A Phase 1b, Double-Blind, Randomized, Dose-Escalating, Age De-Escalating, Placebo-Controlled Study to Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine Delivered Intranasally In a Healthy Pediatric Population 6 Months Through 17 Years of Age.

This is a Phase 1b, randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled study of 200 children, ages 6 months to 17 years. This clinical trial is designed to assess the safety, tolerability/reactogenicity, and immunogenicity of one and two doses of Sing2016 M2SR H3N2 influenza vaccine (manufactured by FluGen) administered intranasally in seven cohorts of children. The study design includes pre-planned Safety Review Committee( SRC) reviews.
The first two groups to be vaccinated will be Cohorts 1 and 2. Cohort 1 consists of 45 children 9-17 years old. Thirty of them will receive one dose of the vaccine at a dose of 10^9 TCID50, and 15 will receive one dose of placebo. Cohort 2 comprises 45 children 2-8 years old. Thirty of them will receive one dose of the vaccine at a dose of 10^8 TCID50 and 15 will receive one dose of placebo.
Cohort 3 consists of 25 children 2-8 years old. 15 of them will receive one dose of vaccine at 10^9 TCID50 and 10 will receive one dose of placebo. Once 25 participants in Cohort 3 have completed Day 8 of follow-up, similar to Cohorts 1 and 2, the SRC will review to ensure no halting rules are met and if no rules are met, and the SRC determines it is safe to proceed, simultaneous enrollment into Cohorts 4 and 5 can begin. If any halting rules are met or any concerns are raised by the SRC, an external SMC may meet to discuss the data for recommendations on either progression or clinical trial modification before progression to the next cohort.
Cohort 4 consists of 25 children 2-8 years old; 15 of them will receive two doses of vaccine at 10^9 TCID50 and 10 will receive two doses of placebo, with a 28-day interval between the first and second doses. Due to the limited availability of product, and funding to support additional years of enrollment into Cohorts 5, 6, and 7, the decision was made to stop enrollment after the final participant was enrolled into Cohort 4.
The primary study objective is to assess the safety and tolerability of one and two administrations of the Sing2016 M2SR H3N2 influenza vaccine at 10^8 or 10^9 TCID50 delivered intranasally to healthy participants, 2 to 17 years of age.

Start Date10 Sep 2021

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT04785794 / CompletedPhase 1

Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old.

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.

Start Date30 Jun 2021

Sponsor / Collaborator

FluGen, Inc.

[+1]

NCT03999554 / CompletedPhase 1

Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Bris10 (A/Brisbane/10/2007) M2SR and Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccines

This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.

Start Date03 Sep 2019

Sponsor / Collaborator

FluGen, Inc.

100 Clinical Results associated with H3N2 M2SR influenza vaccine (FluGen)

100 Translational Medicine associated with H3N2 M2SR influenza vaccine (FluGen)

100 Patents (Medical) associated with H3N2 M2SR influenza vaccine (FluGen)

Literatures (Medical) associated with H3N2 M2SR influenza vaccine (FluGen)

01 Jul 2024·The Lancet Infectious Diseases

Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65–85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial

Article

Author: Murray, Bryan ; Neumann, Gabriele ; Herber, Renee ; Fierro, Carlos ; Kawaoka, Yoshihiro ; Moser, Michael J ; Davis, Matthew ; Bilsel, Pamuk ; Aitchison, Roger ; Coelingh, Kathleen ; Rhee, Margaret ; Marshall, David ; White, Alexander ; Eiden, Joseph ; Greenberg, Harry ; Belshe, Robert ; Turner, Mark

