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

NCT05477186 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 218595
• Study Type: interventional
• Target: 185
• Locations: 3 countries
• Sites: 17

Brief Summary

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

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19; Pandemic; Booster vaccination

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination

  Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.

  From Day 1 to Day 7 (including Day 7)

• Number of Participants With Solicited Systemic AE During 7 Days After Vaccination

  Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.

  From Day 1 to Day 7 (including Day 7)

• Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination

  An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.

  From Day 1 to day 28 (including day 28)

• Number 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.

  From Day 1 up to Day 180 (including Day 180)

• Number 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.

  From Day 1 up to Day 180 (including Day 180)

• Number 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.

  From Day 1 up to Day 180 (including Day 180)

• Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination

  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.

  8 days from vaccination at Day 1

Secondary Outcomes (3)

• 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

  At Day 1, Day 15, Day 29, Day 91, and Day 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

  At Day 15, Day 29, Day 91, and Day 181

• 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

  At day 29 (28 days after the booster dose)

Study Arms (7)

Part A: CV0501 Dose Cohort 1 (12 μg)

EXPERIMENTAL

Healthy participants received a single dose of 12 microgram (μg) CV0501 vaccine intramuscularly at Day 1.

Biological: CV0501 (12 μg)

Part A: CV0501 Dose Cohort 2 (25 μg)

EXPERIMENTAL

Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.

Biological: CV0501 (25 μg)

Part A: CV0501 Dose Cohort 3 (50 μg)

EXPERIMENTAL

Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.

Biological: CV0501 (50 μg)

Part A: CV0501 Dose Cohort 4 (100 μg)

EXPERIMENTAL

Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.

Biological: CV0501 (100 μg)

Part A: CV0501 Dose Cohort 5 (200 μg)

EXPERIMENTAL

Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.

Biological: CV0501 (200 μg)

Part B: CV0501 Dose Cohort 6 (3 μg)

EXPERIMENTAL

Healthy participants received a single dose of 3 μg CV0501 vaccine intramuscularly at Day 1.

Biological: CV0501 (6 μg)

Part B: CV0501 Dose Cohort 7 (6 μg)

EXPERIMENTAL

Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.

Biological: CV0501 (3 μg)

Interventions

CV0501 (3 μg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

Part B: CV0501 Dose Cohort 7 (6 μg)

CV0501 (6 μg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

Part B: CV0501 Dose Cohort 6 (3 μg)

CV0501 (12 μg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

Part A: CV0501 Dose Cohort 1 (12 μg)

CV0501 (25 μg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

Part A: CV0501 Dose Cohort 2 (25 μg)

CV0501 (50 μg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

Part A: CV0501 Dose Cohort 3 (50 μg)

CV0501 (100 μg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

Part A: CV0501 Dose Cohort 4 (100 μg)

CV0501 (200 μg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

Part A: CV0501 Dose Cohort 5 (200 μg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must provide documented informed consent prior to any study procedures being performed
• Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits
• 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
• Negative for SARS-CoV-2 infection by RT-PCR test at screening
• Is a male or nonpregnant female \>= 18 years old
• 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.
• Agrees to refrain from blood or plasma donation from the first study vaccination through end of study.
• Has a body mass index of 18 to 40 kg/m\^2, inclusive, at screening.
• Is healthy or medically stable as determined by investigator judgment based on medical history, clinical laboratory tests, vital sign measurements, and physical examination findings

You may not qualify if:

• Participant is female and has a positive pregnancy test result at screening.
• Participant is female and is breastfeeding or will (re)start breastfeeding from the study vaccination to 3 months after vaccination.
• 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.
• Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening.
• 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.
• 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.
• 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).
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Has a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Sacramento, California, 95864, United States

Location

GSK Investigational Site

Hollywood, Florida, 33024, United States

Location

GSK Investigational Site

Melbourne, Florida, 32934, United States

Location

GSK Investigational Site

Savannah, Georgia, 31406, United States

Location

GSK Investigational Site

Peoria, Illinois, 61614-4896, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006-5322, United States

Location

GSK Investigational Site

Rockville, Maryland, 20854, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Binghamton, New York, 13760, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45212, United States

Location

GSK Investigational Site

Norfolk, Virginia, 68701, United States

Location

GSK Investigational Site

Brookvale, New South Wales, 2100, Australia

Location

GSK Investigational Site

Merewether, New South Wales, 2291, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Wollongong, New South Wales, 2500, Australia

Location

GSK Investigational Site

Cavite, 4114, Philippines

Location

GSK Investigational Site

Iloilo City, 5000, Philippines

Location

Related Publications (2)

• Essink BJ, Shapiro C, Isidro MGD, Bradley P, Pragalos A, Bloch M, Santiaguel J, Frias MV, Miyakis S, Alves de Mesquita M, Berre S, Servais C, Waugh N, Hoffmann C, Baba E, Schonborn-Kellenberger O, Wolz OO, Koch SD, Ganyani T, Boutet P, Mann P, Mueller SO, Ramanathan R, Gaudinski MR, Vanhoutte N. Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2408863. doi: 10.1080/21645515.2024.2408863. Epub 2024 Oct 18.

  PMID: 39422261 BACKGROUND

• Roth N, Gergen J, Kovacikova K, Mueller SO, Ulrich L, Schon J, Halwe NJ, Fricke C, Corleis B, Dorhoi A, Hoffmann D, Beer M, Maione D, Petsch B, Rauch S. Assessment of Immunogenicity and Efficacy of CV0501 mRNA-Based Omicron COVID-19 Vaccination in Small Animal Models. Vaccines (Basel). 2023 Jan 31;11(2):318. doi: 10.3390/vaccines11020318.

  PMID: 36851196 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

CV0501 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 28, 2022
• Study Start: August 12, 2022
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

PH (2); US (11); AU (4)