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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05083039
Other study ID # BV-PM-05/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 14, 2020
Est. completion date September 3, 2021

Study information

Verified date February 2023
Source Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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%.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date September 3, 2021
Est. primary completion date December 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Locations

Country Name City State
Russian Federation Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia Kirov

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of detected cases The number of detected cases confirmed by laboratory (PCR and / or serological tests). within 12 months by groups
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