BACKGROUNDOlder adults (aged ≥65 years) show increased susceptibility to severe disease with influenza virus infection, accounting for 70-85% of annual influenza-related fatalities in the USA. Stimulating mucosal antibodies and T cells might enhance the low vaccine effectiveness seen in older adults for currently licensed inactivated influenza vaccines, which induce mainly serum antibodies. We aimed to evaluate the safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication (M2SR) vaccine, alone or coadministered with a licensed inactivated influenza vaccine (Fluzone High-Dose Quadrivalent; hereafter referred to as Fluzone HD), in older adults.METHODSIn this multicentre, randomised, double-blind, double-dummy, phase 1b trial, individuals aged 65-85 years who were considered healthy or with stable chronic conditions with no recent (<6 months) influenza vaccinations were recruited from five clinical trial sites in the USA and randomly assigned (3:3:3:1) using a permuted block design to receive the H3N2 M2SR vaccine and Fluzone HD, the H3N2 M2SR vaccine and placebo, Fluzone HD and placebo, or placebo alone. All participants received a single intranasal spray and a single intramuscular injection, whether active or placebo, to maintain masking. The primary outcome was to assess the safety of H3N2 M2SR, administered alone or with Fluzone HD, in the safety analysis set, which included all participants who were randomly assigned and received treatment. Serum and mucosal antibodies were assessed as a secondary endpoint, and cell-mediated immunity as an exploratory endpoint, in participants in the per-protocol population, which included individuals in the safety analysis set without major protocol deviations. This trial is registered with ClinicalTrials.gov, NCT05163847.FINDINGSBetween June 14 and Sept 15, 2022, 305 participants were enrolled and randomly assigned to receive the H3N2 M2SR vaccine plus placebo (n=89), H3N2 M2SR vaccine plus Fluzone HD (n=94), Fluzone HD plus placebo (n=92), or placebo alone (n=30). All randomly assigned participants were included in the safety analysis set. The most frequently reported local symptoms up to day 8 in groups that received M2SR were rhinorrhoea (43% [38 of 89] in the H3N2 M2SR plus placebo group and 38% [36 of 94] in the H3N2 M2SR plus Fluzone HD group), nasal congestion (51% [45 of 89] and 35% [33 of 94]), and injection-site pain (8% [seven of 89] and 49% [46 of 94]), and the most frequently reported solicited systemic symptoms were sore throat (28% [25 of 89]) for M2SR and decreased activity (26% [24 of 94]) for the M2SR plus Fluzone HD group. In the Fluzone HD plus placebo group, the most frequently reported local symptom was injection-site pain (48% [44 of 92]) and systemic symptom was muscle aches (22% [20 of 92]). The frequency of participants with any treatment-emergent adverse event related to vaccination was low across all groups (2-5%). One serious adverse event was reported, in a participant in the Fluzone HD plus placebo group. M2SR with Fluzone HD induced seroconversion (≥four-fold increase in haemagglutination inhibition antibodies from baseline to day 29) in 44 (48%) of 91 participants, compared with 28 (31%) of 90 participants who seroconverted in the Fluzone HD plus placebo group (p=0·023). M2SR with Fluzone HD also induced mucosal and cellular immune responses.INTERPRETATIONThe H3N2 M2SR vaccine coadministered with Fluzone HD in older adults was well tolerated and provided enhanced immunogenicity compared with Fluzone HD administered alone, suggesting potential for improved efficacy of influenza vaccination in this age group. Additional studies are planned to assess efficacy.FUNDINGUS Department of Defense.

01 Apr 2024·Vaccine

Mucosal immunization with dual influenza/COVID-19 single-replication virus vector protects hamsters from SARS-CoV-2 challenge

Article

Author: Kawaoka, Yoshihiro ; Bielefeldt-Ohmann, Helle ; Marshall, David ; Hill-Batorski, Lindsay ; Bowen, Richard ; Neumann, Gabriele ; Bilsel, Pamuk ; Moser, Michael J ; Matejka, Sarah M

The COVID-19 pandemic has highlighted the need for mucosal vaccines as breakthrough infections, short-lived immune responses and emergence of new variants have challenged the efficacy provided by the first generation of vaccines against SARS-CoV-2 viruses. M2SR SARS-CoV-2, an M2-deleted single-replication influenza virus vector modified to encode the SARS-CoV-2 receptor binding domain, was evaluated following intranasal delivery in a hamster challenge model for protection against Wuhan SARS-CoV-2. An adjuvanted inactivated SARS-CoV-2 whole virus vaccine administered intramuscularly was also evaluated. The intranasal M2SR SARS-CoV-2 was more effective than the intramuscular adjuvanted inactivated whole virus vaccine in providing protection against SARS-CoV-2 challenge. M2SR SARS-CoV-2 elicited neutralizing serum antibodies against Wuhan and Omicron SARS-CoV-2 viruses in addition to cross-reactive mucosal antibodies. Furthermore, M2SR SARS-CoV-2 generated serum HAI and mucosal antibody responses against influenza similar to an H3N2 M2SR influenza vaccine. The intranasal dual influenza/COVID M2SR SARS-CoV-2 vaccine has the potential to provide protection against both influenza and COVID.

04 Apr 2023·Vaccines

Quadrivalent Formulation of Intranasal Influenza Vaccine M2SR (M2-Deficient Single Replication) Protects against Drifted Influenza A and B Virus Challenge.

