NCT05233826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

February 3, 2022

Last Update Submit

January 11, 2023

Conditions

COVID-19SARS-CoV-2

Keywords

Covid-19 vaccinesCovid-19 vaccine booster shotHeterologous prime boostCOVID-19 vaccinationVaccines, attenuated

Outcome Measures

Primary Outcomes (6)

  • Humoral Immunogenicity

    IgG Titer measured by ELISA on day 1

    Day 1

  • Humoral Immunogenicity

    IgG Titer measured by ELISA on day 29

    Day 1

  • Humoral Immunogenicity

    IgG Titer measured by ELISA on day 181

    Day 181

  • Humoral Immunogenicity measured by neutralizing antibodies

    neutralising antibody titer measured by microneutralisation assay in serum on days 1

    Day 1

  • Humoral Immunogenicity measured by neutralizing antibodies

    neutralising antibody titer measured by microneutralisation assay in serum on day 29

    Day 29

  • Humoral Immunogenicity measured by neutralizing antibodies

    neutralising antibody titer measured by microneutralisation assay in serum on day 181

    Day 181

Secondary Outcomes (2)

  • Vaccine and Virus Shedding

    Day 4

  • Vaccine and Virus Shedding

    Day 8

Study Arms (1)

COVI-VAC

EXPERIMENTAL

COVI-VAC Nose Drops

Biological: COVI-VAC

Interventions

COVI-VACBIOLOGICAL

Intranasal, live attenuated vaccine against SARS-CoV-2

COVI-VAC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HMR

London, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVI-VAC

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 10, 2022

Study Start

April 14, 2022

Primary Completion

July 21, 2022

Study Completion

December 22, 2022

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations

GB(1)