Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19

NCT05083039 | Completed

• 1 other identifier: BV-PM-05/20
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronavirus Infections; Vaccine; Polio

Keywords

Covid-19; SARS-Cov-2; Coronavirus Infections; Immunobiological medicine

Outcome Measures

Primary Outcomes (1)

• The number of detected cases

  The number of detected cases confirmed by laboratory (PCR and / or serological tests).

  within 12 months by groups

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products: lead

Study Sites (1)

Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia

Kirov, 610027, Russia

Location

Related Publications (1)

• 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.

  PMID: 35711442 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Poliomyelitis; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 19, 2021
• Study Start: May 14, 2020
• Primary Completion: December 14, 2020
• Study Completion: September 3, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

RU (1)