Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.

The present study OVX836-006 aims principally to:
Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

开始日期2023-05-10

申办/合作机构

Osivax SAS初创企业

[+2]

NCT05569239 / Not yet recruiting临床2期

Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of One Dose of OVX836 Influenza Vaccine 480μg, After Intramuscular Administration in Healthy Subjects Aged 18-55 Years

The present study will evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-55 years.

开始日期2023-04-01

申办/合作机构

Osivax SAS初创企业

[+2]

NCT05284799 / Completed临床2期

Phase 2a, Randomized, Double-blind (Double-dummy), Controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and a Quadrivalent Inactivated Influenza Vaccine Given Intramuscularly as 2 Separate Injections in the Same Arm, in Comparison to Co-administration of Quadrivalent Inactivated Influenza Vaccine and Placebo and to Co-administration of OVX836 and Placebo Given Intramuscularly in Healthy Subjects.

The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.

开始日期2022-05-09

申办/合作机构

Osivax SAS初创企业

[+2]

100 项与 OVX836 相关的临床结果

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100 项与 OVX836 相关的转化医学

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100 项与 OVX836 相关的专利（医药）

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项与 OVX836 相关的文献（医药）

2023-12-01·The Lancet. Infectious diseases

Immunogenicity, safety, and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: a randomised, double-blind, placebo-controlled, phase 2a trial

Article

作者: Leroux-Roels, Isabel ; Waerlop, Gwenn ; De Boever, Fien ; Leroux-Roels, Geert ; Nicolas, Florence ; Tourneur, Jessika ; Janssens, Yorick ; Alhatemi, Azhar ; Willems, Paul ; Bruhwyler, Jacques ; Le Vert, Alexandre ; Jacobs, Bart

BACKGROUND:

OVX836, a recombinant vaccine containing the nucleoprotein of the influenza A virus A/WSN/1933 (H1N1) and the oligomerisation domain OVX313, has displayed a good safety profile and elicited dose-dependent humoral and cellular immune responses at 90 μg or 180 μg (intramuscularly) in previous clinical trials. The aim of this study was to explore higher doses, since no maximum tolerated dose had been reached.

METHODS:

In this phase 2a, randomised, double-blind, placebo-controlled study, we recruited 137 healthy adults aged 18-55 years in a single centre in Belgium. Participants were randomly assigned (interactive web response system; block size=4) using SAS (version 9.4) to receive one single intramuscular administration of OVX836 influenza vaccine at three doses (180 μg [n=33], 300 μg [n=35], and 480 μg [n=36]) or placebo (n=33). The two primary endpoints were the safety and the cell-mediated immune response to OVX836 at the three doses in terms of change of nucleoprotein-specific IFNγ spot forming cell (SFC) frequencies in the peripheral blood mononuclear cell (PBMC) population, measured by IFNγ ELISpot, at day 8 versus pre-injection baseline (day 1). The population used for the safety analysis is the modified intention-to-treat cohort. The population used for the immunogenicity analysis is the per-protocol cohort. This trial is registered with ClinicalTrials.gov, NCT05060887, and EudraCT, 2021-002535-39.

FINDINGS:

Participants were recruited between Nov 15, 2021, and Feb 1, 2022. OVX836 had a favourable safety profile up to 480 μg without reaching the maximum tolerated dose, and showed a good safety profile at all doses with mild local and systemic reactogenicity. 7 days after vaccination, although no significant differences were observed between the doses, OVX836 increased the frequency of nucleoprotein-specific IFNγ SFCs per million PBMCs from days 1 to 8 (primary endpoint): by 124 SFCs per 10⁶ PMBCs (95% CI 67 to 180; p=0·002) at 180 μg; by 202 SFCs per 10⁶ PMBCs (95% CI 138 to 267; p<0·0001) at 300 μg; by 223 SFCs per 10⁶ PMBCs (95% CI 147 to 299; p<0·0001) at 480 μg; and decreased by 1 SFCs per 10⁶ PMBCs (95% CI -24 to 22] in the placebo group (Kruskal-Wallis test p<0·0001 followed by Mann-Whitney's tests; per-protocol cohort). Dose-dependent and polyfunctional nucleoprotein-specific CD4 T-cell responses were observed, and CD8 T-cell responses were elicited at 300 μg and 480 μg (secondary endpoints).

INTERPRETATION:

OVX836 appears to be a safe and well tolerated candidate vaccine that elicits humoral and cellular nucleoprotein-specific immune responses (including CD8 T cells at the highest dose levels) and showed a preliminary signal of protection against influenza. Therefore, OVX836 is a promising vaccine candidate for universal influenza A prevention, that warrants further trials.

