QazVac (inactivated coronavirus vaccine) / Research Institute for Biological Safety Problems - LARVOL DELTA

Impact of QazVac vaccination on clinical manifestations and immune responses in post-COVID syndrome: a cross-sectional study. (PubMed, Front Med (Lausanne)) - "A sharp decrease in the frequency of neurological, gastrointestinal, respiratory, and rheumatological symptoms was recorded in vaccinated patients, advocating for the protective role of vaccination against long COVID-19 sequelae. These findings highlight the potential for vaccination to mitigate the burden of post-COVID complications across various organ systems."

Journal • Observational data • Cardiovascular • CNS Disorders • Depression • Diabetes • Gastrointestinal Disorder • Hypertension • Infectious Disease • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Novel Coronavirus Disease • Orthopedics • Pain • Psychiatry • Respiratory Diseases • Rheumatology

Immune reactivity of two biological models to vaccination with inactivated vaccine QazVac against coronavirus infection COVID-19. (PubMed, Vopr Virusol) - "The data obtained indicate that the immune reactivity of white mice to the administration of the QazVac vaccine in terms of the rate and dynamics of the formation of virus-neutralizing antibodies is approximately equivalent to the immune reactivity of Syrian hamsters. Before immunization with the vaccine, SPF white mice, in contrast to Syrian hamsters, do not have humoral immunity specific to the SARS-CoV-2 virus. The immune reactivity equivalent to that observed of Syrian hamsters and the absence of antibodies to the SARS-CoV-2 virus at a baseline indicate the superiority of the use of white mice in assessing the immunogenicity of vaccines against COVID-19 and/or obtaining specific factors of humoral immunity."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Attitude toward vaccination against COVID-19 and acceptance of the national "QazVac" vaccine in the Aktobe city population, West Kazakhstan: A cross-sectional survey. (PubMed, PLoS One) - "History and severity of COVID-19 disease did not play a role in positive perceptions of vaccination, while illness after vaccination substantially affected vaccination approval (p 0.021). No significant differences have been observed regarding the overall performance across five vaccines (QazVac, Sputnik V, CoronaVac, Hayat-Vax, and BioNTech/Pfizer) available for Kazakhstan's population (p 0.27)."

Journal • Infectious Disease • Novel Coronavirus Disease

Safety Assessment: a Comparative Analysis of Quantitative Content of Bacterial Endotoxins and Evaluation of Pyrogenicity of the Kazakhstan Vaccine QazCovid-in® against COVID-19. (PubMed, Bull Exp Biol Med) - "Administration of BVP with LPS resulted in a dose-dependent increase in body temperature in rabbits similar to that caused by LPS alone, which suggests that aluminum hydroxide in the vaccine did not affect the pyrogenic response in rabbits. Moreover, the LAL test showed that the aluminum hydroxide did not hinder LPS activity after serial dilution of samples."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of the first Kazakh inactivated vaccine for COVID-19. (PubMed, Hum Vaccin Immunother) - "A comparative GMT assessment after the first immunization and the re-immunization identified significant differences between model animal groups and a growth of GMT antibodies in all of them; also, differences between the gender groups were statistically significant. Moreover, the most marked MNA immune response to the QazCovid-in® vaccine was seen in the Syrian hamsters, while their SARS-CoV-2-specific antibody activity as assessed with ELISA was the lowest."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and safety of an inactivated whole-virion vaccine against COVID-19, QazCovid-in®, in healthy adults: A multicentre, randomised, single-blind, placebo-controlled phase 3 clinical trial with a 6-month follow-up. (PubMed, EClinicalMedicine) - P3 | "The work was funded by the Science Committee of the Ministry of Education and Science of Kazakhstan within the framework of the Scientific and Technical Program "Development of a vaccine against coronavirus infection COVID-19". State registration number 0.0927."

Journal • P3 data • Cardiovascular • Congestive Heart Failure • Heart Failure • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development of the Inactivated QazCovid-in Vaccine: Protective Efficacy of the Vaccine in Syrian Hamsters. (PubMed, Front Microbiol) - "After challenge infection, 100% of unvaccinated hamsters showed clinical symptoms (stress state, passivity, tousled coat, decreased body temperature, and body weight, and the development of acute pneumonia), with 25 ± 5% dying. These findings pave the way for testing the candidate vaccine in clinical human trials."

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

Safety and immunogenicity of a QazCovid-in® inactivated whole-virion vaccine against COVID-19 in healthy adults: A single-centre, randomised, single-blind, placebo-controlled phase 1 and an open-label phase 2 clinical trials with a 6 months follow-up in Kazakhstan. (PubMed, EClinicalMedicine) - P1/2 | "The results of this study serve as the rationale for the phase 3 study. The QazCovid-in® vaccine is safe and well-tolerated and promotes pronounced humoral immunity which lasts for at least 6 months after double intramuscular immunisation."

Clinical • Journal • P1 data • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P3; N=3000; Completed; Sponsor: Research Institute for Biological Safety Problems; Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P1/2; N=244; Completed; Sponsor: Research Institute for Biological Safety Problems; Trial completion date: Nov 2020 ➔ Apr 2021

Clinical • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P3; N=3000; Active, not recruiting; Sponsor: Research Institute for Biological Safety Problems; Trial primary completion date: Mar 2021 ➔ Jul 2021

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P3; N=3000; Active, not recruiting; Sponsor: Research Institute for Biological Safety Problems; Enrolling by invitation ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Kazakhstan To Roll Out First Locally Produced Sputnik Vaccine (The Moscow Times) - "Kazakhstan will be the first country in the world to locally produce Russia's Sputnik V coronavirus vaccine after a pharmaceutical company received government authorization to make the jab...The company, called the Karaganda Pharmaceutical Complex (KPC), 'was granted certification' to produce the vaccine by Kazakhstan's health ministry...The government has said it plans to inoculate 6 million citizens by the end of the year, with parallel mass vaccinations using a Kazakh-made jab called QazCovid-in expected to begin next month."

Commercial • Infectious Disease • Novel Coronavirus Disease

Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P1/2; N=244; Completed; Sponsor: Research Institute for Biological Safety Problems; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease

Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P3; N=3000; Enrolling by invitation; Sponsor: Research Institute for Biological Safety Problems

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease

Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P1/2; N=244; Active, not recruiting; Sponsor: Research Institute for Biological Safety Problems; Enrolling by invitation ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P1/2; N=244; Enrolling by invitation; Sponsor: Research Institute for Biological Safety Problems; Trial completion date: Apr 2021 ➔ Dec 2020

Clinical • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine (clinicaltrials.gov) - P1/2; N=244; Enrolling by invitation; Sponsor: Research Institute for Biological Safety Problems; Recruiting ➔ Enrolling by invitation

Clinical • Enrollment status • Infectious Disease • Novel Coronavirus Disease