Severe Acute Respiratory SyndromePhase 1NCT04449276
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
A Phase 1 study testing CVnCoV Vaccine in people with Severe Acute Respiratory Syndrome and Coronavirus, run by CureVac at 4 sites in 2 countries.
Trial summary
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2
- What is being tested?
- CVnCoV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 18 Jun 2020to 21 Dec 2021
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female participants aged 18 to 60 years inclusive. Healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication.
- Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
- Physical examination and laboratory results without clinically significant findings according to the Investigator's assessment.
- Body Mass Index (BMI) ≥18.0 and ≤30.0kg/m^2 (≥18.0 and ≤32.0kg/m2 for participants with SARS-CoV-2 positive serology).
- Females: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if the serum pregnancy test was performed more than 3 days before).
- Females of childbearing potential must use highly effective methods of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly:
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- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
- Intrauterine devices (IUDs);
- Intrauterine hormone-releasing systems (IUSs);
- Bilateral tubal occlusion;
- Vasectomized partner;
- Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).
Who cannot join
- The following criterion applies to all open-label sentinel participants:
- Participants with SARS-CoV-2 positive serology as confirmed by testing at enrollment.
- The following criteria apply to all participants, except those with SARS-CoV-2 positive serology:
- Participants considered at the Investigator's discretion to be at increased risk to acquire COVID-19 disease (including, but not limited to, health care workers with direct involvement in patient care or care of long-term care recipients).
- History of confirmed COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.
- The following criteria apply to all participants:
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- Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
- Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration.
- Receipt of any investigational SARS-CoV-2 or other CoV vaccine prior to the administration of the trial vaccine.
- Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied steroids. Corticosteroids used in the context of COVID-19 disease of participants with SARS CoV 2 positive serology are not exclusionary.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection and hepatitis C virus infection.
- History of a pIMD (potential immune-mediated disease).
- History of angioedema.
- Any known allergy, including allergy to any component of CVnCoV or aminoglycoside antibiotics. A history of hay fever or seasonal allergies (pollinosis) that does not require current treatment (e.g., anti-histamines) during the vaccination period (1 month before first vaccination until 1 month after last vaccination) is not exclusionary.
- History of or current alcohol and/or drug abuse.
- Participants who are active smokers, were active smokers within the last year (including any vaping in the last year) or have a total smoking history ≥10 pack years.
- Active or currently active SARS-CoV-2 infection as confirmed by reactive PCR within 3 days of first trial vaccine administration.
- History of confirmed SARS or MERS
- Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
- Presence or evidence of significant acute or chronic, medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to:
- Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.
- Respiratory disease with clinically significant dyspnea in the last 5 years (except COVID-19 disease in participants with SARS-CoV-2 positive serology).
- Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long- and short-acting beta agonists, theophylline, ipratropium, biologics.
- Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery disease, pulmonary embolism) or history of myocarditis or pericarditis as an adult.
- Elevated blood pressure or hypertension, even if well-controlled.
- Diabetes mellitus type 1 or 2.
- History of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
- Current or past malignancy, unless completely resolved without sequelae for >5 years.
- Foreseeable non-compliance with protocol as judged by the Investigator.
- For females: pregnancy or lactation.
- History of any anaphylactic reactions.
- Participants with impaired coagulation or any bleeding disorder in whom an IM injection or a blood draw is contraindicated.
- Participants employed by the Sponsor, Investigator or trial site, or relatives of research staff working on this trial.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Medical University Hannover (MHH)
Hanover, 30625
Ludwig-Maximilians-Universität München
München, Bavaria, 80802
University Hospital Tübingen Institut für Tropenmedizin
Tübingen, 72074
About this study
Official title: COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
Read the detailed description
Funded by Coalition for Epidemic Preparedness Innovations (CEPI).
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Being tested
- CVnCoV Vaccine, Placebo
- Keywords
- Safety, Reactogenicity, Immunogenicity, Vaccine, CEPI
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVnCoV VaccineBiological
Also called CV07050101
Participants will receive an intramuscular injection by needle in the deltoid area.
PlaceboDrug
Participants will receive an intramuscular injection by needle in the deltoid area.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation CVnCoV | Experimental | Participants will be vaccinated with CVnCoV at escalating dose levels on Day 1 and Day 29. Safety data will inform the decision to continue enrolling at the current dose level, or to proceed to dose escalation. Initially, dose levels of 2, 4 and 8 μg will be evaluated.
Dose levels of 2, 4, 6, 8 and 12µg will be evaluated with potential increase to dose levels up to 20 μg. Receives: Biological: CVnCoV Vaccine |
| Dose Escalation Placebo | Placebo comparator | Participants will be given placebo on Day 1 and Day 29. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:
- Resulted in death.
- Was life-threatening.
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Resulted in persistent disability/incapacity.
- Was a congenital anomaly/birth defect in the offspring of the participant.
- Was an important medical event.
Measured: Up to 24 hours after vaccination on Day 1
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:
- Resulted in death.
