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CompletedNCT06851611COV2NOSEUpdated Dec 8, 2025

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

A Phase 1 interventional study of COVID-19 vaccine, low dose level and COVID-19 vaccine, high dose level in COVID19, Sars-Cov-2, sponsored by Rokote Laboratories Finland Oy. Completed at 1 site in Finland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.

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

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 administration methods (nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccine naive subjects.

02

Conditions studied

  • COVID19, Sars-Cov-2

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Keywords

  • nasal vaccine
  • adeno-vectored vaccine
  • mucosal vaccine
  • Sars-CoV-2
  • COVID19
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 enrollment of 40 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

  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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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 · Other: Nasal Drops

  • 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 · Other: Nasal Spray

  • Experimental
    Booster - COV2 High Dose Level - Nasal Drops

    Subjects with prior vaccination with at least two doses of any COVID-19 vaccine

    Biological: COVID-19 vaccine, high dose level · Other: Nasal Drops

  • Experimental
    Booster - COV2 High Dose Level - Nasal Spray

    Subjects with prior vaccination with at least two doses of any COVID-19 vaccine

    Biological: COVID-19 vaccine, high dose level · Other: Nasal Spray

  • Experimental
    Prime - COV2 High Dose Level - Nasal Drops

    Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED

    Biological: COVID-19 vaccine, high dose level · Other: Nasal Drops

  • Experimental
    Prime - COV2 High Dose Level - Nasal Spray

    Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED

    Biological: COVID-19 vaccine, high dose level · Other: Nasal Spray

Interventions

  • BiologicalCOVID-19 vaccine, low dose level

    Test article

    Also known as: COV2

  • BiologicalCOVID-19 vaccine, high dose level

    Test article

    Also known as: COV2

  • OtherNasal Drops

    Method of administration of test article

  • OtherNasal Spray

    Method of administration of test article

06

What researchers measure

Primary outcomes

  1. Primary Immunogenicity

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

    Time frame: 28 days from baseline

  2. Primary Safety

    Treatment-emergent expected and unexpected adverse effects

    Time frame: 28 days from baseline

Secondary outcomes

  1. Secondary Immunogenicity

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

    Time frame: 28 days from baseline

07

Study locations

1 site
  • Kuopio University Hospital
    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 Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06851611
Lead sponsor
Rokote Laboratories Finland Oy
Responsible party
Sponsor
First posted
Feb 28, 2025
Start date
Jan 21, 2025
Primary completion
Jun 25, 2025
Completion
Jun 26, 2025
Last update
Dec 8, 2025

Study contacts

Seppo Ylä-Herttuala, MD, PhD
study director · Rokote Laboratories Finland Oy
Erkko Ylösmäki, PhD
study director · Rokote Laboratories Finland Oy

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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