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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05960097




Registration number
NCT05960097
Ethics application status
Date submitted
24/07/2023
Date registered
25/07/2023

Titles & IDs
Public title
A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
Scientific title
A Phase 2 Randomized, Active-controlled, Observer-blind Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Booster Dose of Investigational COVID-19 mRNA Vaccines in Healthy Adults Who Previously Received a Complete Primary Vaccination Series With or Without Booster Dose(s)
Secondary ID [1] 0 0
2023-504596-25-00
Secondary ID [2] 0 0
219075
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - CV0701 Bivalent High dose
Treatment: Other - CV0701 Bivalent Medium dose
Treatment: Other - CV0701 Bivalent Low dose
Treatment: Other - CV0601 Monovalent High dose
Treatment: Other - Control vaccine
Treatment: Other - CV0801 Monovalent

Experimental: Part A, Group A: CV0701 High dose - Participants receive high dose of CV0701.

Experimental: Part A, Group B: CV0701 Medium dose - Participants receive medium dose of CV0701.

Experimental: Part A, Group C: CV0701 Low dose - Participants receive low dose of CV0701.

Experimental: Part A, Group D: CV0601 High dose - Participants receive high dose of CV0601.

Active comparator: Part A, Group E: Control vaccine - Participants receive control vaccine.

Experimental: Part B, Condition 1: Baseline-control - Participants receive one dose of CV0801.

Experimental: Part B, Condition 2: Intermediate storage - Participants receive one dose of CV0801.

Experimental: Part B, Condition 3: Maximum storage conditions - Participants receive one dose of CV0801.


Treatment: Other: CV0701 Bivalent High dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.

Treatment: Other: CV0701 Bivalent Medium dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.

Treatment: Other: CV0701 Bivalent Low dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.

Treatment: Other: CV0601 Monovalent High dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.

Treatment: Other: Control vaccine
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.

Treatment: Other: CV0801 Monovalent
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
Timepoint [1] 0 0
Day 29
Primary outcome [2] 0 0
Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
Timepoint [2] 0 0
Day 29
Primary outcome [3] 0 0
Part A: Percentage of participants with solicited administration site adverse events (AEs)
Timepoint [3] 0 0
Day 1 to Day 7
Primary outcome [4] 0 0
Part A: Percentage of participants with solicited administration systemic AEs
Timepoint [4] 0 0
Day 1 to Day 7
Primary outcome [5] 0 0
Part A: Percentage of participants with unsolicited AEs
Timepoint [5] 0 0
Day 1 to Day 28
Primary outcome [6] 0 0
Part A: Percentage of participants with medically attended adverse events (MAAEs)
Timepoint [6] 0 0
Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary outcome [7] 0 0
Part A: Percentage of participants with serious adverse events (SAEs)
Timepoint [7] 0 0
Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary outcome [8] 0 0
Part A: Percentage of participants with adverse events of special interest (AESIs)
Timepoint [8] 0 0
Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary outcome [9] 0 0
Part B: Percentage of participants with solicited administration site adverse events (AEs)
Timepoint [9] 0 0
Day 1 to Day 7
Primary outcome [10] 0 0
Part B: Percentage of participants with solicited administration systemic AEs
Timepoint [10] 0 0
Day 1 to Day 7
Primary outcome [11] 0 0
Part B: Percentage of participants with unsolicited AEs
Timepoint [11] 0 0
Day 1 to Day 28
Primary outcome [12] 0 0
Part B: Percentage of participants with medically attended adverse events (MAAEs)
Timepoint [12] 0 0
Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary outcome [13] 0 0
Part B: Percentage of participants with serious adverse events (SAEs)
Timepoint [13] 0 0
Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary outcome [14] 0 0
Part B: Percentage of participants with adverse events of special interest (AESIs) Part B: Percentage of participants with adverse events of special interest (AESIs)
Timepoint [14] 0 0
Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary outcome [15] 0 0
Part B: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
Timepoint [15] 0 0
Day 29
Secondary outcome [1] 0 0
Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
Timepoint [1] 0 0
Day 91 and Day 181
Secondary outcome [2] 0 0
Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
Timepoint [2] 0 0
Day 91 and Day 181
Secondary outcome [3] 0 0
Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein
Timepoint [3] 0 0
Days 29, 91 and 181
Secondary outcome [4] 0 0
Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
Timepoint [4] 0 0
Day 29
Secondary outcome [5] 0 0
Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
Timepoint [5] 0 0
Day 29
Secondary outcome [6] 0 0
Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein
Timepoint [6] 0 0
Day 29
Secondary outcome [7] 0 0
Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
Timepoint [7] 0 0
Days 29, 91 and 181
Secondary outcome [8] 0 0
Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
Timepoint [8] 0 0
Days 29, 91 and 181
Secondary outcome [9] 0 0
Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein
Timepoint [9] 0 0
Days 29, 91 and 181

