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

NCT07416539 | Recruiting Phase 1

• 1 other identifier: COV2FIN12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID - 19; SARS CoV-2

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoints

  Incidence of Treatment-emergent expected and unexpected adverse events

  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

  Day 56 from baseline

Study Arms (2)

COV2 vaccine in Formulation A

EXPERIMENTAL

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

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.

Biological: COVID-19 Vaccines

Interventions

COVID-19 Vaccines BIOLOGICAL

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

COV2 vaccine in Formulation A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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
• Severe obesity (BMI ≥ 35)
• Cancer treated within 5 years
• Known allergy/hypersensitivity to any ingredients of the COV2 vaccine

Sponsors & Collaborators

• Rokote Laboratories Finland Oy: lead
• Estimates OY: collaborator
• Oy Medfiles Ltd: collaborator

Study Sites (1)

Kuopio University Hospital, ENT policlinic

Kuopio, Northern Savonia, 70210, Finland

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Seppo Ylä-Herttuala

  Rokote Laboratories Finland Oy

  STUDY DIRECTOR

Central Study Contacts

Terhi Reunama

CONTACT

+358 40 510 5560; terhi.reunama@rokote.com

Erkko Ylösmäki

CONTACT

+358 40 5836604; erkko.ylosmaki@rokote.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)