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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT05083039

Collaborator

(none)

1,500

Enrollment

Location

15.7

Actual Duration (Months)

95.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infections Vaccine Polio

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

Study Type:

Observational

Actual Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

May 14, 2020

Actual Primary Completion Date :

Dec 14, 2020

Actual Study Completion Date :

Sep 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

The number of detected cases [within 12 months by groups]
The number of detected cases confirmed by laboratory (PCR and / or serological tests).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia	Kirov		Russian Federation	610027