Coronavirus InfectionsNCT05083039
Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19
An observational study of Coronavirus Infections and Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 1 site in Russia.
Trial summary
Observational program, double-blind, placebo-controlled to study the preventive efficacy of the BiVac polio (Oral polio vaccine, divalent, live attenuated of types 1 and 3 vaccine against the incidence of acute respiratory infections, including COVID-19 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections, Vaccine, Polio
- Type of treatment
- Vaccines
- How many people
- 1,500 participants
- Where
- 1 siteRussia
- Study dates
- 14 May 2020to 3 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be invited to participate in the program. The concept of "healthy" is defined as the absence of deviations detected during the collection of a medical history, during standard clinical and instrumental examinations, as well as in the absence of clinically significant deviations (from the reference values of the laboratory) in laboratory blood and urine tests.
Who may be able to join
- Volunteers must meet the following inclusion criteria:
- Healthy volunteers aged 18-65 years.
- The presence of a written and dated informed consent of the volunteer to participate in the program.
- Consent to observe precautionary measures to limit the circulation of the vaccine virus among people around the vaccinated person (personal hygiene, isolation from unvaccinated children and people with immunodeficiency).
- Volunteers who are able to fulfill the requirements of the protocol (i.e., fill out a self-observation diary, remember the dates of control visit).
- Non-inclusion criteria:
Show all 19Show fewer
- COVID-19 infection (including cases of asymptomatic carrier).
- Positive test for COVID-19 (PCR).
- Vaccination with any live and / or replicative vaccine one month before screening.
- Neurological disorders that accompany previous vaccination with oral polio vaccine.
- Immunodeficiency condition (primary).
- Malignant neoplasms.
- Immunosuppression (vaccinations are carried out no earlier than 3 months after the end of the course of therapy).
- Pregnancy.
- Hypersensitivity to any component of the vaccine.
- Strong reaction (temperature above 40°C) or a complication on the previous administration of the drug.
- Acute infectious or non-infectious diseases. Vaccinations are carried out 2-4 weeks after recovery or remission. In case of mild acute respiratory viral infections, acute intestinal diseases, vaccinations are carried out after the temperature normalizes.
- The presence in the family or immediate environment (and provided that it is impossible to separate) of unvaccinated against polio (for example, newborns or children who have contraindications to polio vaccinations).
- The presence of persons with immunodeficiency in the family or immediate environment (and provided that it is impossible to separate).
Who cannot join
- A volunteer can be excluded from the study under the following conditions:
- Refusal of a volunteer to participate in the program.
- The need for procedures and / or drug treatment that are not permitted by the protocol of this study.
- The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol.
- The appearance of non-inclusion criteria during the study.
- Non-compliance with the research procedures by the volunteer.
- Any condition of the volunteer that requires, in the reasonable opinion of the research doctor, the withdrawal of the volunteer from the study.
- The volunteer is out of observation. • For administrative reasons
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia
Kirov, 610027
About this study
Official title: Observational Program to Study the Preventive Efficacy of the BiVac Polio (Oral Polio Vaccine, Divalent, Live Attenuated of Types 1 and 3 ) Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers Aged 18-65
Observational program, double-blind, placebo-controlled to study the preventive efficacy of the BiVac polio (Oral polio vaccine, divalent, live attenuated of types 1 and 3 vaccine against the incidence of acute respiratory infections, including COVID-19
Read the detailed description
To carry out a comparative assessment of the indices of humoral, cellular immunity and cytokine profile in patients with acute respiratory infections.
Current Program Population: 1500 healthy male and female volunteers, aged of between 18 and 65 will be included in the program.
All included volunteers will be divided into groups:
Group 1 - 750 volunteers who will be vaccinated with BiVac polio vaccine; post-vaccination observation period of 12 months.
Group 2 - 750 volunteers, placebo will be administered, post-vaccination observation period of 12 months.
The probability of getting into one of the two groups for each volunteer will be 50%.
- Conditions
- Coronavirus Infections, Vaccine, Polio
- Keywords
- Covid-19, SARS-Cov-2, Coronavirus Infections, Immunobiological medicine
- Medical subject headings
- Coronavirus Infections, Poliomyelitis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 750 volunteers who will be vaccinated with the BiVac polio vaccine | Group 1 - 750 volunteers, Vaccine 0.2 ml, post-vaccination observation period of 12 months. | |
| 750 volunteers who will be given a Placebo. | Group 2 - 750 volunteers, Vaccine 0.2ml, post-vaccination observation period of 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of detected cases
The number of detected cases confirmed by laboratory (PCR and / or serological tests).
Measured: within 12 months by groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start14 May 2020
- Primary completion14 Dec 2020
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083039
- Sponsor's protocol ID
- BV-PM-05/20
- Status last verified
- Feb 2023
- First submitted
- 18 Oct 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yagovkina NV, Zheleznov LM, Subbotina KA, Tsaan AA, Kozlovskaya LI, Gordeychuk IV, Korduban AK, Ivin YY, Kovpak AA, Piniaeva AN, Shishova AA, Shustova EY, Khapchaev YK, Karganova GG, Siniugina AA, Pomaskina TV, Erovichenkov AA, Chumakov K, Ishmukhametov AA. Vaccination With Oral Polio Vaccine Reduces COVID-19 Incidence. Front Immunol. 2022 May 30;13:907341. doi: 10.3389/fimmu.2022.907341. eCollection 2022.
PubMed 35711442
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Program to Study the Preventive Efficacy of the BiVac Polio (Oral Polio Vaccine, Divalent, Live Attenuated of Types 1 and 3 ) Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers Aged 18-65
- ClinicalTrials.gov ID
- NCT05083039
- Acronym / sponsor ID
- BV-PM-05/20
- Conditions
- Coronavirus Infections, Vaccine, Polio
- Keywords
- Covid-19, SARS-Cov-2, Coronavirus Infections, Immunobiological medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological ProductsOther government
- Study start
- 14 May 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational program, double-blind, placebo-controlled to study the preventive efficacy of the BiVac polio (Oral polio vaccine, divalent, live attenuated of types 1 and 3 vaccine against the incidence of acute respiratory infections, including COVID-19
Detailed description
To carry out a comparative assessment of the indices of humoral, cellular immunity and cytokine profile in patients with acute respiratory infections.
Current Program Population: 1500 healthy male and female volunteers, aged of between 18 and 65 will be included in the program.
All included volunteers will be divided into groups:
Group 1 - 750 volunteers who will be vaccinated with BiVac polio vaccine; post-vaccination observation period of 12 months.
Group 2 - 750 volunteers, placebo will be administered, post-vaccination observation period of 12 months.
The probability of getting into one of the two groups for each volunteer will be 50%.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 750 volunteers who will be vaccinated with the BiVac polio vaccine | – | –Group 1 - 750 volunteers, Vaccine 0.2 ml, post-vaccination observation period of 12 months. |
| 750 volunteers who will be given a Placebo. | – | –Group 2 - 750 volunteers, Vaccine 0.2ml, post-vaccination observation period of 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be invited to participate in the program. The concept of "healthy" is defined as the absence of deviations detected during the collection of a medical history, during standard clinical and instrumental examinations, as well as in the absence of clinically significant deviations (from the reference values of the laboratory) in laboratory blood and urine tests.
Key inclusion criteria (19 listed)
- Volunteers must meet the following inclusion criteria:
- COVID-19 infection (including cases of asymptomatic carrier).
- Positive test for COVID-19 (PCR).
- Vaccination with any live and / or replicative vaccine one month before screening.
- Neurological disorders that accompany previous vaccination with oral polio vaccine.
Key exclusion criteria (8 listed)
- A volunteer can be excluded from the study under the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of detected cases
Time frame: within 12 months by groups
The number of detected cases confirmed by laboratory (PCR and / or serological tests).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 35711442Yagovkina NV, Zheleznov LM, Subbotina KA, Tsaan AA, Kozlovskaya LI, Gordeychuk IV, Korduban AK, Ivin YY, Kovpak AA, Piniaeva AN, Shishova AA, Shustova EY, Khapchaev YK, Karganova GG, Siniugina AA, Pomaskina TV, Erovichenkov AA, Chumakov K, Ishmukhametov AA. Vaccination With Oral Polio Vaccine Reduces COVID-19 Incidence. Front Immunol. 2022 May 30;13:907341. doi: 10.3389/fimmu.2022.907341. eCollection 2022.
Related trials for Coronavirus Infections
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections and Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of detected cases (time frame: within 12 months by groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.