NCT05689177

Brief Summary

To evaluate the dynamics of IgG levels to the SARS-CoV-2 virus after a booster dose of Soberana Plus vaccine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 16, 2023

Last Update Submit

January 30, 2023

Conditions

Humoral Immunity

Keywords

COVID-19SARS-CoV-2Humoral immunityBooster dose

Outcome Measures

Primary Outcomes (3)

  • IgG level assessment

    The quantification of the SARS-CoV-2 antibody assay

    42 days after booster dose administration

  • IgG level assessment

    The quantification of the SARS-CoV-2 antibody assay

    90 days after booster dose administration

  • IgG level assessment

    The quantification of the SARS-CoV-2 antibody assay

    180 days after booster dose administration

Study Arms (2)

Booster dose administration to younger participants

EXPERIMENTAL

Participants 18-25 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A), Republic of Cuba)

Biological: Protein subunit vaccine Soberana Plus (FINLAY-FR-1A) is a vaccine against COVID-19 produced by The Finlay Vaccine Institute and The Centre of Molecular Immunology (Republic of Cuba)

Booster dose administration to older participants

EXPERIMENTAL

Participants 26-80 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A) Republic of Cuba)

Biological: Protein subunit vaccine Soberana Plus (FINLAY-FR-1A) is a vaccine against COVID-19 produced by The Finlay Vaccine Institute and The Centre of Molecular Immunology (Republic of Cuba)

Interventions

Protein subunit vaccine Soberana Plus (FINLAY-FR-1A) is a vaccine against COVID-19 produced by The Finlay Vaccine Institute and The Centre of Molecular Immunology (Republic of Cuba)BIOLOGICAL

Booster dose administration

Booster dose administration to older participantsBooster dose administration to younger participants

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 y.o.;
  • More that 4 months after the previous vaccination against COVID-19;
  • No COVID-19 infection registered within 30 days prior to Soberana Plus administration.

You may not qualify if:

  • Age less than 18 y.o. or more than 80 y.o.;
  • Less than 4 months after the previous vaccination against COVID-19;
  • COVID-19 infection registered within 30 days prior to Soberana Plus administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gomel State Medical University

Homyel, 246050, Belarus

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Igor Stoma, MD

    Gomel state medical university, Gomel, Province, Belarus, 246000

    STUDY CHAIR

  • Olga Osipkina

    Gomel State Medical University, Gomel, Province, Belarus, 246000

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 19, 2023

Study Start

December 9, 2022

Primary Completion

March 10, 2023

Study Completion

July 28, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)