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Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Cholera Vaccine-Simplified

A Phase III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Cholera Vaccine-Simplified Compared to ShancholTM in 1 to 40 years old Healthy Nepalese Participants                               

Protocol Number:

OCV-S

Sponsor:

International Vaccine Institute

SNU Research Park, 1 Gwanak-ro, 

Gwanak-gu, Seoul, 08826 

Republic of Korea

Co-sponsor 

Funding Agency: 

 

 

 

EuBiologics Co., Ltd. 

8F, 207 Dosan-Daero, Gangnam-gu, Seoul, 06026Republic of Korea

Bill and Melinda Gates Foundation

Seattle, WA, USA

This is a multicenter, randomized, observer-blinded, controlled study to evaluate immune non-inferiority and safety of OCV-S compared to Shanchol™ in 1 to 40 years old healthy Nepalese participants with the study period of 13 months duration. The sites involved are Kanti Children’s Hospital, Kathmandu, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, B. P. Koirala Institute of Health Sciences, Dharan and Nepalgunj Medical College, Nepalgunj with the objective of:

Primary objectives:

1.      To demonstrate non-inferiority of OCV-S compared to Shanchol™ as measured by seroconversion rates of anti-V. cholerae O1 Inaba and anti-V. cholerae O1 Ogawa vibriocidal titer 2 weeks after second dose for all ages (i.e., one lot of OCV-S)

2.      Assess and compare safety profile in all age strata combined and describe the safety profile in each age stratum 7 days and 28 days after each dose

 

     Secondary objectives:

 

1.      To demonstrate non-inferiority of OCV-S compared to Shanchol™ as measured by GMT of vibriocidal titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa 2 weeks after second dose (i.e., one lot of OCV-S) for all ages

2.      To demonstrate non-inferiority of OCV-S compared to Shanchol™ as measured by seroconversion rates of vibriocidal titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa 2 weeks after second dose (i.e., one lot of OCV-S) in each age stratum

3.      To demonstrate non-inferiority of OCV-S compared to Shanchol™ as measured by GMT of vibriocidal titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa at 2 weeks after second dose (i.e., one lot of OCV-S) in each age stratum 

4.    To demonstrate the equivalence of immunogenicity as measured by GMT of vibriocidal titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa of 3 lots of OCV-S 2 weeks after second dose in adults

 

Test Vaccine- OCV-S

Oral cholera vaccine with formalin inactivated Vibrio cholerae O1 Inaba Phil 6973, EI Tor and O1 Ogawa Cairo 50, Classical biotypes, manufactured by EuBiologics Co., Ltd. in Republic of Korea.

 

Active Control Vaccine

Locally available Shanchol™ manufactured by Shantha Biotechnics Limited.

Getting Informed Assent Consent
Visit 5 follow up

Figure 1. Schedule of Events

·         5 site visits include screening visit, 2 doses of vaccinations and 3 blood samples for immune non-inferiority and lot-to-lot consistency, and safety follow up.

·         3 safety follow-ups via home visit or phone call.

Visit Number V1 V2 Hv/PC* V3 HV/PC* V4 HV/PC* V5 Unschedulded
Visit Day
-7 to 0
0
7†
14
21††
28†††
42††††
182†††††
Visit``````````
Visit Week
-1 to 0
0
1
2
3
4
6
26
Visit window (Days)
NA
NA
±1
+3
±1
±3
±1
±5
Screening
X
Informed Consent/Assent
X
Subject eligibility assessment
X
X
Demographic information
X
Height / Weight
X
Medical history
X
X
X
X
Prior/Concomitant Medication
X
X
X
X
X
X
X
X
X
Physical Examination
X
X
X
X
Vital Signs
X
X
X
X
Urinary Pregnancy Test**
X
X
X
Pregnancy Prevention Counseling
X
Enrollment and Randomization
X
X
Blood Samples
X
X
X
Vaccine Administration
X
X
Diary Card distribution***
X
X
X
X
X
X
X
Diary Card collection***
X
X
X
X
X
X
X
Solicited Adverse Events
X
X
Unsolicited Adverse Events
X
X
X
X
X
X
X
Study Completion Form
X
SAE/Pregnancy Reporting
To be reported at any time throughout the study period

* Home visits/Phone calls 
† 7 days post 1st dose vaccination
†† 7 days post 2nd dose vaccination
††† 28 days post 1st dose vaccination
†††† 28 days post 2nd dose vaccination
††††† 6 months post 2nd dose vaccination

*** Pregnancy test will be performed to all female participants of childbearing age. 
*** When a diary card is collected, a new diary card will be distributed. If the safety follow-up is performed via phone calls or applications, a diary card collection/new diary card distribution can be skipped and deferred to next site visit.

Project status:

Target Enrolment: 633 Subjects 

First enrolment: 08 OCT 2021

Enrolment completion: 17 Jan 2022

Current Status: Follow up Visit 5 from l0 Apr 2022 

 

Team Members:

OCV-S project has 19 team members.