A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety and Immunogenicity in Infants Born to Vaccinated Mothers

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

Start Date15 Nov 2023

Sponsor / Collaborator

ModernaTX, Inc.

NCT06097299 / Active, not recruitingPhase 2

A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Disease

The purpose of the study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years (Cohort 1 and Cohort 3) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of age (Cohort 2) to inform the dose level selection for the next phase of development (Phase 3).

Start Date24 Oct 2023

Sponsor / Collaborator

ModernaTX, Inc.

NCT06067230 / Active, not recruitingPhase 3

A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years.
Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).

Start Date06 Oct 2023

Sponsor / Collaborator

ModernaTX, Inc.

100 Clinical Results associated with Respiratory Syncytial Virus Vaccine(Moderna)

100 Translational Medicine associated with Respiratory Syncytial Virus Vaccine(Moderna)

100 Patents (Medical) associated with Respiratory Syncytial Virus Vaccine(Moderna)

Literatures (Medical) associated with Respiratory Syncytial Virus Vaccine(Moderna)

15 Nov 2024·The Journal of Infectious Diseases

Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults

Article

Author: Priddy, Frances ; Zaman, Khalequz ; Doreski, Pablo A ; Goswami, Jaya ; Stoszek, Sonia K ; Slobod, Karen ; Baqui, Abdullah H ; Wilson, Eleanor ; Das, Rituparna ; Le Cam, Nancy ; Mehta, Shraddah ; Tomassini, Joanne E ; Lan, Lan ; Miller, Jacqueline M ; Ahmed, Salahuddin ; Duncan, Christopher J A ; Ujiie, Mugen ; Perez Marc, Gonzalo ; Jimenez, Gilberto ; Huang, Wenmei ; Kapoor, Archana ; Lin, Nina ; Zhou, Honghong ; Pérez–Breva, Lina ; Du, Jiejun ; Shaw, Christine A ; Rämet, Mika

AbstractBackgroundThe mRNA-1345 vaccine demonstrated efficacy against respiratory syncytial virus (RSV) disease with acceptable safety in adults aged ≥60 years in the ConquerRSV trial. Here, humoral immunogenicity results from the trial are presented.MethodsThis phase 2/3 trial randomly assigned adults (≥60 years) to mRNA-1345 50-µg encoding prefusion F (preF) glycoprotein (n = 17 793) vaccine or placebo (n = 17 748). RSV-A and RSV-B neutralizing antibody (nAb) and preF binding antibody (bAb) levels at baseline and day 29 postvaccination were assessed in a per-protocol immunogenicity subset (PPIS; mRNA-1345, n = 1515; placebo, n = 333).ResultsDay 29 nAb geometric mean titers (GMTs) increased 8.4-fold against RSV-A and 5.1-fold against RSV-B from baseline. Seroresponses (4-fold rise from baseline) in the mRNA-1345 groups were 74.2% and 56.5% for RSV-A and RSV-B, respectively. Baseline GMTs were lower among participants who met the seroresponse criteria than those who did not. mRNA-1345 induced preF bAbs at day 29, with a pattern similar to nAbs. Day 29 antibody responses across demographic and risk subgroups were generally consistent with the overall PPIS.ConclusionsmRNA-1345 enhanced RSV-A and RSV-B nAbs and preF bAbs in adults (≥60 years) across various subgroups, including those at risk for severe disease, consistent with its demonstrated efficacy in the prevention of RSV disease.Clinical Trials RegistrationNCT05127434.

01 Nov 2024·Respiratory Investigation

Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged ≥60 years: A phase 1, randomized, observer-blind, placebo-controlled trial

Article

Author: Reuter, Caroline ; Panozzo, Catherine A ; Shaw, Christine A ; Kapoor, Archana ; Chen, Grace L. ; Wilson, Eleanor ; Wilson, Lauren ; Mills, Anthony ; Chen, Grace L ; Fitz-Patrick, David ; Simorellis, Alana K. ; Panozzo, Catherine A. ; Guo, Ruiting ; Mihara, Hanako ; Goswami, Jaya ; Shaw, Christine A. ; Stoszek, Sonia K. ; Dhar, Rakesh ; Simorellis, Alana K ; Stoszek, Sonia K ; Mithani, Runa

