Work

1102Immunogenicity and Safety of a Second Administration of 13-Valent Pneumococcal Conjugate Vaccine Five Years after Initial Vaccination in Adults 50 Years and Older

Year: 2014

Type: article

Abstract: Immunogenicity and Safety of a Second Administration of 13-Valent Pneumococcal Conjugate Vaccine Five Years after Initial Vaccination in Adults 50 Years and Older Background. Adults ≥50 years are at increased risk for invasive disease and pneumonia caused by S pneumoniae. Previously, we reported a study assessing simultaneous administration of 13-valent pneumococcal conjugate vaccine (PCV13) and trivalent inactivated influenza vaccine (TIV). We now present data on revaccination with PCV13 five years after initial vaccination. Methods. This was a phase 3, randomized trial. Pneumococcal vaccine-naive subjects, 50–59 years old, were vaccinated with PCV13 and TIV, given concomitantly or 1 month apart. All were revaccinated with PCV13 five years after initial vaccination. Blood samples were obtained before and approximately 1 month after each vaccination. Anti-pneumococcal polysaccharide immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) titers (GMTs) were determined. Local reactions and systemic events were collected for 14 days after revaccination, and adverse events (AEs) for 6 months. Deaths were recorded throughout the study. Results. 727 of the 1116 randomized subjects were revaccinated at year 5; 712 completed the 6-month follow-up. Mean age at revaccination was 59.8 ±2.8 years. For all serotypes, IgG GMCs (except serotype 3) and OPA GMTs before revaccination with PCV13 had declined in the 5 years since initial vaccination, but remained significantly higher than levels before initial vaccination. OPA GMTs and IgG GMCs significantly increased from before to 1 month after revaccination with PCV13. OPA GMTs (Table 1) and IgG GMCs (Table 2) were generally comparable or higher 1 month after revaccination compared to levels 1 month after initial PCV13 vaccination. Local reactions were mostly mild. Fever was reported by <4% of subjects; all <39.0°C. AEs were reported by <5% of subjects in the month after revaccination and <1% up to 6 months after revaccination. No serious AEs were vaccine-related. Seven deaths occurred in years 1–5, all before revaccination, none were vaccine-related. Conclusion. PCV13 revaccination 5 years after initial PCV13 vaccination in pneumococcal-naive 50–59 year-olds elicited generally comparable or higher antibody responses for all serotypes compared to initial PCV13 vaccination, and demonstrated an acceptable safety profile Disclosures. R. W. Frenck Jr., Pfizer: Investigator, Funds for clinical trials; GSK: Chairing DSMB for upcoming trial and Investigator, Received funds for clinical trials; Ligocyte (now Takeda): Investigator, Received funds for clinical trials A. Fiquet, Pfizer: Employee, Salary and stock options A. Gurtman, Pfizer: Employee, Salary J. Rubino, Pfizer: Investigator and Shareholder, Research grant W. Smith, Volunteer Research Group: Investigator, payment to conduct Clinical Research Trials V. Sundaraiyer, Pfizer: Employee of a CRO contracted to work on Pfizer projects, Service fee M. Sidhu, Pfizer: Employee, Salary E. A. Emini, Pfizer: Employee and Shareholder, Salary W. C. Gruber, Pfizer: Employee and Shareholder, Salary D. A. Scott, Pfizer: Employee and Shareholder, Salary B. Schmoele-Thoma, Pfizer Vaccines Clinical Research: Employee and Shareholder, Salary

Source: Open Forum Infectious Diseases

DOI: 10.1093/ofid/ofu052.810