Adults 18 to 60, any sex, with Severe Acute Respiratory Syndrome or Coronavirus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First VaccinationPrimary· Up to 24 hours after vaccination on Day 1
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:
* Resulted in death.
* Was life-threatening.
* Required inpatient hospitalization or prolongation of existing hospitalization.
* Resulted in persistent disability/incapacity.
* Was a congenital anomaly/birth defect in the offspring of the participant.
* Was an important medical event.
Any Grade 3 Adverse Reaction
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
3
Dose Escalation CVnCoV: 4 µg
9
Dose Escalation CVnCoV: 6 µg
8
Dose Escalation CVnCoV: 8 µg
14
Dose Escalation CVnCoV: 12 µg
12
Dose Escalation CVnCoV: 16 µg
7
Dose Escalation CVnCoV: 20 µg
8
Dose Escalation Placebo
0
Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
0
Dose Escalation CVnCoV: 4 µg
0
Dose Escalation CVnCoV: 6 µg
0
Dose Escalation CVnCoV: 8 µg
0
Dose Escalation CVnCoV: 12 µg
0
Dose Escalation CVnCoV: 16 µg
0
Dose Escalation CVnCoV: 20 µg
0
Dose Escalation Placebo
0
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First VaccinationPrimary· Up to 60 hours after vaccination on Day 1
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:
* Resulted in death.
* Was life-threatening.
* Required inpatient hospitalization or prolongation of existing hospitalization.
* Resulted in persistent disability/incapacity.
* Was a congenital anomaly/birth defect in the offspring of the participant.
* Was an important medical event.
Any Grade 3 Adverse Reaction
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
3
Dose Escalation CVnCoV: 4 µg
9
Dose Escalation CVnCoV: 6 µg
8
Dose Escalation CVnCoV: 8 µg
14
Dose Escalation CVnCoV: 12 µg
12
Dose Escalation CVnCoV: 16 µg
7
Dose Escalation CVnCoV: 20 µg
8
Dose Escalation Placebo
0
Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
0
Dose Escalation CVnCoV: 4 µg
0
Dose Escalation CVnCoV: 6 µg
0
Dose Escalation CVnCoV: 8 µg
0
Dose Escalation CVnCoV: 12 µg
0
Dose Escalation CVnCoV: 16 µg
0
Dose Escalation CVnCoV: 20 µg
0
Dose Escalation Placebo
0
Number of Participants With Solicited Local Adverse EventsPrimary· Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
32
Dose Escalation CVnCoV: 4 µg
43
Dose Escalation CVnCoV: 6 µg
38
Dose Escalation CVnCoV: 8 µg
41
Dose Escalation CVnCoV: 12 µg
26
Dose Escalation CVnCoV: 16 µg
16
Dose Escalation CVnCoV: 20 µg
11
Dose Escalation Placebo
5
Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading ScalePrimary· Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Grade 1
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
30
Dose Escalation CVnCoV: 4 µg
39
Dose Escalation CVnCoV: 6 µg
32
Dose Escalation CVnCoV: 8 µg
29
Dose Escalation CVnCoV: 12 µg
17
Dose Escalation CVnCoV: 16 µg
12
Dose Escalation CVnCoV: 20 µg
6
Dose Escalation Placebo
5
Grade 2
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
2
Dose Escalation CVnCoV: 4 µg
3
Dose Escalation CVnCoV: 6 µg
5
Dose Escalation CVnCoV: 8 µg
11
Dose Escalation CVnCoV: 12 µg
9
Dose Escalation CVnCoV: 16 µg
4
Dose Escalation CVnCoV: 20 µg
5
Dose Escalation Placebo
0
Grade 3
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
0
Dose Escalation CVnCoV: 4 µg
1
Dose Escalation CVnCoV: 6 µg
1
Dose Escalation CVnCoV: 8 µg
1
Dose Escalation CVnCoV: 12 µg
0
Dose Escalation CVnCoV: 16 µg
0
Dose Escalation CVnCoV: 20 µg
0
Dose Escalation Placebo
0
Duration of Solicited Local Adverse EventsPrimary· Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
1.8
± 0.99
Dose Escalation CVnCoV: 4 µg
2.0
± 0.84
Dose Escalation CVnCoV: 6 µg
2.3
± 1.02
Dose Escalation CVnCoV: 8 µg
2.4
± 1.44
Dose Escalation CVnCoV: 12 µg
2.6
± 1.44
Dose Escalation CVnCoV: 16 µg
2.5
± 0.82
Dose Escalation CVnCoV: 20 µg
3.0
± 1.18
Dose Escalation Placebo
1.2
± 0.45
Number of Participants With Solicited Systemic Adverse EventsPrimary· Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
29
Dose Escalation CVnCoV: 4 µg
45
Dose Escalation CVnCoV: 6 µg
44
Dose Escalation CVnCoV: 8 µg
