A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia

作者：Lim Fong Seng^*; Koh Mia Tuang; Tan Kah Kee; Chan Poh Chong; Chong Chia Yin; Yehudi Yeo Wee Shung; Teoh Yee Leong; Shafi Fakrudeen; Hezareh Marjan; Swinnen Kristien; Borys Dorota

来源：BMC Infectious Diseases, 2014, 14(1): 530.

DOI：10.1186/1471-2334-14-530

• Pneumococcal conjugate vaccine
• Immunogenicity
• Safety
• Non-typeable Haemophilus influenzae
• Infant
• Toddler
• Singapore
• Malaysia

Background: The immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia, where PHiD-CV has been licensed.
Methods: In the primary vaccination phase, 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical (Clin) or the Commercial (Com) lot of PHiD-CV at 2, 3, and 5 months of age. In the booster vaccination phase, 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age. Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and functional opsonophagocytic activity (OPA) assay and to protein D, using ELISA.
Results: Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration (GMC) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype, >= 93.6% and >= 88.5% of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations >= 0.2 mu g/mL and OPA titres >= 8, in the Clin and Com groups, respectively. For each vaccine pneumococcal serotype, >= 60.8% and >= 98.2% of toddlers from Singapore had pre- and post-booster antibody concentrations >= 0.2 mu g/mL, in the Clin and Com groups, respectively. All children, except one, had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic. The incidence of each grade 3 solicited symptom was <= 11.1% in both study phases. No serious adverse events considered causally related to vaccination were reported throughout the study.
Conclusions: PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile. This study has been registered at www.clinicaltrials.gov NCT00808444 and NCT01119625.

• 出版日期2014-10-2