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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05477186




Registration number
NCT05477186
Ethics application status
Date submitted
27/07/2022
Date registered
28/07/2022

Titles & IDs
Public title
Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Scientific title
A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Secondary ID [1] 0 0
218595
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
SARS-CoV-2 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CV0501 (3 µg)
Treatment: Other - CV0501 (6 µg)
Treatment: Other - CV0501 (12 µg)
Treatment: Other - CV0501 (25 µg)
Treatment: Other - CV0501 (50 µg)
Treatment: Other - CV0501 (75 µg)
Treatment: Other - CV0501 (100 µg)
Treatment: Other - CV0501 (150 µg)
Treatment: Other - CV0501 (200 µg)

Experimental: Part A: CV0501 Dose Cohort 1 (12 µg) - Enrollment will be staggered, beginning with Group 1a (12 µg, younger adults). Initiation of enrollment in Group 1b (12 µg, older adults) will depend on Safety Review Team (SRT) review of safety data up to Day 8 from a minimum of 10 participants in Group 1a.

Experimental: Part A: CV0501 Dose Cohort 2 (25 µg) - For both Group 2a (younger) and Group 2b (older age), initiation of enrollment in the subsequent group at the next dose level for Cohorts 2-5 will depend on SRT review of safety data up to Day 8 from a minimum of 10 participants, from the previous dose level in the same age group.

Experimental: Part A: CV0501 Dose Cohort 3 (50 µg) - For both Group 3a (younger) and Group 3b (older age), initiation of enrollment in the subsequent group at the next dose level for Cohorts 2-5 will depend on SRT review of safety data up to Day 8 from a minimum of 10 participants, from the previous dose level in the same age group.

Experimental: Part A: CV0501 Dose Cohort 4 (75 µg or 100 µg) - For each of the groups in Cohort 4, Group 4a (younger) and Group 4b (older age),the SRT may recommend a dose specified by the dosing scenarios in the protocol, based on their review of all available safety data. The SRT will use the same approach, independently, to select the dose levels for older participants (Group 4b) and younger participants (Group 4a).

Experimental: Part A: CV0501 Dose Cohort 5 (100 µg, 150 µg or 200 µg) - For each of the groups in Cohort 5, Group 5a (younger) and Group 5b (older age), the SRT may recommend a dose specified by the dosing scenarios in the protocol, based on their review of all available safety data. The SRT will use the same approach, independently, to select the dose levels for older participants (Group 5b) and younger participants (Group 5a).

Experimental: Part B: CV0501 Dose Cohort 6 (3 µg) - Part B, designed to comprise 2 single age group cohorts, Group 6a (=18 to \<65 years old) will start based on the first interim analysis of safety and immunogenicity data, provided that the SRT assesses the 12 µg dose to be immunogenic and safe.

Experimental: Part B: CV0501 Dose Cohort 7 (6 µg) - Part B, designed to comprise 2 single age group cohorts, Group 7a (=18 to \<65 years old) will start based on the first interim analysis of safety and immunogenicity data, provided that the SRT assesses the 12 µg dose to be immunogenic and safe.


Treatment: Other: CV0501 (3 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (6 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (12 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (25 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (50 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (75 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (100 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (150 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Treatment: Other: CV0501 (200 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with solicited local adverse events (AE) during 7 days after vaccination
Timepoint [1] 0 0
Days 1 through 7
Primary outcome [2] 0 0
Percentage of participants with solicited systemic AE during 7 days after vaccination
Timepoint [2] 0 0
Days 1 through 7
Primary outcome [3] 0 0
Percentage of participants with each abnormal clinical safety laboratory finding for 8 days after study vaccination
Timepoint [3] 0 0
8 days from vaccination at Day 1
Primary outcome [4] 0 0
Percentage of participants with unsolicited AEs for 28 days after study vaccination
Timepoint [4] 0 0
28 days from vaccination at Day 1
Primary outcome [5] 0 0
Percentage of participants with medically attended adverse events (MAAEs) from study vaccination through the end of the study
Timepoint [5] 0 0
180 days from vaccination at Day 1
Primary outcome [6] 0 0
Percentage of participants with adverse events of special interest (AESIs) from study vaccination through the end of the study
Timepoint [6] 0 0
180 days from vaccination at Day 1
Primary outcome [7] 0 0
Percentage of participants with serious adverse events (SAEs) from study vaccination through the end of the study
Timepoint [7] 0 0
180 days from vaccination at Day 1
Secondary outcome [1] 0 0
Geometric Mean Titers (GMTs) of neutralizing Ab against pseudovirus bearing S protein from SARS-CoV-2 WT, Omicron, and Delta variants at each collection timepoint
Timepoint [1] 0 0
Days 1, 8, 15, 29, 91, and 181
Secondary outcome [2] 0 0
Geometric Mean Increase (GMI) from baseline of neutralizing Ab titers against pseudovirus bearing S protein from SARS-CoV-2 WT, Omicron, and Delta variants at each collection time point
Timepoint [2] 0 0
Days 1, 8, 15, 29, 91, and 181
Secondary outcome [3] 0 0
Seroresponse rate 28 days after the booster dose, based on neutralizing Ab titers against pseudoviruses bearing S protein from SARS-CoV-2 WT, Omicron, and Delta variants at each collection timepoint
Timepoint [3] 0 0
At day 29

