Approval Probability
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Adjusted LOA
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MVA-NP+M1 · 2 trials · 2 indications
Measure of nasopharyngeal viral shedding during challenge; recorded as viral area under curve (vAUC) as determined by quantitative real time polymerase chain reaction (qRT-PCR). vAUC is calculated by plotting the log viral particles number/ml for each time point against time and is using the trapezoidal rule.
Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.
Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.
Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.
Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits
Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration
| Arm | Type | Description |
|---|---|---|
| MVA-NP+M1 & H3N2 Challenge Virus | EXPERIMENTAL | Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10\^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml) |
| Saline Placebo & H3N2 Challenge Virus | PLACEBO_COMPARATOR | Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10\^6 TCID50/ml) |
| Single intramuscular injection of MVA-NP+M1 vaccine | EXPERIMENTAL | MVA-NP+M1, a novel vaccine will be administered intramuscular. The total volume given is 0.5ml and the dose given is 1.5E8 pfu. Each volunteer will receive one single injection only over a few seconds. |
| Name | Type | Description |
|---|---|---|
| MVA-NP+M1 | BIOLOGICAL | Trial Vaccine |
| Saline | BIOLOGICAL | Sodium Chloride Placebo |
| H3N2 (A/Belgium/2417/2015) | BIOLOGICAL | Challenge Agent |
Inclusion Criteria: * Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment. * Non-smokers or those who stopped smoking ≥ 3 months prior to screening 1 visit. * Willingness to remain in isolation for the duration of the study. * A female participant is eligible for this ...
Top 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
MVA-NP+M1 is an investigational vaccine being studied for influenza and in human volunteers. It has been evaluated in a Phase 2 human challenge model for influenza H3N2 and in an early Phase 1 study for safety and immunogenicity. It is not approved and remains in clinical development.
MVA-NP+M1 is being developed by Barinthus Biotherapeutics plc, traded on the stock exchange under the ticker BRNS. The company is conducting clinical trials to evaluate the vaccine's safety, immunogenicity, and efficacy in influenza and human volunteer studies.
MVA-NP+M1 has completed a Phase 1 study and a Phase 2 study. The Phase 1 trial assessed safety and immunogenicity, while the Phase 2 trial evaluated efficacy in an influenza H3N2 human challenge model. Both trials are completed, and the vaccine is investigational.
MVA-NP+M1 has been studied in two completed trials: NCT03277456, an early Phase 1 study in the United Kingdom with 6 healthy volunteers, and NCT03883113, a Phase 2 efficacy trial in Belgium with 145 participants using the influenza H3N2 human challenge model.
No, MVA-NP+M1 is not a monoclonal antibody. Although the developer's modality is listed as monoclonal antibody, the vaccine is a candidate influenza vaccine designed to induce an immune response. It has been tested in healthy volunteers and in a human challenge model for influenza.