Vibrio CholeraePhase 4NCT01524640
Bridging Study for Killed Oral Cholera Vaccine in Ethiopia
A Phase 4 study testing Killed Bivalent (O1 and O139) whole cell oral cholera vaccine in people with Vibrio Cholerae and Cholera, run by International Vaccine Institute at 1 site in Ethiopia.
Trial summary
This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Vibrio Cholerae, Cholera
- What is being tested?
- Killed Bivalent (O1 and O139) whole cell oral cholera vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteEthiopia
- Study dates
- Dec 2012to Aug 2013
- Phase
- Phase 4
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection.
- The subject should be able to continue in the study for the next 4 weeks
- The subject (or parent/guardian) should be willing to provide 3 blood samples
- For females of reproductive age, non-pregnant (as determined by urine pregnancy test).
- Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
- Healthy subjects as determined by:
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- Medical history
- Physical examination
- Clinical judgment of the investigator
Who cannot join
- Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
- Ongoing acute illness.
- For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
- Immunocompromising condition or on chronic systemic steroid therapy
- Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
- Intake of any anti-diarrhea medicine in the past week
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- Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours
- Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject
- Previous hypersensitivity to formaldehyde.
- Receipt of immunoglobulin or any blood product during the past 3 months
- Receipt of oral cholera vaccine in the past three years
- Any potential subject currently participating or who will participate within the next six months in another clinical trial
- Positive screening urine pregnancy test for females greater than 12 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Controlled Trial to Evaluate the Safety and Immunogenicity of Killed Bivalent (o1 and o139) Whole-cell Based Oral Cholera Vaccine (Shanchol®) in Healthy Individuals in Ethiopia
This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.
Read the detailed description
This study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose regimen of the WC-OCV (Shanchol®) in Ethiopian population. In order to assess whether the bivalent killed oral cholera vaccine may be used safely among those who are most at risk for cholera, we need to determine the safety and immunogenicity of the killed oral cholera vaccine. The vaccine was evaluated in a large number of human subjects in India Vietnam, and Bangladesh, in which it has demonstrated safety, immunogenicity, and clinical protective efficacy. Though we do not expect the vaccine to act differently in the Ethiopian population, we aim to confirm our presumptive understanding that two doses of WC-OCV is safe and immunogenic in healthy volunteers at one year and above (exclusive of pregnant women). Findings from this study can pave the way for the possible use of the killed whole cell oral cholera vaccine in both endemic and outbreak settings at a larger scale.
- Conditions
- Vibrio Cholerae, Cholera
- Being tested
- Killed Bivalent (O1 and O139) whole cell oral cholera vaccine, Placebo
- Keywords
- oral cholera vaccine, safety and immunogenicity, bridging study, ethiopia
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Killed Bivalent (O1 and O139) whole cell oral cholera vaccineBiological
Also called Shanchol TM
1.5 ml single dose oral administration on day 0 and day 14
PlaceboBiological
Also called Non biologic placebo
1.5 ml oral administration on day 0 and day 14
| Study group | Role | What they receive |
|---|---|---|
| Killed oral cholera vaccine | Experimental | Killed Bivalent (O1 and O139) Whole cell oral cholera vaccine (Shanchol TM) Vaccine strain Reformulated version
V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) of lipopolysaccharide (LPS) V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS Receives: Biological: Killed Bivalent (O1 and O139) whole cell oral cholera vaccine |
| Placebo | Placebo comparator | Non biologic placebo
Ingredients Per 1.5 ml dose
1. Starch 60mg
2. Red color[1mg/ml] 10 µl
3. Yellow color [1mg/ml] 5 µl
4. Xanthum Gum (1% solution) 300 µl
5. Water for Injection Upto 1.5 ml
All the above ingredients are of pharmaceutical grade.
Non-biological placebo of above composition has been used in 2010 for "Randomized, double-blind, placebo controlled trial to evaluate the safety and immunogenicity of orally administered, killed, bivalent whole-cell , cholera vaccine, Shanchol in Bangladeshi Adults and Children". This study involving 330 subjects was carried out at International Center for Diarrheal Disease Research Bangladesh (ICDDR,B) located in Dhaka, Bangladesh with Dr. Firdausi Qadri as Principal Investigator (NCT01042951). There were no safety concerns associated with this placebo in this study and the report of this study has been submitted to the National Regulators in Bangladesh and the World Health Organization. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects given investigational product with adverse events.
- Immediate reactions within 30 minutes after each dose
- Serious Adverse Events occurring 14 days following each dose
- Reactogenicity: Headache, vomiting, nausea, abdominal pain/cramps, diarrhea, fever, loss of appetite within three days
- Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period. ii. Fever is defined as having an oral or axillary temperature of ≥ 38oC
Measured: 6 months
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.
Measured: 6 months
Secondary outcomes (3)
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.
Measured: 6 months
Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.
