CholeraPhase 4BoostNCT01579448
Evaluation of a Boosting Regimen With Oral Cholera Vaccine
A Phase 4 study testing Shanchol™, oral cholera vaccine and Shanchol™, killed, whole cell, bivalent, oral cholera vaccine in people with Cholera, run by Sachin Desai at 1 site in India.
Trial summary
Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholera
- What is being tested?
- Shanchol™, oral cholera vaccine and Shanchol™, killed, whole cell, bivalent, 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
- 426 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Jul 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy the following criteria at study entry:
- Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection.
- The subject should be able to continue in the study for the next 6 weeks
- The subject (or parent/guardian) should be willing to provide 3 blood samples
- 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:
Show all 9Show fewer
- Medical history
- Physical examination
- Clinical judgment of the investigator
Who cannot join
- individuals who are too weak to get out of bed to receive the vaccine
- pregnant women (identified through verbal screening)
- those less than 6 years of age
- Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol™ in India)
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: A Open Labeled Controlled Trial to Evaluate the Immune Response of a Boosting Regimen With Shanchol™, a Killed Whole Cell Oral Cholera Vaccine (WC-OCV), in Previously Immunized Adults and Children in Eastern Kolkata, India
Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial dose.
- Conditions
- Cholera
- Being tested
- Shanchol™, oral cholera vaccine, Shanchol™, killed, whole cell, bivalent, oral cholera vaccine, no intervention
- Keywords
- killed oral cholera vaccine, boosting vaccine regimen, safety and immunogenicity
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shanchol™, oral cholera vaccineBiological
This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient.
Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension.
Shanchol™, killed, whole cell, bivalent, oral cholera vaccineBiological
This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient.
Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension.
no interventionOther
No intervention will be given to this arm of past placebo recipients. To ensure that boosting was not due to natural exposure to Vibrio cholera, we will compare subjects in the boosting arm to this no intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine to past vaccinated participants | Experimental | The first arm includes subjects, who were immunized with two Shanchol™ doses, five years prior. In this study, arm one will receive one Shanchol™ booster dose at baseline and one booster dose on day fourteen. Receives: Biological: Shanchol™, oral cholera vaccine |
| Vaccine to past placebo recipients | Active comparator | The second arm includes subjects, who received two placebo doses, five years prior. Arm two will receive a primary immunization series consisting of one Shanchol™ dose at baseline and one at day fourteen Receives: Biological: Shanchol™, killed, whole cell, bivalent, oral cholera vaccine |
| No intervention to past placebo recipients | Placebo comparator | The third arm includes subjects, who received two placebo doses, five years prior. This third arm will not receive any intervention and will serve to represent a baseline immune response by vaccine naïve individuals exposed to natural exposure. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity provided by a two dose boosting regimen of Shanchol™
To determine whether two doses of Shanchol™ administered to a previously immunized cohort elicits similar immune responses (greater than fourfold rise in serum vibriocidal antibody titers through IgM) to those achieved by a primary immunization series in an unimmunized cohort stratified by age (6-14 and ≥15 years old),
Measured: 28 days
Secondary outcomes (3)
Immunogenicity provided by a one dose boosting regimen of Shanchol™
To determine if a one dose booster regimen of Shanchol™ administered to a previously immunized cohort can elicit similar immune responses (through serum IgM) to those achieved by primary immunization in an unimmunized cohort stratified by age (6-14 and ≥15 years old)
Measured: 28 days
Rises in serum IgA and IgG following boosting regimens
Measure rises in serum IgA and IgG as an adjunct measure of immunogenic response to the Shanchol™ boosting regimens
Measured: 28 days
Proportion of subjects with adverse events
To confirm the safety of one and two dose boosting regimens Shanchol™ in healthy, non-pregnant subjects stratified by age within 28 days following dosing in each intervention group. Screening for number of adverse events (AEs)and severe adverse events (SAEs) will done on all study visits. Adverse events screened for include: diarrhea, fever, vomiting, abdominal pain, itching, rash, nausea, weakness, cough, vertigo, and dryness of mouth. SAEs are those which are incapacitating, preventing normal activities, including death and hospitalization.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sachin Desai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research
