NCT06851611

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

February 24, 2025

Last Update Submit

December 1, 2025

Conditions

COVID19, Sars-Cov-2

Keywords

nasal vaccineadeno-vectored vaccinemucosal vaccineSars-CoV-2COVID19

Outcome Measures

Primary Outcomes (2)

  • Primary Immunogenicity

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

    28 days from baseline

  • Primary Safety

    Treatment-emergent expected and unexpected adverse effects

    28 days from baseline

Secondary Outcomes (1)

  • Secondary Immunogenicity

    28 days from baseline

Study Arms (6)

Booster - COV2 Low Dose Level - Nasal Drops

EXPERIMENTAL

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

Biological: COVID-19 vaccine, low dose levelOther: Nasal Drops

Booster - COV2 Low Dose Level - Nasal Spray

EXPERIMENTAL

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

Biological: COVID-19 vaccine, low dose levelOther: Nasal Spray

Booster - COV2 High Dose Level - Nasal Drops

EXPERIMENTAL

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

Biological: COVID-19 vaccine, high dose levelOther: Nasal Drops

Booster - COV2 High Dose Level - Nasal Spray

EXPERIMENTAL

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

Biological: COVID-19 vaccine, high dose levelOther: Nasal Spray

Prime - COV2 High Dose Level - Nasal Drops

EXPERIMENTAL

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

Biological: COVID-19 vaccine, high dose levelOther: Nasal Drops

Prime - COV2 High Dose Level - Nasal Spray

EXPERIMENTAL

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

Biological: COVID-19 vaccine, high dose levelOther: Nasal Spray

Interventions

COVID-19 vaccine, low dose levelBIOLOGICAL

Test article

Also known as: COV2
Booster - COV2 Low Dose Level - Nasal DropsBooster - COV2 Low Dose Level - Nasal Spray
COVID-19 vaccine, high dose levelBIOLOGICAL

Test article

Also known as: COV2
Booster - COV2 High Dose Level - Nasal DropsBooster - COV2 High Dose Level - Nasal SprayPrime - COV2 High Dose Level - Nasal DropsPrime - COV2 High Dose Level - Nasal Spray
Nasal DropsOTHER

Method of administration of test article

Booster - COV2 High Dose Level - Nasal DropsBooster - COV2 Low Dose Level - Nasal DropsPrime - COV2 High Dose Level - Nasal Drops
Nasal SprayOTHER

Method of administration of test article

Booster - COV2 High Dose Level - Nasal SprayBooster - COV2 Low Dose Level - Nasal SprayPrime - COV2 High Dose Level - Nasal Spray

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has voluntarily signed the written informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70210, Finland

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 VaccinesFloors and FloorcoveringsNasal Sprays

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesFacility Design and ConstructionArchitectureTechnology, Industry, and AgricultureAerosolsColloidsDosage FormsPharmaceutical Preparations

Study Officials

  • Seppo Ylä-Herttuala, MD, PhD

    Rokote Laboratories Finland Oy

    STUDY DIRECTOR

  • Erkko Ylösmäki, PhD

    Rokote Laboratories Finland Oy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 28, 2025

Study Start

January 21, 2025

Primary Completion

June 25, 2025

Study Completion

June 26, 2025

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)