Article

Author: Kawaoka, Yoshihiro ; Hatta, Yasuko ; Bilsel, Pamuk ; Neumann, Gabriele ; Hill-Batorski, Lindsay ; Moser, Michael J. ; Sarawar, Sally

Current influenza vaccines demonstrate low vaccine efficacy, especially when the predominantly circulating strain and vaccine are mismatched. The novel influenza vaccine platform M2- or BM2-deficient single replication (M2SR and BM2SR) has been shown to safely induce strong systemic and mucosal antibody responses and provide protection against significantly drifted influenza strains. In this study, we demonstrate that both monovalent and quadrivalent (Quad) formulations of M2SR are non-pathogenic in mouse and ferret models, eliciting robust neutralizing and non-neutralizing serum antibody responses to all strains within the formulation. Following challenge with wildtype influenza strains, vaccinated mice and ferrets demonstrated reduced weight loss, decreased viral replication in the upper and lower airways, and enhanced survival as compared to mock control groups. Mice vaccinated with H1N1 M2SR were completely protected from heterosubtypic H3N2 challenge, and BM2SR vaccines provided sterilizing immunity to mice challenged with a cross-lineage influenza B virus. Heterosubtypic cross-protection was also seen in the ferret model, with M2SR vaccinated animals exhibiting decreased viral titers in nasal washes and lungs following the challenge. BM2SR-vaccinated ferrets elicited robust neutralizing antibodies toward significantly drifted past and future influenza B strains. Mice and ferrets that received quadrivalent M2SR were able to mount immune responses equivalent to those seen with each of the four monovalent vaccines, demonstrating the absence of strain interference in the commercially relevant quadrivalent formulation.

News (Medical) associated with H3N2 M2SR influenza vaccine (FluGen)

12 Jul 2024

·www.biospace.com

FluGen’s Intranasal M2SR Flu Vaccine, Co-Administered with High Dose Vaccine, in Older Adults Shows Superiority Over Flu Shot Alone

