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OVX836 Universal Influenza Vaccine

Osivax's OVX836 is a first-in-class influenza 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. As of December 2023, OVX836 has been evaluated in several Phase 2 clinical trials against seasonal influenza with initial signals of broad-spectrum protection. The company's 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.

This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 961112. The French State supports this project through the Banque Publique d'Investissement France's program: Programme d'investissements d'avenir and France 2030.

A study published results from a phase 2a study on July 27, 2023, that concluded 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.

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 and strong and sustained B-cell responses. The company is based in Swely Bâtiment C, Slam, ​70 Rue Saint Jean Dieu, 69007 Lyon, France.

OVX836 Vaccine Indication

OVX836 is being tested in healthy adults to prevent seasonal influenza.

OVX836 Vaccine Dosage

The vaccine is being administered intramuscularly or intranasally and tested at three doses in healthy adults (NCT05060887).

OVX836 Vaccine News

December 5, 2023 - Osivax announced that it received over USD 1.5M grant from the National Institute of Allergy and Infectious Diseases.

July 28, 2023 - Osivax announced that The Lancet Infectious Diseases published results from the company's OVX836-003 study under the title, "Immunogenicity, safety and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: randomized, double-blind placebo-controlled, Phase 2a trial." The research article presents the study's results evaluating the safety and immunogenicity of OVX836.

OVX836 Vaccine Clinical Trials

As of December 5, 2023, OVX836 has been tested in 5 clinical trials with 1200 participants and has shown promising safety, immunogenicity, and efficacy read-outs. OVX836 has shown promising safety, immunogenicity, and efficacy data across preclinical and clinical trials (Phase 1 and 2a). It is being evaluated in additional ongoing clinical trials: two co-administration studies conducted in Australia (OVX836-004 and OVX836-006) with OVX836 and quadrivalent inactivated influenza virus (QIV) vaccines. Osivax also recently published the results of a Phase 2a dose-optimization study (OVX836-003) in The Lancet Infectious Diseases, showing efficacy in humans against seasonal strains. 

VBI-2601 (BRII-179) Vaccine Clinical Trials, Dosage, News, Side Effects, Usage

VBI Vaccines Inc. VBI-2601 (BRII-179) is a novel recombinant, protein-based immunotherapeutic hepatitis B vaccine candidate that targets B- and T-cell immunity through several key mechanisms of action, including neutralizing circulation of the hepatitis B virus (HVB) and blocking hepatocytes' infection Pre-S1 immunity, and enabling immune-mediated clearance of HBV-infected hepatocytes. VBI-2601 is uniquely formulated to target B-cell and T-cell immunity through multiple action mechanisms, including neutralizing the circulating hepatitis B virus, blocking hepatitis B infection of hepatocytes mediated through Pre-S1, and enabling immune-mediated clearance of HBV-infected hepatocytes. Many investigational agents work inside the infected liver cells downstream of transcription; BRII-179 is designed to impact the key extracellular steps in the HBV lifecycle to sustain immunologic control over the infection. VBI-2601 is being developed and led by Brii Bio in partnership with VBI Vaccines for patients with chronic HBV infection.

On February 15, 2023, the Company announced interim data from the Phase 2 study evaluating the combination of VBI-2601 (BRII-179) and BRII-835 (VIR-2218) in chronically infected HBV patients. The data, which will be featured in an oral presentation on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses when compared to BRII-835 alone. Notably, in two participants who received the combination therapy, maximum reductions in HBsAg to an undetectable level or the lower limit of quantification (LLOQ) were achieved by Week 40, associated with robust HBV-specific antibody and T-cell responses. Based on the results of this study (ACTRN12619001210167), Brii Biosciences plans to conduct additional combination studies within the Asia-Pacific Economic Cooperation and the more significant China areas.

In July 2023, VBI and Brii Bio announced an expansion of their HBV partnership to include an exclusive global license to develop and commercialize BRII-179 (VBI-2601) and an exclusive license to develop and commercialize PreHevbri®, VBI's prophylactic 3-antigen adult HBV vaccine, in the Asia Pacific region, excluding Japan.

On September 6, 2023, the Company announced topline cohort-level unblinded Week 24 and Week 36 data from interim analysis of a randomized, placebo-controlled, and double-blinded Phase 2 study of BRII-179, a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in patients with chronic hepatitis B (CHB) compared with PEG-IFNα only treatment.

On February 13, 2024, Brii Biosciences Limited announced that it has entered into agreements with VBI Vaccines, Inc., ensuring expansion and control of future clinical and commercial supplies of BRII-179. Brii Bio had commercial rights to BRII-179 (VBI-2601) in the licensed territories of China, Hong Kong, Macau, and Taiwan. Brii Bio will also take control of VBI's Rehovot-based manufacturing facilities for BRII-179 and PreHevbrio/PreHevbri. With operations in the People's Republic of China and the United States, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners, and establish an innovation engine to help improve the public health and wellbeing of patients around the world.

VBI Vaccines Inc. is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet infectious disease and immuno-oncology needs. VBI (Nasdaq: VBIV).

VBI-2601 (BRII-179) Vaccine Indication

BRII-179 (VBI-2601) is a novel recombinant, protein-based immunotherapeutic candidate developed and led by Brii Bio in partnership with VBI Vaccines for patients with chronic HBV infection. VBI-2601 is indicated as the functional cure for treating chronic hepatitis B infection. Hepatitis B infection is the most prevalent global infection, with 250 million infected worldwide, according to the U.S. CDC. Global HBV infection is rampant, and there is also a high unmet need for effective therapies, as current treatments generate a functional cure in less than 10 percent of those treated. Achieving a functional cure, therefore, is a global health priority.

VBI-2601 (BRII-179) Vaccine Dosage

A two-part dose-escalation study assessing a low dose and a high dose of VBI-2601 (BRII-179), with and without an undisclosed adjuvant, has enrolled 46 patients. BRII-179 (VBI-2601) was given by intramuscular injection. On June 23, 2021, 20 μg and 40 μg doses of BRII-179 (VBI-2601) with and without low dose IFN-α administered through intramuscular injection were well-tolerated with no significant adverse events identified.

VBI-2601 (BRII-179) Vaccine Side Effects

A phase 3 study found vaccine discontinuation due to adverse events was uncommon, and serious AEs were infrequent, reported in 42 participants (2%) and 3 participants (0.4%) in the 3A-HBV and 1A-HBV groups, respectively.

VBI-2601 (BRII-179) Vaccine News

February 13, 2024—Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio, stated, "As Brii transitions to late-stage development of HBV programs, a global manufacturing strategy becomes critically important. We look forward to working with the biologics manufacturing experts at the Rehovot site and timely integrating our R&D and manufacturing capabilities."

September 6, 2023 - "We are excited by the data from this proof-of-concept study, which are consistent with our previous proof-of-mechanism studies that BRII-179 induces functional immune responses complementing other curative treatment modalities such as PEG-IFNα," said David Margolis, MD, Chief Medical Officer of Brii Bio.

February 15, 2023 - VBI-2601 (BRII-179) and BRII-835 combination were generally well-tolerated, with no new safety signals observed. The Initial study data suggest that VBI-2601 (BRII-179) and BRII-835 combination induced meaningfully more potent anti-hepatitis B surface antigen (HBsAg)-specific T-cell and antibody responses compared to BRII-835 alone. Data will be featured in an oral presentation by Dr. Man Fung Yuen, M.D., Ph.D., D.Sc., on February 18, 2023.

January 5, 2022 - VBI Vaccines Inc. announced that the first patient had been dosed in a second Phase 2a/2b clinical study evaluating VBI-2601 (BRII-179). This newly announced Phase 2 study will assess VBI-2601 as an add-on therapy to the standard-of-care, nucleos(t)ide reverse transcriptase inhibitor and pegylated interferon (PEG-IFN-α) therapy, which currently has a functional cure rate of approximately 9%. Data from these two Phase 2 studies could become available in the second half of 2022 and the first half of 2023, respectively.

November 3, 2021 - The U.S. CDC's ACIP unanimously passed a universal HBV vaccination recommendation for all adults aged 19-59 and adults aged 60+ with risk factors for infection. The U.S. PDUFA target action date is November 30, 2021.

August 2, 2021 - VBI Vaccine provided a corporate update.

