Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Emergent BioSolutions | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose of Live Oral Cholera Vaccine Candidate, PXVX0200 CVD 103-HgR Strain, in Preventing Cholera following Challenge with Vibrio cholerae O1 El Tor Inaba 10 Days or 3 Months after Vaccination in volunteers aged 18-45 years
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PXVX0200 | Experimental | Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10^8 CFU |
|
| Placebo | Placebo Comparator | Biological: Placebo physiological saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXVX0200 | Biological | Single dose; liquid suspension after reconstitution with buffer; 5x10^8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of Participants With Moderate to Severe Diarrhea | Determine whether a single dose of PXVX0200 provides significantly greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination. The primary endpoint was the occurrence of moderate or severe (>/= 3 liters) diarrhea. | Ten days after vaccination |
| % of Participants With Moderate to Severe Diarrhea | Determine whether a single dose of PXVX0200 provides significant greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination. The primary endpoint was the occurrence of moderate or severe (>/= 3 liters) of diarrhea. | Ninety days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge | Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge. | Through 10 Days following challenge |
| Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James McCarty, MD | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | United States | ||
| Cincinnati Children'S Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27001804 | Result | Chen WH, Cohen MB, Kirkpatrick BD, Brady RC, Galloway D, Gurwith M, Hall RH, Kessler RA, Lock M, Haney D, Lyon CE, Pasetti MF, Simon JK, Szabo F, Tennant S, Levine MM. Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor. Clin Infect Dis. 2016 Jun 1;62(11):1329-1335. doi: 10.1093/cid/ciw145. Epub 2016 Mar 21. | |
| 29655627 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PXVX0200 | Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10^8 to 2x10^9 CFU in a liquid suspension |
| FG001 | Placebo | Biological: Placebo physiological saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PXVX0200 | Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10^8 to 2x10^9 CFU in a liquid suspension |
| BG001 | Placebo | Biological: Placebo physiological saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % of Participants With Moderate to Severe Diarrhea | Determine whether a single dose of PXVX0200 provides significantly greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination. The primary endpoint was the occurrence of moderate or severe (>/= 3 liters) diarrhea. | Posted | Number | percentage of participants | Ten days after vaccination |
|
Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PVXV0200 | Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10^8 CFU. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment | Placebo recipient 01047 was hospitalized for orthopedic surgery considered unrelated to vaccination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA (15.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Cassie, Scientist, Clinical Research | Emergent BioSolutions Canada Inc. | 204-275-4589 | dcassie@ebsi.com |
Not provided
| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Biological |
|
Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge. |
| Through 10 Days following challenge |
| % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge | Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge. | Through 10 Days following challenge |
| % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge | Incidence of mild or worse (any severity) diarrhea following the 90 day cholera challenge. | Through 10 Days following challenge |
| % of Participants With Fever Following the 10 Day Cholera Challenge | Incidence of mild or worse fever following the 10 day cholera challenge. | Through 10 Days following challenge |
| % of Participants With Fever Following the 90 Day Cholera Challenge | Incidence of mild or worse fever following the 90 day cholera challenge. | Through 10 Days following challenge |
| Number of Days With Fecal Shedding Following 10 Day Challenge | Number of days of fecal shedding of wild type V. cholerae following 10 Day Challenge. | Through 10 Days post challenge |
| Number of Days With Fecal Shedding Following 90 Day Challenge | Number of days of fecal shedding of wild type V. cholerae following 90 Day Challenge | Through 10 days following challenge |
| # of Days With Positive Stool Culture Following 10 Day Cholera Challenge | Total number of days with a positive stool culture following the 10 Day Cholera challenge. | Through 10 Days following challenge |
| # of Days With Positive Stool Culture Following 90 Day Cholera Challenge | Total number of days with a positive stool culture following 90 Day Cholera Challenge | Through 10 Days following challenge |
| % of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination | Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever following vaccination (through Day 8). Incidence and severity of unsolicited adverse events following vaccination (through Day 29). | Following vaccination (Days 1 - 8) and to Day 29 |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| Result |
| Haney DJ, Lock MD, Gurwith M, Simon JK, Ishioka G, Cohen MB, Kirkpatrick BD, Lyon CE, Chen WH, Sztein MB, Levine MM, Harris JB. Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection. Vaccine. 2018 May 11;36(20):2768-2773. doi: 10.1016/j.vaccine.2018.04.011. Epub 2018 Apr 11. |
