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This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosage Group 1: RSV Vaccine Dosage 1 | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1. |
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| Dosage Group 1: Placebo | Placebo Comparator | Participants in this arm will receive a single intranasal dose of placebo. |
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| Dosage Group 2: RSV Vaccine Dosage 2 | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2. |
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| Dosage Group 2: Placebo | Placebo Comparator | Participants in this arm will receive a single intranasal dose of placebo. |
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| Dosage Group 3: RSV Vaccine Dosage 3 | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational RSV vaccine MV-012-968 (Dosage 1) | Biological | Single dose administered intranasally on Day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Solicited adverse events (AEs) | Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational 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. | Full study duration, 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. | Full study duration, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum RSV-specific neutralizing antibody titers | Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant. | Baseline through Day 28, an average of six (6) weeks |
| Change in serum binding (RSV F-specific) antibody titers |
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Key Inclusion Criteria:
Key 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 |
|---|---|---|---|---|---|---|
| Meridian Clinical Research | Norfolk | Nebraska | 68701 | United States | ||
| Meridian Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28000669 | Result | 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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The first 15 enrolled participants will be assigned to Dosage Group 1 and be randomly allocated to receive either investigational vaccine at Dosage 1 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 1 safety data through Day 14, to allow dosage escalation. The next 15 enrolled participants will be assigned to Dosage Group 2 and be randomly allocated to receive investigational vaccine at Dosage 2 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 2 safety data through Day 14, to allow dosage escalation. The final group (Dosage Group 3) will consist of up to 12 enrolled participants who will be allocated to receive investigational vaccine at Dosage 3.
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The study is single-mask in 2 of the 3 dosage groups: study participants and their parent(s)/guardian(s) will not know their child's study assignment, whereas investigators, site staff, and site pharmacists will remain unmasked.
| Investigational RSV vaccine MV-012-968 (Dosage 2) | Biological | Single dose administered intranasally on Day 1 |
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| Placebo | Other | Single dose administered intranasally on Day 1 |
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| Investigational RSV vaccine MV-012-968 (Dosage 3) | Biological | Single dose administered intranasally on Day 1 |
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Change in serum binding (RSV F-specific) antibody titers will be measured per participant. |
| Baseline through Day 28, an average of six (6) weeks |
| Change in nasal mucosal binding (RSV F-specific) antibody titers | Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant. | Baseline through Day 28, an average of six (6) weeks |
| Potential vaccine virus shedding: frequency | Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall. | Baseline through Day 28, an average of four (4) weeks |
| Potential vaccine virus shedding: magnitude | If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall. | Baseline through Day 28, an average of four (4) weeks |
| Potential vaccine virus shedding: duration | If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall. | Baseline through Day 28, an average of four (4) weeks |
| Omaha |
| Nebraska |
| 68134 |
| United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| 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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