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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 (100 µg)
Treatment: Other - CV0501 (200 µg)

Experimental: Part A: CV0501 Dose Cohort 1 (12 µg) - Healthy participants received a single dose of 12 microgram (µg) CV0501 vaccine intramuscularly at Day 1.

Experimental: Part A: CV0501 Dose Cohort 2 (25 µg) - Healthy participants received a single dose of 25 µg CV0501 vaccine intramuscularly at Day 1.

Experimental: Part A: CV0501 Dose Cohort 3 (50 µg) - Healthy participants received a single dose of 50 µg CV0501 vaccine intramuscularly at Day 1.

Experimental: Part A: CV0501 Dose Cohort 4 (100 µg) - Healthy participants received a single dose of 100 µg CV0501 vaccine intramuscularly at Day 1.

Experimental: Part A: CV0501 Dose Cohort 5 (200 µg) - Healthy participants received a single dose of 200 µg CV0501 vaccine intramuscularly at Day 1.

Experimental: Part B: CV0501 Dose Cohort 6 (3 µg) - Healthy participants received a single dose of 3 µg CV0501 vaccine intramuscularly at Day 1.

Experimental: Part B: CV0501 Dose Cohort 7 (6 µg) - Healthy participants received a single dose of 6 µg CV0501 vaccine intramuscularly at Day 1.


Treatment: Other: CV0501 (3 µg)
Study vaccine was administered as a single intramuscular injection.

Treatment: Other: CV0501 (6 µg)
Study vaccine was administered as a single intramuscular injection.

Treatment: Other: CV0501 (12 µg)
Study vaccine was administered as a single intramuscular injection.

Treatment: Other: CV0501 (25 µg)
Study vaccine was administered as a single intramuscular injection.

Treatment: Other: CV0501 (50 µg)
Study vaccine was administered as a single intramuscular injection.

Treatment: Other: CV0501 (100 µg)
Study vaccine was administered as a single intramuscular injection.

Treatment: Other: CV0501 (200 µg)
Study vaccine was administered as a single intramuscular injection.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Assessment method [1] 0 0
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Timepoint [1] 0 0
From Day 1 to Day 7 (including Day 7)
Primary outcome [2] 0 0
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Assessment method [2] 0 0
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
Timepoint [2] 0 0
From Day 1 to Day 7 (including Day 7)
Primary outcome [3] 0 0
Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
Assessment method [3] 0 0
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Timepoint [3] 0 0
From Day 1 to day 28 (including day 28)
Primary outcome [4] 0 0
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
Assessment method [4] 0 0
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
Timepoint [4] 0 0
From Day 1 up to Day 180 (including Day 180)
Primary outcome [5] 0 0
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
Assessment method [5] 0 0
An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Timepoint [5] 0 0
From Day 1 up to Day 180 (including Day 180)
Primary outcome [6] 0 0
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
Assessment method [6] 0 0
An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Timepoint [6] 0 0
From Day 1 up to Day 180 (including Day 180)
Primary outcome [7] 0 0
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Assessment method [7] 0 0
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10\^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10\^6/uL; Male: 4.63-6.08x 10\^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10\^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10\^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10\^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10\^3/uL; Platelets: 163-375 x 10\^3/uL; Urea Nitrogen: 5-20 mg/dL.
Timepoint [7] 0 0
8 days from vaccination at Day 1
Secondary outcome [1] 0 0
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Assessment method [1] 0 0
Timepoint [1] 0 0
At Day 1, Day 15, Day 29, Day 91, and Day 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
Assessment method [2] 0 0
Timepoint [2] 0 0
At Day 15, Day 29, Day 91, and Day 181
Secondary outcome [3] 0 0
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Assessment method [3] 0 0
Seroresponse was defined as post-boost titers \>= 4 times pre-boost (baseline) titers for participants with titer \>= LLOQ at pre-vaccination and as post-booster titer \>= 4 times LLOQ for participants with titer \< LLOQ at pre vaccination.
Timepoint [3] 0 0
At day 29 (28 days after the booster dose)

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 childbearing 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/m^2, 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
185
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Brookvale
Recruitment hospital [2] 0 0
GSK Investigational Site - Merewether
Recruitment hospital [3] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [4] 0 0
GSK Investigational Site - Wollongong
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 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
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Philippines
State/province [11] 0 0
Cavite
Country [12] 0 0
Philippines
State/province [12] 0 0
Iloilo City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05477186