Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Jynneos · 1 trial · 1 indication
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...
Jynneos is a monoclonal antibody being developed for the prevention of Monkeypox (Mpox) infection. It is currently in Phase 2 clinical development as an investigational vaccine. The drug is being studied in healthy adult volunteers in the United States to assess its safety and immunogenicity.
Jynneos is a monoclonal antibody designed to target the vaccinia virus, which is closely related to the monkeypox virus. By targeting this virus, Jynneos aims to provide protection against Mpox infection. The specific molecular target has not been disclosed in available information.
Jynneos is being developed by Icon Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ICLR. Icon Plc is conducting clinical trials to evaluate the safety and efficacy of Jynneos for the prevention of Monkeypox (Mpox).
Jynneos is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, indicating that enrollment has been completed and the study is underway.
Jynneos is being evaluated in a Phase 2 clinical trial with the identifier NCT07199569. This trial is titled "Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells" and is being conducted in the United States. The study enrolls 970 healthy adult volunteers aged 18 years and older, with a randomized, double-blind, active-controlled design.
Jynneos is being studied in a trial that compares the MVA-BN vaccine manufactured in different production cells. The trial title suggests that Jynneos may be related to or a version of the MVA-BN vaccine, but the available information does not explicitly state that Jynneos is the same as MVA-BN. The study aims to assess comparability between different manufacturing processes.