– Findings reported today in the journal Lancet Infectious Diseases – Study shows synergistic immunological response generated by M2SR and Fluzone High Dose vaccine when used in combination in the highly vulnerable 65-85 years old population – Results suggest approach could be used for vaccination against future influenza pandemics such as H5N1 MADISON, Wis., July 12, 2024 (GLOBE NEWSWIRE) -- FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced the results of its study comparing the coadministration of intranasal M2SR and the high dose flu shot in an unprecedented study of older adults ages 65-85 years. The findings are reported today in the journal Lancet Infectious Diseases ( (24)00351-7/fulltext). The study evaluated the safety, tolerability, and immunological response to FluGen’s investigational supra-seasonal, live, single-replication, intranasal influenza (flu) vaccine when administered with Sanofi’s Fluzone High Dose inactivated influenza vaccine (IIV). There is a demonstrated unmet need for improved flu vaccine options, as current injectable vaccines primarily generate hemagglutinin (HA) antibodies and have shown only modest efficacy in most flu seasons. Funded by the U.S. Department of Defense (DOD), this study evaluated M2SR and Fluzone High Dose alone, and dosed concomitantly, in healthy adults 65-85 years of age, a population considered highly vulnerable to mortality from flu. “Influenza continues to be a major cause of seasonal respiratory epidemics with significant morbidity and mortality, especially in older adults. Current vaccines fall short in three main areas – they don’t last long enough, they don’t protect against viruses that mutate and they don’t block the initial infection in the upper respiratory tract,” said Robert Belshe, MD, founder of Saint Louis University’s Center for Vaccine Development and recipient of the 2023 American College of Physicians James D. Bruce Memorial Award for Distinguished Contributions in Preventive Medicine “The results from this study represent a potential solution that might save millions of older adults from getting sick or worse.” Intranasal vaccines are known to provide a wall of defense at the site of infection to help prevent influenza viruses from entering the nasal mucosa. Intranasal M2SR has shown the ability to elicit mucosal antibodies and also protect against drifted strains while being durable. Standard flu shots on the other hand, generate antibodies in the blood to help fight off the virus after it has already entered the body. Combining the benefits of both nasally delivered vaccines and the standard shot provide the best of both worlds. The study demonstrated M2SR’s ability to statistically significantly raise mucosal antibodies in the nasal passages, serum antibodies against matched and drifted strains of the influenza virus, and cellular immune responses in subjects when compared to Fluzone High Dose and placebo. In a prior Phase 2 drifted H3N2 challenge trial, M2SR demonstrated efficacy against infection and illness across seven years of flu virus drift. Previous studies have also demonstrated that while currently licensed influenza vaccines administered by intramuscular injection generate tremendous antibody responses, only intranasal M2SR stimulates mucosal and cellular immunity as well as serum antibodies. “The idea of delivering two vaccines in one sitting has become widely accepted,” said Paul Radspinner, President and Chief Executive Officer of FluGen. “Imagine being at your local pharmacy for your annual flu shot and also receiving a quick nasal spray that would greatly enhance your chances not only of becoming seriously ill but of being infected at all. This combination solution could have a tremendous impact on the health of older adults." Radspinner went on to discuss the possible impact on influenza pandemic protection. “If H5N1 or any other mutating influenza strain were to begin infecting millions of people as SARS-CoV-2 did, imagine the benefits of combining an intranasal vaccine, which could stop most infections from occurring, with a strong antibody-based vaccine shot. The impact on human health could be unequalled in our history.” The randomized, double-blind, placebo-controlled Phase 1b study, entitled FluGen H3N2 v006 (ClinicalTrials.gov NCT05163847) was designed to evaluate a monovalent Cambodia 2020 H3N2 M2SR influenza A vaccine in a healthy, older adult population. The study enrolled over 300 subjects in four cohorts receiving either M2SR alone, high dose IIV alone, both vaccines concomitantly or placebo. The primary endpoint was to assess the safety and tolerability of a single dose of monovalent M2SR influenza vaccine delivered intranasally alone or concomitantly with high dose IIV delivered intramuscularly to healthy subjects 65 to 85 years of age. Secondary endpoints included evaluation of serum and mucosal antibody responses to matched and drifted strains of influenza virus following monovalent M2SR influenza vaccine delivered intranasally alone or concomitantly with high dose IIV delivered intramuscularly. Exploratory endpoints included evaluation of additional immune parameters such as T-cell responses. This work was supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of ($11,439,843.00), through the Peer Reviewed Medical Research Program under Award Number (W81XWH-21-1-0563). Opinions, interpretations, conclusions, and recommendations are those of the author(s) and are not necessarily endorsed by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense. About FluGen: FluGen, Inc. is a clinical-stage vaccine company transforming vaccine efficacy in respiratory diseases. The company’s lead candidate is M2SR, a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral, and cellular immunity. In an unprecedented human challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift; and M2SR induces a durable antibody response with potential to cover an entire flu season and beyond. M2SR also has shown positive initial results as a vaccine vector for other respiratory vaccines and infectious diseases, including a COVID-19/flu combination and for RSV. For more information about FluGen, Inc., please visit Contact: Media – Paul V. Radspinner, 608-658-6095, pradspinner@flugen.com

Clinical ResultVaccinePhase 2Phase 1

09 Nov 2022

·www.prnewswire.com

New Data Published in the Journal of Infectious Diseases Demonstrate FluGen's M2SR Vaccine Candidate Substantially Enhances Mucosal & Serum Antibodies Against Drifted Influenza Strains

