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VTP-500 MERS Vaccine Clinical Trials, Dosage, Indication, Side Effects

Barinthus Biotherapeutics plc VTP-500 (ChAdOx1) vaccine candidate prevents the Middle East Respiratory Syndrome Coronavirus (MERS) Coronaviruses (CoV). The ChAdOx1 MERS vaccine candidate contains the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. VTP-500 MERS vaccine utilizes the ChAdOx1 virus platform to encode MERS coronavirus spike protein to induce T cells and antibodies that block virus-host cell receptor binding and fusion or neutralize virus infection.

The patented Vaccitech adenovirus vectors are known as chimpanzee adenovirus Oxford 1 and 2 (ChAdOx1 and ChAdOx2) and are in the group E simian adenovirus family, similar to the widely-studied chimpanzee adenovirus 63. These viruses have been engineered to be replication-deficient and manufactured in well-established HEK293 cell lines containing the adenoviral E1 gene. Vaccitech licensed the needed patents from Oxford University to advance its programs. The ChAdOx1 vector patent was granted in the US and the EU, and the MVA-NP+M1 patent was granted in the EU and is pending in the US. 

The University of Oxford’s Jenner Institute, in collaboration with The King Abdullah International Medical Research Centre (KAIMRC), announced on December 20, 2019, that it has started a Phase I clinical trial in the Kingdom of Saudi Arabia (KSA) for a vaccine against the MERS-CoV. VTP-500 has completed Phase I clinical trials in Britain and Saudi Arabia, and the University of Oxford is now extending the Phase Ib trial in the UK to assess vaccination of older adults.

On December 21, 2023, Barinthus Bio announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of a vaccine candidate known as VTP-500 to prevent MERS. The project will see CEPI, Barinthus Bio, and the University of Oxford take the MERS vaccine candidate from early development through Phase II clinical trials and, if the Phase II clinical trials are successful, develop an investigational ready reserve of 100,000 vaccines. Barinthus Bio will receive $34.8m in addition to previous funds that were committed to the University of Oxford and the CEPI will invest up to $47m to develop and stockpile the ready reserve of the MERS vaccine candidate. The development partners are committed to enabling equitable access to VTP-500 in line with CEPI’s Equitable Access Policy. Due to VTP-500’s potential to significantly address MERS outbreaks, the European Medicines Agency (EMA) confirmed support for the program through the PRIME designation. 

Oxford, England-based Barinthus Biotherapeutics plc (Vaccitech) (NASDAQ: BRNS) is an immunotherapy and vaccine company. The Company’s proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, and the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. 

VTP-500 MERS Vaccine Indication

VTP-500 (ChAdOx1) vaccine candidate is designed to protect people against MERS-CoV.

VTP-500 MERS Vaccine News

December 21, 2023 - “Coronaviruses are one of the most urgent infectious disease threats the world faces, so it’s vital that we get on with developing medical defenses against this particularly deadly one – MERS,” said Dr. Richard Hatchett, CEPI’s Chief Executive Officer. “With this project, we will both advance scientific understanding of the coronavirus family as a whole and, at the same time, bolster humanity’s ability to respond to an ever-present epidemic threat.”

September 18, 2023 - A vaccine to protect people against MERS was launched in September 2023. This is the third Phase I clinical trial of the ChAdOx1 MERS vaccine.

August 12, 2021 - Vaccitech plc provided an overview of the Company’s recent corporate developments. 

April 29, 2021 - Vaccitech plc announced the pricing of its initial public offering in the United States for total gross proceeds of $110.5 million.

March 22, 2021 - Vaccitech Ltd. announces Joseph Scheeren, PharmD, as an independent director to its Board of Directors.

August 21, 2020 - CEPI, Oxford University, and Janssen have entered into a collaboration worth up to $19M to progress the vaccine through Phase 2 studies and establish a human vaccine stockpile with the University. 

June 10, 2020 - RESEARCH ARTICLE: A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques.

April 17, 2020 - NIH press release: Investigational chimp adenovirus MERS-CoV vaccine protects monkeys. Vaccine neutralizes multiple MERS-CoV strains.

December 20, 2019 - Vaccitech’s partner, the University of Oxford’s Jenner Institute, in collaboration with The King Abdullah International Medical Research Centre (KAIMRC), announced that it had started a Phase I clinical trial in the Kingdom of Saudi Arabia (KSA) for a vaccine against the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Vaccitech retains commercial rights to this vaccine. The trial will be the first Phase I clinical trial ever conducted in the KSA and will provide valuable clinical data. The trial is a collaboration between the Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC), funded by the Department of Health and Social Care.

November 8, 2019 - Study: Humoral Immunogenicity and Efficacy of a Single Dose of ChAdOx1 MERS Vaccine Candidate in Dromedary Camels.The vaccination reduced virus shedding and nasal discharge (p = 0.0059 and p = 0.0274). The vaccine enhanced antibody responses in seropositive camels; these camels had a higher average age than seronegative. Older seronegative camels responded more strongly to vaccination than younger animals, and neutralizing antibodies were detected in nasal swabs.

VTP-500 Clinical Trials

Clinical Trial NCT04170829: A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine. This research was funded by the Department of Health and Social Care (project number 16/107/01) as part of the UK Vaccine Network (UKVN), a UK Aid program to develop vaccines for diseases with epidemic potential in low and middle-income countries.

Findings: Between Dec 17, 2019, and June 1, 2020, 24 participants were enrolled (six to the low-dose, nine to the intermediate-dose, and nine to the high-dose group) and received a dose; 23 were available for follow-up at six months. The one dose of ChAdOx1 MERS vaccine was well tolerated with no serious adverse event reported during the six months of follow-up. Most adverse events were mild (67, 74%) and moderate (17, 19%). Six (7%) severe adverse events were reported by two participants in the intermediate-dose group (two feverish, two headache, one joint pain, and one muscle pain). Pain at the injection site was the most common local and overall adverse event, reported by 15 (63%) of the 24 participants. The most common systemic adverse event was headache, reported by 14 (58%), followed by muscle pain reported by 13 (54%). The vaccine-induced antibody and T cell immune responses in all volunteers; antibodies peaked at day 28, and T cell responses peaked at day 14 and continued until the end of follow-up at six months.

Clinical Trial NCT03399578: Suspended (The SARS-CoV-2 pandemic delayed recruitment but also provided an opportunity to apply findings from the rapid development of a ChAdOx1-vectored vaccine against SARS-CoV-2 to the further development of the MERS vaccine).

Findings: Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at six months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 1010 viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed unrelated to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered possibly, probably, or related to ChAdOx1 MERS were predominantly mild and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001). Laboratory adverse events considered at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralizing antibodies against live MERS-CoV was observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralization in a pseudotyped virus neutralization assay.

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).