更新于：2024-09-21
mRNA-1010
更新于：2024-09-21
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
关联
11
项与 mRNA-1010 相关的临床试验A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age
A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older
100 项与 mRNA-1010 相关的临床结果
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100 项与 mRNA-1010 相关的转化医学
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100 项与 mRNA-1010 相关的专利（医药）
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3
项与 mRNA-1010 相关的文献（医药）2024-09-01LANCET INFECTIOUS DISEASES
Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/Yamagata strain in US adults aged 50–75 years: a phase 1/2, open-label, randomised trial
Article
作者: Avanesov, Andrei ; Sanchez-Crespo, Nelia E ; Jayaraman, Akila ; Jorquera, Patricia ; Chen, Hui Ling ; Bhupathy, Vellore ; Hsu, Denise ; Choi, Angela ; Nachbagauer, Raffael ; Ananworanich, Jintanat ; Pucci, Alicia ; Du, Evelyn ; Wadsworth, L Tyler ; Koslovsky, Kindra ; Arunkumar, Guha Asthagiri ; Mancini, Kevin ; Henry, Carole ; Joshi, Riya ; Mao, Xuezhou ; Stadlbauer, Daniel ; Vakil, Jignesh
BACKGROUND:
Inclusion of additional influenza A/H3N2 strains in seasonal influenza vaccines could expand coverage against multiple, antigenically distinct, cocirculating A/H3N2 clades and potentially replace the no longer circulating B/Yamagata strain. We aimed to evaluate the safety and immunogenicity of three next-generation seasonal influenza mRNA vaccines with different compositions that encode for haemagglutinins of multiple A/H3N2 strains, with or without the B/Yamagata strain, in adults.
METHODS:
This randomised, open-label, phase 1/2 trial enrolled healthy adults aged 50-75 years across 22 sites in the USA. Participants were randomly assigned (1:1:1:1:1:1:1) via interactive response technology to receive a single dose of mRNA-1011.1 (pentavalent; containing one additional A/H3N2 strain [Newcastle]), mRNA-1011.2 (quadrivalent; B/Yamagata replaced with one additional A/H3N2 strain [Newcastle]), mRNA-1012 at one of two dose levels (pentavalent; B/Yamagata replaced with two additional A/H3N2 strains [Newcastle and Hong Kong]), or one of three quadrivalent mRNA-1010 controls each encoding one of the A/H3N2 study strains. The primary outcomes were safety, evaluated in all randomly assigned participants who received a study vaccination (safety population), and reactogenicity, evaluated in all participants from the safety population who contributed any solicited adverse reaction data (solicited safety population). The secondary outcome was humoral immunogenicity of investigational mRNA vaccines at day 29 versus mRNA-1010 control vaccines based on haemagglutination inhibition antibody (HAI) assay in the per-protocol population. Here, we summarise findings from the planned interim analysis after participants had completed day 29. The study is registered with ClinicalTrials.gov, NCT05827068, and is ongoing.
FINDINGS:
Between March 27 and May 9, 2023, 1183 participants were screened for eligibility, 699 (59·1%) were randomly assigned, and 696 (58·8%) received vaccination (safety population, n=696; solicited safety population, n=694; per-protocol population, n=646). 382 (55%) of the 696 participants in the safety population self-reported as female and 314 (45%) as male. Frequencies of solicited adverse reactions were similar across vaccine groups; 551 (79%) of 694 participants reported at least one solicited adverse reaction within 7 days after vaccination and 83 (12%) of 696 participants reported at least one unsolicited adverse event within 28 days after vaccination. No vaccine-related serious adverse events or deaths were reported. All three next-generation influenza vaccines elicited robust antibody responses against vaccine-matched influenza A and B strains at day 29 that were generally similar to mRNA-1010 controls, and higher responses against additional A/H3N2 strains that were not included within respective mRNA-1010 controls. Day 29 geometric mean fold rises in HAI titres from day 1 against vaccine-matched A/H3N2 strains were 3·0 (95% CI 2·6-3·6; Darwin) and 3·1 (2·6-3·8; Newcastle) for mRNA-1011.1; 3·3 (2·7-4·1; Darwin) and 4·2 (3·4-5·2; Newcastle) for mRNA-1011.2; 3·4 (2·9-4·0; Darwin), 4·5 (3·6-5·5; Newcastle), and 5·1 (4·2-6·2; Hong Kong) for mRNA-1012 50·0 μg; and 2·6 (2·2-3·1; Darwin), 3·7 (3·0-4·6; Newcastle), and 4·1 (3·3-5·1; Hong Kong) for mRNA-1012 62·5 μg. Inclusion of additional A/H3N2 strains did not reduce responses against influenza A/H1N1 or influenza B strains, and removal of B/Yamagata did not affect responses to B/Victoria.
