Научно-Исследовательский Институт Проблем Биологической Безопасности

THE RECEPTION OF QUESTIONNAIRES OF VOLUNTEERS TO PARTICIPATE IN CLINICAL TRIALS OF THE KAZAKHSTANI QAZCOVID-IN®-COVID-19 INACTIVATED VACCINE, DEVELOPED AT RIBSP HAS BEGUN

The Research Institute for Biological Safety Problems of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan (RIBSP) is recruiting volunteers who will take part in the study of a coronavirus vaccine.

The study will be conducted at the clinical base of the National Scientific Center for Phthisiopulmonology. The age of the volunteers who can take part in the vaccine trial is from 18 to 50 years old, all participants must be in excellent health.

What are the requirements for volunteers:

No history of COVID-19 diagnosis. In addition, in the last 14 days from the start of the study, volunteers should not be in close contact with people who have laboratory-confirmed coronavirus or suspected of being infected. Also, according to the rules of the study, participants should not have chronic infections and any allergic reactions. People with alcohol and drug addiction, mental disorders, serious endocrine and kidney disorders will not be allowed to take part in the tests. Volunteers should not be registered with chronic heart and circulatory system diseases. Pregnant and lactating women will also not be able to participate in the study.

Everyone who is admitted to vaccination must sign a voluntary informed consent, keep a daily self-observation diary and visit a doctor on time for several weeks. Each participant of the study will be provided with insurance.

You can get acquainted with the list of indications and contraindications in more detail after submitting an application. Professor B.M. Khairullin was appointed the main researcher from RIBSP.

Please send preliminary questionnaires to

https://docs.google.com/forms/d/e/1FAIpQLScETOtVoRuKuOBkueiuM077hIRHkf3FpctuA9qibguNi19FUQ/viewform?vc=0&c=0&w=1&flr=0

This questionnaire is intended for the selection of volunteers who are ready to take part in clinical trials of the QazCovid-in® COVID-19 inactivated vaccine.

All information collected using this questionnaire is confidential, protected by the legislation of the Republic of Kazakhstan on the protection of personal data, is not subject to disclosure without your consent, and can only be used for the purpose of conducting clinical trials of the Kazakhstani QazCovid-in®COVID-19 inactivated vaccine.

Recall that the World Health Organization (WHO) has included the Kazakhstan inactivated coronavirus vaccine in the list of candidate vaccines admitted to clinical trials. The domestic vaccine is now in phase 1/2 of clinical trials.

The Kazakhstan QazCovid-in® – COVID-19 inactivated vaccine is registered by WHO as a candidate vaccine for Phase I and II clinical trials. This was reported on the official website of the WHO. A total of 33 candidate vaccines from 19 countries are in clinical trials

Draft landscape of COVID-19 candidate vaccines

COVID-19 DOMESTIC VACCINE DEVELOPED AT RIBSP IS OFFICIALLY APPROVED BY THE WORLD HEALTH ORGANIZATION (WHO) TO CLINICAL TRIALS

The World Health Organization (WHO) has officially included our domestic inactivated vaccine, developed by scientists of our Institute, into the list of vaccines approved for clinical trials.

Kazakhstan vaccine with inactivated virus is in phase 1/2 of clinical trial.

The list of vaccines officially approved for clinical trials by WHO also includes 33 vaccines developed by companies or research institutes from 19 countries of the world, such as Great Britain, China, Russia, USA, Germany, Japan, India, South Korea, Belgium, Sweden, Singapore, Italy, Australia, Taiwan, Cuba, France, Austria, and Canada.

Since September this year clinical trials of the vaccine will begin on 244 volunteers, 44 of whom will receive the vaccine in the first phase of clinical trials, the rest – in the second.

Draft landscape of COVID-19 candidate vaccines

KAZAKHSTAN VACCINE IS READY FOR TESTING ON VOLUNTEERS

Preclinical studies of the Kazakhstan inactivated COVID-19 vaccine developed by the Research Institute for Biological Safety Problems (RIBSP) of SC MES RK on the basis of the pharmacological testing laboratory of the territorial branch of the National Center for Expertise of Medicines and Medical Devices (NCEM) in Almaty have been completed. According to the ministry, the specified vaccine was created on the basis of a virus strain isolated from patients in Kazakhstan. MIA “Kazinform” and the press center “Sputnik Kazakhstan” reported this on their websites.

