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COVID19, Sars-Cov-2Phase 1COV2NOSENCT06851611

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

A Phase 1 study testing COVID-19 vaccine, low dose level, COVID-19 vaccine, high dose level and Nasal Drops in people with COVID19, Sars-Cov-2, run by Rokote Laboratories Finland Oy at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
COVID19, Sars-Cov-2
What is being tested?
COVID-19 vaccine, low dose level, COVID-19 vaccine, high dose level and Nasal Drops
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFinland
Study dates
21 Jan 2025to 26 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

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
  • 18-75 years old
  • Good general health
  • a) Prior vaccination with at least two doses of any COVID-19 vaccine, OR b) No prior COVID-19 vaccination

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Kuopio University Hospital

    Kuopio, Northern Savonia, 70210

Other trials in Finland

About this study

Official title: 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.

Being tested
COVID-19 vaccine, low dose level, COVID-19 vaccine, high dose level, Nasal Drops, Nasal Spray
Keywords
nasal vaccine, adeno-vectored vaccine, mucosal vaccine, Sars-CoV-2, COVID19
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 vaccine, low dose levelBiological

    Also called COV2

    Test article

  • COVID-19 vaccine, high dose levelBiological

    Also called COV2

    Test article

  • Nasal DropsOther

    Method of administration of test article

  • Nasal SprayOther

    Method of administration of test article

Study groups in NCT06851611
Study groupRoleWhat they receive
Booster - COV2 Low Dose Level - Nasal DropsExperimentalSubjects with prior vaccination with at least two doses of any COVID-19 vaccine
Receives: Biological: COVID-19 vaccine, low dose level; Other: Nasal Drops
Booster - COV2 Low Dose Level - Nasal SprayExperimentalSubjects with prior vaccination with at least two doses of any COVID-19 vaccine
Receives: Biological: COVID-19 vaccine, low dose level; Other: Nasal Spray
Booster - COV2 High Dose Level - Nasal DropsExperimentalSubjects with prior vaccination with at least two doses of any COVID-19 vaccine
Receives: Biological: COVID-19 vaccine, high dose level; Other: Nasal Drops
Booster - COV2 High Dose Level - Nasal SprayExperimentalSubjects with prior vaccination with at least two doses of any COVID-19 vaccine
Receives: Biological: COVID-19 vaccine, high dose level; Other: Nasal Spray
Prime - COV2 High Dose Level - Nasal DropsExperimentalSubjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED
Receives: Biological: COVID-19 vaccine, high dose level; Other: Nasal Drops
Prime - COV2 High Dose Level - Nasal SprayExperimentalSubjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED
Receives: Biological: COVID-19 vaccine, high dose level; Other: Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Immunogenicity

    Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Omicron BA.5 variant

    Measured: 28 days from baseline

  2. Primary Safety

    Treatment-emergent expected and unexpected adverse effects

    Measured: 28 days from baseline

Secondary outcomes (1)

  1. Secondary Immunogenicity

    Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Wuhan and JN.1 variants

    Measured: 28 days from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start21 Jan 2025
  3. Primary completion25 Jun 2025
  4. Study completion26 Jun 2025

Resources

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
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06851611
Sponsor's protocol ID
COV2FIN11
Other IDs
2023-509725-49-00, U1111-1299-1228, 2023
Acronym
COV2NOSE
Status last verified
Dec 2025
First submitted
24 Feb 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing COVID-19 vaccine, low dose level, COVID-19 vaccine, high dose level and Nasal Drops in people with COVID19, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Immunogenicity (time frame: 28 days from baseline). 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?

On the ClinicalTrials.gov record for NCT06851611.

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 8 Dec 2025.

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