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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-14

Study Completion Date

2021-09-03

Brief Summary

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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

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Detailed Description

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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

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Coronavirus Infections Vaccine Polio

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

750 volunteers who will be given a Placebo.

Group 2 - 750 volunteers, Vaccine 0.2ml, post-vaccination observation period of 12 months.

No interventions assigned to this group

Eligibility Criteria

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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).

* 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).

* 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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes