Department of Obstetrics and Gynecology, Sendai City Hospital, Sendai, Miyagi, Japan.
Department of Obstetrics and Gynecology, Osaka Habikino Medical Center, Habikino, Osaka, Japan.
Vaccine. 2024 Sep 17;42(22):126041. doi: 10.1016/j.vaccine.2024.06.009. Epub 2024 Jun 8.
Maternal vaccination with respiratory syncytial virus prefusion F vaccine (RSVpreF) is effective at preventing RSV-associated lower respiratory tract illness (LRTI) in newborns/infants.
This subgroup analysis from the global, phase 3, randomized, double-blind, placebo-controlled MATISSE (Maternal Immunization Study for Safety and Efficacy) trial evaluated participants enrolled in Japan. Pregnant women 24-36 weeks' gestation were randomized 1:1 to receive RSVpreF or placebo. Maternal safety endpoints included local reactions/systemic events within 7 days, adverse events (AEs) through 1 month, and serious AEs (SAEs) through 6 months after vaccination. In infants born to maternal participants, safety endpoints included specific birth outcomes, AEs through 1 month after birth, and SAEs and newly diagnosed chronic medical conditions through 12 or 24 months after birth. Vaccine efficacy in infants was assessed against RSV-positive, medically attended LRTI (RSV-MA-LRTI) and severe RSV-MA-LRTI through 180 days after birth.
In Japan, 230 maternal participants received RSVpreF and 232 received placebo; 218 and 216 infants born to these mothers, respectively, were analyzed. Observed vaccine efficacy (95 % CIs) against infant RSV-MA-LRTI within 90 and 180 days after birth was 100.0 % (30.9, 100.0; RSVpreF, 0 cases; placebo, 7 cases) and 87.6 % (7.2, 99.7; RSVpreF, 1 case; placebo, 8 cases), respectively. Vaccine efficacy (95 % CIs) against severe RSV-MA-LRTI within 90 and 180 days was 100.0 % (-140.9, 100.0; RSVpreF, 0 cases; placebo, 3 cases) and 75.1 % (-151.5, 99.5; RSVpreF, 1 case; placebo, 4 cases), respectively. No safety concerns were identified. AE rates ≤1 month after vaccination/birth were similar in the RSVpreF (maternal, 16.1 %; infant, 48.6 %) and placebo (19.8 %; 50.5 %) groups. Preterm birth rates were also similar (RSVpreF, 3.2 %; placebo, 6.0 %).
Safety and efficacy data in Japanese participants were consistent with overall MATISSE results, supporting the efficacy of maternal RSVpreF vaccination against severe MA-RSV-LRTI/MA-RSV-LRTI in infants, with no safety concerns. NCT04424316.
呼吸道合胞病毒预融合 F 疫苗（RSVpreF）的母体疫苗接种可有效预防新生儿/婴儿的呼吸道合胞病毒相关下呼吸道疾病（RSV-LRTI）。
这项来自全球、3 期、随机、双盲、安慰剂对照 MATISSE（母体免疫安全性和疗效研究）试验的亚组分析评估了日本入组的参与者。24-36 周妊娠的孕妇以 1:1 的比例随机接受 RSVpreF 或安慰剂。母体安全性终点包括接种后 7 天内的局部反应/全身事件、接种后 1 个月内的不良事件（AE）和接种后 6 个月内的严重不良事件（SAE）。母亲参与者所生婴儿的安全性终点包括特定的出生结局、出生后 1 个月内的 AE，以及出生后 12 或 24 个月内的新诊断的慢性医疗状况和 SAE。婴儿疫苗效力通过 RSV 阳性、医学治疗的下呼吸道感染（RSV-MA-LRTI）和出生后 180 天内严重 RSV-MA-LRTI 进行评估。
在日本，230 名母体参与者接受 RSVpreF 治疗，232 名参与者接受安慰剂治疗；分别有 218 名和 216 名母亲所生婴儿接受了分析。出生后 90 和 180 天内，婴儿 RSV-MA-LRTI 的观察疫苗效力（95%置信区间）分别为 100.0%（30.9，100.0；RSVpreF，0 例；安慰剂，7 例）和 87.6%（7.2，99.7；RSVpreF，1 例；安慰剂，8 例）。出生后 90 和 180 天内严重 RSV-MA-LRTI 的疫苗效力（95%置信区间）分别为 100.0%（-140.9，100.0；RSVpreF，0 例；安慰剂，3 例）和 75.1%（-151.5，99.5；RSVpreF，1 例；安慰剂，4 例）。未发现安全性问题。接种后/出生后 1 个月内的 AE 发生率在 RSVpreF（母体，16.1%；婴儿，48.6%）和安慰剂（19.8%；50.5%）组之间相似。早产率也相似（RSVpreF，3.2%；安慰剂，6.0%）。
日本参与者的安全性和有效性数据与 MATISSE 的总体结果一致，支持母体 RSVpreF 疫苗接种预防婴儿严重 MA-RSV-LRTI/MA-RSV-LRTI 的疗效，且无安全性问题。NCT04424316。
