A Phase 3 interventional study of CVnCoV Vaccine and Placebo in Coronavirus, Covid19 and SARS-CoV-2, sponsored by CureVac. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by CureVac (part of BioNTech SE) · Phase 3, Interventional, and Prevention
This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.
1,112 studies on the registry are indexed under Coronavirus Infections; 52 are open to participants now.
This study's enrollment of 2,357 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.
Females 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:
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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 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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
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.
Participants in Group 1 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Biological: CVnCoV Vaccine
Participants in Group 2 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Biological: CVnCoV Vaccine
Participants will receive a placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Drug: Placebo
Intramuscular injection
Also known as: CV07050101
Intramuscular injection
Number of Participants Who Experienced a Medically Attended Adverse Event (AE) Occurring in the Following 6 Months After Dose 2
Medically attended AEs were defined as AEs with medically attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Time frame: Up to 6 months after Dose 2 (Days 29 to 211)
Number of Participants Who Experienced a Serious Adverse Event (SAE)
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 occurrence of each AE.
Time frame: Day 1 to Day 393
Intensity of SAEs Per the Investigator's Assessment
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 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: Day 1 to Day 393
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) Occurring in the Following 1 Year After Dose 2
The following events were considered and collected as AESI throughout the trial: * AEs with a suspected immune-mediated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. * COVID-19. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Time frame: Up to 1 year after Dose 2 (Days 29 to 393)
Number of Participants Who Experienced Death Due to SAE
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.
Time frame: Day 1 to Day 393
Number of Participants Who Experienced an AE Leading to Vaccine Withdrawal Occurring in the Following 1 Year After Dose 2
Time frame: Up to 1 year after Dose 2 (Days 29 to 393)
Number of Participants Who Experienced an AE Leading to Trial Discontinuation Occurring in the Following 1 Year After Dose 2
Time frame: Up to 1 year after Dose 2 (Days 29 to 393)
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Time frame: Day 1 to 28 days after Dose 2 (Day 57)
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. 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: Day 1 to 28 days after Dose 2 (Day 57)
Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG) on Day 29 and Day 43
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme-linked immunosorbent assay (ELISA). Percentage with 95% confidence interval (CI) of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 Spike Protein RBD IgG antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Baseline (Day 1), Day 29 and Day 43
SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA and expressed as geometric mean of titers (GMT) with 95% CI, by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Day 1, Day 29 and Day 43
Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
Neutralizing activity of induced antibodies was determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 neutralizing antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Baseline (Day 1), Day 29 and Day 43
SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43
Neutralizing activity of induced antibodies was determined by an activity assay. GMT with 95% CI of SARS-CoV-2 neutralizing antibody levels is presented by group. Individual values below the LLOQ were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Day 1, Day 29 and Day 43
This trial was performed in Germany between 23 December 2020 and 08 June 2022.
| Milestone | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Started | 786 | 786 | 785 |
| Safety analysis set | 783 | 785 | 783 |
| Completed | 617 | 637 | 372 |
| Not completed | 169 | 149 | 413 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Received alternative authorized vaccine | 0 | 1 | 17 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Withdrawal by participant | 83 | 71 | 142 |
| Withdrew: Lost to follow-up | 55 | 53 | 44 |
| Withdrew: Miscellaneous | 27 | 23 | 207 |
| Withdrew: Did not receive treatment | 3 | 1 | 2 |
Medically attended AEs were defined as AEs with medically attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
| Participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Any medically attended AEs | 95 | 133 | 58 |
| Any related medically attended AEs | 34 | 32 | 13 |
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 occurrence of each AE.
| Participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Any SAEs | 8 | 10 | 6 |
| Any related SAEs | 1 | 1 | 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 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: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Any mild SAEs | 0 | 0 | 0 |
| Any moderate SAEs | 2 | 5 | 1 |
| Any severe SAEs | 6 | 5 | 5 |
The following events were considered and collected as AESI throughout the trial: * AEs with a suspected immune-mediated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. * COVID-19. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
| Participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Any AESIs | 14 | 14 | 5 |
| Any related AESIs | 7 | 5 | 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.
| Participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Number of Participants Who Experienced Death Due to SAE | 0 | 0 | 0 |
| Participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Number of Participants Who Experienced an AE Leading to Vaccine Withdrawal Occurring in the Following 1 Year After Dose 2 | 7 | 5 | 2 |
| Participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Number of Participants Who Experienced an AE Leading to Trial Discontinuation Occurring in the Following 1 Year After Dose 2 | 1 | 0 | 1 |
eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
| Participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Any unsolicited AEs | 245 | 270 | 187 |
| Any related unsolicited AEs | 183 | 186 | 88 |
eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. 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: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Any mild unsolicited AEs | 133 | 149 | 114 |
| Any moderate unsolicited AEs | 73 | 71 | 42 |
| Any severe unsolicited AEs | 14 | 28 | 10 |
| Any unsolicited AEs without intensity assessment | 25 | 22 | 21 |
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme-linked immunosorbent assay (ELISA). Percentage with 95% confidence interval (CI) of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 Spike Protein RBD IgG antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
| percentage of participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | CVnCoV: Pooled Lots 1 and 2 | Placebo |
|---|---|---|---|---|
| Day 29 | 8.1 (3.6 to 15.3) | 18.4 (11.3 to 27.5) | 13.2 (8.8 to 18.7) | 0.0 (0.0 to 7.4) |
| Day 43 | 95.5 (88.8 to 98.7) | 94.2 (87.0 to 98.1) | 94.8 (90.4 to 97.6) | 0.0 (0.0 to 8.6) |
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA and expressed as geometric mean of titers (GMT) with 95% CI, by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
| GMT | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | CVnCoV: Pooled Lots 1 and 2 | Placebo |
|---|---|---|---|---|
| Day 1 | 50.000 (50.000 to 50.000) | 50.000 (50.000 to 50.000) | 50.000 (50.000 to 50.000) | 50.000 (50.000 to 50.000) |
| Day 29 | 55.145 (51.403 to 59.160) | 62.236 (56.437 to 68.631) | 58.566 (55.144 to 62.199) | 50.000 (50.000 to 50.000) |
| Day 43 | 1285.722 (1003.885 to 1646.683) | 1151.416 (869.345 to 1525.008) | 1217.489 (1011.594 to 1465.289) | 50.000 (50.000 to 50.000) |
Neutralizing activity of induced antibodies was determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 neutralizing antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
| percentage of participants | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | CVnCoV: Pooled Lots 1 and 2 | Placebo |
|---|---|---|---|---|
| Day 29 | 2.0 (0.2 to 7.1) | 2.0 (0.2 to 7.2) | 2.0 (0.6 to 5.1) | 0.0 (0.0 to 7.4) |
| Day 43 | 76.1 (65.9 to 84.6) | 75.6 (65.1 to 84.2) | 75.9 (68.8 to 82.0) | 0.0 (0.0 to 8.6) |
Neutralizing activity of induced antibodies was determined by an activity assay. GMT with 95% CI of SARS-CoV-2 neutralizing antibody levels is presented by group. Individual values below the LLOQ were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
| GMT | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | CVnCoV: Pooled Lots 1 and 2 | Placebo |
|---|---|---|---|---|
| Day 1 | 5.000 (5.000 to 5.000) | 5.000 (5.000 to 5.000) | 5.000 (5.000 to 5.000) | 5.000 (5.000 to 5.000) |
| Day 29 | 5.160 (4.906 to 5.427) | 5.071 (4.972 to 5.172) | 5.116 (4.980 to 5.256) | 5.000 (5.000 to 5.000) |
| Day 43 | 28.846 (21.716 to 38.318) | 23.976 (18.394 to 31.252) | 26.327 (21.707 to 31.929) | 5.000 (5.000 to 5.000) |
Collected over Day 1 to Day 393. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CVnCoV: Group 1, Lot 1 | 0/783 (0%) | 8/783 (1%) | 542/783 (69.2%) |
| CVnCoV: Group 2, Lot 2 | 0/785 (0%) | 10/785 (1.3%) | 547/785 (69.7%) |
| Placebo | 1/783 (0.1%) | 6/783 (0.8%) | 475/783 (60.7%) |
| Event | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/783 | 0/785 | 2/783 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/783 | 2/785 | 0/783 |
| ArrhythmiaCardiac disorders | 1/783 | 0/785 | 0/783 |
| Mechanical ileusGastrointestinal disorders | 0/783 | 0/785 | 1/783 |
| CholelithiasisHepatobiliary disorders | 0/783 | 0/785 | 1/783 |
| Small intestine gangreneInfections and infestations | 0/783 | 0/785 | 1/783 |
| Ligament ruptureInjury, poisoning and procedural complications | 1/783 | 0/785 | 0/783 |
| Ligament sprainInjury, poisoning and procedural complications | 0/783 | 0/785 | 1/783 |
| SpondylolisthesisMusculoskeletal and connective tissue disorders | 1/783 | 0/785 | 0/783 |
| Chronic lymphocytic leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/783 | 1/785 | 0/783 |
| Event | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 428/783 | 430/785 | 293/783 |
| FatigueGeneral disorders | 425/783 | 427/785 | 278/783 |
| Injection site painGeneral disorders | 387/783 | 390/785 | 160/783 |
| MyalgiaMusculoskeletal and connective tissue disorders | 344/783 | 341/785 | 136/783 |
| ChillsGeneral disorders | 276/783 | 275/785 | 81/783 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 250/783 | 245/785 | 75/783 |
| PyrexiaGeneral disorders | 218/783 | 221/785 | 61/783 |
| NauseaGastrointestinal disorders | 140/783 | 132/785 | 65/783 |
| COVID-19Infections and infestations | 106/783 | 99/785 | 123/783 |
| DiarrhoeaGastrointestinal disorders | 104/783 | 113/785 | 66/783 |
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
| Age, Continuous(years) | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo | Total |
|---|---|---|---|---|
| Mean | 42.2 ± 14.88 | 43.4 ± 14.80 | 42.7 ± 14.52 | 42.7 ± 14.73 |
| Sex: Female, Male(Participants) | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo | Total |
|---|---|---|---|---|
| Female | 527 | 539 | 521 | 1587 |
| Male | 256 | 246 | 262 | 764 |
| Ethnicity (NIH/OMB)(Participants) | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 4 | 14 |
| Not Hispanic or Latino | 764 | 759 | 758 | 2281 |
| Unknown or Not Reported | 14 | 21 | 21 | 56 |
| Race/Ethnicity, Customized(Participants) | CVnCoV: Group 1, Lot 1 | CVnCoV: Group 2, Lot 2 | Placebo | Total |
|---|---|---|---|---|
| White | 755 | 765 | 760 | 2280 |
| Black or African American | 2 | 1 | 0 | 3 |
| Asian | 13 | 9 | 14 | 36 |
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 0 | 2 |
| Other | 4 | 3 | 5 | 12 |
| Unknown or Not Reported | 7 | 6 | 4 | 17 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CVnCoV COVID-19 vaccine