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Active, not recruitingNCT07416539Updated Jul 22, 2026

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

A Phase 1 interventional study of COVID-19 Vaccines and COVID-19 Vaccines in COVID - 19 and SARS CoV-2, sponsored by Rokote Laboratories Finland Oy. Active, not recruiting at 1 site in Finland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Rokote Laboratories Finland Oy · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • COVID - 19
  • SARS CoV-2

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Keywords

  • nasal vaccine
  • COVID-19
  • adenoviral vector-based vaccines
  • Sars CoV-2
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Rokote Laboratories Finland Oy is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BiologicalCOVID-19 Vaccines

    COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.

  • BiologicalCOVID-19 Vaccines

    COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.

06

What researchers measure

Primary outcomes

  1. Primary safety endpoints

    Incidence of Treatment-emergent expected and unexpected adverse events

    Time frame: From Day 0 to day 56

  2. Primary immunogenicity endpoint

    The percentage of participants achieving ≥2-fold rise (seroresponse) in SARS-CoV-2 serum neutralizing antibody (NAb) titers against Omicron BA.5 variant

    Time frame: Day 56 from baseline

07

Study locations

1 site
  • Kuopio University Hospital, ENT policlinic
    Kuopio, Northern Savonia 70210, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07416539
Lead sponsor
Rokote Laboratories Finland Oy
Collaborators
Oy Medfiles Ltd, Estimates OY
Responsible party
Sponsor
First posted
Feb 18, 2026
Start date
Feb 10, 2026
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jul 22, 2026

Study contacts

Seppo Ylä-Herttuala
study director · Rokote Laboratories Finland Oy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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