Results show FluGen's investigational intranasal M2SR vaccine addresses an important unmet need by generating serum and mucosal antibodies against highly drifted strains of the H3N2 influenza virus MADISON, Wis., Nov. 9, 2022 /PRNewswire/ -- FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced the publication of new data in the Journal of Infectious Diseases showing its investigational, high dose, intranasal H3N2 M2SR influenza vaccine candidate substantially enhanced mucosal and serum antibodies against drifted H3N2 influenza viruses. Results showed that M2SR was well-tolerated at all dose levels and may provide substantial protection against infection with highly drifted strains of H3N2 influenza. "Antigenic drift, or circulating influenza virus strains that do not match the current influenza vaccines, are a serious public health problem, and the H3N2 strain has been particularly difficult to protect against in recent years," said Yoshihiro Kawaoka, Head of the Influenza Research Institute of the University of Wisconsin-Madison, Professor of the Institute of Medical Science of the University of Tokyo, and an author of the study. "These data suggest that the intranasal M2SR vaccine evaluated in the study may provide significant advantages over existing injected influenza vaccines." The publication, entitled "Intranasal M2SR ((M2-deficient Single Replication) H3N2 Influenza Vaccine Provides Enhanced Mucosal and Serum Antibodies in Adults", detailed results of a Phase 1B, observer-blinded, dose-escalation study of sero-susceptible subjects ages 18-49 years, randomized to receive two doses (108-109 TCID50) of M2SR or placebo administered 28 days apart. The primary objective was to demonstrate safety of M2SR vaccines (ClinicalTrials.gov number NCT03999554). Specific data demonstrated that, against the Belgium2015 challenge strain, a ≥2-fold increase in MN antibodies were noted among 40% (95% CI 24.9-56.7) of subjects following a single 108 TCID50 M2SR dose and among 80.6% (95% CI 61.4-92.3) after 109 dose (P<0.001). A single 109 TCID50 dose of M2SR generated ≥4-fold HAI seroconversion against the vaccine strain in 71% (95% CI 52.0-85.8) of recipients, a proportion substantially greater than reported for the only currently licensed intranasal flu vaccine. M2SR encoding antigen from 2018-19 influenza vaccine elicited mucosal antibodies that recognized future H3N2 strains that circulated in 2021 and 2022. Cellular immune responses were also induced. These results build on previous clinical evidence which showed that an intranasal dose of FluGen's M2SR vaccine candidate protected against infection and illness from seven years of highly drifted strains of H3N2 in subjects who demonstrated a ≥2-fold increase in microneutralization (MN) antibodies to the challenge strain after vaccination. Previous studies have also demonstrated that while currently licensed influenza vaccines administered by intramuscular injection generate tremendous antibody responses only intranasal M2SR stimulates mucosal, and cellular immunity as well as serum humoral immunity. "For decades, science has struggled to address the burden of viral drift in combatting influenza, as, when the circulating strain drifts, a mismatch between the virus and current vaccine occurs, and efficacy worsens; this is particularly true with the H3N2 strain," said Paul Radspinner, President and Chief Executive Officer of FluGen. "Previous efforts to address this challenge, such as adding adjuvants or quadrupling doses, have failed to improve outcomes for either matched or drifted strains. Now, we see further clinical evidence that our intranasal M2SR influenza vaccine candidate generates strong immunological response against both matched and drifted strains and may potentially be the more effective vaccine option that can help improve how we manage influenza." About FluGen: FluGen, Inc. is a clinical-stage vaccine company transforming vaccine efficacy in respiratory diseases. The company's lead candidate is M2SR, a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral, and cellular immunity. In an unprecedented challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift; and M2SR induces a durable antibody response with potential to cover an entire flu season and beyond. M2SR also has shown activity as a vaccine vector for other respiratory vaccines and infectious diseases, including a COVID-19/flu combination. For more information about FluGen, Inc., please visit . About M2SR: The M2 Deleted Single Replication Live Virus Vaccine (M2SR) offers a potentially differentiating clinical value proposition. FluGen's flu vaccine candidate is developed differently from inactivated or "killed" vaccines, which are comprised of flu viruses grown in eggs, chopped up, and purified for injection. It stimulates mucosal, humoral, and cellular immunity, and offers unprecedented efficacy against infection and illness across seven years of virus drift and documented immune response for at least six months. SOURCE FluGen Inc

VaccineAntibody

07 Sep 2022

·www.prnewswire.com

FluGen Announces Completion of First Cohort in Age De-escalation Clinical Trial of M2SR Flu Vaccine Candidate in Pediatric Subjects Ages 6 Months to 17 Years

