A Phase 3 interventional study of PXVX0200 and placebo in Cholera, sponsored by Bavarian Nordic. Completed at 3 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Bavarian Nordic · Phase 3, Interventional, and Prevention
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
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 197 is below the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
Biological: PXVX0200
Biological: Placebo physiological saline
Biological: placebo
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8
% 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.
Time frame: 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.
Time frame: Ninety days after vaccination
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.
Time frame: Through 10 Days following challenge
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Following vaccination (Days 1 - 8) and to Day 29
| Milestone | PXVX0200 | Placebo |
|---|---|---|
| Started | 95 | 102 |
| Completed | 95 | 102 |
| Not completed | 0 | 0 |
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.
| percentage of participants | PXVX0200 | Placebo |
|---|---|---|
| % of Participants With Moderate to Severe Diarrhea | 5.7 | 59.1 |
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.
| percentage of participants | PXVX0200 | Placebo |
|---|---|---|
| % of Participants With Moderate to Severe Diarrhea | 12.1 | 59.1 |
Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge.
| mL | PXVX0200 | Placebo |
|---|---|---|
| Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge | 309 (154 to 18164) | 4524 (140 to 24374) |
Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge.
| mL | PXVX0200 | Placebo |
|---|---|---|
| Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge | 603 (22 to 9950) | 4524 (140 to 24374) |
Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge.
| % of participants | PXVX0200 | Placebo |
|---|---|---|
| % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge | 14.3 | 92.4 |
Incidence of mild or worse (any severity) diarrhea following the 90 day cholera challenge.
| % of participants | PXVX0200 | Placebo |
|---|---|---|
| % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge | 45.5 | 92.4 |
Incidence of mild or worse fever following the 10 day cholera challenge.
| % of participants | PXVX0200 | Placebo |
|---|---|---|
| % of Participants With Fever Following the 10 Day Cholera Challenge | 2.9 | 27.3 |
Incidence of mild or worse fever following the 90 day cholera challenge.
| % of participants | PXVX0200 | Placebo |
|---|---|---|
| % of Participants With Fever Following the 90 Day Cholera Challenge | 6.1 | 27.3 |
Number of days of fecal shedding of wild type V. cholerae following 10 Day Challenge.
| Days | PXVX0200 | Placebo |
|---|---|---|
| Number of Days With Fecal Shedding Following 10 Day Challenge | 0.0 (0.0 to 2.0) | 3.0 (3.0 to 4.0) |
Number of days of fecal shedding of wild type V. cholerae following 90 Day Challenge
| Days | PXVX0200 | Placebo |
|---|---|---|
| Number of Days With Fecal Shedding Following 90 Day Challenge | 2.0 (1.0 to 3.0) | 3.0 (3.0 to 4.0) |
Total number of days with a positive stool culture following the 10 Day Cholera challenge.
| Days | PVXV0200 | Placebo |
|---|---|---|
| # of Days With Positive Stool Culture Following 10 Day Cholera Challenge | 0.9 ± 1.20 | 3.3 ± 1.01 |
Total number of days with a positive stool culture following 90 Day Cholera Challenge
| Days | PVXV0200 | Placebo |
|---|---|---|
| # of Days With Positive Stool Culture Following 90 Day Cholera Challenge | 2.1 ± 1.41 | 3.3 ± 1.01 |
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).
| % of participants | PVXV0200 | Placebo |
|---|---|---|
| % of Subjects with Reactogenicity | 49.5 | 50.0 |
| % of Subjects with Diarrhea Symptoms | 1.1 | 3.0 |
| % of Subjects with Fever Symptoms | 2.2 | 1.0 |
| % of Subjects with Unsolicited AEs | 17.9 | 16.7 |
Collected over 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).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PVXV0200 | 0/95 (0%) | 0/95 (0%) | 17/95 (17.9%) |
| Placebo | 0/102 (0%) | 2/102 (2%) | 17/102 (16.7%) |
| Event | PVXV0200 | Placebo |
|---|---|---|
| HospitalizationSurgical and medical procedures | 0/95 | 1/102 |
| HyperkalemiaRenal and urinary disorders | 0/95 | 1/102 |
| Event | PVXV0200 | Placebo |
|---|---|---|
| FatigueGeneral disorders | 1/95 | 4/102 |
| Upper Respiratory tract infectionInfections and infestations | 3/95 | 2/102 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/95 | 3/102 |
| DiarrhoeaGastrointestinal disorders | 2/95 | 0/102 |
| FlatulenceGastrointestinal disorders | 2/95 | 1/102 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/95 | 2/102 |
| SneezingRespiratory, thoracic and mediastinal disorders | 0/95 | 2/102 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/95 | 2/102 |
| Eye painEye disorders | 1/95 | 0/102 |
| Abdominal painGastrointestinal disorders | 1/95 | 0/102 |
| Age, Categorical(Participants) | PXVX0200 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 95 | 102 | 197 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | PXVX0200 | Placebo | Total |
|---|---|---|---|
| Mean | 31.5 (18 to 45) | 30.6 (18 to 45) | 31.0 (18 to 45) |
| Sex: Female, Male(Participants) | PXVX0200 | Placebo | Total |
|---|---|---|---|
| Female | 27 | 46 | 73 |
| Male | 68 | 56 | 124 |
| Ethnicity (NIH/OMB)(Participants) | PXVX0200 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 4 | 9 |
| Not Hispanic or Latino | 89 | 97 | 186 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | PXVX0200 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 64 | 69 | 133 |
| White | 26 | 32 | 58 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | PXVX0200 | Placebo | Total |
|---|---|---|---|
| United States | 95 | 102 | 197 |
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