic address: akeda@biken.osaka-u.ac.jp.
2
Research Institute for Microbial Diseases, Osaka University, Osaka, Japan.
3
Takeda Pharmaceutical Company Limited, Osaka, Japan.
4
Research Institute for Microbial Diseases, Osaka University, Osaka, Japan; Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Tokyo, Japan.

Abstract

Haemophilus influenzae type b (Hib) conjugate vaccines have drastically reduced disease incidence worldwide. Protection against Hib infection has relied on the serum bactericidal activity (SBA) of antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate). However, licensure usually relies on measuring induction of antibodies to PRP as a surrogate for SBA. In a phase III clinical trial we compared a PRP-conjugate vaccine using the nontoxic diphtheria toxin mutant, CRM197, as carrier protein with the licensed tetanus toxoid conjugate when administered subcutaneously as a three dose primary series in Japanese infants. As an addition to the phase III study, we have now evaluated SBA and show PRP-CRM197 induces higher levels of SBA than PRP-T four weeks after the primary series, with a statistically significant correlation with anti-PRP titers. This data confirms the superior immunogenicity of PRP-CRM197 compared with PRP-T assessed as SBA following a three-dose primary series by subcutaneous administration. Clinical trial registry: Registered on ClinicalTrials.gov (NCT01379846).

KEYWORDS:

Aluminum phosphate adjuvant; Haemophilus influenzae type b; Hib conjugate vaccine; Seroprotection threshold; Serum bactericidal activity

PMID:
29459064
DOI:
10.1016/j.vaccine.2018.02.011
[Indexed for MEDLINE]
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