The Safety and Antibody Response of the Nasal COV2 Vaccine Against the SARS-CoV-2 Virus (COV2NOSE)

An Open Short-term Clinical Pilot Trial on Safety and Immunogenicity of Nasal COVID-19 Vaccine at Different Dose Levels and Administration Methods

COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing the SARS-CoV-2 spike protein. In this trial, the primary comparison in terms of safety and immunogenicity will be between two different dose levels of COV2 booster vaccine (low, high), and two different administration methods (nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccine naive subjects.

Study Overview

• Status: Completed
• Conditions: COVID19, Sars-Cov-2
• Intervention / Treatment: Biological: COVID-19 vaccine, low dose level; Other: Nasal Drops; Other: Nasal Spray; Biological: COVID-19 vaccine, high dose level

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Northern Savonia
    • Kuopio, Northern Savonia, Finland, 70210
      • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Has voluntarily signed the written informed consent
2. 18-75 years old
3. Good general health
4. a) Prior vaccination with at least two doses of any COVID-19 vaccine, OR b) No prior COVID-19 vaccination

Exclusion Criteria

1. Pregnant, planning to become pregnant or breastfeeding women
2. COVID-19 infection within the last nine (9) months
3. Any other vaccination within the last two (2) months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Booster - COV2 Low Dose Level - Nasal Drops; Subjects with prior vaccination with at least two doses of any COVID-19 vaccine	Biological: COVID-19 vaccine, low dose level; Test article; Other Names: COV2; Other: Nasal Drops; Method of administration of test article
Experimental: Booster - COV2 Low Dose Level - Nasal Spray; Subjects with prior vaccination with at least two doses of any COVID-19 vaccine	Biological: COVID-19 vaccine, low dose level; Test article; Other Names: COV2; Other: Nasal Spray; Method of administration of test article
Experimental: Booster - COV2 High Dose Level - Nasal Drops; Subjects with prior vaccination with at least two doses of any COVID-19 vaccine	Other: Nasal Drops; Method of administration of test article; Biological: COVID-19 vaccine, high dose level; Test article; Other Names: COV2
Experimental: Booster - COV2 High Dose Level - Nasal Spray; Subjects with prior vaccination with at least two doses of any COVID-19 vaccine	Other: Nasal Spray; Method of administration of test article; Biological: COVID-19 vaccine, high dose level; Test article; Other Names: COV2
Experimental: Prime - COV2 High Dose Level - Nasal Drops; Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED	Other: Nasal Drops; Method of administration of test article; Biological: COVID-19 vaccine, high dose level; Test article; Other Names: COV2
Experimental: Prime - COV2 High Dose Level - Nasal Spray; Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED	Other: Nasal Spray; Method of administration of test article; Biological: COVID-19 vaccine, high dose level; Test article; Other Names: COV2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Immunogenicity	Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Omicron BA.5 variant	28 days from baseline
Primary Safety	Treatment-emergent expected and unexpected adverse effects	28 days from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Immunogenicity	Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Wuhan and JN.1 variants	28 days from baseline

Collaborators and Investigators

• Sponsor: Rokote Laboratories Finland Oy
• Investigators: Study Director: Seppo Ylä-Herttuala, MD, PhD, Rokote Laboratories Finland Oy; Study Director: Erkko Ylösmäki, PhD, Rokote Laboratories Finland Oy

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Actual): June 25, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: COVID19; Sars-CoV-2; mucosal vaccine; nasal vaccine; adeno-vectored vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Pharmaceutical Preparations; Dosage Forms; Technology, Industry, and Agriculture; Biological Products; Complex Mixtures; Vaccines; Colloids; Viral Vaccines; Aerosols; Facility Design and Construction; Architecture; COVID-19 Vaccines; Nasal Sprays; Floors and Floorcoverings
• Other Study ID Numbers: COV2FIN11; 2023-509725-49-00 (Ctis); U1111-1299-1228 (Other Identifier: World Health Organization; Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No