Song Joon Young, Cheong Hee Jin, Tsai T F, Chang Hyun-Ah, Choi Min Joo, Jeon Ji Ho, Kang Seong Hee, Jeong Eun Ju, Noh Ji Yun, Kim Woo Joo
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.
Novartis Vaccines, Cambridge, MA, USA.
Vaccine. 2015 Aug 26;33(36):4647-52. doi: 10.1016/j.vaccine.2015.05.003. Epub 2015 May 14.
Concomitant administration of influenza and pneumococcal vaccines facilitates their uptake by older adults; however, data on immunogenicity and safety of concomitant administration of adjuvanted trivalent inactivated influenza vaccine (aIIV3) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) have not been reported.
Subjects aged ≥65 years (N=224) were randomized 1:1:1:1 to receive MF59-aIIV3 alone, MF59-aIIV3+PPSV23 in contralateral arms, MF59-aIIV3+PPSV23 in the same arm or PPSV23 alone (Clinical Trial Number - NCT02225327). Hemagglutination inhibition assay and multiplex opsonophagocytic killing assay were used to compare immunogenicity after single or concomitant vaccination.
All groups met immunogenicity criteria for the influenza vaccine in older adults with similar seroconversion rates and geometric mean fold-increases, irrespective of concomitant vaccinations and injection site. For each pneumococcal serotype, opsonic index (OI) increased markedly after the PPSV23 vaccination, irrespective of the concomitant influenza vaccine. All subjects showed an OI≥8 for serotypes 6B, 18C and 19A post-vaccination, with a suggestion that the ipsilateral concomitant vaccination might be associated with higher OIs for some antigens. Local and systemic adverse events were more common in subjects receiving PPSV23 compared to those receiving aIIV3 alone.
No interference was observed with antibody responses to influenza or pneumococcal antigens when aIIV3 and PPSV23 were administered concomitantly.
同时接种流感疫苗和肺炎球菌疫苗有助于老年人接种；然而，关于佐剂三价灭活流感疫苗（aIIV3）和23价肺炎球菌多糖疫苗（PPSV23）同时接种的免疫原性和安全性的数据尚未见报道。
年龄≥65岁的受试者（N = 224）按1:1:1:1随机分组，分别接受单独的MF59-aIIV3、双侧接种MF59-aIIV3 + PPSV23、同侧接种MF59-aIIV3 + PPSV23或单独接种PPSV23（临床试验编号 - NCT02225327）。采用血凝抑制试验和多重调理吞噬杀伤试验比较单次或同时接种疫苗后的免疫原性。
所有组在老年人中均达到流感疫苗的免疫原性标准，血清转化率和几何平均倍增率相似，与是否同时接种疫苗及注射部位无关。对于每种肺炎球菌血清型，PPSV23接种后调理指数（OI）均显著升高，与是否同时接种流感疫苗无关。所有受试者接种疫苗后6B、18C和19A血清型的OI≥8，提示同侧同时接种可能与某些抗原的OI较高有关。与单独接受aIIV3的受试者相比，接受PPSV23的受试者局部和全身不良事件更为常见。
同时接种aIIV3和PPSV23时，未观察到对流感或肺炎球菌抗原抗体反应的干扰。
