CVnCoV 12 μg Vaccine vs Placebo: Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With Wild Type and Alpha SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00226 | 0.00157 | 0.00324 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00459 | 0.00353 | 0.00595 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00233 | -0.00386 | -0.00089 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.492 | 0.314 | 0.77 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.491 | 0.313 | 0.769 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on CVnCoV 12 μg Vaccine than on Placebo | 429 | 259 | 1,120 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | CVnCoV 12 μg Vaccine | Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. | 29 | 12,851 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. | 56 | 12,211 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With Wild Type and Alpha SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants | ClinicalTrials.gov |
| Description | The characterization of SARS-CoV-2 variants were implemented by viral whole genome sequencing of nasopharyngeal swab samples of participants followed by comparison with previously sequenced and typified genomes. The following phylogenetic clustering was applied:~1. Wild type virus: WT/D614G, lineages A.1/B.1 without the variant of concerns (VOCs) (i.e., without B.1.1.7 \[Alpha\], B.1.351 \[Beta\], B.1.429 \[Epsilon\]).~2. UK VOC: B.1.1.7 (Alpha).~A case of COVID-19 was defined as follows:~* Virologically-confirmed case of COVID-19 defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19.~* Symptom onset ≥ 15 days after second vaccination.~* First episode of virologically-confirmed COVID-19.~* Participant was SARS-CoV-2 naïve at baseline and Day 43.~Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | ClinicalTrials.gov |
| Time frame | Day 44 to Day 393 | ClinicalTrials.gov |
| Population | EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, \& were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older | ClinicalTrials.gov |
| NCT number | NCT04652102 | ClinicalTrials.gov |
| Phases | PHASE2, PHASE3 | ClinicalTrials.gov |
| Conditions | Covid19, SARS-CoV-2 | ClinicalTrials.gov |
| Interventions | CVnCoV, Placebo, Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program | ClinicalTrials.gov |
| Lead sponsor | CureVac | ClinicalTrials.gov |
| Results first posted | 2024-04-29 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04652102?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.