None listed
Conditions
Interventions
Intervention1: Modified killed whole cell oral cholera vaccine(Shancol): 2 doses of 1.5 ml each 2 weeks apart.
It is an open labelled study. Arm 1 comprises of subjects who have received prior vaccin
in each arm there will be 194 subjects, stratified by two age groups (6-14 yrs and more than /equal to 15 yrs). There is a third arm comprising of 38 subjects, again age stratified, who has received p
they will not receive any vaccination, they will serve as a control arm for the first arm to differentiate the vibriocidal titre rise due to vaccination and natural infection.
Control Intervention1: N
they will not receive any vaccination, they will serve as a control arm for the first arm to differentiate the vibriocidal titre rise due to vaccination and natural infection.
Control Intervention2: y
Sponsors
International Vaccine Institute
Eligibility
Inclusion criteria
Inclusion criteria: All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol• and satisfy the following criteria at study entry: 1.Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection. a. The subject should be able to continue in the study for the next 6 weeks b. The subject (or parent/guardian) should be willing to provide 3 blood samples 2.Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 â?? 17 years. 3.Healthy subjects as determined by: a. Medical history b. Physical examination c. Clinical judgment of the investigator
Exclusion criteria
Exclusion criteria: 1. Individuals who are too weak to get out of bed to receive the vaccine; 2.Pregnant women (identified through verbal screening); 3.Those less than 6 years of age; and 4.Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol•India)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of subjects stratified by age (6-14 and â?¥15 years old) with greater than fourfold rise in serum vibriocidal antibody titers compared between subjects receiving a two dose boost, Shancholâ?¢ regimen (previously immunized) and a two dose primary series (previously unimmunized). Timepoint: 1.The four fold rise would be determined by titres measured at baseline and 14 days after the second dose booster compared with baseline and 14 days after completion of the primary series stratified by age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of subjects stratified by age with greater than fourfold rise in serum vibriocidal titers compared between subjects receiving a one dose boosting Shancholâ?¢ regimen and a primary series previously unimmunized. 2.Proportion of subjects stratified by age given a single or two booster doses with any reported serious adverse events throughout the trial 3.To confirm the safety of one and two dose boosting regimens Shancholâ?¢ in healthy, non-pregnant subjects stratified by age.Timepoint: 1/The four fold rise would be determined by titres measured at baseline and 14 days after the single dose booster compared with baseline and 14 days after completion of the primary series.2/For safety:a/All participants will be observed for 30 minutes after receiving the agent, and will be visited by CHWs to assess for any adverse events 3 days following each dose. b/To confirm the safety of one and two dose boosting regimens Shancholâ?¢ stratified by age within 28 days following dosing. | — |
Countries
India
Contacts
Public ContactSuman Kanungo
National institute of cholera and enteric disease(NICED)
Outcome results
None listed