CholeraPhase 2NCT00419133
Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine
A Phase 2 study testing Killed bivalent whole cell oral cholera vaccine in people with Cholera and Diarrhea, run by International Vaccine Institute at 1 site in India.
Trial summary
The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine. Read more about this study
- Who is it for?
- Ages 1 year to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera, Diarrhea, Vibrio Infections
- What is being tested?
- Killed bivalent whole cell oral cholera vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2007to Aug 2007
- 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 1 year to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years
- All subjects must satisfy the following criteria at study entry:
- Male or female adult residents aged 18-40 years or children aged 1- 17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection)
- For females of reproductive age, they must not be pregnant (as determined by verbal screening)
- Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.
- Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.
Who cannot join
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
- one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
- intake of any anti-diarrhoeal medicine in the past week
Show all 11Show fewer
- abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
- acute disease one week prior to enrollment, with or without fever. Temperature > or = 38 degrees C (oral) or axillary temperature > or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject
- receipt of antibiotics in past 14 days
- receipt of live or killed enteric vaccine in last month
- receipt of killed oral cholear vaccine
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, 700010
About this study
Official title: Immune Responses Following One Versus Two Doses of Killed Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India
The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.
Read the detailed description
Cholera is an important public health problem worldwide, particularly in endemic areas of the developing world. In 2004, 101 383 cholera cases and 2345 deaths were reported to the WHO. Provision of safe water and food, adequate sanitation and improved personal and community hygiene are the main public health interventions against cholera. These measures cannot be implemented in the near future in the most cholera-endemic areas.
Phase II trials of this reformulated killed oral cholera vaccine were performed in SonLa, Vietnam and Kolkata, India. Significant vibriocidal antibody responses were observed among vaccine recipients.
Distribution of 2 doses of the cholera vaccine is often difficult in field settings and limits its utility in emergency situations, since an interval of 2 weeks is usually required between doses. Recent data from Vietnam suggests that greater vibriocidal responses following 2 doses are elicited compared to previous formulations. Furthermore, in a study in Bangladesh comparing immune responses to the vaccine among children supplemented with vitamin A and zinc, seroconversion after the first dose was robust in all groups suggesting that one dose may be used in the control of cholera.
Data regarding the immune response following one dose of this reformulated vaccine is currently unavailable. If a single dose of this vaccine is confirmed to be immunogenic to recipients, then this vaccine may be used more extensively for public health purposes, especially during times of outbreaks.
The objective of this study is to confirm the safety of the killed oral cholera vaccine among adult and children volunteers.
- Conditions
- Cholera, Diarrhea, Vibrio Infections
- Being tested
- Killed bivalent whole cell oral cholera vaccine, Heat Killed E. coli Placebo
- Keywords
- Cholera, Vaccine, Kolkata, West Bengal, India, Immunogenicity, Safety
- Medical subject headings
- Cholera, Diarrhea, Vibrio Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Killed bivalent whole cell oral cholera vaccineBiological
Each 1.5 mL dose, given orally, contains:
- cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) 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
Heat Killed E. coli PlaceboBiological
Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cholera Vaccine Receives: Biological: Killed bivalent whole cell oral cholera vaccine |
| 2 | Placebo comparator | Placebo Receives: Biological: Heat Killed E. coli Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
Measured: 14 days after each dose of vaccine or placebo
Secondary outcomes (2)
Geometric mean serum vibriocidal titers compared to baseline
Measured: 14 days after each dose
Proportion of subjects with any of the following adverse events: immediate reactions within 30 minutes after each dose and up to 3 days after each dose and serious adverse events occurring throughout the trial.
Measured: after dosing: 30 minutes to 3 days for adverse events, 28 days for serious adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2007
- Study completionAug 2007
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
- 160 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, Shantha Biotechnics Limited
- Investigators
- Sujit K Bhattacharya, Principal investigator, National Institute of Cholera and Enteric Diseases, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419133
- Sponsor's protocol ID
- C-8IR
- Status last verified
- Dec 2009
- First submitted
- 4 Jan 2007
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.