FUNDING:

OSIVAX, Bpifrance, Wallonia Region, and the EUs Horizon 2020 Research and Innovation Program.

2022-08-12·The Journal of Infectious Diseases2区 · 医学

Phase 1 Randomized, Placebo-Controlled, Dose-Escalating Study to Evaluate OVX836, a Nucleoprotein-Based Influenza Vaccine: Intramuscular Results

2区 · 医学

Article

作者: Lambiel, Manon ; Willems, Paul ; Viviani, Simonetta ; Le Vert, Alexandre ; De Coster, Ilse ; Nicolas, Florence ; Tourneur, Jessika ; Withanage, Kanchanamala ; Van Damme, Pierre ; Cools, Nathalie ; Chevandier, Marion

Abstract:

Background:

OVX836 is a recombinant protein vaccine targeting the highly conserved influenza nucleoprotein (NP), which could confer broad-spectrum protection against this disease.

Methods:

A randomized, placebo-controlled, double-blind, dose-escalating, single- center, first-in-human study was conducted in 36 healthy adults aged 18–49 years. Twelve subjects per cohort (9 vaccine and 3 placebo) received 2 OVX836 intramuscular administrations on days 1 and 28 at the dose level of 30 µg, 90 µg, or 180 µg. Safety and immunogenicity were assessed after each vaccination and for 150 days in total.

Results:

OVX836 was safe and well tolerated at all dose levels, with no difference in solicited local and systemic symptoms, and unsolicited adverse events between the first and second administration, or between dose levels. All subjects presented pre-existing NP-specific immunity at baseline. OVX836 induced a significant increase in NP-specific interferon-gamma T cells and anti-NP immunoglobulin G at all dose levels after the first vaccination. The second vaccination did not further increase the response. There was a trend for a dose effect in the immune response.

Conclusions:

The safety and reactogenicity profile, as well as the humoral and cellular immune responses, encourage further evaluation of OVX836 in a larger Phase 2a study.

Frontiers in immunology2区 · 医学

OVX836 Heptameric Nucleoprotein Vaccine Generates Lung Tissue-Resident Memory CD8+ T-Cells for Cross-Protection Against Influenza

2区 · 医学

ArticleOA

作者: Rousset, Carine ; Marvel, Jacqueline ; Le Vert, Alexandre ; Del Campo, Judith ; Indalecio, Alice ; Haller, Marjorie ; Chevandier, Marion ; Nicolas, Florence ; Bouley, Julien ; Djebali, Sophia ; Guyon-Gellin, Delphine ; Leverrier, Yann ; Combadière, Béhazine ; Hill, Fergal

Tissue-resident memory (TRM) CD8+ T-cells play a crucial role in the protection against influenza infection but remain difficult to elicit using recombinant protein vaccines. OVX836 is a recombinant protein vaccine, obtained by the fusion of the DNA sequence of the influenza A nucleoprotein (NP) to the DNA sequence of the OVX313 heptamerization domain. We previously demonstrated that OVX836 provides broad-spectrum protection against influenza viruses. Here, we show that OVX836 intramuscular (IM) immunization induces higher numbers of NP-specific IFNγ-producing CD8+ T-cells in the lung, compared to mutant NP (NPm) and wild-type NP (NPwt), which form monomeric and trimeric structures, respectively. OVX836 induces cytotoxic CD8+ T-cells and high frequencies of lung TRM CD8+ T-cells, while inducing solid protection against lethal influenza virus challenges for at least 90 days. Adoptive transfer experiments demonstrated that protection against diverse influenza subtypes is mediated by NP-specific CD8+ T-cells isolated from the lung and spleen following OVX836 vaccination. OVX836 induces a high number of NP-specific lung CD8+ TRM-cells for long-term protection against influenza viruses.

项与 OVX836 相关的新闻（医药）

2024-03-26

·BioSpace

Osivax Announces Vaccination of Last Patient in Phase 2a Clinical Trial Evaluating OVX836 Combined with QIVs

