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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Biological: CV0501 (12 μg); Biological: CV0501 (25 μg); Biological: CV0501 (50 μg); Biological: CV0501 (75 μg); Biological: CV0501 (100 μg); Biological: CV0501 (150 μg); Biological: CV0501 (200 μg); Biological: CV0501 (6 μg); Biological: CV0501 (3 μg)

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Brookvale, New South Wales, Australia, 2100
      • Northern Beaches Clinical Research
    • Brookvale, New South Wales, Australia, 2100
      • GSK Investigational Site
    • Merewether, New South Wales, Australia, 2291
      • Hunter Diabetes Centre - Dedicated Research Facility
    • Merewether, New South Wales, Australia, 2291
      • GSK Investigational Site
    • Sydney, New South Wales, Australia, 2010
      • GSK Investigational Site
    • Sydney, New South Wales, Australia, 2010
      • Rainleigh Pty Ltd trading as Holdsworth House Medical Practice
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital
    • Wollongong, New South Wales, Australia, 2500
      • GSK Investigational Site
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • GSK Investigational Site
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
    • Parkville, Victoria, Australia, 3050
      • GSK Investigational Site
• Philippines
  • Dasmarinas, Philippines, 4114
    • GSK Investigational Site
  • Jaro, Iloilo City, Philippines, 5000
    • GSK Investigational Site
  • Quezon City, Philippines, 1109
    • GSK Investigational Site
  • Cavite
    • Dasmariñas, Cavite, Philippines, 4114
      • De La Salle Health Sciences Institute
  • Iloilo
    • Iloilo City, Iloilo, Philippines, 5000
      • West Visayas State University Medical Centere
  • National Capital Region
    • Quezon City, National Capital Region, Philippines, 1109
      • Quirino Memorial Medical Center
• United States
  • California
    • Sacramento, California, United States, 95864
      • Benchmark Research
    • Sacramento, California, United States, 95864
      • GSK Investigational Site
  • Florida
    • Hollywood, Florida, United States, 33024
      • GSK Investigational Site
    • Hollywood, Florida, United States, 33024
      • Research Centers of America - CenExcel
    • Melbourne, Florida, United States, 32934
      • GSK Investigational Site
    • Melbourne, Florida, United States, 32934
      • Optimal Research Florida - Melbourne
  • Georgia
    • Savannah, Georgia, United States, 31406
      • GSK Investigational Site
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research (Savannah Georgia)
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Optimal Research Illinois - Peoria
    • Peoria, Illinois, United States, 61614-4896
      • GSK Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research - Metairie - HyperCore
    • Metairie, Louisiana, United States, 70006-5322
      • GSK Investigational Site
  • Maryland
    • Rockville, Maryland, United States, 20854
      • GSK Investigational Site
    • Rockville, Maryland, United States, 20854
      • Meridian Clinical Research (Rockville Maryland)
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • GSK Investigational Site
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research (Norfolk-Nebraska)
    • Omaha, Nebraska, United States, 68134
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research (Omaha-Nebraska)
  • New York
    • Binghamton, New York, United States, 13901
      • Meridian Clinical Research (Binghamton-New York)
    • Endwell, New York, United States, 13760
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45212
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with solicited local adverse events (AE) during 7 days after vaccination		Days 1 through 7
Percentage of participants with solicited systemic AE during 7 days after vaccination		Days 1 through 7
Percentage of participants with each abnormal clinical safety laboratory finding for 8 days after study vaccination		8 days from vaccination at Day 1
Percentage of participants with unsolicited AEs for 28 days after study vaccination		28 days from vaccination at Day 1
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Pandemic; Booster vaccination
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 218595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No