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This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV Vaccine: Dosage Group #1 | Experimental | Participants in this group will receive a single dose of the RSV vaccine at dosage #1 |
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| RSV Vaccine: Dosage Group #2 | Experimental | Participants in this group will receive a single dose of the RSV vaccine at dosage #2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV vaccine MV-012-968 (dosage #1) | Biological | Single dose administered intranasally on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited adverse events (AEs) | Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that can occur after vaccine administration. | Immediate post-vaccination period |
| Unsolicited AEs | Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine. | Immediate post-vaccination period |
| Serious adverse events (SAEs) | Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational 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. | Vaccination through study completion, an average of 6 months |
| Medically attended adverse events (MAEs) | Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational 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, 'check-ups', and vaccinations, are not considered MAEs. | Vaccination through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum RSV-specific neutralizing antibody (nAb) titers | Post-vaccination change in serum RSV-specific nAb titers will be measured per participant. | Baseline through study completion, an average of 6 months |
| Change in serum RSV F-specific binding antibody titers |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Medzihradsky, MD MPH MS | Meissa Vaccines, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28000669 | Background | Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916. |
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Each enrolled subject will be allocated to 1 of 2 study groups. Group 1 will receive one dosage of the investigational RSV vaccine, and Group 2 will receive a different dosage of the same vaccine.
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| RSV vaccine MV-012-968 (dosage #2) | Biological | Single dose administered intranasally on Day 1 |
|
Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant. |
| Baseline through study completion, an average of 6 months |
| Change in mucosal RSV F-specific binding antibody titers | Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant. | Baseline through study completion, an average of 6 months |
| Potential vaccine virus shedding | The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant. | Baseline through 2 months |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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