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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06851611

Acronym

COV2NOSE

Enrollment

Registered

2025-02-28

Start date

2025-01-21

Completion date

2025-06-26

Last updated

2025-12-08

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

Conditions

COVID19, Sars-Cov-2

Keywords

nasal vaccine, adeno-vectored vaccine, mucosal vaccine, Sars-CoV-2, COVID19

Brief summary

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.

Interventions

BIOLOGICALCOVID-19 vaccine, low dose level

Test article

BIOLOGICALCOVID-19 vaccine, high dose level

Test article

OTHERNasal Drops

Method of administration of test article

OTHERNasal Spray

Method of administration of test article

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

1. Has voluntarily signed the written informed consent 2. 18-75 years old 3. Good general health 4. a) Prior vaccination with at least two doses of any COVID-19 vaccine, OR b) No prior COVID-19 vaccination

Exclusion criteria

1. Pregnant, planning to become pregnant or breastfeeding women 2. COVID-19 infection within the last nine (9) months 3. Any other vaccination within the last two (2) months

Design outcomes

Primary

Measure	Time frame	Description
Primary Immunogenicity	28 days from baseline	Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Omicron BA.5 variant
Primary Safety	28 days from baseline	Treatment-emergent expected and unexpected adverse effects

Secondary

Measure	Time frame	Description
Secondary Immunogenicity	28 days from baseline	Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Wuhan and JN.1 variants

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026