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COVID-19Phase 1NCT05260437

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

A Phase 1 study testing CV2CoV (2 µg), CV2CoV (4 µg) and CV2CoV (8 µg) in people with COVID-19 and SARS-CoV-2, run by GlaxoSmithKline at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Prevention of COVID-19 caused by SARS-CoV-2. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2
What is being tested?
CV2CoV (2 µg), CV2CoV (4 µg) and CV2CoV (8 µg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
24 sitesUnited States
Study dates
24 Mar 2022to 7 Mar 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Reports 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 injections, immunoglobulins, interferons, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of study vaccination.
  • Has a bleeding disorder or prior history of significant bleeding or bruising after IM injections or venipuncture.
  • Has a history of alcohol abuse or other recreational drug use (excluding cannabis) within 6 months before study vaccination.
  • Has any abnormal skin condition or permanent body art that would interfere with the ability to observe local reactions at the study vaccination injection site.
  • Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 14 days before study vaccination.
  • Participant is an employee or family member of the investigator or study site personnel.
  • Has any self-reported or medically-documented significant medical or psychiatric condition. Significant medical conditions include, but are not limited to, the following:
  • Moderate or severe respiratory disease
  • Uncontrolled hypertension, defined as an average systolic blood pressure ≥140 mmHg for participants ≤60 years old, and ≥150 mmHg for participants >60 years old, or a diastolic blood pressure ≥90 mmHg for any age
  • Significant cardiovascular disease or history of myocarditis or pericarditis
  • Neurological or neurodevelopmental conditions
  • Ongoing malignancy or recent diagnosis of malignancy in the last 5 years (excluding basal cell and squamous cell carcinoma of the skin)
  • Tuberculosis or nontuberculosis mycobacterial infection
  • Autoimmune disease, including hypothyroidism without a defined nonautoimmune cause
  • Immunodeficiency of any cause, including from solid organ transplant, blood or bone marrow transplant, use of corticosteroids, or use of other immune weakening medicines
  • Type 1 or 2 diabetes mellitus regardless of disease control
  • Has any of the following self-reported or medically-documented risk factors for severe COVID-19:
  • Cancer
  • Chronic kidney disease
  • Sickle cell disease
  • Cerebrovascular disease
  • Cystic fibrosis
  • Chronic liver disease
  • Pulmonary fibrosis
  • Thalassemia
  • Smoking or other inhaled substance use, including tobacco, cannabis, or nicotine vapors, with an average of ≥5 cigarettes a day or equivalent (currently or within 1 year of Screening).
  • Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before Screening.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Lynn Institute of Denver - ERN

    Aurora, Colorado, 80012-4520

  • GSK Investigational Site

    Cedar Park, Texas, 78613

  • GSK Investigational Site

    Cleveland, Ohio, 44122

  • Velocity Clinical Research - Cleveland

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Dallas, Texas, 75203-1259

  • GSK Investigational Site

    Dallas, Texas, 75234

  • GSK Investigational Site

    Hallandale, Florida, 33009

  • MD Clinical - Velocity

    Hallandale, Florida, 33009

  • GSK Investigational Site

    Lakeland, Florida, 33803-5918

  • Accel Research Sites

    Lakeland, Florida, 33803

  • GSK Investigational Site

    Miami, Florida, 33173

  • Suncoast Research Group LLC - ERN-PPDS

    Miami, Florida, 33173

  • GSK Investigational Site

    Norman, Oklahoma, 73072

  • Lynn Institute of Norman - ERN - PPDS

    Norman, Oklahoma, 73072

  • Affinity Health Corp

    Oak Brook, Illinois, 60523

  • GSK Investigational Site

    Oak Brook, Illinois, 60523

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Palm Springs, Florida, 33406

  • Research Your Health - Elite

    Plano, Texas, 75093

  • DM Clinical - Cyfair Clinical Research Center

    Tomball, Texas, 77375

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    West Jordan, Utah, 84088

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

    West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Safety, Reactogenicity, and Immunogenicity Trial of the CV2CoV mRNA Vaccine Against SARS CoV 2 in Seropositive Adult Participants

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

Conditions
COVID-19, SARS-CoV-2
Being tested
CV2CoV (2 µg), CV2CoV (4 µg), CV2CoV (8 µg), CV2CoV (12 µg), CV2CoV (16 µg)
Keywords
COVID-19, Pandemic, Booster vaccination
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CV2CoV (2 µg)Biological

    Study vaccine was administered as a single intramuscular injection.

  • CV2CoV (4 µg)Biological

    Study vaccine was administered as a single intramuscular injection.

  • CV2CoV (8 µg)Biological

    Study vaccine was administered as a single intramuscular injection.

  • CV2CoV (12 µg)Biological

    Study vaccine was administered as a single intramuscular injection.

  • CV2CoV (16 µg)Biological

    Study vaccine was administered as a single intramuscular injection.

  • 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.

Study groups in NCT05260437
Study groupRoleWhat they receive
CV2CoV Dose Cohort 1 (Group 1a 2μg)ExperimentalParticipants received 2 μg CV2CoV intramuscularly.
Receives: Biological: CV2CoV (2 µg)
CV2CoV Dose Cohort 1 (Group 1b 4μg)ExperimentalParticipants received 4 μg CV2CoV intramuscularly.
Receives: Biological: CV2CoV (4 µg)
CV2CoV Dose Cohort 2 (8 μg)ExperimentalParticipants received 8 μg CV2CoV intramuscularly.
Receives: Biological: CV2CoV (8 µg)
CV2CoV Dose Cohort 3 (12 μg)ExperimentalParticipants received 12 μg CV2CoV intramuscularly.
Receives: Biological: CV2CoV (12 µg)
CV2CoV Dose Cohort 4 (16 μg)ExperimentalParticipants received 16 μg CV2CoV intramuscularly.
Receives: Biological: CV2CoV (16 µg)
CV2CoV Dose Cohort 5 (20 μg)ExperimentalParticipants 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.
Receives: Biological: CV2CoV (20 µg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: From Day 1 to Day 7 (including Day 7)

  5. 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.

    Measured: From Day 1 to Day 7 (including Day 7)

  6. 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.

    Measured: From Day 1 to Day 28 (including Day 28)

Secondary outcomes (5)

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

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

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

    Percentage of participants with seroresponse against antigen SARS-CoV-2 WT, Beta, Omicron BA.1, Omicron BA.2, Delta assessed were reported. Seroresponse was defined as greater than equal to (>=) 4-fold increase from Day 1 (Baseline) to the Day 29. The fold rise was calculated as the ratio of the post-vaccination Neutralizing Antibody Titers to the pre-vaccination Neutralizing Antibody Titers.

    Measured: At Day 29 (29 days post booster dose)

  3. 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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start24 Mar 2022
  3. Primary completion7 Mar 2023
  4. Study completion7 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05260437
Sponsor's protocol ID
217741
Status last verified
Mar 2024
First submitted
25 Feb 2022
Last updated
12 Aug 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CV2CoV (2 µg), CV2CoV (4 µg) and CV2CoV (8 µg) in people with COVID-19 and SARS-CoV-2, run by GlaxoSmithKline at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study (time frame: From Day 1 up to Day 180 (including Day 180)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05260437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.

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