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OpenTrials
Completed

NCT Number: NCT06851611

The Safety and Antibody Response of the Nasal COV2 Vaccine Against the SARS-CoV-2 Virus

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.

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Key information

Conditions

COVID19, Sars-Cov-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kuopio University Hospital

Kuopio, Northern Savonia, 70210, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has voluntarily signed the written informed consent
  • 18-75 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

Exclusion criteria

  • 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

Treatment and study plan

COVID-19 vaccine, low dose level

Biological

Test article

Other names: COV2

COVID-19 vaccine, high dose level

Biological

Test article

Other names: COV2

Nasal Drops

Other

Method of administration of test article

Nasal Spray

Other

Method of administration of test article

Primary outcomes

  1. Primary Immunogenicity

    Time frame: 28 days from baseline

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

  2. Primary Safety

    Time frame: 28 days from baseline

    Treatment-emergent expected and unexpected adverse effects

Secondary outcomes

  1. Secondary Immunogenicity

    Time frame: 28 days from baseline

    Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Wuhan and JN.1 variants

Sponsors and collaborators

Lead sponsor

Rokote Laboratories Finland Oy

Industry

Registry information

Official study title

An Open Short-term Clinical Pilot Trial on Safety and Immunogenicity of Nasal COVID-19 Vaccine at Different Dose Levels and Administration Methods

Acronym: COV2NOSE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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