June 23, 2021 - Brii Biosciences and VBI Vaccines Inc. announced final results from a Phase 1b/2a study on BRII-179 (VBI-2601), a novel recombinant, protein-based immunotherapeutic candidate, in patients with chronic hepatitis B virus (HBV) infection. Data from the study, which evaluated the safety, antiviral activity, and immunogenicity of BRII-179 (VBI-2601) alone or admixed with interferon-alpha as a co-adjuvant, demonstrated that the investigational immunotherapeutic induced both B cell (antibody) and T cell responses and was well-tolerated with no safety signals observed, in non-cirrhotic chronic hepatitis B patients under nucleos(t)ide analog therapy. Furthermore, BRII-179 (VBI-2601) induced and/or boosted S-, Pre-S1-, and/or Pre-S2-specific IFN-gamma producing T cells in 77% of patients across all treatment cohorts, compared to no detectable response in patients in control, NUC-only arm. Additionally, BRII-179 induced hepatitis B antibody responses in 44.2% of patients in the BRII-179 treatment arms.

June 9, 2021 - Brii Biosciences announced that it would present the complete dataset from its Phase 1b/2a study evaluating BRII-179 (VBI-2601) as a treatment for chronic hepatitis B virus (HBV) infection as a late-breaker ePoster at the European Association for the Study of the Liver's (EASL) International Liver Congress 2021, which is taking place virtually from June 23-26, 2021.

May 10, 2021 - VBI Vaccines Inc. reported financial results for the first quarter ending March 31, 2021, and provided a corporate update. Additional data from Phase 1b/2a study in chronic HBV patients demonstrated robust HBV-specific T cell and antibody responses across all study arms.

April 21, 2021 - Vir Biotechnology, Inc. (Nasdaq: VIR), VBI Vaccines Inc., and Brii Biosciences announced that the first patient had been dosed in Phase 2 clinical study evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid-targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

March 2, 2021 - VBI Vaccines Inc. announced financial results for the fourth quarter and twelve months ended December 31, 2020. The Company also provided a corporate update and its outlook for 2021. Partner Brii Biosciences is expected to initiate a Phase 2 combination study to assess VBI-2601 (BRII-179) and BRII-835 (VIR-2218), a novel RNAi therapeutic potential functional cure in chronically infected patients.

December 17, 2020 - Interim data from a Phase 1b/2a trial designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic, demonstrated the induction of both antibody and T cell responses in chronically infected HBV patients. The Company announced that recruitment was completed for a Phase 2 clinical trial for BRII-835 (VIR-2218), a novel, investigational RNA interference (RNAi) therapeutic designed to inhibit the expression of all HBV proteins, including hepatitis B surface antigen (HBsAg). Interim results are expected in the second quarter of 2021. During the first quarter of 2021, the Company is also preparing to launch a Phase 2 clinical trial examining the safety and efficacy of BRII-179 and BRII-835 in combination with patients on the stable nucleus (t)ide therapies.

November 18, 2020 - VBI Vaccines Inc. announced positive interim clinical results from the ongoing Phase 1b/2a study of VBI-2601 (BRII-179), a novel recombinant, protein-based immunotherapeutic candidate for the treatment of chronic hepatitis B virus infection, in development in collaboration with Brii Biosciences.

November 14, 2019 - VBI Vaccines Inc. and Brii Biosciences ("Brii Bio") announced the first patient dosed in Phase 1b/2a proof-of-concept study of BRII-179 (VBI-2601), a novel recombinant, a protein-based immuno-therapeutic candidate in development for the treatment of chronic hepatitis B virus infection.

VBI-2601 (BRII-179) Vaccine Clinical Trial

Brii Biosciences is the sponsor of this newly announced Phase 2a/2b study and, with the support of VBI, has led the design and implementation of this study and the ongoing Phase 2 combination study. The Phase 2a/2b trial of VBI-2601 (BRII-179) is a double-blind, randomized, placebo-controlled, parallel-group study to evaluate the clinical effect of adding VBI-2601 (BRII-179) to existing PEG-IFN-α and Nrtl standard-of-care therapy in non-cirrhotic chronic HBV patients. Patients participating in the study have had partial responses to ongoing PEG-IFN-α and NrtI treatment.

The phase 2, multicenter, randomized, open-label study is designed to evaluate the safety and efficacy of BRII-835 (VIR-2218) compared to the combination of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with and without interferon-alpha as a co-adjuvant. Both agents have demonstrated proof of mechanism in HBV patients (NCT04507269 BRII-835 China study and ACTRN12619001210167 BRII-179 APEC study). Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VIR and VBI and is the sponsor of the Phase 2 study (NCT04749368). It will be conducted at sites in Australia, China, Taiwan, Hong Kong, the Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand.

