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Completed

NCT Number: NCT05233826

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HMR

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
  • Body mass index (BMI) ≤ 35 kg/m2
  • 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
  • Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1

Exclusion criteria

  • Residents of residential care facilities
  • Pregnant or lactating women
  • Inadequate venous access for repeated phlebotomy
  • History of confirmed or suspected SARS-CoV-2 infection

Treatment and study plan

COVI-VAC

Biological

Intranasal, live attenuated vaccine against SARS-CoV-2

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Codagenix, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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