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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002848-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Hvivo | INDUSTRY |
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The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in the Human Viral Challenge model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MV-012-968 | Experimental | Dose: 1 x10^6 Plaque Forming Unit (PFU), given intranasally, followed approximately 28 days later by inoculation with RSV-A (Memphis 37b). |
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| Placebo | Placebo Comparator | Sodium Chloride 0.9% w/v intravenous infusion B.P (Normal Saline) matched to reference article product, given intranasally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MV-012-968 | Biological | MV-012-968 is a recombinant, live attenuated RSV vaccine. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of symptomatic RSV infection, as defined as the occurrence of both: |
| 10 days (days 2 to 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of symptomatic RSV infection, as defined as occurrence of both: |
|
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Key Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariya Kalinova, MD | hVIVO Services Ltd | Principal Investigator |
| Oliver Medzihradsky, MD MPH MS | Meissa Vaccines, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hVIVO Services Ltd | London | E1 2AX | United Kingdom |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| Placebo |
| Other |
Saline solution |
|
| 10 days (days 2 to 12) |
| Frequency of RSV infection, as defined as the occurrence of 2 quantifiable RT-qPCR samples on 2 consecutive days (i.e. at least 1 on each of 2 consecutive days) in nasal wash specimens | 10 days (Day 2 to 12) |
| Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens | 10 days (Day 2 to 12) |
| Mean daily total symptom score using the SDC | 10 days (Day 2 to 12) |
| Mean daily weight of nasal (mucus) discharge | 10 days (Day 2 to 12) |
| RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens | 10 days (Day 2 to 12) |
| Peak RSV load, as measured by RT-qPCR of nasal wash specimens | 10 days (Day 2 to 12) |
| Frequency of solicited adverse events (AEs) as reported in the Subject Vaccination Diary Card, categorized by severity. Solicited AEs are predefined AEs that may occur after study vaccine administration. | Time Frame: 7 days (Day -28 to -21) |
| Frequency of unsolicited AEs after study vaccination, categorized by severity and by study vaccine relatedness. | Unsolicited AEs are any untoward medical occurrences in a participant administered the study vaccine, regardless of causal relationship to the study vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the study vaccine. | 28 days (Day -28 to 0) |
| Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness. | 29 days (Day 0 to 28) |
| Frequency of serious AEs (SAEs) after study vaccination, categorized by study vaccine relatedness. | SAEs are AEs, whether considered causally related to the study vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect. | 180 days (Day -28 to 152) |
| Frequency of medically attended AEs (MAEs) after study vaccination, categorized by study vaccine relatedness. | MAEs are AEs, whether considered causally related to the study vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'checkups', and vaccinations, are not considered MAEs | 180 days (Day -28 to 152) |
| D014777 | Virus Diseases |
| D007239 | Infections |