A Phase 1/2, Randomized, Observer-blind, Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an hMPV/RSV mRNA Vaccine Candidate in Adult Participants Aged 60 Years and Older

The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older.
Overall, the study is designed to address the following goals:
* Assess the safety profile of the candidate formulations.
* Describe the immunogenicity profile of the candidate formulations.
* Select the vaccine formulations (dose) for future development.
* Assess the safety and immunogenicity of a booster vaccination of the selected formulation administered 12 months after the primary vaccination in a subset of the study population.
The study duration is as follows:
-Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 12 additional months for the Booster Cohort
Treatment duration:
* Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination
* Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination
* Stage 2 Expansion Cohort: 1 IM injection. Participants in the selected formulation arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed for 8 months post-vaccination
* Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 12 months post-booster vaccination

开始日期2024-11-18

申办/合作机构

Sanofi Pasteur

NCT06583031 / Recruiting临床1期

A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years

VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.

开始日期2024-10-09

申办/合作机构

Sanofi Pasteur

NCT06604767 / Recruiting临床1期

A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older

The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.

开始日期2024-09-17

申办/合作机构

Sanofi Pasteur

100 项与 RSV/hMPV mRNA Vaccine(Sanofi Pasteur) 相关的临床结果

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100 项与 RSV/hMPV mRNA Vaccine(Sanofi Pasteur) 相关的转化医学

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100 项与 RSV/hMPV mRNA Vaccine(Sanofi Pasteur) 相关的专利（医药）

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项与 RSV/hMPV mRNA Vaccine(Sanofi Pasteur) 相关的文献（医药）

2020-12-01·Journal of medical virology4区 · 医学

The role of M2‐2 PDZ‐binding motifs in pulmonary innate immune responses to human metapneumovirus

4区 · 医学

Article

作者: Yan, Weiyu ; Choudhury, Atanu ; Wu, Wenzhe ; Bao, Xiaoyong ; Li, Liqing ; Chen, Yu ; Choi, Eun‐Jin

Abstract:

Human metapneumovirus (HMPV) is a leading cause of lower respiratory tract infection (LRTI) in pediatric and geriatric populations. We recently found that two PDZ‐binding motifs of the M2‐2 protein, 29‐DEMI‐32 and 39‐KEALSDGI‐46, play a significant role in mediating HMPV immune evasion in airway epithelial cells (AECs). However, their role in the overall pulmonary responses to HMPV infection has not been investigated. In this study, we found that two recombinant HMPVs (rHMPV) lacking the individual M2‐2 PDZ‐binding motif are attenuated in mouse lungs. Mice infected with mutants produce more cytokines/chemokines in bronchoalveolar lavage (BAL) fluid compared to mice infected with wild‐type rHMPV. In addition, both mutants are able to enhance the pulmonary recruitment of dendritic cells (DCs) and T cells and induce effective protections against the HMPV challenge. The DC maturation is also significantly improved by the motif mutation. Taken together, our data provide proof‐of‐principle for two live‐attenuated M2‐2 mutants to be promising HMPV vaccine candidates that are effective in inducing higher pulmonary innate immunity and generating protection against HMPV infection.

2019-10-01·Journal of virology2区 · 医学

A Potent Neutralizing Site III-Specific Human Antibody Neutralizes Human Metapneumovirus In Vivo

2区 · 医学

Article

作者: Mousa, Jarrod J. ; Pena-Briseno, Alma ; Murray, Jackelyn ; Tripp, Ralph A. ; Bar-Peled, Yael ; Huang, Jiachen ; Diaz, Darren

Recent progress in understanding the human immune response to respiratory syncytial virus has paved the way for new vaccine antigens and therapeutics to prevent and treat disease. Progress toward understanding the immune response to human metapneumovirus (hMPV) has lagged behind, although hMPV is a leading cause of lower respiratory tract infection in children. In this report, we advanced the field by isolating a panel of human mAbs to the hMPV F protein. One potent neutralizing mAb, MPV364, targets antigenic site III on the hMPV F protein and incorporates two protomers into its epitope yet is unique from previously discovered site III mAbs, as it does not cross-react with the RSV F protein. We further examined MPV364 in vivo and found that it limits viral replication in BALB/c mice. Altogether, these data provide new mAb candidates for therapeutic development and provide insights into hMPV vaccine development.

2018-07-01·Influenza and other respiratory viruses3区 · 医学

The transmission dynamics and diversity of human metapneumovirus in Peru

3区 · 医学

ArticleOA

作者: Bera, Jayati ; Ocaña, Victor ; Halsey, Eric ; Pollett, Simon ; Calisto, Maria E. ; Mendocilla, Silvia M. ; Halpin, Rebecca A. ; Wentworth, David ; Trovão, Nidia S. ; Garcia, Josefina ; Nelson, Martha I. ; Leguia, Mariana ; Das, Suman R. ; Ampuero, Julia S. ; Eden, John‐Sebastian ; Álvarez, Carlos ; Tan, Yi

Background:

The transmission dynamics of human metapneumovirus (HMPV) in tropical countries remain unclear. Further understanding of the genetic diversity of the virus could aid in HMPV vaccine design and improve our understanding of respiratory virus transmission dynamics in low‐ and middle‐income countries.

Materials & Methods:

We examined the evolution of HMPV in Peru through phylogenetic analysis of 61 full genome HMPV sequences collected in three ecologically diverse regions of Peru (Lima, Piura, and Iquitos) during 2008‐2012, comprising the largest data set of HMPV whole genomes sequenced from any tropical country to date.

Results:

We revealed extensive genetic diversity generated by frequent viral introductions, with little evidence of local persistence. While considerable viral traffic between non‐Peruvian countries and Peru was observed, HMPV epidemics in Peruvian locales were more frequently epidemiologically linked with other sites within Peru. We showed that Iquitos experienced greater HMPV traffic than the similar sized city of Piura by both Bayesian and maximum likelihood methods.

Conclusions:

There is extensive HMPV genetic diversity even within smaller and relatively less connected cities of Peru and this virus is spatially fluid. Greater diversity of HMPV in Iquitos compared to Piura may relate to higher volumes of human movement, including air traffic to this location.

项与 RSV/hMPV mRNA Vaccine(Sanofi Pasteur) 相关的新闻（医药）

2022-06-29

·Endpoints

Reeling from Covid flop, Icosavax says its RSV candidate passed early test. But investors need some more convincing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed. IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported. The interim Phase I/Ib results offer key proof of concept for the Seattle-based biotech’s foundational virus-like particle platform technology, said CEO Adam Simpson. VLP is spontaneously assembling proteins that Icosavax co-founder and synthetic biology researcher Neil King previously described as akin to soccer balls in shape. “They also reaffirm our strategy to combine multiple pathogen targets in one vaccine,” he said in a statement. “As planned, Icosavax will now progress development of IVX-121 combined with a human metapneumovirus (hMPV) VLP, as our IVX-A12 bivalent vaccine candidate.” RSV and hMPV are two leading causes of pneumonia, he added, and neither has an approved vaccine. A host of companies, though, are gunning to bring the first RSV vaccine to the market, with Pfizer , GSK and Bavarian Nordic all touting late-stage data. Icosavax licensed a prefusion stabilized form of the RSV F antigen from the NIH. But its plan, spelled out in an S-1 when it went public last year, has always been to forego a monovalent shot in favor of a 2-in-1 vaccine. In a note, Cowen’s Phil Nadeau noted the neutralizing antibody titers generated by IVX-121 — up to 7,687 IU/mL for the younger group and up to 7,561 IU/mL for the older group — “are in the range of those produced by Pfizer’s RSV vaccine candidate PF-06482077 (RSVpreF) and GSK’s RSVpreF3 OA, suggesting that Icosavax has a viable RSV component for its RSV+hMPV vaccine.” Roger Song at Jefferies also gave the data a thumbs-up: Nonetheless, shares are down about 14% in pre-market trading, putting the stock price at $7.27. In addition to its vaccine, Icosavax also tested an aluminum hydroxide adjuvant in the trial to make sure it didn’t work, as it’s failed in other companies’ studies before. And investigators found that the adjuvant did not make a difference. The company plans to file an IND and start a Phase I trial for IVX-A12 in the second half of the year.

疫苗抗体

2021-04-07

·BioSpace

Icosavax Closes $100 Million Series B Financing to Advance Bivalent RSV/hMPV Vaccine Candidate Into Clinical Trials