“The vaccine has been thoroughly tested for safety and toxic effects on the body of animals when administered in large doses. In addition, within the framework of this study, the absence of an allergic reaction and irritation at the injection site was established. In addition to general research methods, the level of safety of the vaccine was confirmed by hematological and biochemical blood parameters. The impact of the vaccine on the functioning of the internal organs of animals was also assessed” the statement reads.

As noted, the results of the preclinical stage of the study showed that the domestic COVID-19 vaccine is not toxic and can be used in human volunteers in further clinical trials.

The press service of the National centre explained that all the experiments were carried out in the own vivarium of the NCEM on different types of experimental animals. The laboratory for pharmacological research has the status of international accreditation of the Slovak National Accreditation Service (SNAS) for compliance with GLP OECD and is the only laboratory in Kazakhstan to conduct bioequivalence studies.

Earlier, the World Health Organization (WHO) registered the development of Kazakh scientists and included it in the list of COVID-19 candidate vaccines, which are allowed for preclinical studies.

On August 1, 2020, it became known that the second Kazakhstani subunit COVID-19 vaccine of RIBSP was successfully registered on the WHO website as a candidate vaccine.

On July 26, 2020, 7 vaccine developers voluntarily tested the vaccine on themselves to ensure their own safety when working with a live virus.

In mid-October 2020, it is planned to enter the II phase of clinical trials on 200 volunteers who meet the WHO requirements. Phase II clinical trials should be completed in December 2020.

CONSTRUCTION OF A 60-APARTMENT RESIDENTIAL HOUSE FOR SCIENTISTS OF RSE “RESEARCH INSTITUTE FOR BIOLOGICAL SAFETY PROBLEMS” OF THE SCIENCE COMMITTEE OF THE MINISTRY OF EDUCATION AND SCIENCE OF THE REPUBLIC OF KAZAKHSTAN

In early June this year, the Prime Minister of the Republic of Kazakhstan Askar Uzakpaevich Mamin visited the RSE ” Research Institute for Biological Safety Problems” of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan on a working visit. One of the instructions of the Prime Minister during the working trip was the construction of a 60-apartment residential building for the scientists of the Institute.

On August 01, 2020, the construction of a 60-apartment residential building for the scientists of the Institute in the urban-type settlement of Gvardeisky began.

Customer: “Construction Department of Akimat of Zhambyl Region”

Contractor: “Базис ДорСтрой” LLP

Designer: “Табыс Жоба” LLP, ГСЛ-ПИР №1059

Technical supervision: “DACO Инжиниринг” LLP

 Start of construction: August 01, 2020

End of construction: December 31, 2020

 The construction of this residential building will allow solving the housing problem for the retention of scientists and specialists, as well as attracting young specialists.

SCIENTISTS FROM THE RESEARCH INSTITUTE FOR BIOLOGICAL SAFETY PROBLEMS TESTED OWN COVID-19 VACCINE ON THEMSELVES

At the Scientific Research Institute for Biological Safety Problems of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan (hereinafter – RIBSP), on July 26, 2020, five scientists-developers headed by Director General Zakarya K.D. were vaccinated with QazCovid-in – own inactivated COVID-19 vaccine and the next day after observing the vaccinated employees and receiving information that the vaccine was safe, 2 more employees were vaccinated (doctors of science, professors: Kutumbetov L.B. (the first received the vaccine) , Khairullin B.M., Orynbayev M.B., Sultankulova K.T., Abdurayimov Ye.O., Nurabayev S.Sh.). Vaccination made it possible to fully reproduce the I/II phase of the planned clinical trials of the QazCovid-in®-inactivated COVID-19 vaccine, developed in the RIBSP.

Vaccination was necessary for the complete epidemiological protection of NIIPBB researchers who are directly carrying out research work on the development of technology for the manufacture and testing of the first domestic vaccine against COVID-19. In the event of a natural contamination of these researchers with COVID-19, the Institute would be deprived of the most valuable specialists, performing the most important state task of developing a domestic vaccine for a long time.

Vaccination with your own vaccine is an unspoken scientific standard of developers of medical and immunobiological preparations, when the developer, first of all, must investigate the safety and immunogenicity of his own development, and secondly, take full responsibility for the results and quality of his research, thus, ensuring the safety of future volunteers who will take part in clinical trials.

