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A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults

NCT05389319 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-07

No results posted yet for this study

Summary

This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV\_Beta in healthy participants.

Conditions

Interventions

BIOLOGICAL

Prime-2-CoV_Beta

1 intramuscular injection (1.0 mL each) into the deltoid muscle on Day 1

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • VisMederi srl

    collaborator INDUSTRY

  • Staburo GmbH

    collaborator INDUSTRY

  • Viedoc Technologies AB

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Meral Esen, Dr. · University Hospital Tübingen, Institute of Tropical Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT05389319 on ClinicalTrials.gov