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Study of the Immunogenicity, Safety and Tolerability of the Convacell Vaccine.

NCT05156723 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2023-08-30

No results posted yet for this study

Summary

A two-stage trial will involve healthy volunteers. The first stage is open trial, and the second stage is a double-blind trial with randomization of volunteers into three groups. At stage I of the trial, the maximum number of screened healthy volunteers will be 30 of which 20 men aged 18 to over 60 years. At stage II of the trial, the maximum number of screened healthy volunteers will be 150, of which 135 men and women aged 18 to over 60 years eligible according to the inclusion and exclusion criteria are planned to be included and randomized to collect data that will be used for the subsequent safety and immunogenicity assessment. The enrollment of volunteers at stage II will be competitive.

Conditions

  • COVID-19
  • Immunologic Factors
  • Coronavirus Infections
  • Respiratory Tract Infections

Interventions

BIOLOGICAL

Subunit recombinant vaccine for the prevention of coronavirus infection

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Placebo

solution for intramuscular injection, 0.5 ml

Sponsors & Collaborators

  • Crocus Medical B.V (The Netherlands)

    collaborator UNKNOWN

  • St. Petersburg Research Institute of Vaccines and Sera

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2021-08-30
Completion
2022-12-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156723 on ClinicalTrials.gov