Vaccinated employees are monitored daily. As of 4 August 2020, all vaccinated employees are clinically healthy, demonstrating the safety of the vaccine. Studies of biochemical and hematological analysis of blood and urine are carried out, as well as the level of antibodies in blood serum by ELISA and in the neutralization reaction.

As a result of the vaccination carried out before the start of clinical trials, vaccine developers receive valuable information about the safety and immunogenicity of the vaccine when immunizing the population of the Republic of Kazakhstan in comparison with the results of preclinical tests of the vaccine on laboratory animals.

One of the latest examples of vaccination of developers with their own vaccine is vaccination of employees of Vector STU in Novosibirsk and the Research Institute of Epidemiology and Microbiology after Gamaley, Moscow. Russian scientists have vaccinated employees of their institutes with vaccines against Covid-19, developed by these scientific centers before the official start of clinical trials.

AKIM OF ZHAMBYL REGION SAPARBAYEV BERDIBEK MASHBEKOVICH VISITED RSE “RESEARCH INSTITUTE FOR BIOLOGICAL SAFETY PROBLEMS” SC MES RK WITH WORKING VISIT

On August 03, 2020 Akim of Zhambyl region Saparbayev B.M. accompanied by the Akim of the Kordai region and other representatives of the akimats of the Zhambyl oblast, the Kordai region, «КА-СТРОЙ», «Град-Центр» LLP and others, visited the RSE RIBSP.

During the visit, the construction site for the project “Construction of a 60-apartment building for RIBSP employees”, the construction site for the project “Construction of a biopharmaceutical plant for the production of immunobiological drugs that meet the requirements and standards of Good Manufacturing Practice (GMP) at the RIBSP SC MES RK” were inspected.


Also, the Laboratory for Especially Dangerous Infectious Diseases and the Laboratory for Monitoring Infectious Diseases, which are currently working on the development of a COVID-19 coronavirus infection vaccine, were presented to the Akim of Zhambyl region.

After the inspection, a meeting of the headquarters for the construction of the biopharmaceutical plant was held.

During his visit, Akim of Zhambyl region Saparbayev B.M. noted that “the timely delivery of the biopharmaceutical plant is a matter of life and death, since the vaccine produced at the plant can save thousands of lives of citizens of the Republic of Kazakhstan. The development of a coronavirus infection vaccine will be the property and pride of the people.” On the question of the General Director of the RSE RIBSP about the current difficult situation with the supply of reagents for research, Akim of Zhambyl region Saparbayev B.M. replied that he would send a letter to the interdepartmental commission for consideration.

In turn, the general director of the RSE RIBSP Zakarya K.D. noted that RIBSP is ready to deliver vaccines the next month after the construction of the plant by the builders. At present, with the permission of the Ministry of Health of the Republic of Kazakhstan, RIBSP is ready to supply 2 million doses of vaccine up to the end of 2020 without a plant, and with the operation of the plant – several tens of million doses.

Also, during a visit by the Akim of the Zhambyl region Saparbayev B.M. a number of tasks were set to individual representatives of akimats, construction companies, design companies and RSE RIBSP.

THE SECOND KAZAKHSTAN COVID-19 VACCINE REGISTERED BY WHO AS A CANDIDATE

On July 31, 2020, the second Kazakhstan vaccine of the RSE “Research Institute for Biological Safety Problems” of the SC MES RK was successfully registered on the website of the World Health Organization (WHO) as a candidate vaccine. This subunit vaccine, developed on the basis of the surface proteins of the virus, is absolutely harmless and safe. (https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines)

Registration of our vaccines with WHO means that our vaccines are included in the list of vaccine candidates and are approved for preclinical testing in animals.

At this time, RIBSP scientists have already begun preclinical trials of the second vaccine. In case of good results, human clinical trials will be carried out. Then the vaccines must be registered with the Ministry of Health, and only then can the vaccine be used to vaccinate people.

It should be noted that the first inactivated vaccine was registered on the WHO website on May 15 this year. To day, it passed preclinical testing. At present, the inactivated vaccine developed by RIBSP scientists has been sent to the National Center for Expertise of Medicines, and expert work is being carried out on it. After the positive decisions on the examination are received, the package of documents will be sent for approval to the Ministry of Health for clinical trials on humans.

RIBSP has gained high scientific and practical experience in the development and production of various types of vaccines used in medicine. In collaboration with WHO, RIBSP has developed four types of vaccines for health care. There is a modern scientific, technical, technological base and highly qualified personnel, which make it possible to solve problems related to the development, testing and provision of the country with a domestic drug that is not inferior in efficiency to foreign analogues.

Both vaccines were developed in the frame of the implementation of the scientific and technical program “Development of a COVID-19 coronavirus infection vaccine”, RIBSP celebrates the high achievement of its scientists and expresses gratitude to:

– manager of the program, professor Orynbayev M.B., co-manager of the program, Dr. of biol. sc. Zakarya K.D.

– responsible executors of the program: Dr. of vet. sc. Kutumbetov L.B., professor Khairullin B.M.

– project managers: professor Sultankulova K.T., PhD Zhugunissov K.D., Dr. of vet. sc. Abduraimov Ye.O., professor Kassenov M.M., cand. of biol. sc. Chervyakova O.V., s-r res-r Nurpeisova A.S., cand. of vet. sc. Nurabayev S.Sh., cand. of med. sc. Nakhanov A.K., cand. of med. sc. Asanzhanova N.N., PhD Burashev E.D., s-r res-r Rystayeva R.A., Taylakova E.T.

– performers: s-r res-r Kerimbayev A.A., res-r Kopeyev S.K., res-r Shoraeva K.A., res-r Akylbayeva K.K., res-r Dzhekebekov K.K., j-r res-r Abitayev R.T., lab. ass-nt Chukayeva T.S. and many of our other employees.

VIDEOCONFERENCE WITH DUKE-NUS SCHOOL OF MEDICINE (SINGAPORE) ON PRECLINICAL AND CLINICAL TRIALS OF THE COVID-19 VACCINE

On July 28, 2020, within the framework of international cooperation, an online video conference was held between the RSE RIBSP MES RK and the DUKE-NUS School of Medicine (Singapore). The conference was held in the format of consultations and recommendations regarding clinical and preclinical trials of COVID-19 vaccine.

The online conference was attended by professors and scientists from RIBSP – Abdurayimov Ye.O., Orynbayev M.B., Kutumbetov L.B., Khairullin B.M., Sultankulova K.T., Chervyakova O.V. and etc.

Dr. Ooi Eng Eong, Head of the Laboratory Research Group at DUKE-NUS School of Medicine spoke about the development process of the COVID-19 vaccine, the volume and number of doses in preclinical and clinical trials, the number of volunteers taking part in them, etc.

At the end of the online conference, the parties thanked each other for the opportunity and expressed hope for further fruitful cooperation.

 

ESTABLISHMENT OF A NEW COLLECTIVE USE LABORATORY

The RSE “Research Institute for Biological Safety Problems” of the SC MES RK (RIBSP), as the main institute for virological and microbiological research, still uses the “gold standard” methods, using which a large number of significant results have been obtained. However, the development of new technologies and methods requires the discovery of a new direction. To solve this problem, the management of RIBSP decided to establish a new laboratory for collective use. 

The Collective Use Laboratory (CUL) has been created on the basis of the Laboratory for Molecular Biology and Genetic Engineering since July 01, 2020. The CUL will function in order to achieve an advanced level of research and development work, as well as to effectively use the material, technical and personnel potential of the Laboratory. The head of the laboratory was appointed Erbol Dosanovich Burashev, Ph.D. 

The main goal of the CUis to provide access for scientific research by RIBSP employees and domestic scientists, regardless of the departmental affiliation and form of ownership of the scientific organization or higher educational institution in which they work, as well as to ensure the conduct of research and development work by subjects of scientific and scientific and technical activities.  

The main areas of CUL work: 

  • electronmicroscopic examination of preparations of viruses and other microorganisms in biomaterials, identification of microorganisms; 
  • isolationof DNA, RNA; 
  • PCR (standard and Real-time);
  • determinationof DNA sequences (full genome sequencing); 
  • creationof genetic passports; 
  • synthesisof specific probes and primers; 
  • genotypingof microorganisms, plants, animals; 
  • conducting seminars, trainings at the workplace.