CholeraPhase 2NCT00119197
Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
A Phase 2 study testing killed whole cell oral cholera vaccine and Heat Killed E. coli in people with Cholera, run by International Vaccine Institute at 1 site in India.
Trial summary
The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India. Read more about this study
- Who is it for?
- Ages 12 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera
- What is being tested?
- killed whole cell oral cholera vaccine and Heat Killed E. coli
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2005to Jul 2006
- Phase
- Phase 2
- 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 12 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years
Who cannot join
- Diarrhea during the past week
- Antibiotic and anti-diarrheal medicine use during the past week
- One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
- Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
- Pregnancy
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal
About this study
Official title: Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal
The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.
Read the detailed description
Cholera remains to be a serious public health problem worldwide. In the mid-1980s following technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for Vietnam's public health programs. A 2-dose regimen of this vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages over the existing Swedish vaccine. It confers protection against the El Tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. However, this vaccine is not licensed for use in countries other than Vietnam.
Through IVI, an agreement between VABIOTECH in Hanoi and Shantha Biotechnics PVT, LTD in India has been reached that will make the bivalent vaccine available in India. A double-blind randomized phase III trial in a cholera-endemic area would be necessary to demonstrate the efficacy of this vaccine in other settings. This would pave the way for the introduction of the vaccine into the national immunization programme in India and the internationalization of this vaccine and licensure in other countries where it is needed. Prior to the phase III trial, a phase II study will be performed among adults and children.
- Conditions
- Cholera
- Being tested
- killed whole cell oral cholera vaccine, Heat Killed E. coli
- Keywords
- watery diarrhea, cholera vaccine
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
killed whole cell oral cholera vaccineBiological
Bivalent oral killed cholera vaccine: each dose of this vaccine contains:
- Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells
- Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells
- Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells
- Inactivated V.Cholerae O139 - 50.109 cells each 1.5 mL dose given orally, two doses given 14 days apart
Heat Killed E. coliBiological
Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine.
Each 1.5 mL dose given orally, two doses given 14 days apart
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Killed Whole Cell Oral Cholera Vaccine Receives: Biological: killed whole cell oral cholera vaccine |
| 2 | Placebo comparator | Heat-killed E. coli Receives: Biological: Heat Killed E. coli |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Measured: immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days
Secondary outcomes (1)
serum vibriocidal antibody response
Measured: baseline and 14 days after second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2006
- Study completionJul 2006
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research, Shantha Biotechnics Limited
- Investigators
- Sujit K Bhatttacharya, MD, Principal investigator, National Institute of Cholera and Enteric Diseases, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119197
- Sponsor's protocol ID
- C-8-ph2
- Status last verified
- Jun 2008
- First submitted
- 4 Jul 2005
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.
PubMed 18523643
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal
- ClinicalTrials.gov ID
- NCT00119197
- Acronym / sponsor ID
- C-8-ph2
- Conditions
- Cholera
- Keywords
- watery diarrhea, cholera vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research, Shantha Biotechnics Limited
- Study start
- Aug 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 13 Jul 2005 (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 the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.
Detailed description
Cholera remains to be a serious public health problem worldwide. In the mid-1980s following technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for Vietnam's public health programs. A 2-dose regimen of this vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages over the existing Swedish vaccine. It confers protection against the El Tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. However, this vaccine is not licensed for use in countries other than Vietnam.
Through IVI, an agreement between VABIOTECH in Hanoi and Shantha Biotechnics PVT, LTD in India has been reached that will make the bivalent vaccine available in India. A double-blind randomized phase III trial in a cholera-endemic area would be necessary to demonstrate the efficacy of this vaccine in other settings. This would pave the way for the introduction of the vaccine into the national immunization programme in India and the internationalization of this vaccine and licensure in other countries where it is needed. Prior to the phase III trial, a phase II study will be performed among adults and children.
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 |
|---|---|---|
| 1 | Experimental | Biological: killed whole cell oral cholera vaccineKilled Whole Cell Oral Cholera Vaccine |
| 2 | Placebo comparator | Biological: Heat Killed E. coliHeat-killed E. coli |
Who may qualify
- Ages
- 12 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years
Key exclusion criteria (5 listed)
- Diarrhea during the past week
- Antibiotic and anti-diarrheal medicine use during the past week
- One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
- Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
- Pregnancy
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 whole cell oral cholera vaccineBivalent oral killed cholera vaccine: each dose of this vaccine contains: * Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells * Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells * Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells * Inactivated V.Cholerae O139 - 50.109 cells each 1.5 mL dose given orally, two doses given 14 days apart | Biological | 1 |
| Heat Killed E. coliEscherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine. Each 1.5 mL dose given orally, two doses given 14 days apart | Biological | 2 |
Primary outcome
adverse events
Time frame: immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days
1 secondary outcome
serum vibriocidal antibody response
Time frame: baseline and 14 days after second dose
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 Jul 2008.
- Background: PubMed 18523643Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.
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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.
Sujit K Bhatttacharya, MD principal investigator
National Institute of Cholera and Enteric Diseases, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing killed whole cell oral cholera vaccine and Heat Killed E. coli in people with Cholera, run by International Vaccine Institute at 1 site in India.
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 1 inclusion and 5 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 Jul 2008. 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 India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
adverse events (time frame: immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days). 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 NCT00119197, 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 Jul 2008.