CholeraPhase 1NCT01585181
Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200
A Phase 1 study testing PXVX0200 in people with Cholera, run by Bavarian Nordic at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera
- What is being tested?
- PXVX0200
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Jan 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Men or women, age 18 to 50 years (inclusive) without significant medical history, physical or clinical lab abnormalities (as per protocol defined ranges)
- Women of childbearing potential must have negative urine pregnancy test and must be willing to use adequate birth control for 2 months following vaccination and have additional pregnancy tests as indicated
- Vaccinees must live alone or have no more than two household contacts willing to sign informed consent and participate in the study
- Household contacts must be healthy (based on medical history) men or women aged 18-65 years (inclusive)
Who cannot join
- Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have unstable medical condition or are under the age of 18
- Childcare workers who have direct contact with children who are 2 years of age or younger or those employed in the food service industry
- Resides with HHCs who are under the age of 18 or over the age of 65
- Has abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months
- Has known allergy to, or known medical condition that precludes the use of both tetracycline or ciprofloxacin
- Previously received a licensed or investigational cholera vaccine
Show all 10Show fewer
- Has history of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge)
- Travel to a cholera-endemic area and experienced symptoms consistent with traveler's diarrhea in the previous 5 years
- Received or plans to receive any other licensed vaccines from 14 days prior to the study vaccination until Day 28
- Received or plans to receive antibiotics (other than protocol-specified) or chloroquine within 14 days prior to the study vaccination through to Day 28
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
University of Kentucky
Lexington, Kentucky, 40536-0084
About this study
Official title: A Phase 1 Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the LIve Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae Serotype 01 Inaba CVD 103-HgR Vaccine Strain
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.
Read the detailed description
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.
- Conditions
- Cholera
- Being tested
- PXVX0200, Placebo
- Keywords
- Vaccine, Bacterial disease condition, Cholera
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXVX0200Biological
Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
PlaceboBiological
Approx 2 grams of lactose reconstituted in water
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| PXVX0200 | Experimental | Not described Receives: Biological: PXVX0200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs
Measured: 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
Measured: Day 0-28
Secondary outcomes (4)
Kinetics
Kinetics of serum Inaba vibriocidal antibody after 1 oral dose of CVD 103-HgR
Measured: Day 0-28
Serum anti-cholera toxin (CT) IgG antibody conversion rates
Anti-cholera toxin IgG antibody conversion rates
Measured: Day 0-28
Fecal shedding
Fecal shedding of CVD 103-HgR by vaccine recipient
Measured: 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
Measured: Day 0-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585181
- Sponsor's protocol ID
- PXVX-VC-0200-002
- Status last verified
- Jun 2023
- First submitted
- 23 Apr 2012
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24173028
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the LIve Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae Serotype 01 Inaba CVD 103-HgR Vaccine Strain
- ClinicalTrials.gov ID
- NCT01585181
- Acronym / sponsor ID
- PXVX-VC-0200-002
- Conditions
- Cholera
- Keywords
- Vaccine, Bacterial disease condition, Cholera
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo |
| PXVX0200 | Experimental | Biological: PXVX0200 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Men or women, age 18 to 50 years (inclusive) without significant medical history, physical or clinical lab abnormalities (as per protocol defined ranges)
- Women of childbearing potential must have negative urine pregnancy test and must be willing to use adequate birth control for 2 months following vaccination and have additional pregnancy tests as indicated
- Vaccinees must live alone or have no more than two household contacts willing to sign informed consent and participate in the study
- Household contacts must be healthy (based on medical history) men or women aged 18-65 years (inclusive)
Key exclusion criteria (10 listed)
- Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have unstable medical condition or are under the age of 18
- Childcare workers who have direct contact with children who are 2 years of age or younger or those employed in the food service industry
- Resides with HHCs who are under the age of 18 or over the age of 65
- Has abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months
- Has known allergy to, or known medical condition that precludes the use of both tetracycline or ciprofloxacin
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 |
|---|---|---|
| PXVX0200Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension | Biological | PXVX0200 |
| PlaceboApprox 2 grams of lactose reconstituted in water | Biological | Placebo |
Primary outcome
Safety
Time frame: Day 0-180
Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs
Immunogenicity
Time frame: Day 0-28
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
4 secondary outcomes
Kinetics
Time frame: Day 0-28
Serum anti-cholera toxin (CT) IgG antibody conversion rates
Time frame: Day 0-28
Fecal shedding
Time frame: Day 0-7
Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts
Time frame: Day 0-28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 24173028Chen 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.
- PubMed (results)Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PXVX0200 in people with Cholera, run by Bavarian Nordic at 2 sites in United States.
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 10 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 27 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 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: Day 0-180). The study lists 2 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 NCT01585181, 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 27 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.