Last updated: 03/07/2024 08:10:26
Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: Prevention of COVID-19 caused by SARS-CoV-2.
Primary purpose:
Prevention
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with adverse events of special interest (AESIs) from study vaccination through the end of the study
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: From Day 1 to Day 7 (including Day 7)
Number of participants with each solicited systemic AEs up to 7 days after study vaccination
Timeframe: 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
Timeframe: From Day 1 to Day 28 (including Day 28)
Secondary outcomes:
Geometric Mean Titers (GMTs) of neutralizing antibody titers against pseudovirus bearing spike protein from SARS CoV 2 wild type (WT)
Timeframe: 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
Timeframe: 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
Timeframe: 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)
Timeframe: 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
Timeframe: At Day 8, Day 15, Day 29, Day 85, and Day 180
Interventions:
Enrollment:
99
Primary completion date:
2023-07-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
COVID-19, SARS-CoV-2
Product
Not applicable
Collaborators
CureVac
Study date(s)
March 2022 to March 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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, including being willing and able to use electronic devices during the study.
- 1. Participant is female and has a positive serum pregnancy test result at Screening or plans to become pregnant during the study.
- 2. Participant is female and is breastfeeding or plans to breastfeed from study vaccination to 3 months after study vaccination.
Inclusion and exclusion criteria
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, including being willing and able to use electronic devices during the study. 3. 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. 4. Negative for SARS-CoV-2 infection by RT-PCR test at Screening. 5. 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. 6. Has a body mass index of 18 to 34.9 kg/m^2, inclusive, at Screening. 7. 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. 8. Agrees to refrain from blood or plasma donation from Screening and throughout the end of the study. 9. 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.
Exclusion criteria:
- 1. Participant is female and has a positive serum pregnancy test result at Screening or plans to become pregnant during the study. 2. Participant is female and is breastfeeding or plans to breastfeed from study vaccination to 3 months after study vaccination. 3. Has any clinically significant abnormal biochemistry or hematology finding (defined as ≥Grade 1) at Screening. 4. 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. 5. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy. 6. 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. 7. 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. 8. Has a prior confirmed diagnosis of chronic hepatitis B, hepatitis C, or HIV 1/2 infection or evidence of active infection at Screening. 9. 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. 10. 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. 11. 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. 12. 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). 13. Has received or plans to receive immunoglobulins or any blood or blood products within 90 days before study vaccination and throughout the study. 14. 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. 15. Has a history of hypersensitivity or severe allergic reaction (including anaphylaxis, generalized urticaria, angioedema, and other significant reactions) to beta lactam antibiotics. 16. 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. 17. Has a bleeding disorder or prior history of significant bleeding or bruising after IM injections or venipuncture. 18. Has a history of alcohol abuse or other recreational drug use (excluding cannabis) within 6 months before study vaccination. 19. 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. 20. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 14 days before study vaccination. 21. Participant is an employee or family member of the investigator or study site personnel. 22. Has any self-reported or medically-documented significant medical or psychiatric condition. Significant medical conditions include, but are not limited to, the following: a. Moderate or severe respiratory disease b. 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 c. Significant cardiovascular disease or history of myocarditis or pericarditis d. Neurological or neurodevelopmental conditions e. Ongoing malignancy or recent diagnosis of malignancy in the last 5 years (excluding basal cell and squamous cell carcinoma of the skin) f. Tuberculosis or nontuberculosis mycobacterial infection g. Autoimmune disease, including hypothyroidism without a defined nonautoimmune cause h. Immunodeficiency of any cause, including from solid organ transplant, blood or bone marrow transplant, use of corticosteroids, or use of other immune weakening medicines i. Type 1 or 2 diabetes mellitus regardless of disease control 23. Has any of the following self-reported or medically-documented risk factors for severe COVID-19: a. Cancer b. Chronic kidney disease c. Sickle cell disease d. Cerebrovascular disease e. Cystic fibrosis f. Chronic liver disease g. Pulmonary fibrosis h. Thalassemia i. 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). 24. Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before Screening.
Trial location(s)
Location
GSK Investigational Site
Cedar Park, Texas, United States, 78613
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75203-1259
Status
Study Complete
Location
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
Status
Study Complete
Location
GSK Investigational Site
Lakeland, Florida, United States, 33803-5918
Status
Study Complete
Location
GSK Investigational Site
Norman, Oklahoma, United States, 73072
Status
Study Complete
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
Palm Springs, Florida, United States, 33406
Status
Study Complete
Location
Velocity Clinical Research – San Diego
La Mesa, California, United States, 91942
Status
Terminated/Withdrawn
Location
Lynn Institute of Denver - ERN
Aurora, Colorado, United States, 80012-4520
Status
Study Complete
Location
MD Clinical - Velocity
Hallandale Beach, Florida, United States, 33009
Status
Study Complete
Location
Suncoast Research Group LLC – ERN-PPDS
Miami, Florida, United States, 33173
Status
Study Complete
Location
CTMD research Inc – Palm Springs Hunt PPDS
Palm Springs, Florida, United States, 33406-7671
Status
Terminated/Withdrawn
Location
Velocity Clinical Research - Cleveland
Cleveland, Ohio, United States, 44122
Status
Study Complete
Location
Lynn Institute of Norman – ERN - PPDS
Norman, Oklahoma, United States, 73072
Status
Study Complete
Location
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
Research Your Health - Elite
Plano, Texas, United States, 75093
Status
Study Complete
Location
DM Clinical – Cyfair Clinical Research Center
Tomball, Texas, United States, 77375
Status
Study Complete
Location
Velocity Clinical Research – Salt Lake City – Jordan Valley-ERN-PPDS
West Jordan, Utah, United States, 84088
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2023-07-03
Actual study completion date
2023-07-03
Plain language summaries
Summary of results in plain language
Available language(s): English, Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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