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

February 6, 2023 updated by: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Kirov, Russian Federation, 610027
        • Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
within 12 months by groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2020

Primary Completion (ACTUAL)

December 14, 2020

Study Completion (ACTUAL)

September 3, 2021

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (ACTUAL)

October 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BV-PM-05/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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