Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old

COVID-19 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05477186
• Other study ID #: 218595
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2022
• Est. completion date: August 18, 2023

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prevention of COVID-19 caused by SARS-CoV-2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Biological:
• CV0501 (3 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (6 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (12 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (25 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (50 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (75 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (100 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (150 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.
• CV0501 (200 µg)
Study vaccine will be administered as a single intramuscular injection in the deltoid area, preferably in the nondominant arm.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Brookvale	New South Wales
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Merewether	New South Wales
Australia	Hunter Diabetes Centre - Dedicated Research Facility	Merewether	New South Wales
Australia	GSK Investigational Site	Parkville	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	GSK Investigational Site	Sydney	New South Wales
Australia	Rainleigh Pty Ltd trading as Holdsworth House Medical Practice	Sydney	New South Wales
Australia	GSK Investigational Site	Wollongong	New South Wales
Australia	Wollongong Hospital	Wollongong	New South Wales
Philippines	GSK Investigational Site	Dasmarinas
Philippines	De La Salle Health Sciences Institute	Dasmariñas	Cavite
Philippines	West Visayas State University Medical Centere	Iloilo City	Iloilo
Philippines	GSK Investigational Site	Jaro, Iloilo City
Philippines	GSK Investigational Site	Quezon City
Philippines	Quirino Memorial Medical Center	Quezon City	National Capital Region
United States	Meridian Clinical Research (Binghamton-New York)	Binghamton	New York
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Hollywood	Florida
United States	Research Centers of America - CenExcel	Hollywood	Florida
United States	GSK Investigational Site	Melbourne	Florida
United States	Optimal Research Florida - Melbourne	Melbourne	Florida
United States	Benchmark Research - Metairie - HyperCore	Metairie	Louisiana
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Norfolk	Nebraska
United States	Meridian Clinical Research (Norfolk-Nebraska)	Norfolk	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	Meridian Clinical Research (Omaha-Nebraska)	Omaha	Nebraska
United States	GSK Investigational Site	Peoria	Illinois
United States	Optimal Research Illinois - Peoria	Peoria	Illinois
United States	GSK Investigational Site	Rockville	Maryland
United States	Meridian Clinical Research (Rockville Maryland)	Rockville	Maryland
United States	Benchmark Research	Sacramento	California
United States	GSK Investigational Site	Sacramento	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	GSK Investigational Site	Savannah	Georgia
United States	Meridian Clinical Research (Savannah Georgia)	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with solicited local adverse events (AE) during 7 days after vaccination		Days 1 through 7
Primary	Percentage of participants with solicited systemic AE during 7 days after vaccination		Days 1 through 7
Primary	Percentage of participants with each abnormal clinical safety laboratory finding for 8 days after study vaccination		8 days from vaccination at Day 1
Primary	Percentage of participants with unsolicited AEs for 28 days after study vaccination		28 days from vaccination at Day 1
Primary	Percentage of participants with medically attended adverse events (MAAEs) from study vaccination through the end of the study	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.	180 days from vaccination at Day 1
Primary	Percentage of participants with adverse events of special interest (AESIs) from study vaccination through the end of the study	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.	180 days from vaccination at Day 1
Primary	Percentage of participants with serious adverse events (SAEs) from study vaccination through the end of the study	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.	180 days from vaccination at Day 1
Secondary	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		Days 1, 8, 15, 29, 91, and 181
Secondary	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		Days 1, 8, 15, 29, 91, and 181
Secondary	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	Seroresponse is defined as postboost titers = 4× preboost titers	At day 29