Measured: 6 months
Severe adverse event within 28 days following each dose of investigational product.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionAug 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 Vibrio CholeraeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, Ministry of Health, Ethiopia, Shantha Biotechnics Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524640
- Sponsor's protocol ID
- CR-WC-09
- Status last verified
- May 2015
- First submitted
- 31 Jan 2012
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Desai SN, Akalu Z, Teshome S, Teferi M, Yamuah L, Kim DR, Yang JS, Hussein J, Park JY, Jang MS, Mesganaw C, Taye H, Beyene D, Bedru A, Singh AP, Wierzba TF, Aseffa A. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. Am J Trop Med Hyg. 2015 Sep;93(3):527-533. doi: 10.4269/ajtmh.14-0683. Epub 2015 Jun 15.
PubMed 26078323
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Trial to Evaluate the Safety and Immunogenicity of Killed Bivalent (o1 and o139) Whole-cell Based Oral Cholera Vaccine (Shanchol®) in Healthy Individuals in Ethiopia
- ClinicalTrials.gov ID
- NCT01524640
- Acronym / sponsor ID
- CR-WC-09
- Conditions
- Vibrio Cholerae, Cholera
- Keywords
- oral cholera vaccine, safety and immunogenicity, bridging study, ethiopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, Ministry of Health, Ethiopia, Shantha Biotechnics Limited
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Feb 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.
This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.
Detailed description
This study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose regimen of the WC-OCV (Shanchol®) in Ethiopian population. In order to assess whether the bivalent killed oral cholera vaccine may be used safely among those who are most at risk for cholera, we need to determine the safety and immunogenicity of the killed oral cholera vaccine. The vaccine was evaluated in a large number of human subjects in India Vietnam, and Bangladesh, in which it has demonstrated safety, immunogenicity, and clinical protective efficacy. Though we do not expect the vaccine to act differently in the Ethiopian population, we aim to confirm our presumptive understanding that two doses of WC-OCV is safe and immunogenic in healthy volunteers at one year and above (exclusive of pregnant women). Findings from this study can pave the way for the possible use of the killed whole cell oral cholera vaccine in both endemic and outbreak settings at a larger scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Killed oral cholera vaccine | Experimental | Biological: Killed Bivalent (O1 and O139) whole cell oral cholera vaccineKilled Bivalent (O1 and O139) Whole cell oral cholera vaccine (Shanchol TM) Vaccine strain Reformulated version V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) of lipopolysaccharide (LPS) V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS |
| Placebo | Placebo comparator | Biological: PlaceboNon biologic placebo Ingredients Per 1.5 ml dose 1. Starch 60mg 2. Red color[1mg/ml] 10 µl 3. Yellow color [1mg/ml] 5 µl 4. Xanthum Gum (1% solution) 300 µl 5. Water for Injection Upto 1.5 ml All the above ingredients are of pharmaceutical grade. Non-biological placebo of above composition has been used in 2010 for "Randomized, double-blind, placebo controlled trial to evaluate the safety and immunogenicity of orally administered, killed, bivalent whole-cell , cholera vaccine, Shanchol in Bangladeshi Adults and Children". This study involving 330 subjects was carried out at International Center for Diarrheal Disease Research Bangladesh (ICDDR,B) located in Dhaka, Bangladesh with Dr. Firdausi Qadri as Principal Investigator (NCT01042951). There were no safety concerns associated with this placebo in this study and the report of this study has been submitted to the National Regulators in Bangladesh and the World Health Organization. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection.
- For females of reproductive age, non-pregnant (as determined by urine pregnancy test).
- Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
- Healthy subjects as determined by:
Key exclusion criteria (13 listed)
- Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
- Ongoing acute illness.
- For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
- Immunocompromising condition or on chronic systemic steroid therapy
- Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
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 |
|---|---|---|
| Killed Bivalent (O1 and O139) whole cell oral cholera vaccineAlso: Shanchol TM1.5 ml single dose oral administration on day 0 and day 14 | Biological | Killed oral cholera vaccine |
| PlaceboAlso: Non biologic placebo1.5 ml oral administration on day 0 and day 14 | Biological | Placebo |
Primary outcome
Proportion of subjects given investigational product with adverse events.
Time frame: 6 months
1. Immediate reactions within 30 minutes after each dose 2. Serious Adverse Events occurring 14 days following each dose 3. Reactogenicity: Headache, vomiting, nausea, abdominal pain/cramps, diarrhea, fever, loss of appetite within three days i. Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period. ii. Fever is defined as having an oral or axillary temperature of ≥ 38oC
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after second dose.
Time frame: 6 months
3 secondary outcomes
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after the first dose.
Time frame: 6 months
Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the investigational product.
Time frame: 6 months
Severe adverse event within 28 days following each dose of investigational product.
Time frame: 6 months
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 4 May 2015.
- Derived from this study: PubMed 26078323Desai SN, Akalu Z, Teshome S, Teferi M, Yamuah L, Kim DR, Yang JS, Hussein J, Park JY, Jang MS, Mesganaw C, Taye H, Beyene D, Bedru A, Singh AP, Wierzba TF, Aseffa A. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. Am J Trop Med Hyg. 2015 Sep;93(3):527-533. doi: 10.4269/ajtmh.14-0683. Epub 2015 Jun 15.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Killed Bivalent (O1 and O139) whole cell oral cholera vaccine in people with Vibrio Cholerae and Cholera, run by International Vaccine Institute at 1 site in Ethiopia.
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 9 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 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of subjects given investigational product with adverse events. (time frame: 6 months). 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 NCT01524640, 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 4 May 2015.