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| Name | Class |
|---|---|
| National Institute of Cholera and Enteric Diseases, India | OTHER |
| Indian Council of Medical Research | OTHER_GOV |
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Data demonstrates that Shancholâ„¢ (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 Shancholâ„¢ given five years after the initial dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine to past vaccinated participants | Experimental | The first arm includes subjects, who were immunized with two Shancholâ„¢ doses, five years prior. In this study, arm one will receive one Shancholâ„¢ booster dose at baseline and one booster dose on day fourteen. |
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| 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 Shancholâ„¢ dose at baseline and one at day fourteen |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shancholâ„¢, oral cholera vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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), | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days |
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Inclusion Criteria:
All subjects must be presently enrolled in the Phase 3 NICED RCT of Shancholâ„¢ 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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suman Kanungo, MBBS | National Institute of Cholera and Enteric Diseases, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cholera and Enteric Diseases | Kolkata | West Bengal | India |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000588783 | shanchol |
| D022121 | Cholera Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Shancholâ„¢, killed, whole cell, bivalent, oral cholera vaccine | Biological | 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 intervention | Other | 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. |
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| 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 Shancholâ„¢ boosting regimens | 28 days |
| Proportion of subjects with adverse events | To confirm the safety of one and two dose boosting regimens Shancholâ„¢ 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. | 42 days |
| D007239 | Infections |