April 7, 2021 11:00 UTC Company’s novel computationally designed virus-like particle (VLP) technology has the potential to create safe, effective, and durable vaccines against life-threatening respiratory viruses in older adults SEATTLE--(BUSINESS WIRE)-- Icosavax, Inc. today announced the close of a $100 million Series B Financing, led by RA Capital Management and joined by Janus Henderson Investors, Perceptive Advisors, Viking Global Investors, Cormorant Asset Management, Omega Funds, and Surveyor Capital (a Citadel company). Icosavax’s existing investors also participated, including Qiming Venture Partners USA, Adams Street Partners, Sanofi Ventures, and ND Capital. A previously announced funding from Open Philanthropy was included in this round. In conjunction with the financing, Peter Kolchinsky, Ph.D., founder and Managing Partner of RA Capital Management, will join the company’s Board of Directors. The proceeds of the financing will support the development of Icosavax’s bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine program through initial clinical studies, continued evaluation of its SARS-CoV-2 vaccine candidate, and further expansion of the company’s pipeline of VLP vaccine candidates focused on protecting older adults from life-threatening respiratory diseases. “There are currently no approved vaccines against RSV and hMPV, two respiratory viruses that are disproportionately life-threatening for the elderly. We are excited to lead this investment in Icosavax alongside a great syndicate to advance the combination RSV/hMPV candidate through development and into the clinic,” said Peter Kolchinsky, Ph.D., Managing Partner at RA Capital Management. “We are delighted to have attracted a top-tier investor syndicate who recognize the potential of our VLP technology to create more effective and durable vaccines for at-risk populations, like the elderly, where traditional vaccines have reduced efficacy,” said Adam Simpson, Chief Executive Officer of Icosavax. “Based on preclinical data, we believe our vaccine candidates could offer significant protection against leading viral causes of pneumonia in older adults where no licensed vaccines currently exist.” The company’s RSV vaccine candidate, IVX-121, incorporates a stabilized prefusion F antigen licensed from NIAID/NIH (DS-Cav1; Science 2019). In a Phase 1 clinical study conducted by NIAID/NIH, DS-Cav1 was shown to induce robust neutralizing antibody titers, higher than titers shown in previous studies with RSV postfusion F vaccine candidates. Extensive preclinical studies suggest that the VLP display of DS-Cav1 in IVX-121 induces higher and more durable neutralizing antibody titers compared to the DS-Cav1 antigen alone, and presentation of DS-Cav1 on the VLP confers improved stability. Icosavax plans to advance IVX-121 into clinical studies this year. Data from the first in human study of IVX-121 in young and older adults will inform and enable the transition to a bivalent RSV/hMPV clinical program. For COVID-19, Icosavax is advancing a SARS-CoV-2 receptor binding domain VLP vaccine candidate, IVX-411, into initial clinical studies in 2021. Preclinical data on IVX-411 and precursor candidates in mice and non-human primates show induction of robust neutralizing antibody titers and protection from viral challenge (Cell 2020, Preprint 2021). Data from the IVX-411 clinical study will inform potential development paths in the rapidly evolving COVID vaccine landscape. About Icosavax’s Computationally Designed Virus-Like Particle (VLP) Technology Naturally occurring VLPs that have been licensed or in development have shown the ability to induce high neutralizing titers in both older and young adults, long duration of protective immunity and the ability to be used as combination vaccines. VLPs enable multivalent display of antigens in a manner that closely resembles viruses, with an important difference. VLPs contain no genetic material, so they are non-infectious and can provide a safer alternative to live-attenuated or inactivated vaccines. However, VLPs engineered to display other complex viral antigens have been difficult to successfully manufacture at scale, including for RSV and hMPV. Icosavax’s vaccine technology solves the problem of designing and manufacturing VLPs displaying complex antigens by utilizing a two-component computationally designed protein structure that self-assembles, without interfering with the critical three-dimensional conformation of the displayed antigens. The individual protein components are expressed and purified using traditional recombinant protein techniques, and then spontaneously self-assemble into VLPs when mixed together. The high yield and stability of the protein components generated and assembled with Icosavax’s technology suggest that manufacture of these VLP vaccines will be highly scalable. About RA Capital Management RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies developing drugs, medical devices, and diagnostics. RA Capital’s flexible strategy allows it to provide seed funding to startups and lead private, IPO, and follow-on financings for its portfolio companies, thereby driving value creation from idea inception through commercialization. For more info, visit . About Icosavax Icosavax is focused on developing safe and effective vaccines against infectious diseases that cause severe, life-threatening respiratory illnesses. Icosavax is advancing VLP vaccine candidates against respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and SARS-CoV-2 (COVID-19). These vaccine candidates have shown induction of high and durable neutralizing antibody titers in preclinical studies and could protect the most vulnerable populations, including older adults. Icosavax was founded on breakthrough computationally designed VLP technology developed at the Institute for Protein Design. Icosavax exclusively licensed the technology for use in several vaccine fields from the University of Washington. For SARS-CoV-2, Icosavax has a worldwide license with an exclusive option for IVX-411 in North America and Europe from the University of Washington. Icosavax is located in Seattle. For more info, visit .

疫苗抗体IPO

100 项与 RSV/hMPV mRNA Vaccine(Sanofi Pasteur) 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
人类偏肺病毒感染	临床2期	美国	Sanofi Pasteur	2023-11-01
人类偏肺病毒感染	临床2期	波多黎各	Sanofi Pasteur	2023-11-01
呼吸道合胞体病毒感染	临床2期	美国	Sanofi Pasteur	2023-11-01
呼吸道合胞体病毒感染	临床2期	波多黎各	Sanofi Pasteur	2023-11-01
副流感病毒感染 NOS	临床1期	澳大利亚	Sanofi Pasteur	2024-09-17
人偏肺病毒感染	临床1期	美国	Sanofi Pasteur	2024-01-23
人偏肺病毒感染	临床1期	澳大利亚	Sanofi Pasteur	2024-01-23