- Was life-threatening.
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Resulted in persistent disability/incapacity.
- Was a congenital anomaly/birth defect in the offspring of the participant.
- Was an important medical event.
Measured: Up to 60 hours after vaccination on Day 1
Number of Participants With Solicited Local Adverse Events
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.
Measured: Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)
Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Measured: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Duration of Solicited Local Adverse Events
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Measured: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Number of Participants With Solicited Systemic Adverse Events
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.
Measured: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Measured: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Duration of Solicited Systemic Adverse Events
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Measured: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Measured: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Number of Participants With Unsolicited Adverse Events
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.
Measured: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Intensity of Unsolicited Adverse Events Assessed by the Investigator
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
- Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.
- Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities.
- Severe: an event that prevented normal everyday activities.
Measured: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Measured: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Number of Participants With One or More Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, at any dose:
- Resulted in death.
- Was life-threatening.
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Resulted in persistent disability/incapacity.
- Was a congenital anomaly/birth defect in the offspring of the participant.
- Was an important medical event.
Measured: Baseline to Day 393
Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine
An SAE was defined as any untoward medical occurrence that, at any dose:
- Resulted in death.
- Was life-threatening.
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Resulted in persistent disability/incapacity.
- Was a congenital anomaly/birth defect in the offspring of the participant.
- Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Measured: Baseline to Day 393
Number of Participants With One or More Adverse Events of Special Interest (AESIs)
The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.
Measured: Day 1 to Day 393
Secondary outcomes (6)
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline.
Measured: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline.
Measured: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline.
Measured: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Measured using an activity assay.
Measured: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start18 Jun 2020
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Acute Respiratory SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureVac
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449276
- Sponsor's protocol ID
- CV-NCOV-001
- Other IDs
- 2020-001286-36
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2020
- Last updated
- 30 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults
- ClinicalTrials.gov ID
- NCT04449276
- Acronym / sponsor ID
- CV-NCOV-001
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Keywords
- Safety, Reactogenicity, Immunogenicity, Vaccine, CEPI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- CureVacIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Posted 30 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
Detailed description
Funded by Coalition for Epidemic Preparedness Innovations (CEPI).
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation CVnCoV | Experimental | Biological: CVnCoV VaccineParticipants will be vaccinated with CVnCoV at escalating dose levels on Day 1 and Day 29. Safety data will inform the decision to continue enrolling at the current dose level, or to proceed to dose escalation. Initially, dose levels of 2, 4 and 8 μg will be evaluated. Dose levels of 2, 4, 6, 8 and 12µg will be evaluated with potential increase to dose levels up to 20 μg. |
| Dose Escalation Placebo | Placebo comparator | Drug: PlaceboParticipants will be given placebo on Day 1 and Day 29. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male and female participants aged 18 to 60 years inclusive. Healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication.
- Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
- Physical examination and laboratory results without clinically significant findings according to the Investigator's assessment.
- Body Mass Index (BMI) ≥18.0 and ≤30.0kg/m^2 (≥18.0 and ≤32.0kg/m2 for participants with SARS-CoV-2 positive serology).
- Females: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if the serum pregnancy test was performed more than 3 days before).
Key exclusion criteria (33 listed)
- Participants with SARS-CoV-2 positive serology as confirmed by testing at enrollment.
- The following criteria apply to all participants, except those with SARS-CoV-2 positive serology:
- Participants considered at the Investigator's discretion to be at increased risk to acquire COVID-19 disease (including, but not limited to, health care workers with direct involvement in patient care or care of long-term care recipients).
- History of confirmed COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.
- Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVnCoV VaccineAlso: CV07050101Participants will receive an intramuscular injection by needle in the deltoid area. | Biological | Dose Escalation CVnCoV |
| PlaceboParticipants will receive an intramuscular injection by needle in the deltoid area. | Drug | Dose Escalation Placebo |
Primary outcome
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination
Time frame: Up to 24 hours after vaccination on Day 1
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event.
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination
Time frame: Up to 60 hours after vaccination on Day 1
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event.
Number of Participants With Solicited Local Adverse Events
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.
Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Duration of Solicited Local Adverse Events
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Number of Participants With Solicited Systemic Adverse Events
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.
Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Duration of Solicited Systemic Adverse Events
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Number of Participants With Unsolicited Adverse Events
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.
Intensity of Unsolicited Adverse Events Assessed by the Investigator
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities.
Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Number of Participants With One or More Serious Adverse Events (SAEs)
Time frame: Baseline to Day 393
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event.
Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine
Time frame: Baseline to Day 393
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Number of Participants With One or More Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Day 393
The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.
6 secondary outcomes
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVnCoV Vaccine in people with Severe Acute Respiratory Syndrome and Coronavirus, run by CureVac at 4 sites in 2 countries.
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 13 inclusion and 33 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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Belgium. 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. Some participants in this study may receive a placebo. 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 30 Jan 2023). 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 Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination (time frame: Up to 24 hours after vaccination on Day 1). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2023.