– Four leading pediatric infectious disease institutions will study M2SR vaccine response in pediatric subjects, a population in which infection rates are often highest – – Collaborative study led by National Institute of Allergy and Infectious Diseases' "Collaborative Influenza Vaccine Innovation Centers" program – MADISON, Wis., Sept. 7, 2022 /PRNewswire/ -- FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced the completion of enrollment of the first cohort in an age de-escalation clinical trial of M2SR ( M2 Deficient Single Replication) live virus vaccine, the company's investigational supra-seasonal intranasal influenza (flu) vaccine, in volunteers ages 6 months to 17 years old. This study is the first of its kind to evaluate M2SR in children under 9 years old, a population with the greatest rates of flu infection each year and who are at higher risk of serious complications or death. The study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) program will assess safety, tolerability, and immunological response to M2SR. "Influenza can have serious complications in young children, a particularly vulnerable patient population, and there is a demonstrated need for improved vaccines that can mitigate the impact of the flu," said Dr. James Campbell, Professor of Pediatrics at the University of Maryland School of Medicine and Principal Investigator of the study. "The M2SR vaccine candidate has already shown a robust safety profile in adults, and we look forward to advancing scientific understanding of the potential benefits of M2SR in children." The randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled, Phase 1b study, (clinicaltrials.gov NCT04960397) is designed to evaluate a monovalent Singapore 2016 H3N2 M2SR influenza A vaccine in children. The primary endpoint is to measure the safety and tolerability of M2SR. The secondary endpoint is to assess the humoral immunogenicity (serum antibody and mucosal antibody responses) directed against the matched virus strain. The study will enroll 220 participants in three cohorts: 9-17 years old (n=45); 2-8 years old (n=115); and 6-23 months old (n=60); and will occur over two flu seasons. Participants will be randomized to receive either one or two doses of a monovalent M2SR vaccine (at increasing doses of 107, 108, or 109 TCID50) or placebo delivered intranasally. All participants will be offered the seasonal influenza vaccine at the end of the study period. "The rate of influenza infection is highest in pediatric patients, and the current standard-of-care does not meet the needs of this unprotected population," said Paul Radspinner, President and Chief Executive Officer of FluGen. "We are pleased that the NIH has selected our M2SR flu vaccine candidate to be studied as part of its CIVICs program, and look forward to sharing further updates, and the initial results of the study, which are expected in the first half of 2023." FluGen's novel supra-seasonal, intranasal M2SR flu vaccine has already been studied in more than 200 subjects aged 9 to 55 years and has shown a strong safety and immunogenicity profile. It is also being studied in a separate ongoing study in adults 55 to 85 years old. The study in pediatric subjects is supported by NIH CIVICs under contract numbers 75N93019C00055 to University of Maryland School of Medicine and 75N93019C00054 to Duke University. In addition to James Campbell, M.D. at the University of Maryland, Emmanuel Walter, M.D. at Duke University, Clarence Creech at Vanderbilt University and Patricia Winokur, M.D. at the University of Iowa will serve as investigators for the study. The content of this announcement is the responsibility solely of FluGen, Inc. and does not necessarily represent the official views of NIH. About FluGen: FluGen, Inc. is a clinical-stage vaccine company transforming vaccine efficacy in respiratory diseases. The company's lead candidate is M2SR, a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral, and cellular immunity. In an unprecedented challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift; and M2SR induces a durable antibody response with potential to cover an entire flu season and beyond. M2SR also has shown activity as a vaccine vector for other respiratory vaccines and infectious diseases, including a COVID-19/flu combination. For more information about FluGen, Inc., please visit . About M2SR: The M2 Deleted Single Replication Live Virus Vaccine (M2SR) offers a potentially differentiating clinical value proposition. FluGen's flu vaccine candidate works differently, stimulating mucosal, humoral, and cellular immunity, and offering unprecedented efficacy against infection and illness across seven years of virus drift, and documented immune response for at least six months. SOURCE FluGen, Inc.

VaccineCollaborateAntibody

100 Deals associated with H3N2 M2SR influenza vaccine (FluGen)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 1	US	FluGen, Inc.	01 Jun 2016
Influenza A virus infection	Discovery	BE	FluGen, Inc.	28 Apr 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04785794 (CTgov)	Phase 1	Influenza, Human	122	Sing2016 M2SR H3N2 influenza vaccine (M2SR Dose, 50-64 Years of Age)	epwiruqaek(yfeonhsdcf) = unfmwcayzv piwoixgrib (margmpjnil, wraftlmszh - gewyfxciwf) View more	-	15 Jun 2023
				Placebo (Placebo Dose, 50-64 Years of Age)	epwiruqaek(yfeonhsdcf) = jsnpwhvcpv piwoixgrib (margmpjnil, hmoygoncdm - wpdjfmumot) View more
NCT03999554 (Pubmed)	Phase 1	Influenza, Human	206	M2SR vaccine 109 TCID50	llmaneandx(jjwaqpwozs) = xxcbktxfvw vnpcqvgych (kvfpvieufm, 52.0 - 85.8)	Positive	09 Nov 2022
NCT03999554 (CTgov)	Phase 1	Influenza A virus infection	206	LD Bris10 M2SR H3N2 influenza vaccine (Low Dose Bris10 M2SR)	(psdhyvcyib) = ajgamwhhhx nmkvuhnegp (rgjxoemzgr, hqqegiguek - scyevhuhcg) View more	-	04 Mar 2022
				Placebo (Placebo)	(psdhyvcyib) = xyambnsafg nmkvuhnegp (rgjxoemzgr, lqydqijnhz - euqorxshsf) View more

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