Clinical Trial ACTRN12619001210167: A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B. A Phase 1b/2a clinical study of BRII-179 (VBI-2601) is a randomized, controlled study designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601) in patients with chronic HBV infection.

MV-LASV Lassa Fever Vaccine Candidate Clinical Trials, Dosage, News, Side Effects, Usage

MV-LASV is a recombinant, live-attenuated, viral vectored Lass fever (LF) vaccine candidate based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection. On October 29, 2019, Themis Bioscience and the Coalition for Epidemic Preparedness Innovations announced the first administration to healthy volunteers in a Phase 1 clinical trial with Themis’ vaccine candidate against Lassa fever. 

On March 16, 2023, The Lancet published Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomized, placebo-controlled, first-in-human trial. Interpretation: MV-LASV showed an acceptable safety and tolerability profile, and immunogenicity seemed to be unaffected by pre-existing immunity against the vector. MV-LASV is, therefore, a promising candidate for further development. The Coalition for Epidemic Preparedness Innovations funded this phase 1 study.

According to the World Health Organization, LF vaccines should be cost-effective, affordable in endemic areas, and stable for a reasonable time without extensive cold chain facilities.

In June 2020, Merck acquired Themis, a privately held company focused on vaccines and immune-modulation therapies for infectious diseases and cancer.

MV-LASV Indication

MV-LASV vaccine candidate is indicated for at-risk populations during outbreaks of Lassa Fever, an emerging infectious disease. Lassa fever is an acute viral hemorrhagic disease caused by the Lassa virus (LASV). It is endemic in West Africa and infects about 300,000 people yearly, leading to approximately 5000 deaths annually. Therefore, the World Health Organization has listed the development of the LASV vaccine as a priority since 2018. 

MV-LASV Dosage

MV-LASV is administered at two different dose levels intramuscularly. Injection. The aim is to investigate the safety, tolerability, and immunogenicity of MV-LASV after administering two different dose levels of MV-LASV. 

MV-LASV Clinical Trial

Clinical Trial NCT04055454: A Trial to Evaluate the Optimal Dose of MV-LASV—The trial is complete and registered with the European Union Drug Regulating Authorities Clinical Trials Database, 2018-003647-40.

Findings - Between September 26, 2019, and January 20, 2020, 60 participants were enrolled and assigned to receive a placebo (n=12) or MV-LASV (n=48). All 60 participants received at least one study treatment. Most adverse events occurred during the treatment phase. Frequencies of total solicited or unsolicited adverse events were similar between treatment groups, with 96% of participants in the low-dose group, 100% of those in the high-dose group, and 92% of those in the placebo group having any solicited adverse event (p=0·6751) and 76% of those in the low-dose group, 70% of those in the high-dose group, and 100% of those in the placebo group having any unsolicited adverse event (p=0·1047). The only significant difference related to local solicited adverse events, with higher frequencies observed in groups receiving MV-LASV (24 [96%] of 25 participants in the low-dose group; all 23 [100%] participants in the high-dose group) than in the placebo group (6 [50%] of 12 participants; p=0·0001, Fisher-Freeman-Halton test). Adverse events were mainly of mild or moderate severity, and no serious adverse events were observed. MV-LASV also induced substantial concentrations of LASV-specific IgG (geometric mean titre 62·9 EU/ml in the low-dose group and 145·9 EU/ml in the high-dose group on day 42).

TetraVax-DV (V180) Dengue Vaccine Clinical Trials, Dosage, News, Side Effects, Usage

Merck & Co., Instituto Butantan, and Medigen Vaccine Biologics (MVB), co-developed TetraVax-DV, V180, Butantan-DV, and TV003) adjuvanted, tetravalent subunit dengue vaccine candidate comprised truncated forms of envelope proteins (DEN-80E), derived from strains of all four dengue virus serotypes (DEN-1 strain 258848, DEN-2 strain PR159 S1, DEN-3 strain CH53489, and DEN-4 strain H241). The DEN-80E subunits are expressed from plasmids in the Drosophila S2 cell expression system and are formulated with either ISCOMATRIX (saponin, cholesterol, and phospholipid adjuvant; CSL) or Alhydrogel (aluminum hydroxide gel adjuvant; Brenntag Nordic).