- Responsible party
- Sponsor-investigator, Sachin Desai, International Vaccine Institute
- Investigators
- Suman Kanungo, MBBS, Principal investigator, National Institute of Cholera and Enteric Diseases, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579448
- Sponsor's protocol ID
- CR-WC-11
- Acronym
- Boost
- Status last verified
- Sep 2013
- First submitted
- 11 Apr 2012
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open Labeled Controlled Trial to Evaluate the Immune Response of a Boosting Regimen With Shanchol™, a Killed Whole Cell Oral Cholera Vaccine (WC-OCV), in Previously Immunized Adults and Children in Eastern Kolkata, India
- ClinicalTrials.gov ID
- NCT01579448
- Acronym / sponsor ID
- Boost / CR-WC-11
- Conditions
- Cholera
- Keywords
- killed oral cholera vaccine, boosting vaccine regimen, safety and immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Sachin DesaiUniversity, hospital or other
- Collaborators
- National Institute of Cholera and Enteric Diseases, India, Indian Council of Medical Research
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 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.
Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine to past vaccinated participants | Experimental | Biological: Shanchol™, oral cholera vaccineThe first arm includes subjects, who were immunized with two Shanchol™ doses, five years prior. In this study, arm one will receive one Shanchol™ booster dose at baseline and one booster dose on day fourteen. |
| Vaccine to past placebo recipients | Active comparator | Biological: Shanchol™, killed, whole cell, bivalent, oral cholera vaccineThe second arm includes subjects, who received two placebo doses, five years prior. Arm two will receive a primary immunization series consisting of one Shanchol™ dose at baseline and one at day fourteen |
| No intervention to past placebo recipients | Placebo comparator | Other: no interventionThe third arm includes subjects, who received two placebo doses, five years prior. This third arm will not receive any intervention and will serve to represent a baseline immune response by vaccine naïve individuals exposed to natural exposure. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy the following criteria at study entry:
- Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection.
- 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 (4 listed)
- individuals who are too weak to get out of bed to receive the vaccine
- pregnant women (identified through verbal screening)
- those less than 6 years of age
- Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol™ in India)
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 |
|---|---|---|
| Shanchol™, oral cholera vaccineThis killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient. Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension. | Biological | Vaccine to past vaccinated participants |
| Shanchol™, killed, whole cell, bivalent, oral cholera vaccineThis killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient. Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension. | Biological | Vaccine to past placebo recipients |
| no interventionNo intervention will be given to this arm of past placebo recipients. To ensure that boosting was not due to natural exposure to Vibrio cholera, we will compare subjects in the boosting arm to this no intervention arm. | Other | No intervention to past placebo recipients |
Primary outcome
Immunogenicity provided by a two dose boosting regimen of Shanchol™
Time frame: 28 days
To determine whether two doses of Shanchol™ administered to a previously immunized cohort elicits similar immune responses (greater than fourfold rise in serum vibriocidal antibody titers through IgM) to those achieved by a primary immunization series in an unimmunized cohort stratified by age (6-14 and ≥15 years old),
3 secondary outcomes
Immunogenicity provided by a one dose boosting regimen of Shanchol™
Time frame: 28 days
Rises in serum IgA and IgG following boosting regimens
Time frame: 28 days
Proportion of subjects with adverse events
Time frame: 42 days
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 25 Sep 2013.
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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.
Suman Kanungo, MBBS 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 4 study testing Shanchol™, oral cholera vaccine and Shanchol™, killed, whole cell, bivalent, oral cholera vaccine in people with Cholera, run by Sachin Desai 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 9 inclusion and 4 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 25 Sep 2013. 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 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?
Immunogenicity provided by a two dose boosting regimen of Shanchol™ (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2013.