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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-21

Study Completion Date

2025-06-26

Brief Summary

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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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Detailed Description

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Conditions

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COVID19, Sars-Cov-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Booster - COV2 Low Dose Level - Nasal Drops

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

Group Type EXPERIMENTAL

COVID-19 vaccine, low dose level

Intervention Type BIOLOGICAL

Test article

Nasal Drops

Intervention Type OTHER

Method of administration of test article

Booster - COV2 Low Dose Level - Nasal Spray

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

Group Type EXPERIMENTAL

COVID-19 vaccine, low dose level

Intervention Type BIOLOGICAL

Test article

Nasal Spray

Intervention Type OTHER

Method of administration of test article

Booster - COV2 High Dose Level - Nasal Drops

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

Group Type EXPERIMENTAL

COVID-19 vaccine, high dose level

Intervention Type BIOLOGICAL

Test article

Nasal Drops

Intervention Type OTHER

Method of administration of test article

Booster - COV2 High Dose Level - Nasal Spray

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

Group Type EXPERIMENTAL

COVID-19 vaccine, high dose level

Intervention Type BIOLOGICAL

Test article

Nasal Spray

Intervention Type OTHER

Method of administration of test article

Prime - COV2 High Dose Level - Nasal Drops

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

Group Type EXPERIMENTAL

COVID-19 vaccine, high dose level

Intervention Type BIOLOGICAL

Test article

Nasal Drops

Intervention Type OTHER

Method of administration of test article

Prime - COV2 High Dose Level - Nasal Spray

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

Group Type EXPERIMENTAL

COVID-19 vaccine, high dose level

Intervention Type BIOLOGICAL

Test article

Nasal Spray

Intervention Type OTHER

Method of administration of test article

Interventions

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COVID-19 vaccine, low dose level

Test article

Intervention Type BIOLOGICAL

COVID-19 vaccine, high dose level

Test article

Intervention Type BIOLOGICAL

Nasal Drops

Method of administration of test article

Intervention Type OTHER

Nasal Spray

Method of administration of test article

Intervention Type OTHER

Other Intervention Names

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COV2 COV2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes