A Phase 2 interventional study of CVnCoV 6 μg and CVnCoV 12 μg in Coronavirus, Covid19 and SARS-CoV-2, sponsored by CureVac. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by CureVac (part of BioNTech SE) · Phase 2, Interventional, and Prevention
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.
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.).
1,112 studies on the registry are indexed under Coronavirus Infections; 52 are open to participants now.
This study's enrollment of 668 is above the median of 120 across 655 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →CureVac is the lead sponsor of 18 studies on the registry; none are open to participants now.
First submitted before CureVac became part of BioNTech SE.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants of childbearing potential must use highly effective methods of 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:
Exclusion Criteria:
Presence or evidence of significant uncontrolled acute or chronic medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: CVnCoV 6 μg
Participants will be vaccinated with CVnCoV on Day 1 and Day 29. Participants in this group will be aged over 60 years old.
Biological: CVnCoV 6 μg
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.
Biological: CVnCoV 12 μg
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.
Biological: CVnCoV 12 μg
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.
Biological: Hepatitis A vaccine
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.
Biological: Pneumococcal vaccine
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.
Biological: CVnCoV 12μg
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.
Biological: Hepatitis A vaccine
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.
Biological: CVnCoV 12μg
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.
Biological: Pneumococcal vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.
Also known as: CV07050101
Participants will receive an intramuscular injection by needle in the deltoid area.
Also known as: CV07050101
Participants will receive an intramuscular injection by needle in the deltoid area.
Participants will receive an intramuscular injection by needle in the deltoid area.
Participants will receive an intramuscular injection by needle in the deltoid area.
Also known as: CV07050101
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 29 and Day 43
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
This trial was performed in Peru and Panama between 21 September 2020 and 21 February 2022.
| Milestone | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Started | 12 | 11 | 289 | 295 | 31 | 30 |
| Completed | 11 | 10 | 274 | 268 | 28 | 20 |
| Not completed | 1 | 1 | 15 | 27 | 3 | 10 |
| Withdrew: Withdrawal by subject | 1 | 0 | 10 | 18 | 1 | 8 |
| Withdrew: Lost to follow-up | 0 | 1 | 5 | 6 | 2 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Miscellaneous | 0 | 0 | 0 | 1 | 0 | 1 |
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.
| Participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Dose 1: Any solicited local AEs | 9 | 5 | 253 | 220 | 17 | 26 |
| Dose 1: Any solicited systemic AEs | 4 | 6 | 229 | 193 | 13 | 14 |
| Dose 1: Any related solicited systemic AEs | 4 | 5 | 228 | 190 | 13 | 14 |
| Dose 2: Any solicited local AEs | 9 | 3 | 208 | 188 | 6 | 22 |
| Dose 2: Any solicited systemic AEs | 9 | 8 | 217 | 195 | 13 | 11 |
| Dose 2: Any related solicited systemic AEs | 8 | 8 | 217 | 193 | 13 | 11 |
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.
| Participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Dose 1: Any solicited local AEs — Grade 1 | 9 | 5 | 191 | 203 | 16 | 25 |
| Dose 1: Any solicited local AEs — Grade 2 | 0 | 0 | 61 | 17 | 1 | 1 |
| Dose 1: Any solicited local AEs — Grade 3 | 0 | 0 | 1 | 0 | 0 | 0 |
| Dose 1: Any solicited systemic AEs — Grade 1 | 4 | 4 | 122 | 122 | 7 | 11 |
| Dose 1: Any solicited systemic AEs — Grade 2 | 0 | 2 | 96 | 65 | 6 | 3 |
| Dose 1: Any solicited systemic AEs — Grade 3 | 0 | 0 | 11 | 6 | 0 | 0 |
| Dose 2: Any solicited local AEs — Grade 1 | 9 | 2 | 166 | 162 | 5 | 17 |
| Dose 2: Any solicited local AEs — Grade 2 | 0 | 1 | 42 | 25 | 1 | 5 |
| Dose 2: Any solicited local AEs — Grade 3 | 0 | 0 | 0 | 1 | 0 | 0 |
| Dose 2: Any solicited systemic AEs — Grade 1 | 7 | 5 | 100 | 103 | 7 | 8 |
| Dose 2: Any solicited systemic AEs — Grade 2 | 2 | 1 | 109 | 83 | 6 | 3 |
| Dose 2: Any solicited systemic AEs — Grade 3 | 0 | 2 | 8 | 9 | 0 | 0 |
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.
| days | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Dose 1: Any solicited local AEs | 1.3 ± 0.50 | 1.2 ± 0.45 | 2.1 ± 1.12 | 1.8 ± 1.54 | 1.6 ± 0.87 | 2.0 ± 1.20 |
| Dose 1: Any solicited systemic AEs | 1.5 ± 1.00 | 1.5 ± 0.84 | 1.9 ± 1.25 | 2.1 ± 1.42 | 1.9 ± 0.86 | 2.4 ± 2.17 |
| Dose 2: Any solicited local AEs | 2.1 ± 1.27 | 2.3 ± 1.15 | 2.2 ± 1.11 | 1.9 ± 1.33 | 2.2 ± 1.17 | 2.2 ± 0.96 |
| Dose 2: Any solicited systemic AEs | 2.1 ± 2.32 | 2.3 ± 2.43 | 1.9 ± 1.13 | 2.1 ± 1.49 | 2.2 ± 2.45 | 2.3 ± 2.05 |
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.
| Participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Dose 1: Any unsolicited AEs | 5 | 6 | 120 | 105 | 7 | 5 |
| Dose 1: Any related unsolicited AEs | 2 | 1 | 33 | 26 | 0 | 1 |
| Dose 2: Any unsolicited AEs | 4 | 3 | 77 | 75 | 10 | 7 |
| Dose 2: Any related unsolicited AEs | 1 | 2 | 13 | 7 | 1 | 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.
| Participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Dose 1: Unsolicited AEs — Mild | 3 | 6 | 94 | 88 | 6 | 4 |
| Dose 1: Unsolicited AEs — Moderate | 2 | 0 | 21 | 15 | 1 | 1 |
| Dose 1: Unsolicited AEs — Severe | 0 | 0 | 5 | 2 | 0 | 0 |
| Dose 2: Unsolicited AEs — Mild | 4 | 1 | 54 | 63 | 9 | 1 |
| Dose 2: Unsolicited AEs — Moderate | 0 | 2 | 20 | 9 | 1 | 6 |
| Dose 2: Unsolicited AEs — Severe | 0 | 0 | 3 | 3 | 0 | 0 |
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.
| Participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Any SAEs | 0 | 1 | 8 | 6 | 0 | 1 |
| Any related SAEs | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Any AESIs | 1 | 3 | 36 | 23 | 7 | 3 |
| Any related AESIs | 0 | 0 | 0 | 1 | 0 | 0 |
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.
| percentage of participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Day 29 | 0 (0.0 to 26.5) | 10.0 (0.3 to 44.5) | 11.6 (7.8 to 16.4) | 7.8 (4.8 to 11.9) | 0 (0.0 to 14.2) | 4.3 (0.1 to 21.9) |
| Day 43 | 83.3 (51.6 to 97.9) | 80.0 (44.4 to 97.5) | 93.9 (90.0 to 96.6) | 80.9 (75.2 to 85.7) | 0 (0.0 to 16.1) | 4.8 (0.1 to 23.8) |
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.
| titers | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Day 29 | 50.000 ± 1.0000 | 57.154 ± 1.5264 | 67.221 ± 2.6624 | 63.828 ± 2.6005 | 56.724 ± 1.5434 | 52.112 ± 1.2195 |
| Day 43 | 462.744 ± 3.4299 | 464.788 ± 4.2969 | 1733.125 ± 4.2886 | 552.782 ± 5.1208 | 57.455 ± 1.5663 | 62.667 ± 2.8146 |
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.
| percentage of participants | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Day 29 | 0 (0.0 to 26.5) | 0 (0.0 to 30.8) | 8.3 (4.7 to 13.4) | 7.8 (4.1 to 13.2) | 0 (0.0 to 21.8) | 0 (0.0 to 20.6) |
| Day 43 | 66.7 (34.9 to 90.1) | 70.0 (34.8 to 93.3) | 86.4 (80.5 to 91.1) | 77.1 (69.6 to 83.5) | 0 (0.0 to 24.7) | 0 (0.0 to 21.8) |
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.
| titers | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years |
|---|---|---|---|---|---|---|
| Day 29 | 5.000 ± 1.0000 | 5.000 ± 1.0000 | 5.912 ± 2.0106 | 6.234 ± 2.4723 | 5.000 ± 1.0000 | 5.000 ± 1.0000 |
| Day 43 | 16.339 ± 3.6716 | 20.705 ± 2.8993 | 50.298 ± 4.0175 | 26.848 ± 3.9517 | 5.000 ± 1.0000 | 5.000 ± 1.0000 |
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.
| Participants | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Any solicited local AEs | 15 | 24 | 12 |
| Any solicited systemic AEs | 15 | 24 | 8 |
| Any related solicited systemic AEs | 15 | 24 | 8 |
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.
| Participants | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Any solicited local AEs — Grade 1 | 14 | 18 | 9 |
| Any solicited local AEs — Grade 2 | 1 | 5 | 3 |
| Any solicited local AEs — Grade 3 | 0 | 1 | 0 |
| Any solicited systemic AEs — Grade 1 | 13 | 11 | 6 |
| Any solicited systemic AEs — Grade 2 | 2 | 12 | 2 |
| Any solicited systemic AEs — Grade 3 | 0 | 1 | 0 |
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.
| days | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Any solicited local AEs | 1.7 ± 0.80 | 2.0 ± 1.53 | 1.6 ± 0.79 |
| Any solicited systemic AEs | 2.8 ± 2.18 | 2.0 ± 1.71 | 2.0 ± 2.07 |
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.
| Participants | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Any unsolicited AEs | 7 | 6 | 2 |
| Any related unsolicited AEs | 1 | 4 | 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.
| Participants | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Mild | 6 | 5 | 2 |
| Moderate | 1 | 0 | 0 |
| Severe | 0 | 1 | 0 |
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.
| percentage of participants | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Day 57 | 82.1 (63.1 to 93.9) | — | — |
| Day 85 | 100 (86.3 to 100) | — | — |
| Day 180 | 100 (83.9 to 100) | 90.5 (69.6 to 98.8) | 69.2 (38.6 to 90.9) |
| Day 208 | — | 100 (83.2 to 100) | 100 (69.2 to 100) |
| Day 393 | — | 100 (2.5 to 100) | — |
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.
| titers | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Day 57 | 516.198 ± 4.6157 | — | — |
| Day 85 | 2889.963 ± 2.9473 | — | — |
| Day 180 | 1449.055 ± 2.1869 | 445.661 ± 3.1744 | 153.160 ± 2.8146 |
| Day 208 | — | 10094.652 ± 2.1020 | 4153.249 ± 2.2450 |
| Day 393 | — | 915.460 ± NA | — |
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.
| percentage of participants | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Day 57 | 75.0 (55.1 to 89.3) | — | — |
| Day 85 | 96.0 (79.6 to 99.9) | — | — |
| Day 180 | 57.1 (34.0 to 78.2) | 28.6 (11.3 to 52.2) | 7.7 (0.2 to 36.0) |
| Day 208 | — | 100 (83.2 to 100) | 90.0 (55.5 to 99.7) |
| Day 393 | — | 100 (2.5 to 100) | — |
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.
| titers | CVnCoV 12 μg: Aged >60 Years - Day 57 Booster | CVnCoV 12 μg: Aged 18-60 Years - Day 180 Booster | CVnCoV 12 μg: Aged >60 Years - Day 180 Booster |
|---|---|---|---|
| Day 57 | 25.937 ± 4.4384 | — | — |
| Day 85 | 74.642 ± 3.0879 | — | — |
| Day 180 | 16.957 ± 3.3656 | 7.308 ± 2.5328 | 5.867 ± 1.7802 |
| Day 208 | — | 141.724 ± 2.0232 | 54.639 ± 3.3018 |
| Day 393 | — | 28.280 ± NA | — |
Collected over Day 1 to Day 393. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CVnCoV 6 μg | 0/23 (0%) | 1/23 (4.3%) | 21/23 (91.3%) |
| CVnCoV 12 μg | 3/584 (0.5%) | 14/584 (2.4%) | 567/584 (97.1%) |
| Active Control | 1/61 (1.6%) | 1/61 (1.6%) | 59/61 (96.7%) |
| Event | CVnCoV 6 μg | CVnCoV 12 μg | Active Control |
|---|---|---|---|
| COVID-19Infections and infestations | 1/23 | 1/584 | 0/61 |
| Retinal vein occlusionEye disorders | 0/23 | 0/584 | 1/61 |
| AppendicitisInfections and infestations | 0/23 | 2/584 | 0/61 |
| Cholecystitis acuteHepatobiliary disorders | 0/23 | 2/584 | 0/61 |
| COVID-19 pneumoniaInfections and infestations | 0/23 | 1/584 | 0/61 |
| Extraocular muscle paresisEye disorders | 0/23 | 1/584 | 0/61 |
| Clavicle fractureInjury, poisoning and procedural complications | 0/23 | 1/584 | 0/61 |
| Multiple injuriesInjury, poisoning and procedural complications | 0/23 | 1/584 | 0/61 |
| Wrist fractureInjury, poisoning and procedural complications | 0/23 | 1/584 | 0/61 |
| Ovarian cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/23 | 1/584 | 0/61 |
| Event | CVnCoV 6 μg | CVnCoV 12 μg | Active Control |
|---|---|---|---|
| Injection site painGeneral disorders | 17/23 | 526/584 | 47/61 |
| HeadacheNervous system disorders | 13/23 | 390/584 | 33/61 |
| FatigueGeneral disorders | 7/23 | 315/584 | 22/61 |
| MyalgiaMusculoskeletal and connective tissue disorders | 9/23 | 315/584 | 13/61 |
| ChillsGeneral disorders | 8/23 | 254/584 | 10/61 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/23 | 237/584 | 12/61 |
| PyrexiaGeneral disorders | 4/23 | 182/584 | 4/61 |
| NasopharyngitisInfections and infestations | 4/23 | 155/584 | 12/61 |
| DiarrhoeaGastrointestinal disorders | 5/23 | 107/584 | 6/61 |
| COVID-19Infections and infestations | 3/23 | 108/584 | 12/61 |
Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available.
| Age, Continuous(years) | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years | Total |
|---|---|---|---|---|---|---|---|
| Mean | 50.2 ± 8.44 | 65.6 ± 4.08 | 38.1 ± 12.08 | 69.0 ± 6.06 | 31.6 ± 12.31 | 66.7 ± 5.07 | 53.4 ± 18.16 |
| Sex: Female, Male(Participants) | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years | Total |
|---|---|---|---|---|---|---|---|
| Female | 7 | 4 | 118 | 139 | 12 | 16 | 296 |
| Male | 5 | 7 | 171 | 156 | 19 | 14 | 372 |
| Ethnicity (NIH/OMB)(Participants) | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 12 | 11 | 283 | 287 | 31 | 30 | 654 |
| Not Hispanic or Latino | 0 | 0 | 6 | 8 | 0 | 0 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | CVnCoV 6 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Active Control - Pneumococcal Vaccine: Aged >60 Years | Total |
|---|---|---|---|---|---|---|---|
| White | 0 | 0 | 3 | 10 | 0 | 1 | 14 |
| Black or African American | 0 | 0 | 2 | 1 | 1 | 0 | 4 |
| Asian | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Other | 12 | 11 | 283 | 284 | 30 | 29 | 649 |
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Studies of the drug tested here: CVnCoV COVID-19 vaccine