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更新于：2026-01-27

H1N1 influenza vaccine(MedImmune)

更新于：2026-01-27

概要

概要

基本信息

药物类型

预防性疫苗

别名

Live attenuated nasal spray vaccine for H1N1 AstraZeneca、Monovalent live attenuated pandemic influenza vaccine AstraZeneca、Pandemic flu vaccine AstraZeneca

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靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

H1N1流感

原研机构

MedImmune LLCNational Institute of Allergy & Infectious Diseases

在研机构-

非在研机构

National Institute of Allergy & Infectious Diseases

权益机构-

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

项与 H1N1 influenza vaccine(MedImmune) 相关的临床试验

NCT00992017

/ Completed临床2期IIT

A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Monovalent Influenza A (H1N1) Vaccine in HIV-1 Infected Pregnant Women

Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.

开始日期2009-10-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT00945893

/ Completed临床4期

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults

The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.

开始日期2009-08-01

申办/合作机构

MedImmune LLC

[+1]

100 项与 H1N1 influenza vaccine(MedImmune) 相关的临床结果

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100 项与 H1N1 influenza vaccine(MedImmune) 相关的转化医学

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100 项与 H1N1 influenza vaccine(MedImmune) 相关的专利（医药）

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项与 H1N1 influenza vaccine(MedImmune) 相关的文献（医药）

2024-10-01·MICROBIAL PATHOGENESIS

Astragalus Polysaccharide improves immunogenicity of influenza vaccine as well as modulate gut microbiota in BALB/c mice

Article

作者: Song, Wenwen ; Wu, Haibo ; Wan, Chuanqi ; Yang, Yang ; Lu, Rufeng ; Yu, Zhihong ; Wu, Xiaowei ; Yan, Sijing ; Peng, Wei ; Fang, Bangjiang ; Zhu, Chen ; Jiang, Mei ; He, Yuzhou

BACKGROUND:

Vaccination is the best way to prevent influenza virus infection, and insufficient antibodies make it difficult to resist influenza virus invasion. Astragalus Polysaccharide (APS) has a boosting effect on immunity, so we evaluate the effect of APS as an immune adjuvant for H1N1 influenza vaccines in this study.

METHODS:

The mice were immunized twice with influenza A (H1N1) vaccine and APS. Subsequently, the serum antibody levels were assessed using enzyme-linked immunosorbent assay (ELISA). The frequency of peripheral immune T cells was determined by flow cytometry. Following this, the immunized mice were exposed to a lethal dose of the virus, and changes in body weight and survival rates were recorded. Hematoxylin-eosin staining was employed to observe pathological alterations in lung and intestinal tissues. Western blot analysis was conducted to detect the expression of intestinal barrier function proteins (Occludin and Claudin-1). ELISA was utilized to measure the expression level of serum inflammatory cytokine TNF-α. Fresh mouse feces were collected after the initial immunization as well as after viral infection for 16S rRNA analysis aimed at detecting alterations in gut microbiota.

RESULTS:

Compared to the Hemagglutinin (HA) group, the APS group demonstrated higher levels of immunoglobulin G (IgG), IgG1, and IgG3, as well as neutralizing antibody levels. Additionally, it increased the frequency of CD8⁺ cells to enhance resistance against lethal infection. On day 14 post-infection, the high-dose APS group exhibited a higher survival rate (71.40 %) compared to the HA group (14.28 %), along with faster weight recovery. Furthermore, APS was found to ameliorate alveolar damage in lung tissue and rectify intestinal structural disorder. It also upregulated the expression levels of tight junction proteins Occludin and Claudin-1 in intestinal tissue while reducing serum TNF-α expression levels. In addition, populations of Colidextribacter, Peptococcaceae, and Ruminococcaceae were the dominant gut microbiota in the APS group after viral infection.

CONCLUSION:

APS has an immune-enhancing effect and is expected to be a novel adjuvant in the H1N1 influenza vaccine.

2024-07-01·VIRUS RESEARCH

Preparation and characterization of mouse-derived monoclonal antibodies against the hemagglutinin of the H1N1 influenza virus

Article

作者: Yan, Sijing ; Lin, Xiantian ; Wu, Haibo ; Shi, Danrong ; Yang, Fan ; Wu, Han ; Yao, Hangping ; Zhao, Yuxi ; Wang, Ping ; Li, Lanjuan

