MATISSE（孕产妇呼吸道合胞病毒预融合F蛋白疫苗安全性和有效性的孕产妇免疫研究）孕产妇呼吸道合胞病毒预融合F蛋白疫苗试验的疗效、安全性和免疫原性。
Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial.
作者信息
Simões Eric A F, Pahud Barbara A, Madhi Shabir A, Kampmann Beate, Shittu Emma, Radley David, Llapur Conrado, Baker Jeffrey, Pérez Marc Gonzalo, Barnabas Shaun L, Fausett Merlin, Adam Tyler, Perreras Nicole, Van Houten Marlies A, Kantele Anu, Huang Li-Min, Bont Louis J, Otsuki Takeo, Vargas Sergio L, Gullam Joanna, Tapiero Bruce, Stein Renato T, Polack Fernando P, Zar Heather J, Staerke Nina B, Padilla María Duron, Richmond Peter C, Sarwar Uzma N, Baber James, Koury Kenneth, Lino Maria Maddalena, Kalinina Elena V, Li Weiqiang, Cooper David, Anderson Annaliesa S, Swanson Kena A, Gurtman Alejandra, Munjal Iona
机构信息
Children's Hospital Colorado, Aurora, Colorado; Vaccine Research and Development, Pfizer Inc, Pearl River, New York; the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and Wits Infectious Diseases and Oncology Research Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, and Famcru, Department of Paediatrics and Child Health, University of Stellenbosch, and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, SA-MRC Unit on Child and Adolescent Health, University of Cape Town, Cape Town, South Africa; Vaccines and Immunity Team, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, the Gambia; Institute for International Health Charité, Universitätsmedizin, Berlin, Germany; Vaccine Research and Development, Pfizer Ltd, Marlow, United Kingdom; Instituto de Maternidad y Ginecología Nuestra Señora de Las Mercedes, San Miguel de Tucumán, and iTrials-Hospital Militar Central and iTrials, Buenos Aires, Argentina; Clinical Research Prime, Idaho Falls, Idaho; Boeson Research, Missoula, Montana; Meridian Clinical Research, Hastings, Nebraska; Asian Hospital and Medical Center, Manila, the Philippines; Department of Pediatrics, Spaarne Gasthuis, Haarlem and Hoofddorp, the Department of Pediatrics, Department of Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, and the ReSViNET Foundation, Zeist, the Netherlands; Meilahti Vaccine Research Center MeVac, Inflammation Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; National Taiwan University Hospital, Taipei, Taiwan; the Department of Obstetrics and Gynecology, Sendai City Hospital, Sendai, Japan; Institute of Biomedical Sciences, University of Chile School of Medicine, Santiago, Chile; University of Otago and New Zealand Clinical Research, Christchurch, New Zealand; CHU Sainte-Justine, Montreal, Quebec, Canada; Hospital Moinhos de Vento and Pontifícia Universidade Católica RGS, Porto Alegre, Brazil; the Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Arké SMO S.A. de C.V., Mexico City, Mexico; University of Western Australia School of Medicine, Vaccine Trials Group, Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, and Perth Children's Hospital, Nedlands, Western Australia, and Vaccine Clinical Research, Pfizer Inc, Sydney, Australia; and Worldwide Safety, Pfizer Srl, Milan, Italy.
出版信息
Obstet Gynecol. 2025 Feb 1;145(2):157-167. doi: 10.1097/AOG.0000000000005816. Epub 2025 Jan 2.
OBJECTIVE
To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).
METHODS
MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose. Primary efficacy endpoints included newborn and infant severe RSV-associated medically attended lower respiratory tract illness within 180 days after birth. The RSV-A and RSV-B serum neutralizing antibody titers were determined in a subset of pregnant participants and their newborns.
RESULTS
In this final analysis, 7,420 pregnant participants were randomized, and 7,307 children were born (RSVpreF n=3,660, placebo n=3,647). Vaccine efficacy , defined as protection against newborn and infant severe RSV-associated medically attended lower respiratory tract illness, was 82.4% (95% CI, 57.5-93.9) and 70.0% (95% CI, 50.6-82.5) within 90 and 180 days of birth, respectively. The RSVpreF induced robust immune responses in pregnant participants and resulted in highly efficient transfer of maternal antibodies to their newborns across subgroups (by gestational age at delivery and at vaccination, number of days from vaccination to delivery, country, maternal age). Final RSVpreF safety results in pregnant and newborn and infant participants were consistent with the primary analysis with no new safety concerns identified.
CONCLUSION
This final analysis of MATISSE trial data confirms the primary analysis conclusions: Maternal vaccination with RSVpreF has a favorable safety profile in both pregnant and newborn and infant participants and demonstrates efficacy against RSV-associated lower respiratory tract illness in infants through age 6 months. The RSVpreF induces robust immune responses in pregnant individuals, with corresponding high RSV-neutralizing titers in their newborns.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov , NCT04424316.
目的
通过全球3期MATISSE（呼吸道合胞病毒（RSV）二价预融合F蛋白疫苗（RSVpreF）安全性和有效性的母体免疫研究）母体疫苗试验完成后的研究，评估描述性疗效数据、探索性免疫原性数据及安全性随访情况。
方法
MATISSE是一项3期随机双盲安慰剂对照试验。妊娠24至36周、年龄49岁及以下的健康孕妇被随机（1:1）分配接受单剂120微克RSVpreF或安慰剂。主要疗效终点包括出生后180天内新生儿和婴儿与RSV相关的需就医的严重下呼吸道疾病。在部分孕妇及其新生儿中测定了RSV-A和RSV-B血清中和抗体滴度。
结果
在本次最终分析中，7420名孕妇被随机分组，7307名儿童出生（RSVpreF组n = 3660，安慰剂组n = 3647）。疫苗效力定义为预防新生儿和婴儿与RSV相关的需就医的严重下呼吸道疾病，在出生后90天和180天内分别为82.4%（95%CI，57.5 - 93.9）和70.0%（95%CI，50.6 - 82.5）。RSVpreF在孕妇中诱导了强烈的免疫反应，并导致母体抗体高效转移至其新生儿，跨越各亚组（按分娩时和接种时的孕周、从接种到分娩的天数、国家、孕妇年龄）。RSVpreF在孕妇、新生儿和婴儿参与者中的最终安全性结果与初步分析一致，未发现新的安全问题。
结论
MATISSE试验数据的本次最终分析证实了初步分析结论：孕妇接种RSVpreF在孕妇、新生儿和婴儿参与者中均具有良好的安全性，并证明对6个月龄以内婴儿的RSV相关下呼吸道疾病有效。RSVpreF在孕妇中诱导了强烈的免疫反应，其新生儿具有相应的高RSV中和滴度。
临床试验注册
ClinicalTrials.gov，NCT04424316。
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