≥50 岁成年人同时接种破伤风白喉联合疫苗和 13 价肺炎球菌结合疫苗的免疫原性和安全性。
Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults.
机构信息
Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Asian Pacific Influenza Institute (APII), Korea University College of Medicine, Seoul, Republic of Korea.
出版信息
BMC Infect Dis. 2018 Dec 5;18(1):628. doi: 10.1186/s12879-018-3479-9.
BACKGROUND
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction.
METHODS
Subjects aged ≥50 years were randomized 1:1:1 to receive tetanus-diphtheria (Td) + 13-valent pneumococcal conjugate vaccine (PCV13; Group 1), PCV13 alone (Group 2), or Td alone (Group 3). After single or concomitant vaccination, enzyme-linked immunosorbent assay and opsonophagocytic assay (OPA) were performed to compare immunogenicity for Td and PCV13, respectively.
RESULTS
A total of 448 subjects were available for the assessment. After concomitant administration, the non-inferiority criteria of geometric mean titer (GMT) ratios were met for tetanus, diphtheria, and all four pneumococcal serotypes (1, 5, 18C, and 19A). However, subjects in Group 3 (Td alone) were more likely to have a high IgG anti-tetanus antibody titer (≥ 0.5 U/mL) than those in Group 1 (Td + PCV13) (p < 0.01). As for the pneumococcal serotype 1, the OPA GMT was significantly higher in Group 1 (PCV13 + Td) compared to Group 2 (PCV13 alone) (p = 0.02). No serious adverse event occurred.
CONCLUSIONS
Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles.
TRIALS REGISTRATION
NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).
背景
当同时接种两种或更多疫苗时，人们担心疫苗相互作用会引起安全性和免疫原性问题。
方法
将年龄≥50 岁的受试者按 1:1:1 的比例随机分配至接受破伤风类毒素-白喉（Td）+13 价肺炎球菌结合疫苗（PCV13；第 1 组）、单独 PCV13（第 2 组）或单独 Td（第 3 组）。在单次或同时接种后，通过酶联免疫吸附试验和调理吞噬试验（OPA）分别比较 Td 和 PCV13 的免疫原性。
结果
共有 448 名受试者可进行评估。同时给药后，破伤风、白喉和所有 4 种肺炎球菌血清型（1、5、18C 和 19A）的几何平均滴度（GMT）比值符合非劣效性标准。然而，第 3 组（单独 Td）的受试者比第 1 组（Td+PCV13）更有可能具有较高的 IgG 抗破伤风抗体滴度（≥0.5 U/mL）（p<0.01）。对于肺炎球菌血清型 1，第 1 组（PCV13+Td）的 OPA GMT 显著高于第 2 组（单独 PCV13）（p=0.02）。未发生严重不良事件。
结论
同时接种 Td 和 PCV13 可诱导充分的免疫应答，且无明显干扰，具有良好的安全性。
试验注册
NCT03552445 于 2018 年 6 月 11 日在 http://www.clinicaltrials.gov 上注册（追溯性注册）。
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