NCT05389319 is a Phase 1 clinical trial of Prime-2-CoV_Beta in COVID-19, sponsored by University Hospital Tuebingen.

Who is sponsoring NCT05389319?

NCT05389319 is sponsored by University Hospital Tuebingen.

What drugs are being tested in NCT05389319?

Interventions in NCT05389319: Prime-2-CoV_Beta.

Is NCT05389319 still recruiting?

NCT05389319 is currently recruiting now. Last updated 7 April 2026.

Last reviewed 2026-04-07 · How we verify

NCT05389319

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 7 April 2026

What this trial tests

Phase 1 trial testing Prime-2-CoV_Beta in COVID-19 in 96 participants. Currently enrolling.

Timeline

24 June 2022

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	96
Start date	24 June 2022
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	2 locations across Germany

Drugs / interventions tested

Prime-2-CoV_Beta — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

University Hospital Tuebingen

Who can join

Adults 18 to 55, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Overview of Nucleocapsid-Targeting Vaccines against COVID-19.
Rak A, Isakova-Sivak I, Rudenko L. · · 2023 · cited 15× · PMID 38140214 · DOI 10.3390/vaccines11121810
A multiantigenic Orf virus-based vaccine efficiently protects hamsters and nonhuman primates against SARS-CoV-2.
Reguzova A, Müller M, Pagallies F, Burri D, et al · · 2024 · cited 6× · PMID 39414789 · DOI 10.1038/s41541-024-00981-2
First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster.
Esen M, Fischer-Herr J, Gabor JJ, Gaile JM, et al · · 2024 · cited 5× · PMID 39591190 · DOI 10.3390/vaccines12111288
An investigation of excipients for a stable Orf viral vector formulation.
Eilts F, Harsy YMJ, Lothert K, Pagallies F, et al · · 2023 · cited 3× · PMID 37657509 · DOI 10.1016/j.virusres.2023.199213
A novel multi-antigenic parapoxvirus-based vaccine demonstrates efficacy in protecting hamsters and non-human primates against SARS-CoV-2 challenge
Reguzova A, Sigle M, Pagallies F, Salomon F, et al · · 2023 · DOI 10.21203/rs.3.rs-2832501/v1

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other University Hospital Tuebingen trials

Trials by the same sponsor.

NCT07378670 — DEfeating PEnile CAncer-2 · NA · recruiting
NCT07276503 — Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperati · not yet recruiting
NCT07411365 — Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI · NA · not yet recruiting
NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07378891 — Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI) · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05389319 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Tuebingen
Last refreshed: 7 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05389319.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing