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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05233826
Recruitment Status : Completed
First Posted : February 10, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Codagenix, Inc

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Biological: COVI-VAC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1 Study Evaluating the Safety and Immunogenicity of COVI-VAC as a Booster Dose in Previously Vaccinated Adults Against COVID-19
Actual Study Start Date : April 14, 2022
Actual Primary Completion Date : July 21, 2022
Actual Study Completion Date : December 22, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: COVI-VAC
COVI-VAC Nose Drops
 Biological: COVI-VAC
Intranasal, live attenuated vaccine against SARS-CoV-2


Outcome Measures
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Primary Outcome Measures :
  1. Humoral Immunogenicity [ Time Frame: Day 1 ]
    IgG Titer measured by ELISA on day 1

  2. Humoral Immunogenicity [ Time Frame: Day 1 ]
    IgG Titer measured by ELISA on day 29

  3. Humoral Immunogenicity [ Time Frame: Day 181 ]
    IgG Titer measured by ELISA on day 181

  4. Humoral Immunogenicity measured by neutralizing antibodies [ Time Frame: Day 1 ]
    neutralising antibody titer measured by microneutralisation assay in serum on days 1

  5. Humoral Immunogenicity measured by neutralizing antibodies [ Time Frame: Day 29 ]
    neutralising antibody titer measured by microneutralisation assay in serum on day 29

  6. Humoral Immunogenicity measured by neutralizing antibodies [ Time Frame: Day 181 ]
    neutralising antibody titer measured by microneutralisation assay in serum on day 181


Secondary Outcome Measures :
  1. Vaccine and Virus Shedding [ Time Frame: Day 4 ]
    SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4

  2. Vaccine and Virus Shedding [ Time Frame: Day 8 ]
    SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05233826


Locations
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United Kingdom
HMR
London, United Kingdom
Sponsors and Collaborators
Codagenix, Inc
More Information
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Responsible Party: Codagenix, Inc
ClinicalTrials.gov Identifier: NCT05233826    
Other Study ID Numbers: CDX-CoV-002
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Codagenix, Inc:
Covid-19 vaccines
Covid-19 vaccine booster shot
Heterologous prime boost
COVID-19 vaccination
Vaccines, attenuated
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases