COVID - 19Phase 1NCT07416539
Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19
A Phase 1 study testing COVID-19 Vaccines in people with COVID - 19 and SARS CoV-2, run by Rokote Laboratories Finland Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID - 19, SARS CoV-2
- What is being tested?
- COVID-19 Vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 10 Feb 2026to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Kuopio University Hospital, ENT policlinic
Kuopio, Northern Savonia, 70210
About this study
Official title: 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.
- Conditions
- COVID - 19, SARS CoV-2
- Being tested
- COVID-19 Vaccines
- Keywords
- nasal vaccine, COVID-19, adenoviral vector-based vaccines, Sars CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccinesBiological
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
COVID-19 VaccinesBiological
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.
| Study group | Role | What they receive |
|---|---|---|
| COV2 vaccine in Formulation A | Experimental | COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose. Receives: Biological: COVID-19 Vaccines |
| COV2 vaccine in formulation B | Experimental | COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose. Receives: Biological: COVID-19 Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoints
Incidence of Treatment-emergent expected and unexpected adverse events
Measured: From Day 0 to day 56
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
Measured: Day 56 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start10 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rokote Laboratories Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oy Medfiles Ltd, Estimates OY
- Responsible party
- Sponsor
- Investigators
- Seppo Ylä-Herttuala, Study director, Rokote Laboratories Finland Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416539
- Sponsor's protocol ID
- COV2FIN12
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07416539
- Acronym / sponsor ID
- COV2FIN12
- Conditions
- COVID - 19, SARS CoV-2
- Keywords
- nasal vaccine, COVID-19, adenoviral vector-based vaccines, Sars CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rokote Laboratories Finland OyIndustry (pharma, biotech, devices)
- Collaborators
- Oy Medfiles Ltd, Estimates OY
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COV2 vaccine in Formulation A | Experimental | Biological: COVID-19 VaccinesCOV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose. |
| COV2 vaccine in formulation B | Experimental | Biological: COVID-19 VaccinesCOV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccinesCOV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose. | Biological | COV2 vaccine in Formulation A |
| COVID-19 VaccinesCOV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose. | Biological | COV2 vaccine in formulation B |
Primary outcome
Primary safety endpoints
Time frame: From Day 0 to day 56
Incidence of Treatment-emergent expected and unexpected adverse events
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seppo Ylä-Herttuala study director
Rokote Laboratories Finland Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVID-19 Vaccines in people with COVID - 19 and SARS CoV-2, run by Rokote Laboratories Finland Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoints (time frame: From Day 0 to day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.