INTERPRETATION:
These data support the continued clinical development of mRNA-based next-generation seasonal influenza vaccines with broadened influenza A/H3N2 strain coverage.
FUNDING:
Moderna.
2023-06-19Nature communications1区 · 综合性期刊
Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis.
1区 · 综合性期刊
ArticleOA
作者: Schrempp, Daniela Ramirez ; Schwartz, Howard ; Schaefers, Kristi ; Lee, Ivan T ; Stadlbauer, Daniel ; Paris, Robert ; Ananworanich, Jintanat ; Chen, Ren ; Huang, Wenmei ; Ensz, David ; Avanesov, Andrei ; Henry, Carole ; Nachbagauer, Raffael ; Carmona, Lizbeth
Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent messenger RNA (mRNA) vaccine against seasonal influenza, mRNA-1010, from the first 2 parts of a 3-part, first-in-human, phase 1/2 clinical trial in healthy adults aged ≥18 years (NCT04956575). In the placebo-controlled Part 1, a single dose of mRNA-1010 (50 µg, 100 µg, or 200 µg) elicited hemagglutination inhibition (HAI) titers against vaccine-matched strains. In the active-comparator-controlled Part 2, mRNA-1010 (25 µg, 50 µg, or 100 µg) elicited higher HAI titers than a standard dose, inactivated seasonal influenza vaccine for influenza A strains and comparable HAI titers for influenza B strains. No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active comparator. These interim data support continued development of mRNA-1010.
JOURNAL OF INFECTIOUS DISEASES
Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial
Article
作者: Lee, Ivan T ; Henry, Carole ; Nachbagauer, Raffael ; McGrath, Shannon ; Kuo, Hsiao-Hsuan ; Choi, Angela ; Chen, Ren ; Huang, Wenmei ; Paris, Robert ; Stadlbauer, Daniel ; Ensz, David ; Avanesov, Andrei ; Pucci, Alicia ; Schaefers, Kristi ; Ananworanich, Jintanat ; Carmona, Lizbeth
Abstract:
Background:
Seasonal influenza remains a global public health concern. A messenger RNA (mRNA)–based quadrivalent seasonal influenza vaccine, mRNA-1010, was investigated in a first-in-human, phase 1/2 clinical trial conducted in 3 parts.
Methods:
In parts 1 to 3 of this stratified observer-blind study, adults aged ≥18 years were randomly assigned to receive a single dose (6.25–200 µg) of mRNA-1010 or placebo (part 1) or an active comparator (Afluria; parts 2 and 3). Primary study objectives were assessment of safety, reactogenicity, and humoral immunogenicity of mRNA-1010, placebo (part 1), or active comparator (parts 2 and 3). Exploratory end points included assessment of cellular immunogenicity (part 1) and antigenic breadth against vaccine heterologous strains (A/H3N2; parts 1 and 2).