In 2024, according to a phase 3 clinical study conducted in Brazil, the V180 vaccine candidate was found to be 79.6% effective in preventing dengue. During this period, no serious dengue cases were reported in the participants. The positive result is the result of more than ten years of work with international partners. In the phase 2 clinical trial, the results were published in an article in The Lancet Infectious Diseases. According to the clinical study report, no vaccine-related SAEs were observed in 54 subjects aged 20-70. The immunogenicity data demonstrates that the vaccinated group produced higher neutralizing antibody titers (GMTs of PRNT50, and had a higher seropositivity rate against types of Dengue virus than the controlled group. Moreover, the vaccinated group remained expressing neutralizing responses on day 180 and day 365 after vaccination, this result reveals that MVC's dengue vaccine shows immunogenicity not only within 20-50-year-old subjects but also in the elder group aged 51-70 years old.

Development of the tetravalent dengue vaccine began at Butantan Institute in 2010 with FAPESP's support (Grant number: 08/50029-7), using a formulation created by researchers affiliated with the US National Institutes of Health (NIH). Clinical trials in Brazil began in 2013, with the support of the Butantan Foundation and BNDES, Brazil's national development bank, under the aegis of the project "Development of a tetravalent dengue vaccine," led by Neuza Frazatti Gallina, winner of the 2023 Péter Murányi Prize.

On December 16, 2022, Merck announced, 'We are highly encouraged by the tremendous progress scientists and clinicians at the Instituto Butantan have made in developing their single-dose dengue vaccine candidate.' In February 2024, infectious disease specialist Esper Kallás informed Agência FAPESP, "In June (2024), we'll complete the five-year follow-up period. Once the data has been consolidated, we'll know how long the vaccine-induced protection will last."

Instituto Butantan, in São Paulo state, Brazil, is the largest producer of vaccines and serums in Latin America and the main producer of immunological products in Brazil. MVC is a biopharmaceutical company focusing on developing and mass-producing vaccines and biologics. It is located at No. 68, Shengyi 3rd Rd., Zhubei City, Hsinchu County 302, Taiwan (R.O.C.).

TetraVax-DV (V180) Vaccine Dosage

V180 is administered as an intramuscular injection. A single dose schedule was evaluated in the phase 3 study. The two-dose schedule could still be improved to reduce the risk of non-compliance. However, it is believed that V180 would achieve significant commercial potential as part of a heterologous prime-boost strategy.

TetraVax-DV (V180) Dengue Vaccine News

February 1, 2024 - The NEJM published an Original Article - Live, Attenuated, Tetravalent Butantan–Dengue Vaccine in Children and Adults.

April 8, 2023 - The phase II study for the dengue vaccine in Taiwan finished the bridging and proof-of-concept study assessed ethnic differences and evaluated the immunogenicity of the elderly population.

December 16, 2022 - Butantan confirmed its dengue vaccine is 79.6% effective in phase 3 study results.

April 13, 2022 - A new strain of dengue was detected in Brazil in a man from Aparecida de Goiânia by researchers from the Oswaldo Cruz Foundation and the Central Public Health Laboratory of Goiás. The serotype two genotype, also known as the cosmopolitan genotype, is the most widespread dengue virus lineage globally, but it had never been found in Brazil.

March 24, 2020 - The Lancet published a study: Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomized placebo-controlled phase 2 trial. Butantan-DV and TV003 were safe and induced robust, balanced neutralizing antibody responses against the four DENV serotypes. The efficacy evaluation of the Butantan-DV vaccine is ongoing.

February 15, 2018 - Global Drug Analysis: V180 - More Compact Dosing Schedule Could Make It a More Attractive Alternative to Dengvaxia.

V180 Dengue Vaccine Clinical Trials

ClinicalTrials NCT02406729: Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or placebo (5976 participants). The overall 2-year vaccine efficacy was 79.6% (95% confidence interval [CI], 70.0 to 86.3) — 73.6% (95% CI, 57.6 to 83.7) among participants with no evidence of previous dengue exposure and 89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure.

Clinical Trial NCT02450838: Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005).

Clinical Trial NCT01477580:  Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001) (Completed, No results posted).