Background: Pneumococcal protein-based vaccines are being investigated to extend protection beyond the capsular polysaccharides included in pneumococcal conjugate vaccines (PCVs). In a phase II trial (NCT01204658) we have shown that 2 investigational vaccine formulations containing pneumococcal proteins pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) each at either 10µg (PHiD-CV/dPly/PhtD-10) or 30µg (PHiD-CV/dPly/PhtD-30) combined with polysaccharide conjugates of 10-valent PCV (PHiD-CV, GSK Vaccines [not licensed in USA]) had a safety profile comparable to that of PHiD-CV after primary vaccination in European infants. Results for safety and reactogenicity of booster vaccination in the same study are presented here.
Methods: In this phase II, multicenter, observer-blind, controlled trial in Europe, infants aged 614-weeks were randomized 1:1:1:1 and received primary and booster vaccination at ages 2, 3, 4 and 1215 months with either PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV or 13-valent PCV (PCV13, Pfizer), co-administered with DTPa-HBV-IPV/Hib. Solicited and unsolicited adverse events (AEs) were recorded within 7 and 31 days post-vaccination, respectively, and serious AEs (SAEs) throughout the study.
Results: Of 576 infants who participated in this study 564 received booster vaccination and were included in the total vaccinated cohort. SAEs were reported for 4 toddlers after the booster dose: 1 in the PHiD-CV/dPly/PhtD-10 group (thermal burn) and 3 in the PCV13 group (febrile convulsions, skull fracture, and head injury); none were fatal or considered vaccination-related. Table 1 shows AE reporting. No large swelling reactions (>50 mm diameter) were reported at injection site of any of the 2 investigational vaccines, while 6 were reported for the other vaccines; all were resolved. The most commonly reported unsolicited AEs were nasopharyngitis, viral infection, rhinitis and rash; 3 vaccine-related unsolicited AEs were reported (all in the PHiD-CV and in the PCV13 groups).
Conclusion: The safety profile of PHiD-CV/dPly/PhtD-10 and PHiD-CV/dPly/PhtD-30 booster vaccination was similar to the one of PHiD-CV.
Funding: GlaxoSmithKline Biologicals SA
S. A. Silfverdal, GSK: Investigator , The study was financed by GSK to institution and no personal fee or honoraria was given
J. Wysocki, GSK: Grant Investigator , investigator fee
P. Albrecht, GSK: Investigator , Research support
Pfizer: Grant Investigator , Educational grant and Research support
M. Traskine, GSK: Employee , Salary
A. Gardev, GSK: Formerly employed by GSK , Salary at the time of GSK employment
Y. Song, GSK: Consultant , Consulting fee
D. Borys, GSK Biologicals: Employee and Shareholder , I have share options/shares of GSK Biologicals and Salary