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CTRI Number  CTRI/2023/01/049320 [Registered on: 31/01/2023] Trial Registered Prospectively
Last Modified On: 17/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Hillchol Phase III Safety study 
Scientific Title of Study   A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the non-inferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine Shancholâ„¢ along with lot-to-lot consistency of Hillchol® (BBV131). 
Trial Acronym  BBIL/BBV-Hillchol®(BBV131 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/BBV-Hillchol®(BBV131)/2021Addendum01dated 12.01.2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVKrishna Mohan 
Designation  Executive Director 
Affiliation  Bharat Biotech international limited 
Address  Genome Valley Turkapally Shamirpet Hyderabad
Genome Valley Turkapally Shamirpet Hyderabad
Hyderabad
TELANGANA
500078
India 
Phone    
Fax    
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Scientific Query  
Name  DrVKrishna Mohan 
Designation  Executive Director 
Affiliation  Bharat Biotech international limited 
Address  Genome Valley Turkapally Shamirpet Hyderabad
Genome Valley Turkapally Shamirpet Hyderabad
Hyderabad
TELANGANA
500078
India 
Phone    
Fax    
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Public Query  
Name  DrVKrishna Mohan 
Designation  Executive Director 
Affiliation  Bharat Biotech international limited 
Address  Genome Valley Turkapally Shamirpet Hyderabad
Genome Valley Turkapally Shamirpet Hyderabad
Hyderabad
TELANGANA
500078
India 
Phone    
Fax    
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Limited 
 
Primary Sponsor  
Name  Bharat Biotech international limited 
Address  Genome Valley, Turkapally, Shamirpet, Hyderabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrChandramani Singh  All india institute of Medical sciences Patna  Dept.of community &Family Medicine AIIMS ,PATNA,1st floor ,room 105,Bihar-801507
Patna
BIHAR 		 9931733280

cmaiims57@gmail.com 
Dr Raghu Raj Singh  Dr Raghu Raj Singh  New Leelamani Hospital Pvt Ltd 14/116,C-1,Parade Chauraha Civil Lines, Kanpur, UP-208001
Kanpur Nagar
UTTAR PRADESH 		 9555989176

drraghurajsingh156@gmail.com 
DrGirish pCharde  Gillurkar Multispeciality Hospital  Gillurkar Multispeciality Hospital R-20,1st floor room no.103,reshimbag,umred road,Nagpur,Maharashtra,India-440024
Nagpur
MAHARASHTRA 		 9823606363

girishdr123@gmail.com 
DrEVenkata Rao  Institude of Medical sciences & Sum Hospital  Institude of Medical sciences & Sum Hospital 2nd floor,room no.205,K8,Kalinga nagar,Ghatikia,Bhubaneshwar-751003,Odisha
Khordha
ORISSA 		 7853889552

e.venkata.rao@gmail.com 
DrAbhishek T Chavan  Jeevan Rekha Hospital  Jeevan rekha Hospital,2nd floor room no:203,near Nagshanti motors showroom,veer chambers,opp.civil Hospital raod,Belagavi-590002
Belgaum
KARNATAKA 		 9113222185

dr.abhishektchavan@gmail.com 
DrSNarayana Rao  King George Hospital  King George Hospital 4th floor room no.401,Maharanipeta,Vizag-530002,Andhra pradesh,India
Visakhapatnam
ANDHRA PRADESH 		 7799348777

narayanarao.kghamc@gmail.com 
DrMettu pradeep Reddy  Malla reddy Narayana Multispeciality Hospital  Malla reddy Narayana Multispeciality Hospital Suraram X-roads,Jeedimetla,3rd floor room no.304,Hyderabad-500055
Hyderabad
TELANGANA 		 8897242789

mettupradeepreddy@gmail.com 
DrSavita verma  Post Graduate Institute of Medical Sciences  Post Graduate Institute of Medical Sciences 3rd floor room no:305,Rohtak,Haryana,india-124001
Rohtak
HARYANA 		 9812283746

verma.savi@gmail.com 
DrArun Kumar  Rajarajeswari Medical College and Hospital  Rajarajeswari Medical College and Hospital 2nd floor,room no.202,kambipura,Mysore road,Bangalore-560074
Bangalore
KARNATAKA 		 8904111627

arunpatil2001@gmail.com 
Dr Vishal Tripathi  Rana hospital Pvt Ltd  3rd Floor, Room no 301 Rail Vihar Medical College Road Chargawa Gorakhpur 273001
Gorakhpur
UTTAR PRADESH 		 8700304154

dr.vishaltripathi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee Jeevan Rekha Hospital, Belgaum  Approved 
Gillurkar Hospital Ethics Committee  Approved 
Institutional Ethics Committe King George Hospital, Vizag  Approved 
Institutional Ethics Committe Malla Redy Medical College for Women  Approved 
Institutional Ethics Committe PGIMS/UHS, Rothak  Approved 
Institutional Ethics Committe raja Rajeswari Medical College and Hospital, bangalore  Approved 
Institutional Ethics Committee All India Institute of Medical Sciences Patna  Approved 
Institutional Ethics Committee, IMS and SUM Hospital, Odisha  Submittted/Under Review 
Institutional Ethics Committee-Leelamani Hospital, Kanpur  Approved 
Institutional Ethics Committee-Rana Hospital, Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cholera 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HillChol® (BBV131)   V. Cholerae (O1 EI Tor Hikojima Serotype recombinant strain) formaldehyde Inactivated Whole Cell administerd as 1.5ml on ay 0 and day 14 by oral 
Comparator Agent  Not applicable  Not Applicable 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Participants /Legally acceptable representatives who have the ability to
provide written informed consent.
2. Participants of either gender of age . 1 year.
3. Expressed interest and availability to fulfill the study requirements.
a. Willing to receive two doses of the vaccine at the specific study site. 
 
ExclusionCriteria 
Details  1. Any history of anaphylaxis in relation to vaccination.
2. Participants with Immune function disorders including
immunodeficiency diseases, or taking immunosuppressive/cytotoxic
agents.
3. An individual is thought to have difficulty participating in the study due
to severe chronic diseases, based on the judgment of the investigator.
4. Participants with 38℃ or higher body temperature measured within 24
hours or at the time of investigational product dosing.
5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours
before study initiation
6. Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat
diarrhea within 1 week before study initiation.
7. Other vaccination within 4 weeks before study initiation.
8. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months
before study initiation.
9. Participation in another clinical trial.
10. History of cholera vaccinations or history of cholera diarrhea.
11. Pregnancy, lactation or willingness/intention to become pregnant during
the study.
12. History of cancer (except basal cell carcinoma of the skin and cervical
carcinoma in situ).
13. History of any psychiatric condition likely to affect participation in the
study.
14. Suspected or known current alcohol abuse is defined by an alcohol
intake of greater than 42 units every week.
15. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the study or
would render the subject unable to comply with the protocol. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the frequency and
severity of all solicited and
unsolicited adverse events after administration of two doses of
Hillchol® (BBV131) among all three age groups. 		 Day 0 and 14 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="1800"
Sample Size from India="1800" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1800" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   06/02/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In this study, a total sample size of 1800 participants will be enrolled in three age groups and administered with Hillchol® (BBV131).

Group-I (Age: ≥18): In this group, a total of 600 participants aged ≥18 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14.

Group-II (Age: ≥5 to <18): In this group, a total of 600 participants aged ≥5 to <18 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14.

Group-III (Age: ≥1 to <5): In this group, a total of 600 participants aged ≥1 to <5 will be enrolled and administered two doses of Hillchol® (BBV131) on day 0 and 14. 
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