| 28566334 | Result | Haney DJ, Lock MD, Simon JK, Harris J, Gurwith M. Antibody-Based Correlates of Protection Against Cholera Analysis of a Challenge Study in a Cholera-Naive Population. Clin Vaccine Immunol. 2017 May 31;24(8):e00098-17. doi: 10.1128/CVI.00098-17. Online ahead of print. |
| 31743334 | Derived | Hossain M, Islam K, Kelly M, Mayo Smith LM, Charles RC, Weil AA, Bhuiyan TR, Kovac P, Xu P, Calderwood SB, Simon JK, Chen WH, Lock M, Lyon CE, Kirkpatrick BD, Cohen M, Levine MM, Gurwith M, Leung DT, Azman AS, Harris JB, Qadri F, Ryan ET. Immune responses to O-specific polysaccharide (OSP) in North American adults infected with Vibrio cholerae O1 Inaba. PLoS Negl Trop Dis. 2019 Nov 19;13(11):e0007874. doi: 10.1371/journal.pntd.0007874. eCollection 2019 Nov. |
| 29624592 | Derived | Islam K, Hossain M, Kelly M, Mayo Smith LM, Charles RC, Bhuiyan TR, Kovac P, Xu P, LaRocque RC, Calderwood SB, Simon JK, Chen WH, Haney D, Lock M, Lyon CE, Kirkpatrick BD, Cohen M, Levine MM, Gurwith M, Harris JB, Qadri F, Ryan ET. Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers. PLoS Negl Trop Dis. 2018 Apr 6;12(4):e0006376. doi: 10.1371/journal.pntd.0006376. eCollection 2018 Apr. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | % of Participants With Moderate to Severe Diarrhea | Determine whether a single dose of PXVX0200 provides significant greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination. The primary endpoint was the occurrence of moderate or severe (>/= 3 liters) of diarrhea. | Posted | Number | percentage of participants | Ninety days after vaccination |
|
|
|
|
| Secondary | Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge | Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge. | Intent to Treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Median | Full Range | mL | Through 10 Days following challenge |
|
|
|
|
| Secondary | Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge | Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge. | Intent to Treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Median | Full Range | mL | Through 10 Days following challenge |
|
|
|
|
| Secondary | % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge | Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge. | Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Number | % of participants | Through 10 Days following challenge |
|
|
|
|
| Secondary | % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge | Incidence of mild or worse (any severity) diarrhea following the 90 day cholera challenge. | Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Number | % of participants | Through 10 Days following challenge |
|
|
|
|
| Secondary | % of Participants With Fever Following the 10 Day Cholera Challenge | Incidence of mild or worse fever following the 10 day cholera challenge. | Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Number | % of participants | Through 10 Days following challenge |
|
|
|
|
| Secondary | % of Participants With Fever Following the 90 Day Cholera Challenge | Incidence of mild or worse fever following the 90 day cholera challenge. | Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Number | % of participants | Through 10 Days following challenge |
|
|
|
|
| Secondary | Number of Days With Fecal Shedding Following 10 Day Challenge | Number of days of fecal shedding of wild type V. cholerae following 10 Day Challenge. | Intent to treat (ITT) population | Posted | Median | Inter-Quartile Range | Days | Through 10 Days post challenge |
|
|
|
|
| Secondary | Number of Days With Fecal Shedding Following 90 Day Challenge | Number of days of fecal shedding of wild type V. cholerae following 90 Day Challenge | Intent to treat (ITT) population | Posted | Median | Inter-Quartile Range | Days | Through 10 days following challenge |
|
|
|
|
| Secondary | # of Days With Positive Stool Culture Following 10 Day Cholera Challenge | Total number of days with a positive stool culture following the 10 Day Cholera challenge. | Intent to treat (ITT) comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Mean | Standard Deviation | Days | Through 10 Days following challenge |
|
|
|
|
| Secondary | # of Days With Positive Stool Culture Following 90 Day Cholera Challenge | Total number of days with a positive stool culture following 90 Day Cholera Challenge | Intent to treat (ITT) comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo. | Posted | Mean | Standard Deviation | Days | Through 10 Days following challenge |
|
|
|
|
| Secondary | % of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination | Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever following vaccination (through Day 8). Incidence and severity of unsolicited adverse events following vaccination (through Day 29). | Posted | Number | % of participants | Following vaccination (Days 1 - 8) and to Day 29 |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 17 |
| 95 |
| EG001 | Placebo | Biological: Placebo physiological saline | 0 | 102 | 2 | 102 | 17 | 102 |
|
| Hyperkalemia | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment | Placebo recipient 03019 developed potentially life-threatening hyperkalemia 3 days post-challenge and was considered unrelated to vaccination. |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Upper Respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sports injury | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
Not provided
| D007239 | Infections |
| % of Subjects with Fever Symptoms |
|
| % of Subjects with Unsolicited AEs |
|