CoviVac / Chumakov Centre - LARVOL DELTA

Effect of inactivated whole-virion concentrated purified vaccine for the prevention of COVID-19 on clinical and biochemical blood parameters of immature rats (PubMed, Vopr Virusol) - "The safety of the CociVac vaccine in relation to clinical and biochemical blood parameters has been demonstrated."

Journal • Preclinical • Hematological Disorders • Infectious Disease • Leukopenia • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases • Thrombocytopenia

Development and Clinical Validation of a Skin Test for In Vivo Assessment of SARS-CoV-2 Specific T-Cell Immunity. (PubMed, Viruses) - "An integrated clinical analysis included 374 volunteers stratified by vaccination status (EpiVacCorona, Gam-COVID-Vac, CoviVac) prior to COVID-19 infection (Wuhan/Alpha, Delta, Omicron variants), and SARS-CoV-2-naïve controls...047119). Its high safety profile and consistent performance across diverse cohorts support its utility for mass screening and monitoring of cellular immune protection following infection or vaccination."

Journal • Preclinical • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (Phase 1) (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam | Phase classification: P1/2 ➔ P1 | N=420 ➔ 120

Enrollment change • Phase classification • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial. (PubMed, Vaccine) - "NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Considering that induction of neutralising antibodies against SARS-CoV-2 has been correlated with the efficacy of COVID-19 vaccines, including VAXZEVRIA, our results suggest that vaccination with COVIVAC may afford clinical benefit matching or exceeding that of the VAXZEVRIA vaccine. ClinicalTrials.govNCT05940194."

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

Inactivated whole virion vaccine protects K18-hACE2 Tg mice against Omicron SARS-CoV-2 variant via cross-reactive T cells and non-neutralizing antibody responses. (PubMed, Eur J Immunol) - "Multiple vaccines against Wuhan variant of SARS-CoV-2 have been developed including a whole virion beta-propiolactone-inactivated vaccine based on B.1.1 strain (CoviVac)...Subsequently, vaccinated K18-hACE2 Tg mice rapidly cleared the infection via cross-reactive T cell responses and cross-reactive, non-neutralizing antibodies recognizing Omicron variant Spike protein. Thus, our data indicate that efficient protection from SARS-CoV-2 variants can be achieved by the orchestrated action of cross-reactive T cells and non-neutralizing antibodies."

Journal • Preclinical • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of Inactivated Whole Virion COVID-19 Vaccine CoviVac in Clinical Trials in 18-60 and 60+ Age Cohorts. (PubMed, Viruses) - "We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial phase I/II of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in volunteers aged 18-60 and open multi-center comparative phase IIb clinical trial in volunteers aged 60 years and older. In participants who were seropositive at screening and had nAB titers below 1:256, a single vaccination led to a fourfold increase in nAB levels in 85.2% of cases. These findings indicate that CoviVac can be successfully used both for primary vaccination in a two-dose regimen and for booster vaccination as a single dose in individuals with reduced neutralizing antibody levels."

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

NDV-HXP-S Vaccine Clinical Trial (COVIVAC) (clinicaltrials.gov) - P2 | N=374 | Completed | Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam

New P2 trial • Infectious Disease • Novel Coronavirus Disease

An Open Comparative Study of the Effectiveness and Incomparable Study of the Immunogenicity and Safety of the Vaccine (CoviVac) for Adults Aged 60 Years and Older (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive" (clinicaltrials.gov) - P3 | N=300 | Active, not recruiting | Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

New P3 trial • Infectious Disease • Novel Coronavirus Disease

An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) (clinicaltrials.gov) - P3 | N=29000 | Recruiting | Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

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

Microarray Profiling of Vaccination-Induced Antibody Responses to SARS-CoV-2 Variants of Interest and Concern. (PubMed, Int J Mol Sci) - "Microarray-based profiling of vaccinated donors revealed a substantial difference in anti-VOC Ab levels elicited by the replication-deficient adenovirus vector-base (Sputnik V) and whole-virion (CoviVac Russia COVID-19) vaccines...Importantly, all samples were collected in the pre-Omicron period but showed noticeable responses to the receptor-binding domain (RBD) of the Omicron spike protein. Thus, using the new express Ab-profiling system, we confirmed the inter-variant cross-reactivity of the anti-SARS-CoV-2 Abs and demonstrated the relative potency of the vaccines against new VOCs."

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

An ELISA Platform for the Quantitative Analysis of SARS-CoV-2 RBD-neutralizing Antibodies As an Alternative to Monitoring of the Virus-Neutralizing Activity. (PubMed, Acta Naturae) - "The highest RBD-neutralizing activity was observed in the group of hospitalized patients. The protective effect in the group of individuals vaccinated with Gam-COVID-Vac vaccine was 25% higher than that in outpatients and almost four times higher than that in individuals vaccinated with the CoviVac vaccine."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Gam-COVID-Vac, EpiVacCorona, and CoviVac effectiveness against lung injury during Delta and Omicron variant surges in St. Petersburg, Russia: a test-negative case-control study. (PubMed, Respir Res) - P=N/A | "Gam-COVID-Vac remained effective against lung injury associated with COVID-19 during Delta and Omicron VOC surges, and one Gam-COVID-Vac booster could be seen as an appropriate option after a two-dose regimen. CoviVac was also effective against lung injury. EpiVacCorona use in population-based vaccination should be halted until effectiveness and efficacy evidence is provided. Trial registration The joint study of COVID-19 vaccine effectiveness in St. Petersburg was registered at ClinicalTrials.gov (NCT04981405, date of registration-August 4, 2021)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 vaccines effectiveness against symptomatic SARS-CoV-2 during Delta variant surge: a preliminary assessment from a case-control study in St. Petersburg, Russia. (PubMed, BMC Public Health) - "Our preliminary results show that in contrast to other Russian vaccines, Gam-COVID-Vac is effective against symptomatic SARS-CoV-2 infection caused by Delta VOC. Effectiveness is likely higher than the estimated 56% due to bias arising from high prevalence of the past COVID-19 in St. Petersburg."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immune responses to inactivated vaccine against COVID-19 (CoviVac) in adults’ individuals (IVC-MG 2022) - "There were no observed clinically significant deviations of blood biochemical parameters from their normal values both before and after vaccination. The studied inactivated vaccine "CoviVac" has shown a sufficient level of safety, immunogenicity and effectiveness."

Clinical • Cough • Fatigue • Human Immunodeficiency Virus • Immunology • Infectious Disease • Novel Coronavirus Disease • Otorhinolaryngology • Pain • Respiratory Diseases • CRP

SAFETY OF COVID-19 VACCINES IN PATIENTS WITH RHEUMATOID ARTHRITIS (PRELIMINARY DATA). (EULAR 2022) - "103 patients received disease-modifying antirheumatic drugs (54 - methotrexate, 30 - leflunomide, 10 - hydroxychloroquine, 8 - sulfasalazine, 1 - mofetil mycophenolate), 68 - biological drugs (58 - rituximab, 5 – TNF-α inhibitors, 4 - abatacept, 1 - tocilizumab), 64 - glucocorticoids, 10 - did not receive therapy...In the control group, 91 were vaccinated with Sputnik V, 16 with CoviVac, 6 with BNT162b2, 5 with Sputnik Light, 2 with EpiVacCorona, 1 with mRNA-1273 (114 participants received two components of the vaccine)... According to preliminary data, the tolerance of vaccines against COVID-19 in RA patients is satisfactory. Further studies are needed to study the safety, immunogenicity and clinical efficacy of immunization against COVID-19 in patients of this cohort."

Clinical • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Novel Coronavirus Disease • Orthopedics • Pain • Rheumatoid Arthritis • Rheumatology

SAFETY OF VACCINES AGAINST COVID-19 IN PATIENTS WITH SPONDYLOARTHRITIS (PRELIMINARY DATA). (EULAR 2022) - "Objectives: To study the safety of COVID-19 vaccines in patients with SpA in real clinical practice...20 patients received disease-modifying antirheumatic drugs (12 - methotrexate, 8 - sulfasalazine), 10 - biological drugs (8 – TNF-ɑ inhibitors, 2 - IL-17 inhibitors), 6 - glucocorticoids, 1 - tofacitinib, 12 - only nonsteroidal anti-inflammatory drugs, 8 - did not receive therapy...In the control group 69 were vaccinated with Sputnik V, 15 - CoviVac, 5 - Sputnik Light and BNT162b2, 2 - EpiVacCorona, 1 - mRNA-1273... According to preliminary data, the tolerability of vaccines against COVID-19 in patients with SpA is satisfactory. Further studies with an increased sample are needed to study the safety, immunogenicity and clinical efficacy of immunization against COVID-19 in patients of this cohort."

Clinical • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) (clinicaltrials.gov) - P3 | N=29000 | Recruiting | Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 (clinicaltrials.gov) - P1/2; N=400; Completed; Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products; Active, not recruiting ➔ Completed

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

This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 (clinicaltrials.gov) - P1/2; N=400; Active, not recruiting; Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies. (PubMed, Emerg Microbes Infect) - "Robustness of the manufacturing process was demonstrated as well. These data encouraged further evaluation of CoviVac in clinical trials."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines. (PubMed, Diagnostics (Basel)) - "The remaining five (Convidicea (AD5-nCOV); Johnson & Johnson (Ad26.COV2.S); Sinopharm (BBIBP-CorV); Covaxin (BBV152), and Sinovac (CoronaVac)) were discussed based on their immunogenicity, and safety reported by the recipients since only phases 1 and 2 were conducted without clear evidence published regarding their efficacy. CoviVac and EpiVacCorona have just been approved, which is why no published article could be found. All adverse events reported following the administration of one of the four vaccines ranged from mild to moderate; limited exceptions in which the patients either developed severe forms or died, because most effects were dose-dependent. It can be concluded that aforementioned vaccines are efficient and safe, regardless of age and sex, being well-tolerated by the recipients."

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

Russia approves its third COVID-19 vaccine: PM (Reuters) - "Russia on Saturday approved a third coronavirus vaccine for domestic use, Prime Minister Mikhail Mishustin said on state TV. The first 120,000 doses, labelled CoviVac and produced by the Chumakov Centre in St. Petersburg, will be released for domestic use in March, he added."

Non-US regulatory • Infectious Disease • Novel Coronavirus Disease