CholeraPhase 3NCT02094586
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
A Phase 3 study testing PXVX0200 Lot A, PXVX0200 Lot B and PXVX0200 Lot C in people with Cholera, run by Bavarian Nordic at 25 sites in 2 countries.
Trial summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera
- What is being tested?
- PXVX0200 Lot A, PXVX0200 Lot B and PXVX0200 Lot C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,146 participants
- Where
- 25 sitesin 2 countries
- Study dates
- May 2014to Jun 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men or women,
- age 18 to 45 years inclusive;
- normal medical history and physical examination
- Women must have a negative pregnancy test.
Who cannot join
- travel to a cholera endemic area in the previous 5 years;
- abnormal stool pattern or regular use of laxatives;
- Currently active unstable or undiagnosed medical conditions
- current or recent antibiotic use;
- pregnancy or nursing;
- Previously received a licensed or investigational cholera vaccine
Show all 13Show fewer
- History of cholera or enterotoxigenic E. coli infection
- History of Guillain-Barré Syndrome
- Received or plans to receive any other licensed vaccines, except for seasonal influenza
- Recipient of bone marrow or solid organ transplant
- Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
- Use of systemic chemotherapy in the previous 5 years prior to the study
- any immunosuppressive medical condition
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States19 sites
Emory University
Atlanta, Georgia, 30322
Boston University
Boston, Massachusetts, 02218
Research Across America
Dallas, Texas, 75234
Avail Clinical Research
DeLand, Florida, 32720
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Clinical Research Consortium Las Vegas
Las Vegas, Nevada, 89119
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Central Kentucky Research
Lexington, Kentucky, 40509
University of Kentucky
Lexington, Kentucky, 40536
Miami Research Associates
Miami, Florida, 33143
Coastal Clinical Research
Mobile, Alabama, 36608
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464
Lion Research
Norman, Oklahoma, 73069
Clinical Reseach Consortium Arizona
Phoenix, Arizona, 85004
Rochester Clinical Research
Rochester, New York, 14609
Jean Brown Research
Salt Lake City, Utah, 84124
St. Louis University
St Louis, Missouri, 63104
Palm Beach Research
West Palm Beach, Florida, 33409
Heartland Research Associates
Wichita, Kansas, 67207
Australia6 sites
CMAX
Adelaide, South Australia, 5000
QIMR Berghofer Medical Research Institiue
Herston, Queensland, 4006
Emeritis Research
Malvern East, Victoria, 3145
Nucleus Network
Melbourne, Victoria, 3004
Linear Clinical Research
Nedlands, Western Australia, 6009
AUS Trials Pty Ltd
Sherwood, Queensland, 4035
About this study
Official title: Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Read the detailed description
The primary goal of this Phase III study is to compare three lots for consistency of manufacture.
- Conditions
- Cholera
- Being tested
- PXVX0200 Lot A, PXVX0200 Lot B, PXVX0200 Lot C, Placebo
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXVX0200 Lot ABiological
Lot P700-1CA03
PXVX0200 Lot BBiological
Lot P700-3CA03
PXVX0200 Lot CBiological
Lot P700-6BA03
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PXVX0200 Lot A | Experimental | PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension Receives: Biological: PXVX0200 Lot A |
| PXVX0200 Lot B | Experimental | PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension Receives: Biological: PXVX0200 Lot B |
| PXVX0200 Lot C | Experimental | PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension Receives: Biological: PXVX0200 Lot C |
| Placebo | Placebo comparator | Placebo physiological saline Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.
Measured: Day 11
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Measured: Day 11
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Measured: Day 11
Secondary outcomes (4)
SVA Seroconversion at Day 11
Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11
Measured: Day 11
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
Measured: Day 1 - 181
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable.
Measured: Day 1 - 181
Adverse Events
Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever \& vomiting were collected from Day 1 - 8.
Incidence and severity of unsolicited adverse events were collected till Day 29.
Measured: Day 1 - 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Responsible party
- Sponsor
- Investigators
- James McCarty, MD, Study director, Emergent Travel Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094586
- Sponsor's protocol ID
- PXVX-VC-200-004
- Status last verified
- Jun 2023
- First submitted
- 20 Mar 2014
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018 Feb 1;36(6):833-840. doi: 10.1016/j.vaccine.2017.12.062. Epub 2018 Jan 6.
PubMed 29317118
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
- ClinicalTrials.gov ID
- NCT02094586
- Acronym / sponsor ID
- PXVX-VC-200-004
- Conditions
- Cholera
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,146 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Posted 15 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Detailed description
The primary goal of this Phase III study is to compare three lots for consistency of manufacture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PXVX0200 Lot A | Experimental | Biological: PXVX0200 Lot APXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
| PXVX0200 Lot B | Experimental | Biological: PXVX0200 Lot BPXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
| PXVX0200 Lot C | Experimental | Biological: PXVX0200 Lot CPXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo physiological saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy men or women,
- age 18 to 45 years inclusive;
- normal medical history and physical examination
- Women must have a negative pregnancy test.
Key exclusion criteria (13 listed)
- travel to a cholera endemic area in the previous 5 years;
- abnormal stool pattern or regular use of laxatives;
- Currently active unstable or undiagnosed medical conditions
- current or recent antibiotic use;
- pregnancy or nursing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PXVX0200 Lot ALot P700-1CA03 | Biological | PXVX0200 Lot A |
| PXVX0200 Lot BLot P700-3CA03 | Biological | PXVX0200 Lot B |
| PXVX0200 Lot CLot P700-6BA03 | Biological | PXVX0200 Lot C |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
Time frame: Day 11
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
Time frame: Day 11
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
Time frame: Day 11
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
4 secondary outcomes
SVA Seroconversion at Day 11
Time frame: Day 11
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
Time frame: Day 1 - 181
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
Time frame: Day 1 - 181
Adverse Events
Time frame: Day 1 - 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29317118McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018 Feb 1;36(6):833-840. doi: 10.1016/j.vaccine.2017.12.062. Epub 2018 Jan 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James McCarty, MD study director
Emergent Travel Health Inc.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PXVX0200 Lot A, PXVX0200 Lot B and PXVX0200 Lot C in people with Cholera, run by Bavarian Nordic at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B (time frame: Day 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.