Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial. Issue 21 (17th May 2018)

• Record Type: Journal Article
• Authors: Togashi, Takehiro; Mitsuya, Nodoka; Sumino, Shuji; Takanami, Yohei
• Is Part Of: Vaccine. Volume 36:Issue 21(2018)
• Page Start: 2968
• Page End: 2972
• Publication Date: 2018-05-17
• Subjects: Haemophilus influenzae type b -- Vaccine -- Immunogenicity -- Safety -- Intramuscular -- Japan; AE adverse event -- CI confidence interval -- GMT geometric mean anti-PRP titer -- Hib Haemophilus influenzae type b -- MedDRA Medical Dictionary for Regulatory Activities -- PRP polyribosyl-ribitol-phosphate -- PRP-D PRP-diphtheria toxoid -- PRP-T PRP-tetanus toxoid -- PRP-CRM197 PRP-mutated nontoxic diphtheria toxin -- PRP-OMP PRP-Neisseria meningitidis outer membrane protein complex -- SAE serious AE -- SD standard deviation; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2018.04.040
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Background: Japan licensed the conjugate Haemophilus influenzae type b vaccine, Vaxem™ Hib, based on clinical studies using subcutaneous injection. The present study was performed to ensure this vaccine is suitable for intramuscular injection in Japanese children. Methods: Thirty-one healthy 2–6-month-old infants received three doses of Vaxem™ Hib by intramuscular injection at 4-week intervals and a booster dose 1 year later, concomitant with routine infant (DTaP-IPV and pneumococcal) and toddler (measles–rubella) vaccines. Immunogenicity was assessed before and after the primary series and booster dose by enzyme-linked immunosorbent assay for anti-polyribosyl-ribitol-phosphate (PRP) antibodies. Safety was assessed by medical examination and diary cards completed by the subjects' parents/legal guardians. Results: There were no vaccine-related serious adverse events or withdrawals; all children completed the study. Four weeks after the primary series, the geometric mean anti-PRP titer (GMT) was 19.68 μg/mL, and all children had seroprotective titers (≥0.15 μg/mL) that persisted until the booster dose. Proportions of titers indicative of long-term protection (≥1.0 μg/mL) were 100% after the primary series and 77.4% before the booster. Anamnestic responses to the booster had a GMT of 51.33 μg/mL, and 100% had titers ≥1.0 μg/mL. All but one subject reported injection site reactions as resolved within 3 days of vaccination; systemic reactions due to Hib and routine vaccines were also resolved within this period. Conclusions: Vaxem™ Hib was generally well tolerated and immunogenic in Japanese children when administered by intramuscular injection in a three-dose primary series and as a booster with concomitant routine vaccines. Clinical trial registry: Registered on Clinical Trials.gov : NCT02074345.