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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
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The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (first 60 subjects) PHV02 high dose | Experimental |
| |
| Cohort 1 (first 60 subjects) PHV02 medium dose | Experimental |
| |
| Cohort 1 (first 60 subjects) PHV02 low dose | Experimental |
| |
| Cohort 1 (first 60 subjects) Placebo | Placebo Comparator |
| |
| Cohort 2 (next 60 subjects) PHV02 high dose | Experimental |
| |
| Cohort 2 (next 60 subjects) PHV02 medium dose | Experimental |
| |
| Cohort 2 (next 60 subjects) PHV02 low dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHV02 | Biological | Nipah virus vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with local injection site and systemic adverse events (AEs) | 14 days after each dose | |
| Percentage of participants with joint related symptoms, rash and unsolicited AEs | 28 days after each dose | |
| Percentage of participants with neurologic AEs | Study Days 1-57 | |
| Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs) | From time of injection through final study visit (Day 197) | |
| Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva | From time of injection through Day 43 | |
| Proportion of participants who seroconvert compared to Day 1 | Day 29 and Day 57 | |
| Geometric mean titers of IgG and ELISA neutralizing antibodies | Day 1, 29, 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Fusco, PhD | Public Health Vaccines | Study Chair |
| Thomas P Monath, MD | Quigley Biopharma | Study Director |
| Gray P Heppner, MD | Quigley Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cenexel ACT (Anaheim Clinical Trials) | Anaheim | California | 92801 | United States | ||
| Cenexel RCA (Research Centers of America) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37731485 | Background | Monath TP, Nichols R, Feldmann F, Griffin A, Haddock E, Callison J, Meade-White K, Okumura A, Lovaglio J, Hanley PW, Clancy CS, Shaia C, Rida W, Fusco J. Immunological correlates of protection afforded by PHV02 live, attenuated recombinant vesicular stomatitis virus vector vaccine against Nipah virus disease. Front Immunol. 2023 Sep 4;14:1216225. doi: 10.3389/fimmu.2023.1216225. eCollection 2023. |
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| Cohort 2 (next 60 subjects) Placebo | Placebo Comparator |
|
| Lactated Ringer's | Biological | Placebo |
|
| Hollywood |
| Florida |
| 33024 |
| United States |
| Cenexel JBR (JBR Clinical Research) | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D045464 | Henipavirus Infections |
| ID | Term |
|---|---|
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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