PubMed 19761838
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses Following One Versus Two Doses of Killed Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India
- ClinicalTrials.gov ID
- NCT00419133
- Acronym / sponsor ID
- C-8IR
- Conditions
- Cholera, Diarrhea, Vibrio Infections
- Keywords
- Cholera, Vaccine, Kolkata, West Bengal, India, Immunogenicity, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- National Institute of Cholera and Enteric Diseases, India, Shantha Biotechnics Limited
- Study start
- Jun 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Jan 2007 (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 one and two doses of the killed oral cholera vaccine.
Detailed description
Cholera is an important public health problem worldwide, particularly in endemic areas of the developing world. In 2004, 101 383 cholera cases and 2345 deaths were reported to the WHO. Provision of safe water and food, adequate sanitation and improved personal and community hygiene are the main public health interventions against cholera. These measures cannot be implemented in the near future in the most cholera-endemic areas.
Phase II trials of this reformulated killed oral cholera vaccine were performed in SonLa, Vietnam and Kolkata, India. Significant vibriocidal antibody responses were observed among vaccine recipients.
Distribution of 2 doses of the cholera vaccine is often difficult in field settings and limits its utility in emergency situations, since an interval of 2 weeks is usually required between doses. Recent data from Vietnam suggests that greater vibriocidal responses following 2 doses are elicited compared to previous formulations. Furthermore, in a study in Bangladesh comparing immune responses to the vaccine among children supplemented with vitamin A and zinc, seroconversion after the first dose was robust in all groups suggesting that one dose may be used in the control of cholera.
Data regarding the immune response following one dose of this reformulated vaccine is currently unavailable. If a single dose of this vaccine is confirmed to be immunogenic to recipients, then this vaccine may be used more extensively for public health purposes, especially during times of outbreaks.
The objective of this study is to confirm the safety of the killed oral cholera vaccine among adult and children volunteers.
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 bivalent whole cell oral cholera vaccineCholera Vaccine |
| 2 | Placebo comparator | Biological: Heat Killed E. coli PlaceboPlacebo |
Who may qualify
- Ages
- 1 year to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years
- Male or female adult residents aged 18-40 years or children aged 1- 17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection)
- For females of reproductive age, they must not be pregnant (as determined by verbal screening)
- Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.
- Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.
Key exclusion criteria (11 listed)
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
- one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
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 whole cell oral cholera vaccineEach 1.5 mL dose, given orally, contains: V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) 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 | Biological | 1 |
| Heat Killed E. coli PlaceboHeat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose. | Biological | 2 |
Primary outcome
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
Time frame: 14 days after each dose of vaccine or placebo
2 secondary outcomes
Geometric mean serum vibriocidal titers compared to baseline
Time frame: 14 days after each dose
Proportion of subjects with any of the following adverse events: immediate reactions within 30 minutes after each dose and up to 3 days after each dose and serious adverse events occurring throughout the trial.
Time frame: after dosing: 30 minutes to 3 days for adverse events, 28 days for serious adverse events
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 7 Dec 2009.
- Results publication: PubMed 19761838Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.
Related trials for Cholera
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Not yet recruitingPhase 4
Study on Changes in Gut Microbiota, Inflammatory Factors, and Bowel Habits Following Oral Administration of Recombinant B-subunit/Whole Cell Cholera Vaccine in a Community Population
Bowel Habits, Gut Microbiomes
RecruitingPhase 1
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
Cholera Vaccination Reaction
RecruitingPhase 4
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination
Enrolling by invitationPhase 4
A Post-marketing Observational Study of Oral Cholera Vaccine
Diarrhea
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 Bhattacharya 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 bivalent whole cell oral cholera vaccine in people with Cholera and Diarrhea, 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 6 inclusion and 11 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 7 Dec 2009. 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?
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline (time frame: 14 days after each dose of vaccine or placebo). 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 NCT00419133, 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 7 Dec 2009.