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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 a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative 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 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 3: RSV Vaccine Dosage 3 (Single-dose) | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 |
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| Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose) | Experimental | Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later |
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| Placebo (Single-dose) | Placebo Comparator | Participants in this arm will receive a single intranasal dose of placebo |
| 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 1 year |
| 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 1 year |
| Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations | Change in serum binding (RSV F-specific) IgG concentrations will be measured per participant | Baseline through Day 28, an average of six (6) weeks |
| Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations |
| Measure | Description | Time Frame |
|---|---|---|
| RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation | Frequency of RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity. | Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jay Lieberman, MD | Contact | 3107538943 | jay.lieberman@meissavaccines.com |
| Name | Affiliation | Role |
|---|---|---|
| Jay Lieberman, MD | Meissa Vaccines, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedPharmics | Recruiting | Phoenix | Arizona | 85015 | 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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1st 5 subjects will be in Group 1 and randomized to investigational vaccine (IP) Dosage 1 or placebo. Safety Monitoring Committee (SMC) will review Group 1 data to Day 15 to allow dose escalation. Next 10 subjects will be in Group 2 and randomized to IP Dosage 2 or placebo. SMC will review Group 2 data to Day 15 to allow dose escalation. Next 12 enrolled subjects will be in Group 3 and randomized to IP Dosage 3 or placebo. SMC will review Group 3 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 4 and randomized to IP Dosage 4 or placebo. SMC will review Group 4 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 3a and randomized to IP Dosage 3 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose. Final 12 subjects will be in Group 4a and randomized to IP Dosage 4 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose.
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The study is single-mask. Study participants and their parent(s)/guardian(s) will not know their child's study assignment; investigators, site staff, and site pharmacists will remain unmasked.
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| Placebo (Two-dose) | Placebo Comparator | Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later |
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| Investigational RSV vaccine MV-012-968 (Dosage 2) | Biological | Single dose administered intranasally on Day 1 |
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| Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose) | Biological | Single dose administered intranasally on Day 1 |
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| Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose) | Biological | Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit |
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| Placebo (single-dose) | Other | Single dose administered intranasally on Day 1 |
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| Placebo (two-dose) | Other | Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit |
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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 nasal mucosal binding (RSV F-specific) IgA concentrations will be measured per participant |
| Baseline through Day 28, an average of six (6) weeks |
| Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency | Frequency of any post-vaccination shedding of vaccine virus (as detected by plaque assay) after a single intranasal dose of MV-012-968 will be measured per dosage group and overall. | Intranasal inoculation through Day 22, an average of three (3) weeks |
| Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude | If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall | Intranasal inoculation through Day 22, an average of three (3) weeks |
| Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration | If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, duration of shedding (in days) will be measured per dosage group and overall. | Intranasal inoculation through Day 22, an average of three (3) weeks |
| RSV-confirmed medically attended acute lower respiratory infection | Frequency of RSV-confirmed medically attended acute lower respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity. | Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology |
| Paradigm Clinical Research | Not yet recruiting | La Mesa | California | 91942 | United States |
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| The Emory Children's Center | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Clinical Research Prime | Not yet recruiting | Idaho Falls | Idaho | 83404 | United States |
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| MedPharmics | Recruiting | Metairie | Louisiana | 70006 | United States |
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| Meridian Clinical Research | Not yet recruiting | Hastings | Nebraska | 68901 | United States |
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| Meridian Clinical Research | Recruiting | Omaha | Nebraska | 68134 | United States |
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| Meridian Clinical Research | Recruiting | Binghamton | New York | 41348 | United States |
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| Aventiv Research | Not yet recruiting | Columbus | Ohio | 43213 | United States |
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| Coastal Pediatric Research | Not yet recruiting | Summerville | South Carolina | 29486 | United States |
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| PanAmerican Clinical Research | Not yet recruiting | Brownsville | Texas | 78520 | United States |
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| Benchmark Research | Recruiting | San Antonio | Texas | 78240 | United States |
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