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| Name | Class |
|---|---|
| Emergent BioSolutions | INDUSTRY |
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The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.
Approximately 60 subjects and up to 120 household contacts will be enrolled in the United States. Vaccinees will be randomly assigned to receive either PXVX0200 or placebo in a 5:1 ratio and will be followed for 180 days postdose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PXVX0200 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXVX0200 | Biological | Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs | Day 0-180 |
| Immunogenicity | Immunogenicity as defined as rate of seroconversion (4-fold rise) of serum Inaba vibriocidal antibody and initial estimates of between subject variability of vibriocidal antibody response | Day 0-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics | Kinetics of serum Inaba vibriocidal antibody after 1 oral dose of CVD 103-HgR | Day 0-28 |
| Serum anti-cholera toxin (CT) IgG antibody conversion rates | Anti-cholera toxin IgG antibody conversion rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536-0084 | United States | ||
| University of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24173028 | Derived | Chen WH, Greenberg RN, Pasetti MF, Livio S, Lock M, Gurwith M, Levine MM. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR, prepared from new master and working cell banks. Clin Vaccine Immunol. 2014 Jan;21(1):66-73. doi: 10.1128/CVI.00601-13. Epub 2013 Oct 30. |
| Label | URL |
|---|---|
| PubMed (results) | View source |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Placebo | Biological | Approx 2 grams of lactose reconstituted in water |
|
| Day 0-28 |
| Fecal shedding | Fecal shedding of CVD 103-HgR by vaccine recipient | Day 0-7 |
| Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts | Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts | Day 0-28 |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| D007239 | Infections |