Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Solid Organ Transplant (SOT) Candidates and Recipients.

Abstract

Purpose:The United States Advisory Committee on Immunization Practices recommends that PCV13 be given in addition to 23-valent pneumococcal polysaccharide vaccine to immunocompromised adults, such as chronic renal failure and SOT. However, data regarding this is sparse. The present study aimed to assess the immunogenicity and safety of PCV13 in SOT candidates and recipients. Methods: Consecutive patients receiving pre-SOT evaluation and SOT receipts with stable clinical conditions 6 months post transplant were enrolled. Symptoms developed within 7 days after one dose PCV13 and anti-capsular antibody responses against 4 serotypes (6B, 14, 19F and 23F) at baseline and 1 month following vaccination were recorded. Significant antibody responses were defined as 2-fold or greater increase of antibody levels at 1 month compared with the baseline. Results:From 2013/10/1 to 2013/12/30, a total of 21 study patients were enrolled. PCV13 was given to 19 (90.5%) SOT candidates and 2 (9.5%) heart recipients; the two heart recipients received PCV13 60 months and 1320 months after transplantation. Two SOT candidates received liver transplantation after PCV13 administration; the durations from PCV13 vaccination to transplantation were 44 and 23 days, respectively. Only 2 (9.5%) study patients felt pain at PCV13 injection site, and 1 (4.8%) had fever after PCV13 administration; all symptoms subsided spontaneously. Of 19 study patients receiving PCV13 before transplantation, 13 (68.4%) were liver transplant candidates, 5 (26.3%) were heart transplant candidates, and 1 (5.3%) was lung transplant candidate. The geometric mean titer of baseline antibody titer for 6B, 14, 19F, and 23F of the 21 study patients were 2719.04 ng/mL, 15259.20 ng/mL, 3828.42 ng/mL, and 1897.98 ng/mL, respectively. Thirteen (61.9%) patients had 1-month follow-up. At 1 month, 58.3%, 58.3%, 70.0%, and 75.0% of the study patients had significant antibody responses against 6B, 14, 19F and 23F, respectively. None of them developed pneumonia at the time of the abstract drafting. Conclusion: The use of PCV13 appeared safe and immunogenic in SOT candidates and recipients during a short-term follow-up.