Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19
NCT07416539 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-07-22
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
Interventions
- BIOLOGICAL
-
COVID-19 Vaccines
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
- BIOLOGICAL
-
COVID-19 Vaccines
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.
Sponsors & Collaborators
-
Oy Medfiles Ltd
collaborator INDUSTRY -
Estimates OY
collaborator UNKNOWN -
Rokote Laboratories Finland Oy
lead INDUSTRY
Principal Investigators
-
Seppo Ylä-Herttuala · Rokote Laboratories Finland Oy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-10
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- Finland
Study Locations
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