背景:单剂量研究性呼吸道合胞病毒(RSV)疫苗,RSV预融合蛋白F3(RSVPreF3),与单剂量四价流感疫苗(FLU-D-QIV)在3期,随机,控制,多中心健康研究,18-49岁的非孕妇。
方法:该研究是观察盲的,以评估RSVPreF3的批次间一致性,以及单盲评估免疫反应,安全,与FLU-D-QIV共同给药的RSVPreF3和反应原性。
结果:共1415名参与者被纳入符合方案组。在第31天,3个RSVPreF3疫苗批次中的每一个都有强烈的免疫反应;调整后的几何平均浓度比(95%置信区间[CI])为1.01(0.91,1.12),0.93(0.84,1.03),RSV1/RSV2、RSV1/RSV3和RSV2/RSV3分别为0.92(0.83,1.02)。对于与RSVPreF3共同施用的FLU-D-QIV,与在第31天单独施用的FLU-D-QIV相比,评估的4个菌株中有3个符合非劣效性,几何平均比率>0.67的95%CI下限。
结论:证明了3个单独批次的RSVPreF3的免疫原性一致性。比较单独施用的FLU-D-QIV时,证明了免疫原性非劣效性,对于3株FLU-D-QIV,与RSVPreF3共同给药相比。共同管理耐受性良好,两种疫苗均具有临床上可接受的安全性和反应原性。
背景:NCT05045144;EudraCT,2021-000357-26。
这是一项3期研究,比较了给予3种不同生产批次的RSV预融合蛋白F3(称为RSVPreF3)疫苗的女性之间针对呼吸道合胞病毒(或简称RSV)的抗体。该研究还比较了接受RSV疫苗和流感疫苗(称为FLU-D-QIV)的女性之间的抗体。或者单独的流感疫苗。流感疫苗含有4种不同的流感病毒株。这项研究涉及1415名健康的人,18-49岁的非孕妇。31天后检查的抗体对所有3个RSV疫苗生产批次均显示出强烈的免疫反应,3个RSV疫苗生产批次之间的免疫反应相似。当流感疫苗与RSV疫苗一起给予时,4种流感毒株中的3种的免疫应答不少于单独给予流感疫苗时的免疫应答,并且两种疫苗都具有良好的耐受性。
BACKGROUND: A single-dose investigational respiratory syncytial virus (RSV) vaccine, RSV prefusion protein F3 (RSVPreF3), was co-administered with a single-dose quadrivalent influenza vaccine (FLU-D-QIV) in a phase 3, randomized, controlled, multicenter study in healthy, non-pregnant women aged 18-49 years.
METHODS: The study was observer-blind to evaluate the lot-to-lot consistency of RSVPreF3, and single-blind to evaluate the immune response, safety, and
reactogenicity of RSVPreF3 co-administered with FLU-D-QIV.
RESULTS: A total of 1415 participants were included in the per-protocol set. There was a robust immune response at day 31 across each of the 3 RSVPreF3 vaccine lots; adjusted geometric mean concentration ratios (95% confidence interval [CI]) were 1.01 (0.91, 1.12), 0.93 (0.84, 1.03), and 0.92 (0.83, 1.02) for RSV1/RSV2, RSV1/RSV3, and RSV2/RSV3, respectively. For FLU-D-QIV co-administered with RSVPreF3, versus FLU-D-QIV alone at day 31, noninferiority was satisfied for 3 of 4 strains assessed, with the lower limit of the 95% CI for geometric mean ratio >0.67.
CONCLUSIONS: Immunogenic consistency was demonstrated for 3 separate lots of RSVPreF3. Immunogenic noninferiority was demonstrated when comparing FLU-D-QIV administered alone, versus co-administered with RSVPreF3, for 3 strains of FLU-D-QIV. Co-administration was well tolerated, and both vaccines had clinically acceptable safety and
reactogenicity profiles.
BACKGROUND: NCT05045144; EudraCT, 2021-000357-26.
This was a phase 3 study that compared antibodies against respiratory syncytial virus (or RSV for short) between women who were given 3 different production batches of RSV prefusion protein F3 (known as RSVPreF3) vaccine. The study also compared the antibodies between women who received either an RSV vaccine together with a flu vaccine (known as FLU-D-QIV), or a flu vaccine alone. The flu vaccine contained 4 different strains of flu virus. The study involved 1415 healthy, non-pregnant women aged 18–49 years. The antibodies checked after 31 days showed strong immune responses for all 3 RSV vaccine production batches, and similar immune responses between each of the 3 RSV vaccine production batches. The immune response of 3 of the 4 flu strains was not less when the flu vaccine was given together with the RSV vaccine than the immune response when flu vaccine was given alone and both vaccines were well tolerated.