Eligibility
Key inclusion criteria
1. Must provide documented informed consent prior to any study procedures being performed
2. Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits
3. Has received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®), with the last dose of vaccine received at least 6 months prior to screening
4. Negative for SARS-CoV-2 infection by RT-PCR test at screening
5. Is a male or nonpregnant female =18 years old
6. If the participant is a woman of child bearing potential, the participant agrees to use at least 1 highly effective form of contraception for at least 30 days prior to the study vaccination up to 3 months after study vaccination.
7. Agrees to refrain from blood or plasma donation from the first study vaccination through end of study.
8. Has a body mass index of 18 to 40 kg/m2, inclusive, at screening.
9. Is healthy or medically stable as determined by investigator judgment based on medical history, clinical laboratory tests, vital sign measurements, and physical examination findings
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participant is female and has a positive pregnancy test result at screening.
2. Participant is female and is breastfeeding or will (re)start breastfeeding from the study vaccination to 3 months after vaccination.
3. Has an acute febrile illness with temperature =38.0°C or =100.4°F within 72 hours before study vaccination. Individuals with suspected COVID-19 symptoms should be excluded and referred for medical care.
4. Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening.
5. Has a documented medical history of HIV, hepatitis B or hepatitis C infection prior to screening, or a positive test for these conditions at screening.
6. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy immunotherapy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of the first study vaccination. Inclusion of persons who use low dose topical, ophthalmic, inhaled, or intranasal steroid preparations is permitted.
7. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (eg, due to enterovirus or adenovirus), and celiac disease.
8. Has a new onset, clinically significant, abnormal biochemistry or hematology finding (defined as =Grade 1) at screening (adults with Grade 1 laboratory abnormalities that have been stable for at least 6 months before enrollment may be included in the study).
9. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain- Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), Takayasu arteritis, granulomatosis with polyangiitis, psoriasis, and insulin-dependent diabetes mellitus (Type 1).
10. Has an unstable chronic medical condition. This refers to a condition requiring a new medication or increase in dose of current medication(s) or a condition requiring hospitalization within 6 months prior to screening.
11. Has a history of hypersensitivity or severe allergic reaction, including anaphylaxis, generalized urticaria, angioedema, and other significant reactions, to vaccines or to any component of the investigational product.
12. Has received or plans to receive any licensed vaccine, within 4 weeks before or 4 weeks after study vaccination. Inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study vaccination.
13. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study vaccination. Rescreening of these participants permitted after quarantine period is complete.
14. Has participated or plans to participate in another investigational study involving any investigational product or device within 6 months or 5 half-lives, whichever is longer, before the study vaccination through end of study.
15. Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before the first study vaccination through end of study.
16. Has a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
17. Has a history of alcohol abuse or other recreational drug use (excluding cannabis) within 6 months before study vaccination.
18. Has any abnormal skin condition or permanent body art (eg, tattoo) that would interfere with the ability to observe local reactions at the injection site.
19. Has a medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the individual at an unacceptable risk of injury, render the individual unable to meet the requirements of the protocol, or interfere with the individual's successful completion of the trial.
20. Participant is an employee or family member of the investigator or study site personnel.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2023
Sample size
Target
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Brookvale
Recruitment hospital [2] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [3] 0 0
GSK Investigational Site - Merewether
Recruitment hospital [4] 0 0
Hunter Diabetes Centre - Dedicated Research Facility - Merewether
Recruitment hospital [5] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [6] 0 0
Rainleigh Pty Ltd trading as Holdsworth House Medical Practice - Sydney
Recruitment hospital [7] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [8] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [9] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [10] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [11] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
Philippines
State/province [11] 0 0
Cavite
Country [12] 0 0
Philippines
State/province [12] 0 0
Iloilo
Country [13] 0 0
Philippines
State/province [13] 0 0
National Capital Region
Country [14] 0 0
Philippines
State/province [14] 0 0
Dasmarinas
Country [15] 0 0
Philippines
State/province [15] 0 0
Jaro, Iloilo City
Country [16] 0 0
Philippines
State/province [16] 0 0
Quezon City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05477186