NCT05367843 is a Phase 1 clinical trial of PRIME-2-CoV_Beta in SARS-CoV-2 Infection, sponsored by Speransa Therapeutics.

Who is sponsoring NCT05367843?

NCT05367843 is sponsored by Speransa Therapeutics.

What drugs are being tested in NCT05367843?

Interventions in NCT05367843: PRIME-2-CoV_Beta.

What condition does NCT05367843 study?

NCT05367843 studies SARS-CoV-2 Infection.

Is NCT05367843 still recruiting?

NCT05367843 is currently terminated. Last updated 9 February 2024.

Last reviewed 2024-02-09 · How we verify

NCT05367843

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

A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV_2 Spike and Nucleocapsid Proteins

Terminated Phase 1 Last updated 9 February 2024

What this trial tests

Phase 1 trial testing PRIME-2-CoV_Beta in SARS-CoV-2 Infection in 103 participants. Terminated before completion.

Timeline

20 June 2022

Primary endpoint
18 July 2023

8 November 2023

Quick facts

Lead sponsor	Speransa Therapeutics
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	103
Start date	20 June 2022
Primary completion	18 July 2023
Estimated completion	8 November 2023
Sites	7 locations across United States, Germany

Drugs / interventions tested

PRIME-2-CoV_Beta — full drug profile →

Conditions studied

SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →

Sponsor

Speransa Therapeutics — full company profile →

Who can join

Adults 18 to 85, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PRIME-2-CoV\_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants.

Publications & conference data

8 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 novel orf virus vector-based COVID-19 booster vaccine shows cross-neutralizing activity in the absence of anti-vector neutralizing immunity.
Klinkardt U, Schunk M, Ervin J, Schindler C, et al · · 2024 · cited 8× · PMID 39397784 · DOI 10.1080/21645515.2024.2410574
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
Novel Multi-Antigen Orf-Virus-Derived Vaccine Elicits Protective Anti-SARS-CoV-2 Response in Monovalent and Bivalent Formats.
Burri DJ, Renz L, Mueller M, Pagallies F, et al · · 2024 · cited 3× · PMID 38793740 · DOI 10.3390/vaccines12050490
Nanotechnology Platform for Advancing Vaccine Development against the COVID-19 Virus.
Chowdhury N, Kundu A. · · 2023 · cited 3× · PMID 38131983 · DOI 10.3390/diseases11040177
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
mRNA Vaccine Technology Beyond COVID-19.
Oloruntimehin S, Akinyi F, Paul M, Ariyo O. · · 2025 · cited 2× · PMID 40573932 · DOI 10.3390/vaccines13060601
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 SARS-CoV-2 Infection

Currently open trials in the same condition.

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NCT05172011 — Understanding the Long-term Impact of COVID on Children and Families · active not recruiting
NCT05141058 — T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients · Phase 1 · recruiting
NCT05046470 — SARS-CoV-2 Transmission in Belgian Primary Schools of the Federation Wallonia - Brussels: An Epidemiological Pilot Study · active not recruiting

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 NCT05367843 (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 Speransa Therapeutics
Last refreshed: 9 February 2024

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/NCT05367843.

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