BACKGROUNDRespiratory syncytial virus (RSV) represents a global health concern, including in older adults. This study assessed the safety and immunogenicity of mRNA-1345, an investigational mRNA RSV vaccine, in adults aged ≥60 years of Japanese descent.METHODSIn this phase 1, randomized, observer-blind, placebo-controlled study, participants were randomized to receive one injection of mRNA-1345 100 μg or placebo. Solicited local and systemic adverse reactions (ARs) were collected within 7 days following injection. Unsolicited adverse events (AEs) were collected up to 28 days after injection; AEs of special interest, medically attended AEs, and serious AEs were collected through end of study. Immunogenicity was assessed at baseline and months 1, 2, 3, and 6 following injection.RESULTSTwenty-five adults of Japanese descent aged ≥60 years received one injection of mRNA-1345 100 μg (n = 21) or placebo (n = 4). mRNA-1345 was well-tolerated; the most common local and systemic solicited ARs were injection site pain, and fatigue and myalgia, respectively, which were generally mild to moderate and transient. No serious AEs were reported. Neutralizing (nAb) and binding (bAb) antibodies were detectable at baseline, consistent with prior RSV exposure. mRNA-1345 boosted RSV nAb titers and preF bAb concentrations 1 month post-injection (geometric mean fold rise: RSV-A nAb, 11.2; RSV-B nAb, 6.6; preF bAb, 9.1). Titers among mRNA-1345 recipients remained above baseline through 6 months.CONCLUSIONSmRNA-1345 100 μg was well-tolerated among older adults of Japanese descent and induced nAbs and bAbs which were durable through 6 months, supporting its continued development.TRIAL REGISTRATIONClinicalTrials.gov, NCT04528719.

14 Dec 2023·New England Journal of MedicineQ1 · MEDICINE

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults

Q1 · MEDICINE

Article

Author: Du, Jiejun ; Perez-Marc, Gonzalo ; Zaman, Khalequ ; Baqui, Abdullah H ; Ghaswalla, Parinaz ; Slobod, Karen ; Duncan, Christopher J A ; Rämet, Mika ; Kuter, Barbara J ; Mithani, Runa ; Doreski, Pablo A ; Lan, Lan ; Panozzo, Catherine A ; Dhar, Rakesh ; Stoszek, Sonia K ; Shaw, Christine A ; Simorellis, Alana K ; Huang, Wenmei ; Chen, Grace L ; Falsey, Ann R ; Ujiie, Mugen ; Miller, Jacqueline M ; Monroy, Jorge ; Mehta, Shraddha ; Wilson, Lauren ; Kapoor, Archana ; Wilson, Eleanor ; Goswami, Jaya ; Das, Rituparna ; Walsh, Edward E ; Reuter, Caroline ; Schödel, Florian ; Pérez-Breva, Lina

BACKGROUNDRespiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation.METHODSIn this ongoing, randomized, double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 μg) or placebo. The two primary efficacy end points were the prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease. Safety was also assessed.RESULTSOverall, 35,541 participants were assigned to receive the mRNA-1345 vaccine (17,793 participants) or placebo (17,748). The median follow-up was 112 days (range, 1 to 379). The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions. Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and of systemic adverse reactions (47.7% vs. 32.9%); most reactions were mild to moderate in severity and were transient. Serious adverse events occurred in 2.8% of the participants in each trial group.CONCLUSIONSA single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease and of RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434.).

News (Medical) associated with Respiratory Syncytial Virus Vaccine(Moderna)

11 Nov 2024

·www.pharmaceutical-technology.com

Moderna’s mRESVIA vaccine gains Health Canada approval

The approval marks the introduction of the first mRNA RSV vaccine in Canada. Credit: MargJohnsonVA via Shutterstock. Moderna has received Health Canada’s approval for its respiratory syncytial virus messenger ribonucleic acid (mRNA) vaccine mRESVIA, designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over. This marks the introduction of the first mRNA RSV vaccine in Canada and the second approved product of Moderna in the country. The approval by Health Canada is supported by the outcomes from the ConquerRSV Phase III study, which involved approximately 37,000 patients aged 60 and above across 22 countries. The trial’s primary analysis indicated an 83.7% efficacy in preventing RSV LRTD after a median follow-up of 3.7 months. Moderna CEO Stéphane Bancel said: “Today’s approval is an example of how our mRNA platform can help address significant public health challenges like RSV. “As our second product approved by Health Canada, mRESVIA underscores our commitment to leveraging mRNA technology to protect vulnerable populations and contribute to a healthier future for Canadians.” mRESVIA is reportedly currently the only vaccine available in a distinct single-dose prefilled syringe format. This is intended to streamline the vaccination process for healthcare professionals, potentially reducing the risk of errors and saving time. The expected availability of mRESVIA in Canada is in early 2025. The company is also actively seeking marketing authorisations in various jurisdictions globally. Canada is the fourth to grant approval, following Europe, Qatar, and the US. Canada’s National Advisory Committee on Immunization endorses RSV vaccination for those aged 75 and over and for individuals aged 60 years and above living in chronic care facilities and nursing homes. Vaccination for community-dwelling individuals over 60 is advised to be a personal decision made after consulting with a healthcare provider. The vaccine comprises an mRNA sequence that encodes the RSV F glycoprotein, which is essential for the virus’ ability to infect host cells. The drug also received US Food and Drug Administration approval in June this year and is anticipated to be available in the country in time for the 2024-25 respiratory virus season. mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Enhance your mRNA production with market leading capping Optimising mRNA production raises myriad questions for biomanufactures around how to navigate costs and maximise efficiency. TriLink BioTechnologies has leveraged its expertise to provide answers. Their CleanCap® M6 analog improves mRNA yields and boosts protein expression. With its newly optimised pulse-feed protocol, manufacturers can double production at just a fraction of the cost. As a proven solution in scalable IVT reactions, CleanCap® M6 ensures consistent quality and reduced costs for mRNA production. Download now to learn more. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Trilink Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Trilink Thematic and that your personal data will be used as described in their Privacy Policy

Phase 3Drug ApprovalVaccineClinical ResultmRNA

18 Oct 2024

·www.pharmaceutical-technology.com

mRNA licensing agreements surge 800% amid GSK lawsuits

COVID-19 mRNA vaccines have sparked interest in the potential of mRNA technology, but they have also put producers at the centre of licensing lawsuits. Credit: wacomka / Shutterstock. mRNA-based innovator pharmaceuticals have experienced a massive increase in licensing agreement deal values following success with the technology in Covid-19 vaccines, which helped to curtail the pandemic. Data and analytics provider GlobalData identified an 800% increase in deal values between 2019 and 2024 so far and has noted that key companies are continuing to invest heavily in the development of mRNA-based pharmaceuticals. GlobalData is Pharamceutical Technology’s parent company. However, recent lawsuits filed by GSK against mRNA vaccine producers Pfizer , BioNTech and most recently (15 October) Moderna , have put the licensing of mRNA-based pharmaceuticals in the spotlight. In its lawsuit, GSK has alleged the use of its technology without proper licenses. GSK is suing Moderna in two lawsuits regarding its mRNA vaccines: Spikevax for Covid-19 and mResvia for RSV. The British pharma giant alleges that Moderna ignored patents relating to lipid nanoparticles used in mRNA vaccine formulation technology. See Also: FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment Glaukos eyes FDA approval for ocular therapy after Phase III win It follows a similar lawsuit against Pfizer and BioNTech filed in April in which GSK alleges the companies were in violation of five patents relating to mRNA vaccine technology. Pfizer/BioNTech’s Covid-19 vaccine, known as Comirnaty, was approved by the FDA in August 2021 and was the first mRNA vaccine to enter the global market. It was followed by the approval of Moderna’s Spikevax in January 2022, although an emergency use authorization (EUA) had made Moderna’s vaccine available earlier. Ophelia Chan, business fundamentals senior analyst at GlobalData, has pointed to Covid-19 vaccines as a turning point for the mRNA sector. “The Covid-19 pandemic highlighted the key advantages of mRNA technology in vaccine development, including rapid production, precise immune targeting and streamlined manufacturing factors that drove the success of mRNA-based Covid-19 vaccines,” she said. mRNA Covid-19 vaccine sales declined significantly in 2023 compared to 2022. However, GlobalData reported that 2023 still saw Moderna’s Spikevax generate around $18.4bn in global revenue , while Pfizer and BioNTech’s Comirnaty generated around $42.4bn. Considering the reasons behind the jump in licensing deal values, Chan added: “Licensing agreement deal values for mRNA-based pharmaceuticals have doubled since 2023 , reaching $3.8bn as major players like GSK and Bristol Myers Squibb invest in mRNA therapeutics to address unmet medical needs.” In April, Bristol Myers Squibb entered into a multi-year, $1.87bn strategic collaboration with Repertoire Immune Medicines looking to develop mRNA-based tolerising vaccines. Meanwhile, GSK and Curevac contributed to the jump in licensing value in July, with a new licensing agreement worth up to $1.57bn. Beyond licensing, GlobalData also expects the sector to see growth across mRNA sales, predicting that the global sales of innovator mRNA-based drugs will rise from $22bn in 2023 to $26.2bn in 2030.

License out/inVaccinemRNADrug ApprovalPatent Infringement

04 Oct 2024

·endpts.com

RSV vaccines off to a sluggish start in US this season, with volumes behind 2023

This season’s uptake of RSV vaccines in the US has been slower than expected, according to Wall Street analysts tracking prescriptions, and appears to be missing even modest projections for growth compared with 2023. The RSV, or respiratory syncytial virus, space is dominated by GSK’s first-to-market vaccine Arexvy, which has around 60% retail market share, according to Jefferies analysts, who put out an analysis of the market on Friday. Almost all of the rest has gone to Pfizer’s Abrysvo, with Moderna’s mRESVIA taking only a small slice, they said. Last year at this time, 1.5 million prescriptions had been issued for the vaccines. But this year, only 900,000 have, according to Jefferies. That represents a 40% drop compared to last year. The RSV vaccination season runs from August to October. GSK has been hit especially hard — weekly Arexvy prescriptions are down more than half versus last year, Barclays analysts said in a separate note issued Tuesday. The product is a major part of GSK’s strategy targeting infectious diseases, and last year sales reached about £1.2 billion ($1.6 billion) in 2023 in what the company described as an “exceptional launch” after FDA approval in early May. There are some signs of growth. In the final week of September, Arexvy prescriptions were up 11% week-over-week, according to Jefferies, and prescriptions of Pfizer’s Abrysvo are growing 15% week-over-week. Abrysvo was cleared by the FDA in late May last year, and is the only one of the three vaccines recommended for use in pregnant women. In July when the company shared quarterly results, CEO Emma Walmsley said that “with a best-in-class data profile, we are confident Arexvy will return to growth next year and longer term can achieve more than £3 billion in peak year sales.” A GSK spokesperson told Endpoints News that the company’s projections have not changed. The Barclays analysts said they have reduced their Arexvy forecasts for the year “given the uncertainty around revaccination” frequency, adding that higher rates of Covid-19 vaccinations are also likely to “have a dampening effect on RSV.” GSK recently released details of a clinical study of the shot which is assessing the efficacy of dosing every three to four years. In June, the CDC’s Advisory Committee on Immunization Practices declined to make a recommendation for Arexvy for people aged 50 to 59 years — a key age group for which GSK had been hoping to expand coverage. The following month, Walmsley described the committee’s delay as “surprising,” but said the drugmaker remains “confident” that Arexvy’s benefit to these patients will be recognized. Meanwhile, Moderna’s mRESVIA prescriptions are growing every week but remain “incremental,” Jefferies analysts said. “We are waiting for an inflection point as [the company] works on securing contracting which likely won’t have an impact until the following season,” they said in their report to investors. Moderna’s shot secured approval in May, roughly a year after the two other vaccines.

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100 Deals associated with Respiratory Syncytial Virus Vaccine(Moderna)

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Indication	Country/Location	Organization	Date
Pneumonia due to respiratory syncytial virus	EU	Moderna Biotech Spain, S.L.	22 Aug 2024
Pneumonia due to respiratory syncytial virus	NO	Moderna Biotech Spain, S.L.	22 Aug 2024
Pneumonia due to respiratory syncytial virus	LI	Moderna Biotech Spain, S.L.	22 Aug 2024
Pneumonia due to respiratory syncytial virus	IS	Moderna Biotech Spain, S.L.	22 Aug 2024
Respiratory Syncytial Virus Infections	US	ModernaTX, Inc.	31 May 2024

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	NDA/BLA	CH	Moderna, Inc.	05 Jul 2023
Respiratory Syncytial Virus Infections	NDA/BLA	AU	Moderna, Inc.	05 Jul 2023
Influenza, Human	Phase 3	US	ModernaTX, Inc.	01 Apr 2022
Severe Acute Respiratory Syndrome	Phase 3	US	ModernaTX, Inc.	01 Apr 2022
Human Metapneumovirus Infection	Phase 1	ES	ModernaTX, Inc.	15 Feb 2023
Human Metapneumovirus Infection	Phase 1	GB	ModernaTX, Inc.	15 Feb 2023
Human Metapneumovirus Infection	Phase 1	US	ModernaTX, Inc.	15 Feb 2023
COVID-19	Phase 1	US	ModernaTX, Inc.	14 Oct 2022
COVID-19	Phase 1	AU	ModernaTX, Inc.	14 Oct 2022
COVID-19	Phase 1	GB	ModernaTX, Inc.	14 Oct 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05127434 (Pubmed) Manual	Phase 2/3	Respiratory Syncytial Virus Infections	35,541	mRNA-1345	(pychsbhjhd) = nvpkgxsurj djhjlacrco (epptelpemd, 66.0 - 92.2) View more	Positive	14 Dec 2023
				Placebo	(yhcrjyokac) = guhowuevmy wzrcwrwoht (qszpnqzoap )
ConquerRSV (Biospace) Manual	Phase 3	Respiratory Syncytial Virus Infections	37,000	mRNA-1345	(bsdrpvklvi) = zaqtvtklid qksjpchsjl (fjcygnrfuz, 66.1 - 92.2) View more	Positive	03 Aug 2023
NCT05127434 (Accesswire) Manual	Phase 3	Respiratory Syncytial Virus Infections	37,000	mRNA-1345	jtyvatcxrm(hszdirkznv) = qkknsbnxtt vvhhwhngaq (mzznlquwzt ) Met View more	Positive	17 Jan 2023
				Placebo	jtyvatcxrm(hszdirkznv) = jktlmgejcl vvhhwhngaq (mzznlquwzt ) Met View more

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