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:

1. Is at least 18 years old and has achieved legal age according to local regulations in each participating country.
2. Must provide documented informed consent prior to any study procedures being performed.
3. Can and will comply with the requirements of the protocol, in the opinion of the investigator.
4. Is healthy or medically stable as determined by the investigator's judgment based on medical history, vital sign measurements, and physical examination findings. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
5. Prior receipt of an mRNA COVID-19 vaccine. This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine. The last vaccination must be an mRNA COVID-19 vaccination received at least 3 months prior to randomization.
6. If the participant is a woman of childbearing potential, the participant may be enrolled in the study, if they:

* have practiced adequate contraception for 30 days prior to study intervention administration; and
* have a negative pregnancy test result on the day of study intervention administration; and
* have agreed to continue adequate contraception for 2 months after study intervention administration.

Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as current salpingectomy, hysterectomy, ovariectomy, or postmenopausal.

Participants are excluded from the study if any of the following criteria apply:

1. Is pregnant or has a positive pregnancy test result at Visit 1.
2. Is breastfeeding or will (re)start breastfeeding from the study intervention administration to 3 months after study intervention administration.
3. Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol or may interfere with successful completion of the study.
4. Has any history of an immunosuppressive or immunodeficient condition resulting from disease.
5. Has used immunosuppressants or other immune-modifying drugs for 14 consecutive days or more within 3 months prior to the study intervention administration. Non-systemic corticosteroids are allowed. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration.
6. Has an acute medical illness or acute febrile illness with oral temperature =38.0°C or =100.4°F within 72 hours prior to study intervention administration.
7. Has participated in another study involving any investigational product, vaccine, or device within 28 days before the study intervention administration and/or planned participation through end of study (EoS).
8. Has participated in Part A of this study.
9. Has a history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reactions to any previous mRNA vaccine or any component of the study intervention(s).
10. Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before study intervention administration through EoS.
11. Has a bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections.
12. Has a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
13. Has a 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 and persistent myocardial infection.
14. Has received a live vaccine 30 days before the study intervention administration or has a planned administration within 30 days after the study intervention administration.
15. Has received a non-replicating vaccine 8 days before the study intervention administration or has a planned administration within 14 days after the study intervention administration.
16. Has a documented history of confirmed SARS-CoV-2 infection within 3 months before study intervention administration.
17. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study intervention administration.
18. Is an employee or family member of the investigator or study site staff.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2024
Sample size
Target
Accrual to date
Final
675
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research - Canberra - PPDS - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research - Western Sydney - PPDS - Blacktown
Recruitment hospital [3] 0 0
Emeritus Research - Sydney - PPDS - Botany
Recruitment hospital [4] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [5] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [6] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [7] 0 0
Paratus Clinical Research - Central Coast - PPDS - Kanwal
Recruitment hospital [8] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [9] 0 0
Paratus Clinical Research - Brisbane Clinic - PPDS - Herston
Recruitment hospital [10] 0 0
Austrials Pty Ltd - Taringa - Taringa
Recruitment hospital [11] 0 0
AusTrials Wellers Hill - Tarragindi
Recruitment hospital [12] 0 0
Cmax - Ppds - Norwood
Recruitment hospital [13] 0 0
Emeritus Research- Melbourne PPDS - Camberwell
Recruitment hospital [14] 0 0
Hunter Diabetes Center - Merewether
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2259 - Blacktown
Recruitment postcode(s) [3] 0 0
2019 - Botany
Recruitment postcode(s) [4] 0 0
2100 - Brookvale
Recruitment postcode(s) [5] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [6] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [7] 0 0
2259 - Kanwal
Recruitment postcode(s) [8] 0 0
2035 - Maroubra
Recruitment postcode(s) [9] 0 0
4006 - Herston
Recruitment postcode(s) [10] 0 0
4068 - Taringa
Recruitment postcode(s) [11] 0 0
4075 - Tarragindi
Recruitment postcode(s) [12] 0 0
5000 - Norwood
Recruitment postcode(s) [13] 0 0
3124 - Camberwell
Recruitment postcode(s) [14] 0 0
2291 - Merewether
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
Illinois

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
CureVac
Address [1] 0 0
Country [1] 0 0

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?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.gsk.com/en-gb/innovation/trials/data-transparency/


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/NCT05960097