CoronavirusPhase 2NCT04515147
A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
A Phase 2 study testing CVnCoV 6 μg, CVnCoV 12 μg and Hepatitis A vaccine in people with Coronavirus and Covid19, run by CureVac at 2 sites in 2 countries.
Trial summary
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Covid19, SARS-CoV-2
- What is being tested?
- CVnCoV 6 μg, CVnCoV 12 μg and Hepatitis A vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Sep 2020to 21 Feb 2022
- Phase
- Phase 2
- 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
- Healthy male and female participants ≥18 years of age. A healthy participant is defined as an individual who is in good general health, according to the Investigator's assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator.
- Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
- Participants are able to understand and willing to provide informed consent.
- Physical examination without clinically significant findings according to the Investigator's assessment.
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2.
- Female participants of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for female participants presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before).
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- Female participants of childbearing potential must use highly effective methods of birth control from 2 weeks 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:
- 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;
- Intrauterine hormone-releasing systems;
- Bilateral tubal occlusion;
- Vasectomized partner;
- Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).
- Male participants should be instructed not to get their partners pregnant until 3 months after the last administration.
Who cannot join
- 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 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration (primary dose or booster dose).
- Receipt of any investigational or licensed/authorized SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
- Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
- Use of hormonal therapy for gender reassignment.
- 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.
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- History of immune-mediated or autoimmune disease.
- History of angioedema (known C1 inhibitor deficiency).
- History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics.
- 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. A pack year is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
- History of virologically-confirmed Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or COVID-19 disease or known exposure (without any personal protective equipment) to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
- Presence or evidence of significant uncontrolled acute or chronic medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to:
- Uncontrolled respiratory disease (e.g., chronic obstructive pulmonary disease, asthma), including use of the following asthma medications: intravenous corticosteroids, leukotriene modifiers, biologics.
- Uncontrolled cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery disease, pulmonary embolism).
- History of myocarditis or pericarditis as an adult.
- Diabetes mellitus (insulin-dependent).
- Uncontrolled neurological disorders or Guillain-Barré syndrome or history of seizure, except for 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 female participants: pregnancy or lactation.
- Participants with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated. This includes participants on treatment with anticoagulants (e.g., vitamin K antagonists, novel oral anticoagulants, and heparin). Use of platelet aggregation inhibitors is not exclusionary.
- Participants employed by the Sponsor, Investigator, or trial site, or relatives of research staff working on this trial.
- Participants considered at the Investigator's discretion to be at increased risk of exposure to COVID-19 disease.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Panama1 site
Centro de vacunación internacional - CEVAXIN Panama Clinic
Panama City, 0831
About this study
Official title: COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.
Read the detailed description
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
- Coronavirus, Covid19, SARS-CoV-2, Severe Acute Respiratory Syndrome
- Being tested
- CVnCoV 6 μg, CVnCoV 12 μg, Hepatitis A vaccine, Pneumococcal vaccine, CVnCoV 12μg
- Keywords
- Vaccine, SARS, COVID, Safety, Reactogenicity, Immunogenicity
- Medical subject headings
- Coronavirus Infections, COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVnCoV 6 μgBiological
Also called CV07050101
Participants will receive an intramuscular injection by needle in the deltoid area.
CVnCoV 12 μgBiological
Also called CV07050101
Participants will receive an intramuscular injection by needle in the deltoid area.
Hepatitis A vaccineBiological
Participants will receive an intramuscular injection by needle in the deltoid area.
Pneumococcal vaccineBiological
Participants will receive an intramuscular injection by needle in the deltoid area.
CVnCoV 12μgBiological
Also called CV07050101
Participants will receive an intramuscular injection by needle in the deltoid area.
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Group 1: CVnCoV 6 μg | Experimental | Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. Receives: Biological: CVnCoV 6 μg |
| Part 1, Group 2: CVnCoV 6 μg | Experimental | Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged over 60 years old. Receives: Biological: CVnCoV 6 μg |
| Part 1, Group 3: CVnCoV 12 μg | Experimental | Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be between the ages of 18 to 60 years old.
CVnCoV will be administered again as a booster vaccination on Day 180 in a sub-group of participants. Receives: Biological: CVnCoV 12 μg |
| Part 1, Group 4: CVnCoV 12 μg | Experimental | Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged over 60 years old.
CVnCoV will be administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants. Receives: Biological: CVnCoV 12 μg |
| Part 1, Group 5: Hepatitis A vaccine | Active comparator | Participants will be vaccinated with a hepatitis A vaccine on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. Receives: Biological: Hepatitis A vaccine |
| Part 1, Group 6: Pneumococcal vaccine | Active comparator | Participants will be vaccinated with a pneumococcal vaccine on Day 1 and Day 29. Participants in this group will be aged over 60 years old. Receives: Biological: Pneumococcal vaccine |
| Part 2, Group 1: CVnCoV 12 µg | Experimental | Participants will be vaccinated with CVnCoV 12 µg on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. Receives: Biological: CVnCoV 12μg |
| Part 2, Group 2: Hepatitis A vaccine | Active comparator | Participants will be vaccinated with a hepatitis A vaccine on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. Receives: Biological: Hepatitis A vaccine |
| Part 2, Group 3: CVnCoV 12 µg | Experimental | Participants will be vaccinated with CVnCoV 12 µg on Day 1 and Day 29. Participants in this group will be aged over 60 years old. Receives: Biological: CVnCoV 12μg |
| Part 2, Group 4: Pneumococcal vaccine | Active comparator | Participants will be vaccinated with a pneumococcal vaccine on Day 1 and Day 29. Participants in this group will be aged over 60 years old. Receives: Biological: Pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Measured: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). 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 Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after day 8 are included.
Measured: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants 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 Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. 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 Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial
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: Up to Day 393
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
AESIs included:
- AEs with a suspected immune-medicated etiology.
- COVID-19 disease.
- Other AEs relevant to SARS-CoV-2 vaccine development or the target disease.
Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever was earlier. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Measured: Up to Day 393
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43
As measured by enzyme-linked immunosorbent assay (ELISA). In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: Baseline, Day 29 and Day 43
Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43
As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: Day 29 and Day 43
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Measured: Baseline, Day 29 and Day 43
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: Day 29 and Day 43
Secondary outcomes (9)
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Measured: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). 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 booster vaccination (Days 57 to 64 and Days 180 to 187)
Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the adverse event.
Measured: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants 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 booster vaccination (Days 57 to 85 and Days 180 to 208)
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. 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 booster vaccination (Days 57 to 85 and Days 180 to 208)
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by ELISA. In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Measured: For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Measured: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by an activity assay. The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Measured: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start21 Sep 2020
- Primary completion21 Feb 2022
- Study completion21 Feb 2022
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 CoronavirusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureVac
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515147
- Sponsor's protocol ID
- CV-NCOV-002
- Status last verified
- Sep 2023
- First submitted
- 13 Aug 2020
- Last updated
- 28 Sep 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age
- ClinicalTrials.gov ID
- NCT04515147
- Acronym / sponsor ID
- CV-NCOV-002
- Conditions
- Coronavirus, Covid19, SARS-CoV-2, Severe Acute Respiratory Syndrome
- Keywords
- Vaccine, SARS, COVID, Safety, Reactogenicity, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- CureVacIndustry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Posted 28 Sep 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 investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.
Detailed description
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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1, Group 1: CVnCoV 6 μg | Experimental | Biological: CVnCoV 6 μgParticipants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. |
| Part 1, Group 2: CVnCoV 6 μg | Experimental | Biological: CVnCoV 6 μgParticipants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged over 60 years old. |
| Part 1, Group 3: CVnCoV 12 μg | Experimental | Biological: CVnCoV 12 μgParticipants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be between the ages of 18 to 60 years old. CVnCoV will be administered again as a booster vaccination on Day 180 in a sub-group of participants. |
| Part 1, Group 4: CVnCoV 12 μg | Experimental | Biological: CVnCoV 12 μgParticipants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged over 60 years old. CVnCoV will be administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants. |
| Part 1, Group 5: Hepatitis A vaccine | Active comparator | Biological: Hepatitis A vaccineParticipants will be vaccinated with a hepatitis A vaccine on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. |
| Part 1, Group 6: Pneumococcal vaccine | Active comparator | Biological: Pneumococcal vaccineParticipants will be vaccinated with a pneumococcal vaccine on Day 1 and Day 29. Participants in this group will be aged over 60 years old. |
| Part 2, Group 1: CVnCoV 12 µg | Experimental | Biological: CVnCoV 12μgParticipants will be vaccinated with CVnCoV 12 µg on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. |
| Part 2, Group 2: Hepatitis A vaccine | Active comparator | Biological: Hepatitis A vaccineParticipants will be vaccinated with a hepatitis A vaccine on Day 1 and Day 29. Participants in this group will be aged between 18 and 60 years old. |
| Part 2, Group 3: CVnCoV 12 µg | Experimental | Biological: CVnCoV 12μgParticipants will be vaccinated with CVnCoV 12 µg on Day 1 and Day 29. Participants in this group will be aged over 60 years old. |
| Part 2, Group 4: Pneumococcal vaccine | Active comparator | Biological: Pneumococcal vaccineParticipants will be vaccinated with a pneumococcal vaccine on Day 1 and Day 29. Participants in this group will be aged over 60 years old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy male and female participants ≥18 years of age. A healthy participant is defined as an individual who is in good general health, according to the Investigator's assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator.
- Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
- Participants are able to understand and willing to provide informed consent.
- Physical examination without clinically significant findings according to the Investigator's assessment.
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2.
Key exclusion criteria (25 listed)
- 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 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration (primary dose or booster dose).
- Receipt of any investigational or licensed/authorized SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
- Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
- Use of hormonal therapy for gender reassignment.
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 6 μgAlso: CV07050101Participants will receive an intramuscular injection by needle in the deltoid area. | Biological | Part 1, Group 1: CVnCoV 6 μg, Part 1, Group 2: CVnCoV 6 μg |
| CVnCoV 12 μgAlso: CV07050101Participants will receive an intramuscular injection by needle in the deltoid area. | Biological | Part 1, Group 3: CVnCoV 12 μg, Part 1, Group 4: CVnCoV 12 μg |
| Hepatitis A vaccineParticipants will receive an intramuscular injection by needle in the deltoid area. | Biological | Part 1, Group 5: Hepatitis A vaccine, Part 2, Group 2: Hepatitis A vaccine |
| Pneumococcal vaccineParticipants will receive an intramuscular injection by needle in the deltoid area. | Biological | Part 1, Group 6: Pneumococcal vaccine, Part 2, Group 4: Pneumococcal vaccine |
| CVnCoV 12μgAlso: CV07050101Participants will receive an intramuscular injection by needle in the deltoid area. | Biological | Part 2, Group 1: CVnCoV 12 µg, Part 2, Group 3: CVnCoV 12 µg |
Primary outcome
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2
Time frame: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2
Time frame: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). 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 AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2
Time frame: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after day 8 are included.
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2
Time frame: Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2
Time frame: Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. 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 Who Experienced a Serious Adverse Event (SAE) During the Trial
Time frame: Up 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 Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
Time frame: Up to Day 393
AESIs included: * AEs with a suspected immune-medicated etiology. * COVID-19 disease. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever was earlier. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43
Time frame: Baseline, Day 29 and Day 43
As measured by enzyme-linked immunosorbent assay (ELISA). In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43
Time frame: Day 29 and Day 43
As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
Time frame: Baseline, Day 29 and Day 43
As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
Time frame: Day 29 and Day 43
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
9 secondary outcomes
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days
Time frame: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days
Time frame: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days
Time frame: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days
Time frame: Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208)
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days
Time frame: Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208)
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
Time frame: For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
Time frame: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
Time frame: For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
Time frame: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVnCoV 6 μg, CVnCoV 12 μg and Hepatitis A vaccine in people with Coronavirus and Covid19, run by CureVac at 2 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 15 inclusion and 25 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Panama, Peru. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Sep 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 Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 (time frame: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)). The study lists 11 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 28 Sep 2023.