Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07199569 | Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells | PHASE2 | ACTIVE NOT_RECRUITING | 970 | — | — | Oct 27, 2025 | Nov 30, 2026 | Apr 8, 2026 | 10 | United States |
Titer of serum neutralizing antibodies against vaccinia virus as measured by plaque reduction neutralization tests (PRNTs)
Number and percentage of study participants reporting any serious adverse events at any time during the trial period
Number and percentage of study participants reporting any Adverse Events of Special Interest (AESI)
Number and percentage of study participants reporting any Medically Attended Adverse Events (MAAE)
Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse event (AE) assessed as related to trial vaccine
Number and percentage of study participants reporting any solicited local AE (pain, swelling, pruritus, erythema, induration)
Number and percentage of study participants reporting any solicited systemic AE (body temperature, headache, fatigue, myalgia, nausea, chills)
Number and percentage of study participants reporting any unsolicited AE
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | MVA-BN (CEF) |
| Group 2 | EXPERIMENTAL | MVA-BN (Quail) |
| Name | Type | Description |
|---|---|---|
| Jynneos | BIOLOGICAL | MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29). |
| MVA-BN (Quail) | BIOLOGICAL | MVA-BN manufactured in CCX.E10 quail cell line. Vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U. and is a LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29). |
Inclusion Criteria: 1. 18 to 49 years of age 2. Informed consent form (ICF) signed and dated by the participant after reading the form and being advised of the risks and benefits of the trial in a language understood by the participant and before performance of any trial-specific procedures 3. Gene...