The Safety and Antibody Response of the Nasal COV2 Vaccine Against the SARS-CoV-2 Virus (COV2NOSE)

Rokote Laboratories Finland Oy

Status and phase: Completed; Phase 1

Conditions: COVID19, Sars-Cov-2

Treatments: Biological: COVID-19 vaccine, high dose level; Biological: COVID-19 vaccine, low dose level; Other: Nasal Spray; Other: Nasal Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT06851611

COV2FIN11

U1111-1299-1228 (Other Identifier)

2023-509725-49-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 6 patient groups

Booster - COV2 Low Dose Level - Nasal Drops

Experimental group

Description:

Subjects with prior vaccination with at least two doses of any COVID-19 vaccine

Treatment:

Other: Nasal Drops

Biological: COVID-19 vaccine, low dose level

Booster - COV2 Low Dose Level - Nasal Spray

Experimental group

Description:

Subjects with prior vaccination with at least two doses of any COVID-19 vaccine

Treatment:

Other: Nasal Spray

Biological: COVID-19 vaccine, low dose level

Booster - COV2 High Dose Level - Nasal Drops

Experimental group

Description:

Subjects with prior vaccination with at least two doses of any COVID-19 vaccine

Treatment:

Other: Nasal Drops

Biological: COVID-19 vaccine, high dose level

Booster - COV2 High Dose Level - Nasal Spray

Experimental group

Description:

Subjects with prior vaccination with at least two doses of any COVID-19 vaccine

Treatment:

Other: Nasal Spray

Biological: COVID-19 vaccine, high dose level

Prime - COV2 High Dose Level - Nasal Drops

Experimental group

Description:

Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED

Treatment:

Other: Nasal Drops

Biological: COVID-19 vaccine, high dose level

Prime - COV2 High Dose Level - Nasal Spray

Experimental group

Description:

Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED

Treatment:

Other: Nasal Spray

Biological: COVID-19 vaccine, high dose level