MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax - LARVOL DELTA

Immunogenicity of second booster-dose COVID-19 mRNA vaccine among older adults in Taiwan. (PubMed, Biomed J) - "A second mRNA COVID-19 booster increased neutralizing antibodies and enhanced T cell responses against SARS-CoV-2 variants. Adapted vaccines targeting new subvariants are critical to strengthen immunity, particularly for older adults facing vaccine-resistant strains."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Hypermetabolism of Axillary Lymph Nodes Following COVID-19 Vaccination: A Longitudinal Follow-up and Comparison of Vaccines Utilizing Different Technologies (EANM 2024) - "A total of 668 patients vaccinated with ChAdOx1 nCoV-19, mRNA-1273, or MVC-COV1901 were included in the analysis... mRNA vaccines showed the highest incidence of HLN hypermetabolism, followed by virus vector vaccines, while spike protein vaccines had the lowest incidence. There was a notable negative correlation between metabolic avidity and the time elapsed since vaccination, suggesting a decrease in metabolic response over time."

Infectious Disease • Novel Coronavirus Disease • Oncology

Immunogenicity of COVID-19 Vaccine on Heterologous Schedule (clinicaltrials.gov) - P2 | N=100 | Completed | Sponsor: Chang Gung Memorial Hospital | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

MRNA VACCINES EXERT A BIPOLAR CLINICAL EFFECTIVENESS IN PATIENTS WITH RITUXIMAB-TREATED IMMUNE-MEDIATED INFLAMMATORY DISEASES OF VARYING DISEASE ACTIVITY STATUSES (EULAR 2024) - "Objectives: This study aims to explore the associations between the exposure mechanism of the SARS-CoV-2 vaccine and the outcomes of COVID-19 infection in IMID patients who have previously received RTX treatment...Using the National Immunization Information System (NIIS), the vaccination history of each patient was identified, and divided into three types: mRNA vaccines (BNT162b2/Pfizer–BioNTech and mRNA -1273/Moderna), protein-based vaccines (MVC-CoV1901/Medigen and NVX-CoV2373/Novavax), and adenoviral vectored vaccine (ChAdOx1/AstraZeneca)... mRNA vaccines protect against hospitalization in patients with higher serum albumin levels, but they are correlated with worse outcomes in patients with lower serum albumin levels. Albumin, being a negative acute-phase reactant, can serve as a marker of disease activity in patients with IMID. Vaccine effectiveness varies according to individual disease activity status."

Clinical • CNS Disorders • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

An Outline of the Immunogenic Potential of Progressing SARSCoV- 2 Vaccine Technologies among Children and Adolescents. (PubMed, Recent Pat Biotechnol) - "Currently, the WHO is analyzing emerging evidence to issue an emergency use list of vaccines for vaccinating children and adolescents."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Temporal changes in biomarkers of neutrophil extracellular traps and NET-promoting autoantibodies following adenovirus-vectored, mRNA, and recombinant protein COVID-19 vaccination. (PubMed, J Med Virol) - "The increased levels of citH3/MPO-DNA accompanied by NET-promoting autoantibodies suggest a potential connection between mRNA-1273/ChAdOx1-S vaccines and cardiovascular complications. These findings provide insights for risk assessments of future vaccines."

Biomarker • Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Thrombocytopenia • MPO

A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in Adults (clinicaltrials.gov) - P4 | N=220 | Completed | Sponsor: National Taiwan University Hospital | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Population-Based Evaluation of Vaccine Effectiveness against SARS-CoV-2 Infection, Severe Illness, and Death, Taiwan. (PubMed, Emerg Infect Dis) - "We also found 95.8% VE against hospitalization for 3 doses of BNT162b2, 91.0% for MVC-COV1901, 81.8% for mRNA-1273, and 65.7% for AZD1222, which had the lowest overall VE. Our findings indicated that protein subunit vaccines provide similar protection against SARS-CoV-2---associated hospitalization as mRNA vaccines and can inform mix-and-match vaccine selection in other countries."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The application of cardiac MRI in Myocarditis after COVID-19 vaccines: Case series from single medical center in Taiwan. (PubMed, J Chin Med Assoc) - "Cardiac MRI characterizes myocardial features such as edema, inflammation, and fibrosis, and has been proven to diagnose myocarditis accurately with a sensitivity of 87.5% and a specificity of 96.2% according to the 2018 Lake Louise criteria. This diagnosis was achieved without invasive procedures such as endomyocardial biopsy or coronary angiography."