478 participants were enrolled across Australia Full immunogenicity and safety results expected in the second half of 2024 LYON, France--(BUSINESS WIRE)-- Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating viruses, today announced that all participants have completed their final visit in the Phase 2a clinical trial (NCT05734040) evaluating OVX836, Osivax’ broad-spectrum influenza A vaccine candidate, in combination with Quadrivalent Influenza Vaccines (QIVs). Topline results from this study are expected in the second half of 2024. The randomized, double-blind, double placebo-controlled, parallel-group, multicentric clinical trial evaluated the safety and immunogenicity of a 480μg dose of the OVX836 vaccine with licensed QIVs and placebo in healthy participants across Australia. The enrolled 478 healthy volunteers from 18 to 60 years old were observed over a period of 180 days following the concomitant administration of the OVX836 vaccine with licensed QIVs, as two separate intramuscular injections into opposite arms, compared to one administration of OVX836, QIVs or placebo. Laboratory analyses of the vaccine immunogenicity are being performed at VisMederi - Siena, KCAS Bio - Lyon, Osivax Quality Control lab – Angleur, and the CEVAC lab - Ghent. “The data gathered from this Phase 2a trial is a necessary step in demonstrating OVX836’s ability to provide long-lasting, improved protection in combination with QIVs. We look forward to analyzing the data to confirm the promising results we have observed with OVX836 to date,” commented Dr. Nicola Groth, CMO of Osivax. “We would like to thank the volunteers and dedicated staff of researchers and clinicians whose contributions have ensured the trial’s successful completion.” “The need for more effective and safe flu vaccines remains high and the conclusion of our trial which evaluates OVX836 in combination with QIVs brings us one step closer to providing improved protection,” said Alexandre Le Vert, CEO & Co-Founder of Osivax. “The data collected from this trial will bolster our development of OVX836 as a broad-spectrum influenza vaccine.” About OVX836 OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOM™ technology enables the design and production of a recombinant version of the NP which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX836 has been tested in 5 clinical trials with 1200 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM™, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum “universal” influenza candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,200 volunteers tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: View source version on businesswire.com: Contacts Alexandre LE VERT, CEO contact@osivax.com +33 (0)9 70 30 13 80 For Media Inquiries Trophic Communications Desmond James or Valeria Fisher osivax@trophic.eu +49 (0) 151 678 59086 or +49 (0) 175 804 1816 Source: Osivax View this news release online at:

临床2期疫苗临床结果

2024-02-15

·BioSpace

Osivax Announces Vaccination of First Participant in First-in-Human Trial Evaluating Sarbecovirus Vaccine Candidate OVX033

Phase 1 study to evaluate safety and immunogenicity of sarbecovirus (coronavirus) vaccine candidate, OVX033, at ascending dose levels The trial will enroll 48 participants in France LYON, France--(BUSINESS WIRE)-- Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that the first participant has been vaccinated in its new Phase 1 trial (NCT06128382) evaluating OVX033, a broad-spectrum sarbecovirus vaccine candidate. Recently, preclinical data published in Frontiers in Immunology demonstrated OVX033’s proof of cross-protection against three SARS-CoV-2 variants of concern. In a rabbit toxicology study, the vaccine candidate also showed an excellent safety and tolerance pro intramuscular administration. The first-in-human study will be conducted at the Clinical Investigation Center in Vaccinology Cochin Pasteur (CIC) in Cochin Hospital in Paris (AP-HP, Inserm) under the supervision of Odile Launay, MD, PhD, Professor at Paris Cité University. “OVX033 has been shown in preclinical models to effectively provide broad protection across multiple strains of coronavirus,” commented Prof. Odile Launay, the Principal Investigator. “We are proud to participate in this first-in-human study to evaluate the vaccine candidate’s role in preventing the pandemic-level spread of current and future SARS-CoV-2 variants.” “Transitioning our second broad-spectrum vaccine candidate into the clinic further validates our self-assembling nanoparticle platform, OligoDOMTM, and our position as a pioneer in the advancement of a new class of vaccines,” said Alexandre Le Vert, CEO & Co-Founder of Osivax. “With the Phase 1 initiation for OVX033 underway, we hope to advance a broad-spectrum coronavirus vaccine that can be positioned against all SARS-CoV-2 variants and against future coronavirus pandemic threats.” The single-center trial is a randomized, double-blind, placebo-controlled Phase 1 clinical study evaluating the safety and immunogenicity of OVX033 at three dose levels (100 µg, 250 µg, and 500 µg). One single dose of OVX033 vaccine or of placebo will be administered intramuscularly in 48 healthy subjects aged 18-49 years. OVX033 is based on Osivax’ cutting-edge technology, OligoDOMTM, which has already established promising proof-of-concept data with OVX836, a broad-spectrum influenza A vaccine candidate currently being evaluated in several Phase 2 clinical studies. Results on immunogenicity, safety and preliminary efficacy were published in The Lancet Infectious Disease in 2023. About OVX033 OVX033 is a first-in-class coronavirus vaccine candidate that targets the nucleocapsid (N), a highly conserved internal antigen. Unlike surface antigens such as Spike (S), N is much less likely to mutate, providing a broader and more universal immune response, with the objective inducing broad-spectrum protection against all current and future variants of SARS-CoV-2 as well as against future pandemic coronavirus strains. Osivax’ oligoDOMTM technology enables the design and production of a recombinant version of the nucleocapsid which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX033 has demonstrated a preclinical proof of concept for cross-protective efficacy in a hamster challenge model published in Frontiers in Immunology. Further preclinical studies and a First-In-Human clinical trial are ongoing. This project is supported by the French government, through France 2030, “Programme Investissements d’Avenir” operated by Bpifrance. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOMTM, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum “universal” influenza candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,200 subjects tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: View source version on businesswire.com: Contacts Alexandre LE VERT, CEO contact@osivax.com +33 (0)9 70 30 13 80 For Media Inquiries Trophic Communications Desmond James or Valeria Fisher osivax@trophic.eu +49 (0) 151 678 59086 or +49 (0) 175 804 1816 Source: Osivax View this news release online at:

疫苗临床1期临床2期临床结果

2024-01-25

·BioSpace

Osivax Appoints Dr. Nicola Groth as Chief Medical Officer

LYON, France--(BUSINESS WIRE)-- Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, announced today the appointment of Dr. Nicola Groth, MD, PhD to its executive committee as Chief Medical Officer. She brings over 25 years of experience in vaccine development with considerable expertise in influenza vaccines, from early-stage clinical development to approval and post-marketing commitments. Dr. Groth joins Osivax as the company advances the development of its lead candidate, OVX836, a best-in-class broad-spectrum influenza vaccine candidate currently being evaluated in several Phase 2 clinical trials. Dr. Groth takes over from Dr. Willems, whose contribution has been instrumental in advancing Osivax’ clinical strategy. “We are thrilled to announce the addition of Nicola to our executive team as CMO. With her extensive leadership background in vaccine development and interactions with regulatory agencies, particularly in influenza vaccines, she brings invaluable expertise to our organization. Nicola’s experience in managing late-stage clinical trials and building registration packages for influenza vaccines will be crucial as we progress OVX836 through Phase 2 clinical testing and approach the clinic with our universal coronavirus vaccine candidate, OVX033,” commented Alexandre Le Vert, CEO and Co-Founder of Osivax. “I would also like to express my gratitude for the contributions of Dr. Paul Willems, MD, whose dedication has brought Osivax to this point of development.” “Joining the high-performing team at Osivax represents a unique opportunity to support the development of a new class of vaccines capable of providing broad-spectrum protection against infectious viruses and diseases that continue posing global health threats,” said Dr. Nicola Groth, CMO of Osivax. “I am eager to lend my expertise to further drive Osivax’ clinical programs and impact in this field.” Before joining Osivax, Dr. Groth served as Global Head of Safety Evaluation & Risk Management at GlaxoSmithKline (GSK) Vaccines. She has also held various strategic positions in vaccine development, epidemiology, and medical affairs at Novartis Vaccines and Diagnostics and the Chiron Corporation. Nicola Groth holds a Doctor of Medicine and a PhD in Hygiene and Preventive Medicine from the University of Siena, Italy. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM®, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum, “universal” influenza candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,200 subjects tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of sarbecovirus in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: View source version on businesswire.com: Contacts Alexandre Le Vert, CEO contact@osivax.com +33 (0)9 70 30 13 80 For Media Inquiries Trophic Communications Desmond James or Valeria Fisher osivax@trophic.eu +49 (0) 151 678 59086 or +49 (0) 175 804 1816 Source: Osivax View this news release online at:

临床2期疫苗高管变更

100 项与 OVX836 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2期	比利时	Osivax SAS初创企业	2019-12-11

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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


NCT05060887 (NEWS) 人工标引	临床2期	流感病毒感染	137	OVX836	醖壓鹽範艱衊壓鹹製範(廠蓋簾構選鹹製憲憲製) = OVX836 provided an 84% level of protection against PCR-confirmed symptomatic influenza compared to placebo. 製糧鑰積糧願築鏇餘襯 (簾繭獵壓糧鑰範顧繭觸 )	积极	2023-07-27
				placebo
NCT05060887 (Pubmed)	临床2期	流感病毒感染	137	OVX836 influenza vaccine 180 μg	築齋餘遞獵餘蓋構壓獵(顧築艱醖壓憲鑰襯簾築) = 廠窪憲構襯網觸廠繭構鑰構簾積鏇簾鹹憲繭夢 (積鹽鬱鹽蓋鏇願淵憲餘, 67 ~ 180)	-	2023-07-27
				OVX836 influenza vaccine 300 μg	築齋餘遞獵餘蓋構壓獵(顧築艱醖壓憲鑰襯簾築) = 製憲繭餘積獵範糧範餘鑰構簾積鏇簾鹹憲繭夢 (積鹽鬱鹽蓋鏇願淵憲餘, 138 ~ 267)