Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19

COVID-19 Clinical Trial

Official title:

Phase 1 Study Evaluating the Safety and Immunogenicity of COVI-VAC as a Booster Dose in Previously Vaccinated Adults Against COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05233826
• Other study ID #: CDX-CoV-002
• Status: Completed
• Phase: Phase 1
• Start date: April 14, 2022
• Est. completion date: December 22, 2022

Study information

• Verified date: January 2023
• Source: Codagenix, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given as a single booster dose in healthy adults previously vaccinated against COVID-19 with an authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC is administered by drops into each nostril. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving COVI-VAC or placebo.

During the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. Adverse events and medication use will be recorded.

Blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 22, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF

2. Body mass index (BMI) = 35 kg/m2

3. In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator

4. Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen = 3 months before Day 1

Exclusion Criteria:

1. Residents of residential care facilities

2. Pregnant or lactating women

3. Inadequate venous access for repeated phlebotomy

4. History of confirmed or suspected SARS-CoV-2 infection

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Biological:
• COVI-VAC
Intranasal, live attenuated vaccine against SARS-CoV-2

Locations

Country	Name	City	State
United Kingdom	HMR	London

Sponsors (1)

Lead Sponsor	Collaborator
Codagenix, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral Immunogenicity	IgG Titer measured by ELISA on day 1	Day 1
Primary	Humoral Immunogenicity	IgG Titer measured by ELISA on day 29	Day 1
Primary	Humoral Immunogenicity	IgG Titer measured by ELISA on day 181	Day 181
Primary	Humoral Immunogenicity measured by neutralizing antibodies	neutralising antibody titer measured by microneutralisation assay in serum on days 1	Day 1
Primary	Humoral Immunogenicity measured by neutralizing antibodies	neutralising antibody titer measured by microneutralisation assay in serum on day 29	Day 29
Primary	Humoral Immunogenicity measured by neutralizing antibodies	neutralising antibody titer measured by microneutralisation assay in serum on day 181	Day 181
Secondary	Vaccine and Virus Shedding	SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4	Day 4
Secondary	Vaccine and Virus Shedding	SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8	Day 8