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RECRUITING
NCT07416539
PHASE1

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

Sponsor: Rokote Laboratories Finland Oy

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-02-10

Completion Date

2026-11

Last Updated

2026-02-20

Healthy Volunteers

Yes

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.

Locations (1)

Kuopio University Hospital, ENT policlinic

Kuopio, Northern Savonia, Finland