Journal • Cardiovascular • Fibrosis • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability, and Immunogenicity of Booster Dose with MVC-COV1901 or MVC-COV1901-Beta SARS-CoV-2 Vaccine in Adults: A Phase I, Prospective, Randomized, Open-Labeled Study. (PubMed, Vaccines (Basel)) - "At four weeks after the booster dose, participants with two prior doses of MVC-COV1901 had higher levels of neutralizing antibodies against ancestral SARS-CoV-2, Beta, and Omicron variants than participants with three prior doses of MVC-COV1901, regardless of the type of booster used. MVC-COV1901 and MVC-COV1901-Beta can both be effectively used as booster doses against SARS-CoV-2, including the BA.4/BA.5 Omicron variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 in Adults Aged 18 Years and Above (clinicaltrials.gov) - P3 | N=250 | Completed | Sponsor: Medigen Vaccine Biologics Corp. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222 (clinicaltrials.gov) - P3 | N=200 | Completed | Sponsor: Medigen Vaccine Biologics Corp. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Risk reduction analysis of mix-and-match vaccination strategy in healthcare workers during SARS-CoV-2 Omicron variant predominant period: A multi-center cohort study in Taiwan. (PubMed, Hum Vaccin Immunother) - "This study investigated the relative effectiveness of a mix-and-match vaccination strategy, primarily comprising ChAdOx1 nCOV-19, mRNA-1273, BNT162b2, and a protein-based vaccine, MVC-COV1901, against COVID-19 in a healthcare worker (HCW) cohort in Taiwan during a period when the Omicron variant was predominant...Secondly, for HCWs receiving an mRNA-1273 booster, compared to those receiving ChAdOx1 nCOV-19 as the primary series, mixed primary series and homologous mRNA-1273 primary series were associated with a higher (Adj HR 1.144; 95% CI 1.021‒1.282, P = .021) and lower risk (Adj HR 0.735; 95% CI 0.671‒0.805, P < .001) of acquiring infection, respectively. Our study demonstrated that mix-and-match vaccination strategy may be associated with different level of risk reduction in acquiring infection, and sizable, prospective studies are encouraged to further elucidate our observation."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study. (PubMed, J Formos Med Assoc) - P4 | "Our results show that heterologous boost with MVC-COV1901 yielded an inferior immunogenicity but significantly fewer adverse events, compared with homologous boost with mRNA-1273. In people experienced severe adverse events after prime dose of mRNA-1273, as well as in periods when the supply of mRNA-1273 is limited, MVC-COV1901 could serve as an acceptable alternative heterologous boost."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial. (PubMed, Vaccine) - P2 | "Overall, MVC-COV1901 as a booster showed the best safety profiles. MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Achievements of COVID-19 vaccination programs: Taiwanese perspective. (PubMed, J Formos Med Assoc) - "It has shown a good safety profile, with promising neutralizing antibody titers against SARS-CoV-2. Given the global pandemic due to emerging novel variants of SARS-CoV-2, booster COVID-19 vaccines and appropriate intervals between booster doses need to be investigated."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

How Taiwan has responded to COVID-19 and how COVID-19 has affected Taiwan, 2020-2022. (PubMed, J Microbiol Immunol Infect) - "However, COVID-19 exhibited some adverse impacts on the healthcare systems, such as emergency medical service on out of hospital cardiac arrest, cancer screening, HIV screening and prevention services, and public health, namely the psychosocial status of healthcare workers. Although the outbreak of SARS-CoV-2 infections may gradually subsided, we should keep monitoring its associated impact and appropriately response to this pandemic."

Journal • Review • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Humoral and cellular immunity in three different types of COVID-19 vaccines against SARS-CoV-2 variants in a real-world data analysis. (PubMed, J Microbiol Immunol Infect) - "This study compared memory T cells, total spike-binding antibody levels, and neutralizing capacity against WT, Delta, and Omicron variants between the MVC vaccine and the widely used Moderna and AZ vaccines, which provides valuable information for future vaccine development strategies."

Journal • Real-world • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Acute reactions after a homologous primary COVID-19 vaccination series: Analysis of Taiwan V-Watch data. (PubMed, Vaccine) - "Acute reactogenicity and impact of work absenteeism for the four COVID vaccines in the V-Watch survey were mild and of short duration."

Journal • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19 (clinicaltrials.gov) - P2 | N=804 | Completed | Sponsor: Medigen Vaccine Biologics Corp. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Medigen COVID-19 protein vaccine. (PubMed, Vaccine) - "This article uses the BRAVATO template to review the features of the MVC-COV1901 vaccine, a recombinant protein subunit vaccine based on the stabilized pre-fusion SARS-CoV-2 spike protein S-2P, adjuvanted with CpG 1018 and aluminum hydroxide, manufactured by Medigen Vaccine Biologics Corporation in Taiwan...The main clinical trials include placebo-controlled phase 2 studies in healthy adults (CT-COV-21), adolescents (CT-COV-22), and elderly population (CT-COV-23) as well as 3 immunobridging phase 3 trials (CT-COV-31, CT-COV-32, and CT-COV-34) in which MVC-COV1901 was compared to AZD1222...Antigen-specific T-cell responses, particularly a Th1-biased immune response characterized by high levels of interferon gamma and IL-2 cytokines, have also been observed. Coupled with this, MVC-COV1901 has favorable thermostability and better safety profiles when compared to other authorized vaccines from different platforms, which make it potentially a good candidate for vaccine supply..."

Benefit-risk assessment • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19 (clinicaltrials.gov) - P1 | N=107 | Completed | Sponsor: Medigen Vaccine Biologics Corp. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222 (clinicaltrials.gov) - P3 | N=250 | Active, not recruiting | Sponsor: Medigen Vaccine Biologics Corp. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

REAL-WORLD EFFECTIVENESS OF mRNA, SUBUNIT, AND VECTOR-BASED VACCINES AGAINST COVID-19 (CROI 2023) - "BNT162v2 (Pfizer-BioNTech), mRNA-1273 (Moderna), AZD1222 (AstraZeneca), and locally produced MVC-COV1901 (Medigen) are provided under the National Vaccination Program... Individuals who received their primary series as AZD1222 might not have adequate protection against Covid-19 severity so encourage those vulnerable groups to receive additional booster doses. The study also indicated that protein subunit vaccines provide similar protection against severity and death as mRNA vaccines. Vaccine Effectiveness and Severity and Death Incidence Rate by Vaccine Type and Mix-and-Match Groups"

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COMPARISON OF THE EFFECTIVENESS OF DIFFERENT COVID-19 VACCINES AMONG PLWH (CROI 2023) - "Different types of COVID-19 vaccines were available in the vaccination program, including BNT162b2, mRNA-1273 (either 50 or 100 μg), MVC-COV1901 and NVX-CoV2373 vaccines... Our study demonstrated that clinical effectiveness of the third dose of different vaccines available to PLWH was similar in preventing SARS-CoV-2 infection or seroconversion of anti-N IgG Taiwan. PLWH aged less than 50 years and those with newly diagnosed HCV infection were at higher risk of acquiring COVID-19."

Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases