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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07416539

Enrollment

Registered

2026-02-18

Start date

2026-02-10

Completion date

2026-11-01

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID - 19, SARS CoV-2

Keywords

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

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.

Interventions

BIOLOGICALCOVID-19 Vaccines

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * Current use of immunosuppressant medication (except topical and inhaled steroids, which are permitted in indications not prohibited in the

Design outcomes

Primary

Measure	Time frame	Description
Primary safety endpoints	From Day 0 to day 56	Incidence of Treatment-emergent expected and unexpected adverse events
Primary immunogenicity endpoint	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

Countries

Finland

Contacts

STUDY_DIRECTORSeppo Ylä-Herttuala

Rokote Laboratories Finland Oy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026