Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19

February 18, 2026 updated by: Rokote Laboratories Finland Oy

A Phase 1a, Single-Blind, Randomized Comparative Clinical Trial Evaluating the Impact of Vaccine Formulation on the Safety and Immunogenicity of the COV2 Vaccine in Healthy Adults

This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccine formulation randomized trial designed to investigate and compare the safety and immunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein.

Participants will receive one of the two COV2 formulations in two doses on Day 0 and Day 28.

This trial consists of two parts; Part 1 is a vaccination phase assessing safety and immunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistence of immune response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Recruiting
        • Kuopio University Hospital, ENT policlinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heikki Löppönen, MD, PhD
        • Sub-Investigator:
          • Sakari Nieminen, MD
        • Sub-Investigator:
          • Butoto Kazera, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • Has voluntarily signed the written informed consent
  • Male or female aged ≥18 to ≤75 years
  • Good general health based upon the results of the medical history, laboratory tests, physical examination, ENT clinical examination, and vital signs as assessed by the investigator
  • Prior vaccination with at least two doses of any COVID-19 vaccine with last dose obtained ≥180 days before the planned baseline (Day 0) visit
  • Has a personal smartphone, tablet or computer with internet access, and is considered willing and able to report the data in the ePRO and to comply with the reporting timelines
  • Willing and able to comply with the instructions to participants
  • Not of childbearing potential or willing and able to use a highly effective contraception method consistently and correctly during the entire trial

Exclusion criteria

  • Pregnant, planning to become pregnant, or breastfeeding women
  • Received any investigational drug < 180 days prior baseline
  • Antigen positivity or PCR confirmed SARS-CoV-2 infection less than 180 days apart from screening or during screening and/or baseline
  • Any SARS-CoV vaccination was administrated < 180 days prior the planned baseline (Day 0) visit
  • Any other vaccination within 60 days prior the planned baseline (Day 0) visit
  • Administration of immunoglobulins or blood products within 90 days prior baseline
  • Current use of immunosuppressant medication (except topical and inhaled steroids, which are permitted in indications not prohibited in the exclusion criteria)
  • Use of steroid nasal sprays within 30 days prior to screening
  • Use of any oral or nasal decongestants within 7 days prior to screening
  • Any confirmed or suspected immunodeficient state
  • Chronic respiratory diseases (except treatment -controlled asthma)

  • Severe chronic cardiovascular and endocrinological diseases (e.g., medicine or insulin treated diabetes), liver and renal insufficiency or serious psychiatric diseases

    - Medication for elevated cholesterol or blood pressure or dietary treated diabetes or hypothyreosis are not exclusion criteria

  • Any diagnosed disease or abnormality in the nasal or upper respiratory tract, such as acute/chronic rhinosinusitis; nasal polyposis; mucosal pathology or tumor of nasal cavity, pharynx or nasopharynx; significant obstructive nasal deformity; recurrent epistaxis; sleep apnea; anosmia

    - History of adenoidectomy and/or tonsillectomy are not exclusion criteria

  • Severe obesity (BMI ≥ 35)
  • Cancer treated within 5 years
  • Known allergy/hypersensitivity to any ingredients of the COV2 vaccine
  • Previous anaphylactic reaction
  • Any clinically significant abnormal finding in the screening laboratory tests
  • Inability to sign ICF or to understand and comply with trial related instructions and requirements
  • Individuals who are employees of, or directly affiliated with, the sponsor, or site staff or their immediate family members.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COV2 vaccine in Formulation A
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
Biological: COVID-19 Vaccines
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
Biological: COVID-19 Vaccines
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.
Experimental: COV2 vaccine in formulation B
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.
Biological: COVID-19 Vaccines
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
Biological: COVID-19 Vaccines
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary immunogenicity endpoint
Time Frame: Day 56 from baseline
The percentage of participants achieving ≥2-fold rise (seroresponse) in SARS-CoV-2 serum neutralizing antibody (NAb) titers against Omicron BA.5 variant
Day 56 from baseline
Primary safety endpoints
Time Frame: From Day 0 to day 56
Incidence of Treatment-emergent expected and unexpected adverse events
From Day 0 to day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rokote Laboratories Finland Oy

Collaborators

Oy Medfiles Ltd
Estimates OY

Investigators

  • Study Director: Seppo Ylä-Herttuala, Rokote Laboratories Finland Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COV2FIN12

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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