H1N1 influenza virus is a significant global public health concern. Monoclonal antibodies (mAbs) targeting specific viral proteins such as hemagglutinin (HA) have become an important therapeutic strategy, offering highly specific targeting to block viral transmission and infection. This study focused on the development of mAbs targeting HA of the A/Victoria/2570/2019 (H1N1pdm09, VIC-19) strain by utilizing hybridoma technology to produce two mAbs with high binding capacity. Notably, mAb 2B2 has demonstrated a strong affinity for HA proteins in recent H1N1 influenza vaccine strains. In vitro assessments showed that both mAbs exhibited broad-spectrum hemagglutination inhibition and potent neutralizing effects against various vaccine strains of H1N1pdm09 viruses. 2B2 was also effective in animal models, offering both preventive and therapeutic protection against infections caused by recent H1N1 strains, highlighting its potential for clinical application. By individually co-cultivating each of the aforementioned mAbs with the virus in chicken embryos, four amino acid substitution sites in HA (H138Q, G140R, A141E/V, and D187E) were identified in escape mutants, three in the antigenic site Ca2, and one in Sb. The identification of such mutations is pivotal, as it compels further investigation into how these alterations could undermine the binding efficacy and neutralization capacity of antibodies, thereby impacting the design and optimization of mAb therapies and influenza vaccines. This research highlights the necessity for continuous exploration into the dynamic interaction between viral evolution and antibody response, which is vital for the formulation of robust therapeutic and preventive strategies against influenza.

2022-04-01·Viral immunology4区 · 医学

Immunomodulatory Effects of α -Tocopherol on the H1N1 Influenza Vaccine: Improving the Potency and Efficacy of the Influenza Vaccine in Aged Mice

4区 · 医学

Article

作者: Abdoli, Asghar ; Mahdavi, Mehdi ; Taghizadeh, Morteza ; Vahdani, Yasaman ; Karimi, Pegah ; Eshraghi, Yasaman ; Abdollahpour-Alitappeh, Meghdad

Declined immune response is the main cause of decreased potency of the influenza vaccine in the elderly, regardless of virus mutations. Herein, we hypothesized that the addition of α-tocopherol to the influenza vaccine formulation might increase vaccine potency and efficacy. Hemagglutinin of the H1N1 virus was formulated in Alum and α-tocopherol, and then aged (16-20-month-old) and young (6-8-week-old) mice were immunized subcutaneously two times with 2-week intervals with 5 μg of different vaccine formulations. Two weeks after the final boosting, IFN-γ and IL-4 cytokines were assessed by using ELISA. Humoral immune responses were assessed by hemagglutination inhibition (HI). In addition, vaccine efficacy was determined by intranasal viral challenge of mice using mouse-adapted H1N1 virus. Our results showed that the new vaccine formulation improved IFN-γ and IL-4 responses in the experimental mice. However, the increase was evident mainly in the aged group and, to some extent, in the young group. Results from the HI assay showed that α-tocopherol in the vaccine formulation could increase HI activity in both young and aged mice. Furthermore, α-tocopherol, as an adjuvant, increased the protectivity of the influenza vaccine in both aged and young groups through the decreased lung viral load and increased survival rate of the experimental mice. In conclusion, it seems that α-tocopherol can not only be used as an appropriate adjuvant for aged people, but also empower old and worn out cells to increase the effectiveness of the vaccine in the elderly.

项与 H1N1 influenza vaccine(MedImmune) 相关的新闻（医药）

2026-01-04

·Business Wire

Sinovac Receives Nasdaq Notification Regarding Late Filing of 2025 Half-Year Report

BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it has received a notification letter dated January 2, 2026 (the “Notification Letter”) from Nasdaq Listing Qualifications (“Nasdaq”), stating that the Company was not in compliance with Nasdaq’s Listing Rule 5250(c)(2) since the Company did not timely file a Form 6-K containing an interim balance sheet and income statement as of the end of its second quarter of year 2025. As previously disclosed, the Company received a delisting determination letter (the “Staff Determination”) from Nasdaq in November 2025. The Company requested a hearing before the Nasdaq Hearings Panel to appeal the Staff Determination on November 19, 2025. Nasdaq has informed the Company that the Nasdaq Hearings Panel will also consider the matter addressed in the Notification Letter at a hearing scheduled for January 8, 2026 at which the Company has been invited to present its views regarding this matter. The Company is evaluating the Notification Letter and intends to present its plan and views to the Nasdaq Hearings Panel at the scheduled hearing with the objective of maintaining its Nasdaq listing. Safe Harbor Statement This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "may," "will," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Such statements are based upon current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company's or Board's control, which may cause actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the U.S. Securities and Exchange Commission. The Company and Board do not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law. About SINOVAC Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of "supply vaccines to eliminate human diseases", the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases. The company's diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine. SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world's first inactivated SARS vaccine (Phase I completed), China's first H5N1 influenza vaccine (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally. Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines, recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies. With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics. For more information, please see the Company’s website at www.sinovac.com.

疫苗临床1期

2021-02-23

·BioSpace

Pfizer Accused of Holding Some Countries to “Ransom” Over COVID-19 Negotiations

David L. Ryan/The Boston Globe via Getty Images Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed. David L. Ryan/The Boston Globe via Getty Images Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed. The accusations involve the company’s requests that some countries establish sovereign assets as a guarantee against the costs associated with future legal suits made on behalf of citizens who experience an adverse event after the shot. The story, published in The Bureau of Investigative Journalism , states that demands made by the global pharmaceutical giant Pfizer resulted in a three-month delay in a vaccine deal for one country. In the case of Argentina and Brazil, the countries made no national deals with the company. These slowdowns in deals may be leading to holdups in people receiving much-needed COVID-19 vaccines, particularly in areas with high levels of viral spread. Some experts believe this could lead to a delay in ending this pandemic, as analyses in the U.K. have found that treatment with the Pfizer vaccine have led to an approximate 70% drop in infections just after the first shot. Argentina and officials from other countries in Latin America claim that negotiators on behalf of Pfizer demanded additional indemnity against civil claims citizens might they report experiencing vaccine-related adverse effects. Sovereign assets are being requested by the company, including military bases and embassy buildings, as a guarantee against potential legal costs. According to the investigative article, an official from an unnamed country has described Pfizer’s demands as “high-level bullying” and noted that the country’s government perceived it was being “held to ransom” before it could receive a supply of COVID-19 vaccines. Legal experts are reportedly raising concerns that the company’s demands are quickly accumulating to an abuse of power. Despite this prevailing perception amongst these government officials, most government organizations across the world are offering Pfizer (and other COVID-19 vaccine manufacturers) indemnity. In these cases, the government would be responsible for paying compensation to a citizen who experiences an adverse effect following vaccination, regardless of whether the citizen files a claim against the manufacturer itself. This is generally the case for most vaccines that are released during a pandemic; the AS03-adjuvanted H1N1 influenza vaccine, for instance, was recently linked to an increased risk of narcolepsy . “Pharmaceutical companies shouldn’t be using their power to limit life-saving vaccines in low- and middle-income countries,” according to a statement made by Lawrence Gostin, director of the World Health Organization’s Collaborating Center on National and Global Health Law and published in The Bureau of Investigative Journalism . “[This] seems to be exactly what they’re doing.” Since the beginning, Pfizer has been collaborating with over 100 countries as well as supranational organizations on COVID-19 vaccine deals. The company has reached supply agreements with a total of nine Latin American and Caribbean countries, including Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Panama, Peru and Uruguay. Detailed terms of these supply deals have not yet been fully disclosed. “Some liability protection is warranted, but certainly not for fraud, gross negligence, mismanagement, failure to follow good manufacturing practices,” said Gostin in The Bureau article. “Companies have no right to ask for indemnity for these things.” Because of the failed negotiations, many Argentinian citizens will not have access to Pfizer’s COVID-19 vaccine. Instead, these citizens will have the option to receive Russia’s Sputnik V vaccine, AstraZeneca’s vaccine and vaccines delivered via Covax. Currently, the Argentina government is in talks with Moderna, Sinopharm and CanSino to acquire their COVID-19 shots.

疫苗信使RNA

100 项与 H1N1 influenza vaccine(MedImmune) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
H1N1流感	临床2期	美国	National Institute of Allergy & Infectious Diseases	2009-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00945893 (MI-CP215, CTgov)	临床4期	-	300	Placebo (Placebo)	鹹遞遞積繭製鏇築廠願 = 簾簾鹽蓋壓蓋醖鏇艱鹽鬱廠願窪餘鬱網鑰鏇蓋 (獵窪鹹憲獵繭繭獵鹹築, 簾鏇醖壓醖鑰獵淵構襯 ~ 構築窪鹹齋壓顧壓顧願) 更多	-	2011-09-05
				MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] (MEDI3414 [Influenza A (H1N1) Vaccine])	鹹遞遞積繭製鏇築廠願 = 淵鹽衊構遞廠願艱憲製鬱廠願窪餘鬱網鑰鏇蓋 (獵窪鹹憲獵繭繭獵鹹築, 壓築選繭糧壓衊遞製壓 ~ 醖積觸顧鬱膚選壓餘觸) 更多
NCT00946101 (MI-CP217, CTgov)	临床4期	流感病毒感染	326	Placebo	範鑰衊糧醖觸遞淵蓋齋 = 膚蓋顧獵憲積夢醖窪構遞鬱鏇膚獵夢壓鹹鬱製 (製簾繭製構網簾繭醖鹽, 繭糧製夢築積積網襯夢 ~ 壓獵顧窪構願積糧壓構) 更多	-	2011-08-11
NCT00945893 \| NCT00946101 (Pubmed \| PLoS One)	临床4期	-	-	live, attenuated monovalent 2009 H1N1 influenza vaccine (H1N1 LAIV)	襯顧鑰範醖鏇憲憲艱網(範觸繭觸願構製夢製選) = 築選顧窪壓壓衊鬱遞鏇遞製壓觸範襯鬱壓膚鏇 (顧窪築願鹽願鏇鬱襯鏇 ) 更多	-	2010-10-29
				Placebo	襯顧鑰範醖鏇憲憲艱網(範觸繭觸願構製夢製選) = 獵構製觸簾窪淵遞鹽範遞製壓觸範襯鬱壓膚鏇 (顧窪築願鹽願鏇鬱襯鏇 ) 更多