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MVA-NP+M1 · 1 trial · 1 indication
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.
| 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) |
| 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 8 of 11 competitors
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| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| 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 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
MVA-NP+M1 is an investigational vaccine candidate being developed for the prevention of influenza. It is designed to protect against influenza, including the H3N2 strain, and has been studied in a human challenge model where healthy adult volunteers were exposed to the virus.
MVA-NP+M1 is being developed by Barinthus Biotherapeutics plc, which trades under the ticker BRNS. The company is the sponsor of the clinical program evaluating this influenza vaccine candidate.
MVA-NP+M1 is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this candidate.
MVA-NP+M1 has been evaluated in one completed Phase 2 trial, NCT03883113, titled Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model. The trial enrolled 145 healthy adult volunteers in Belgium and used a randomized, double-blind, placebo-controlled design.
The Phase 2 trial NCT03883113 was a randomized, double-blind, placebo-controlled study conducted in Belgium. It enrolled 145 healthy volunteers aged 18 years and older of all sexes, and it used the influenza H3N2 human challenge model to assess efficacy.