Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants

NCT05260437 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 217741
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 24

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 (6)

• 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 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 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 Solicited Local Adverse Events (AEs) up to 7 Days After Study Vaccination

  Assessed solicited local reactions were injection site pain, redness, swelling, and lymphadenopathy.

  From Day 1 to Day 7 (including Day 7)

• Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination

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

  From Day 1 to Day 7 (including Day 7)

• Number of Participants With Unsolicited AEs up to 28 Days After Study Vaccination, Including Clinically Relevant Abnormal Clinical Safety Laboratory Findings

  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)

Secondary Outcomes (5)

• Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)

  At Day 1, Day 8, Day 15, Day 29, Day 85, and Day 180

• Percentage of Participants With Seroresponse (>= 4 Fold Rise From Baseline) at Day 29 After the Booster Dose

  At Day 29 (29 days post booster dose)

• Geometric Mean Increase (GMI) From Baseline of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 WT at Each Collection Time Point

  At Day 8, Day 15, Day 29, Day 85, and Day 180

• GMTs of Binding Immunoglobulin G (IgG) Against SARS CoV-2 S Protein and Receptor-Binding Domain (RBD)

  At Day 8, Day 15, Day 29, Day 85 and Day 180

• GMI From Baseline of Binding IgG Against SARS CoV-2 S Protein and RBD

  At Day 8, Day 15, Day 29, Day 85, and Day 180

Study Arms (6)

CV2CoV Dose Cohort 1 (Group 1a 2μg)

EXPERIMENTAL

Participants received 2 μg CV2CoV intramuscularly.

Biological: CV2CoV (2 µg)

CV2CoV Dose Cohort 1 (Group 1b 4μg)

EXPERIMENTAL

Participants received 4 μg CV2CoV intramuscularly.

Biological: CV2CoV (4 µg)

CV2CoV Dose Cohort 2 (8 μg)

EXPERIMENTAL

Participants received 8 μg CV2CoV intramuscularly.

Biological: CV2CoV (8 µg)

CV2CoV Dose Cohort 3 (12 μg)

EXPERIMENTAL

Participants received 12 μg CV2CoV intramuscularly.

Biological: CV2CoV (12 µg)

CV2CoV Dose Cohort 4 (16 μg)

EXPERIMENTAL

Participants received 16 μg CV2CoV intramuscularly.

Biological: CV2CoV (16 µg)

CV2CoV Dose Cohort 5 (20 μg)

EXPERIMENTAL

Participants were scheduled to receive 20 μg CV2CoV Intramuscularly, but there were no participants enrolled in this group, and hence, there was no vaccine administered in this study group.

Biological: CV2CoV (20 µg)

Interventions

CV2CoV (2 µg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

CV2CoV Dose Cohort 1 (Group 1a 2μg)

CV2CoV (4 µg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

CV2CoV Dose Cohort 1 (Group 1b 4μg)

CV2CoV (8 µg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

CV2CoV Dose Cohort 2 (8 μg)

CV2CoV (12 µg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

CV2CoV Dose Cohort 3 (12 μg)

CV2CoV (16 µg) BIOLOGICAL

Study vaccine was administered as a single intramuscular injection.

CV2CoV Dose Cohort 4 (16 μg)

CV2CoV (20 µg) BIOLOGICAL

Study vaccine was planned to be administered intramuscularly. No vaccine was administered in the CV2CoV (20 µg) Group, since there were no participants enrolled in it.

CV2CoV Dose Cohort 5 (20 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, including being willing and able to use electronic devices during the study.
• Has received at least 2 doses of Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax) mRNA COVID-19 vaccine with the last dose of vaccine received at least 6 months prior to Screening and has provided documentation of receiving the vaccination series.
• Negative for SARS-CoV-2 infection by RT-PCR test at Screening.
• Is a male or nonpregnant female 18 to \<65 years of age (younger adult group) or ≥65 years of age (older adult group) at Screening.
• Has a body mass index of 18 to 34.9 kg/m\^2, inclusive, at Screening.
• If the participant is a woman of child bearing potential the participant agrees to practice true abstinence or use at least 1 highly effective form of contraception for at least 30 days prior to study vaccination up to 3 months after study vaccination.
• Agrees to refrain from blood or plasma donation from Screening and throughout the end of the study.
• Is healthy or medically stable as determined by medical history, clinical laboratory tests, vital sign measurements, and physical examination findings, as determined by investigator judgment.

You may not qualify if:

• Participant is female and has a positive serum pregnancy test result at Screening or plans to become pregnant during the study.
• Participant is female and is breastfeeding or plans to breastfeed from study vaccination to 3 months after study vaccination.
• Has any clinically significant abnormal biochemistry or hematology finding (defined as ≥Grade 1) at Screening.
• Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant's successful completion of the trial.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
• 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 an acute febrile illness with a temperature ≥38.0°C or ≥100.4°F observed by the participant or at the study site within 72 hours prior to study vaccination. Participants with suspected COVID-19 symptoms should be excluded and referred for medical care.
• Has a prior confirmed diagnosis of chronic hepatitis B, hepatitis C, or HIV 1/2 infection or evidence of active infection at Screening.
• Has participated or plans to participate in another investigational study involving any investigational drug or device within 60 days or 5 half-lives, whichever is longer, before study vaccination and throughout the end of the study.
• Has previously participated in an investigational vaccine study with investigational vaccine administered within 6 months of study vaccination OR has received the last dose of \>1 COVID-19 vaccine series (investigational and/or authorized) in the last 12 months.
• Has received or plans to receive any licensed vaccine within 4 weeks before or 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.
• Is planning to receive a COVID-19 booster vaccination for the duration of the study (for adults who are not covered by local recommendations to receive booster per current standard of care) or is planning to receive a COVID-19 booster vaccination on or before Day 29 of the study (for adults covered by local recommendations to receive booster).
• Has received or plans to receive immunoglobulins or any blood or blood products within 90 days before study vaccination and throughout the study.
• Has a history of hypersensitivity or severe allergic reaction, including anaphylaxis, generalized urticaria, angioedema, and other significant reactions to any previous vaccine or any component of the IP.
• Has a history of hypersensitivity or severe allergic reaction (including anaphylaxis, generalized urticaria, angioedema, and other significant reactions) to beta lactam antibiotics.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• CureVac: collaborator

Study Sites (24)

Lynn Institute of Denver - ERN

Aurora, Colorado, 80012-4520, United States

Location

GSK Investigational Site

Hallandale, Florida, 33009, United States

Location

MD Clinical - Velocity

Hallandale, Florida, 33009, United States

Location

GSK Investigational Site

Lakeland, Florida, 33803-5918, United States

Location

Accel Research Sites

Lakeland, Florida, 33803, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

Suncoast Research Group LLC - ERN-PPDS

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Palm Springs, Florida, 33406, United States

Location

Affinity Health Corp

Oak Brook, Illinois, 60523, United States

Location

GSK Investigational Site

Oak Brook, Illinois, 60523, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

Velocity Clinical Research - Cleveland

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Norman, Oklahoma, 73072, United States

Location

Lynn Institute of Norman - ERN - PPDS

Norman, Oklahoma, 73072, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Cedar Park, Texas, 78613, United States

Location

GSK Investigational Site

Dallas, Texas, 75203-1259, United States

Location

GSK Investigational Site

Dallas, Texas, 75234, United States

Location

Research Your Health - Elite

Plano, Texas, 75093, United States

Location

DM Clinical - Cyfair Clinical Research Center

Tomball, Texas, 77375, United States

Location

GSK Investigational Site

Tomball, Texas, 77375, United States

Location

GSK Investigational Site

West Jordan, Utah, 84088, United States

Location

Velocity Clinical Research - Salt Lake City - Jordan Valley-ERN-PPDS

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

COVID-19

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: February 25, 2022
• First Posted: March 2, 2022
• Study Start: March 24, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-03

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

US (24)