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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR203559 | Other Grant/Funding Number | USAMRAA |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85 years at time of enrollment.
This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with IIV delivered IM to a healthy adult population age 65 to 85 years at time of enrollment. Eligible subjects will be randomized concurrently in a 3:3:3:1 ratio to receive one administration of Cam2020 M2SR alone (Cohort 1, n=90), Cam2020 M2SR along with IIV (Cohort 2, n=90), IIV alone (Cohort 3, n=90), or placebo (Cohort 4, n=30).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M2SR only dose | Experimental | Intranasal M2SR vaccine and intramuscular placebo dose |
|
| M2SR with IIV dose | Experimental | Intranasal M2SR vaccine and intramuscular IIV dose |
|
| IIV only dose | Active Comparator | Intranasal placebo dose and intramuscular IIV dose |
|
| Placebo only dose | Placebo Comparator | Intranasal placebo dose and intramuscular placebo dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cam2020 M2SR H3N2 influenza vaccine | Biological | Administered intranasally on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited AEs during 7 days after experimental treatment | The number and percentage of subjects who experience solicited local and systemic reactions during the 7 days after vaccine administration of M2SR administration alone or with IIV | Day 1 to Day 8 |
| Unsolicited AEs during 28 days after experimental treatment | The number and percentage of subjects who experience unsolicited AEs during the 28 days after vaccine administration of M2SR alone or with IIV. | Day 1 to Day 29 |
| SAEs through 28 days after experimental treatment | The number and percentage of subjects who experience SAEs from the time of informed consent through 28 days after vaccine administration of M2SR alone or with IIV. | Day 1 to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamuk Bilsel | FluGen Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Medical Research | Port Orange | Florida | 32127 | United States | ||
| Velocity Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39004096 | Derived | Eiden J, Fierro C, White A, Davis M, Rhee M, Turner M, Murray B, Herber R, Aitchison R, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65-85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial. Lancet Infect Dis. 2024 Oct;24(10):1118-1129. doi: 10.1016/S1473-3099(24)00351-7. Epub 2024 Jul 11. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 28, 2024 | |
| Reset | Aug 2, 2024 | |
| Release | Apr 21, 2025 |
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Subjects assigned randomly to one of four cohorts concurrently
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Syringes wrapped to obscure color of contents
| Fluzone HD IIV | Biological | Administered intramuscularly on Day 1 |
|
| IN Placebo | Other | Administered intranasally on Day 1 |
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| IM Placebo | Other | Administered intramuscularly on Day 1 |
|
| Meridian |
| Idaho |
| 83642 |
| United States |
| Johnson County Clin Trials | Lenexa | Kansas | 66219 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Velocity Clinical Research | Beechwood | Ohio | 44122 | United States |
| Velocity Clinical Research | Cedar Park | Texas | 78613 | United States |
| Reset | Apr 23, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 28, 2024 | Aug 2, 2024 | |||
| Apr 21, 2025 | Apr 23, 2025 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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