45
Dose Escalation CVnCoV: 12 µg
28
Dose Escalation CVnCoV: 16 µg
16
Dose Escalation CVnCoV: 20 µg
12
Dose Escalation Placebo
19
Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading ScalePrimary· Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Grade 1
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
21
Dose Escalation CVnCoV: 4 µg
22
Dose Escalation CVnCoV: 6 µg
20
Dose Escalation CVnCoV: 8 µg
11
Dose Escalation CVnCoV: 12 µg
1
Dose Escalation CVnCoV: 16 µg
2
Dose Escalation CVnCoV: 20 µg
0
Dose Escalation Placebo
15
Grade 2
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
5
Dose Escalation CVnCoV: 4 µg
14
Dose Escalation CVnCoV: 6 µg
16
Dose Escalation CVnCoV: 8 µg
20
Dose Escalation CVnCoV: 12 µg
16
Dose Escalation CVnCoV: 16 µg
7
Dose Escalation CVnCoV: 20 µg
5
Dose Escalation Placebo
4
Grade 3
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
3
Dose Escalation CVnCoV: 4 µg
9
Dose Escalation CVnCoV: 6 µg
8
Dose Escalation CVnCoV: 8 µg
14
Dose Escalation CVnCoV: 12 µg
11
Dose Escalation CVnCoV: 16 µg
7
Dose Escalation CVnCoV: 20 µg
7
Dose Escalation Placebo
0
Duration of Solicited Systemic Adverse EventsPrimary· Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
3.1
± 5.38
Dose Escalation CVnCoV: 4 µg
2.1
± 1.15
Dose Escalation CVnCoV: 6 µg
2.4
± 2.16
Dose Escalation CVnCoV: 8 µg
3.2
± 2.40
Dose Escalation CVnCoV: 12 µg
3.6
± 1.73
Dose Escalation CVnCoV: 16 µg
2.5
± 0.73
Dose Escalation CVnCoV: 20 µg
3.4
± 1.24
Dose Escalation Placebo
1.8
± 0.96
Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial VaccinePrimary· Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
28
Dose Escalation CVnCoV: 4 µg
45
Dose Escalation CVnCoV: 6 µg
44
Dose Escalation CVnCoV: 8 µg
44
Dose Escalation CVnCoV: 12 µg
28
Dose Escalation CVnCoV: 16 µg
16
Dose Escalation CVnCoV: 20 µg
12
Dose Escalation Placebo
17
Number of Participants With Unsolicited Adverse EventsPrimary· Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
26
Dose Escalation CVnCoV: 4 µg
32
Dose Escalation CVnCoV: 6 µg
29
Dose Escalation CVnCoV: 8 µg
31
Dose Escalation CVnCoV: 12 µg
23
Dose Escalation CVnCoV: 16 µg
13
Dose Escalation CVnCoV: 20 µg
11
Dose Escalation Placebo
16
Intensity of Unsolicited Adverse Events Assessed by the InvestigatorPrimary· Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
* Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.
* Moderate: an event that caused suffic
Mild
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
14
Dose Escalation CVnCoV: 4 µg
17
Dose Escalation CVnCoV: 6 µg
15
Dose Escalation CVnCoV: 8 µg
12
Dose Escalation CVnCoV: 12 µg
9
Dose Escalation CVnCoV: 16 µg
8
Dose Escalation CVnCoV: 20 µg
4
Dose Escalation Placebo
9
Moderate
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
10
Dose Escalation CVnCoV: 4 µg
13
Dose Escalation CVnCoV: 6 µg
10
Dose Escalation CVnCoV: 8 µg
17
Dose Escalation CVnCoV: 12 µg
10
Dose Escalation CVnCoV: 16 µg
5
Dose Escalation CVnCoV: 20 µg
2
Dose Escalation Placebo
6
Severe
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
2
Dose Escalation CVnCoV: 4 µg
2
Dose Escalation CVnCoV: 6 µg
4
Dose Escalation CVnCoV: 8 µg
2
Dose Escalation CVnCoV: 12 µg
4
Dose Escalation CVnCoV: 16 µg
0
Dose Escalation CVnCoV: 20 µg
5
Dose Escalation Placebo
1
Number of Participants With Unsolicited Adverse Events Considered Related to Trial VaccinePrimary· Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Group
Value
95% CI
Dose Escalation CVnCoV: 2 µg
7
Dose Escalation CVnCoV: 4 µg
20
Dose Escalation CVnCoV: 6 µg
15
Dose Escalation CVnCoV: 8 µg
16
Dose Escalation CVnCoV: 12 µg
12
Dose Escalation CVnCoV: 16 µg
4
Dose Escalation CVnCoV: 20 µg
10
Dose Escalation Placebo
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 up to Day 393.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT04860258 — COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults
· Phase 3
· terminated
NCT04674189 — A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CureVac
Last refreshed: 30 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04449276.