Results:
In all study parts, solicited adverse reactions were reported more frequently for mRNA-1010 than placebo or Afluria, and most were grade 1 or 2 in severity. No vaccine-related serious adverse events or deaths were reported. In parts 1 and 2, a single dose of mRNA-1010 (25–200 µg) elicited robust day 29 hemagglutination inhibition titers that persisted through 6 months. In part 3, lower doses of mRNA-1010 (6.25–25 µg) elicited day 29 hemagglutination inhibition titers that were higher or comparable to those of Afluria for influenza A strains. When compared with Afluria, mRNA-1010 (50 µg) elicited broader A/H3N2 antibody responses (part 2). mRNA-1010 induced greater T-cell responses than placebo at day 8 that were sustained or stronger at day 29 (part 1).
Conclusions:
Data support the continued development of mRNA-1010 as a seasonal influenza vaccine.
Clinical Trials Registration:
NCT04956575 (https://clinicaltrials.gov/study/NCT04956575).
127
项与 mRNA-1010 相关的新闻（医药）2024-09-20
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100 项与 mRNA-1010 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 流感病毒感染 | 临床3期 | 阿根廷 | 2022-06-06 | |
| 流感病毒感染 | 临床3期 | 澳大利亚 | 2022-06-06 | |
| 流感病毒感染 | 临床3期 | 哥伦比亚 | 2022-06-06 | |
| 流感病毒感染 | 临床3期 | 巴拿马 | 2022-06-06 | |
| 流感病毒感染 | 临床3期 | 菲律宾 | 2022-06-06 | |
| 新型冠状病毒感染 | 临床2期 | 美国 | 2022-05-13 | |
| 呼吸道合胞体病毒感染 | 临床1期 | 美国 | 2022-10-14 | |
| 呼吸道合胞体病毒感染 | 临床1期 | 澳大利亚 | 2022-10-14 | |
| 呼吸道合胞体病毒感染 | 临床1期 | 英国 | 2022-10-14 | |
| 严重急性呼吸综合征 | 临床1期 | 美国 | 2022-10-14 |
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临床结果
临床结果
适应症
分期
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临床1/2期 | - | 簾齋糧鹽齋網鑰選繭繭(簾獵餘憲膚鹹窪鹽築構) = reported more frequently for mRNA-1010 than placebo or Afluria and most were grade 1 or 2 in severity. 壓繭選膚齋願鬱選醖範 (鏇夢齋艱淵簾膚構齋淵 ) 更多 | 积极 | 2024-06-27 | |||
Placebo | |||||||
临床1/2期 | 550 | placebo+mRNA-1273 (mRNA-1273 + Placebo) | 鬱選積顧壓簾淵獵願醖(膚顧齋遞鹽選齋簾衊齋) = 蓋網廠壓齋齋觸積鏇簾 壓網遞憲築築壓膚顧廠 (簾鏇襯構願繭艱衊淵鬱, 糧簾壓壓夢築窪鏇製糧 ~ 選獵憲繭鏇獵顧廠觸廠) 更多 | - | 2024-02-28 | ||
placebo+mRNA-1010 (mRNA-1010 + Placebo) | 鬱選積顧壓簾淵獵願醖(膚顧齋遞鹽選齋簾衊齋) = 糧醖醖壓衊壓鹽顧醖獵 壓網遞憲築築壓膚顧廠 (簾鏇襯構願繭艱衊淵鬱, 窪窪壓廠顧齋網膚鏇廠 ~ 醖觸鹽憲壓鬱積簾淵觸) 更多 | ||||||
临床3期 | - | 餘廠觸窪鹽獵網鹽襯鬱(鬱齋餘選築醖鹽鬱簾遞) = 餘繭憲築夢淵構積廠範 淵簾蓋憲壓網顧膚衊艱 (憲鹹憲夢鹽鑰夢獵鑰襯 ) | 非劣 | 2023-02-16 | |||
餘廠觸窪鹽獵網鹽襯鬱(鬱齋餘選築醖鹽鬱簾遞) = 願齋蓋願構積鑰憲網壓 淵簾蓋憲壓網顧膚衊艱 (憲鹹憲夢鹽鑰夢獵鑰襯 ) |
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