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To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131) (Hillchol131)

Primary Purpose

Cholera

Status
Recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Hillchol vaccine
Sponsored by
Bharat Biotech International Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholera

Eligibility Criteria

1 Year - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants /Legally acceptable representatives who have the ability to provide written informed consent. Participants of either gender of age > 1 year. Expressed interest and availability to fulfill the study requirements. Willing to receive two doses of the vaccine at the specific study site. Willing to be contacted on the phone to assess adverse events and for study reminders. Agrees not to participate in another clinical study at any time during the study period. Exclusion Criteria: Any history of anaphylaxis in relation to vaccination. Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents. An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator. Participants with 38℃ or higher body temperature measured within 24 hours or at the time of investigational product dosing. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation. Other vaccination within 4 weeks before study initiation. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation. Participation in another clinical trial. History of cholera vaccinations or history of cholera diarrhea. Pregnancy, lactation or willingness/intention to become pregnant during the study.

Sites / Locations

  • King George Hospital, Visakhapatnam
  • Rajarajeswari Medical College and Hospital
  • All India Institute of Medical Sciences, PatnaRecruiting
  • Pt BD Sharma,PGIMS/UHS. RohtakRecruiting
  • Jeevan Rekha Hospital, BelgaumRecruiting
  • Gillurkar Multispecialty HospitalRecruiting
  • Malla Reddy Narayana Multi Speciality Hospital
  • Rana Hospital Pvt LtdRecruiting
  • New Leelamani Hospital Pvt LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group-I (Age: ≥18)

Group-II (Age: ≥5 to <18)

Group-III (Age: ≥1 to <5)

Arm Description

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

Outcomes

Primary Outcome Measures

Immediate reaction
Adverse reactions after administration of each dose
solicited adverse events
Incidence, intensity, and the causality of all solicited adverse events during the 7-day follow up period after each dose.
unsolicited adverse events
Incidence, intensity, and the causality of unsolicited adverse events during the 7-day followup period after each dose.
Serious Adverse Events (SAEs)
Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2023
Last Updated
February 8, 2023
Sponsor
Bharat Biotech International Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05732766
Brief Title
To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)
Acronym
Hillchol131
Official Title
A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate Non-inferiority, Immunogenicity and Safety Cholera Vaccine Hillchol® (BBV131) to the Comparator Vaccine Shanchol™ and Hillchol® Lot Consistency
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2023 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bharat Biotech International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 Shanchol™ along with lot-to-lot consistency of Hillchol®(BBV131). Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to <18 and Group III: ≥1 to <5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart.
Detailed Description
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 Shanchol™ along with lot-to-lot consistency of Hillchol®(BBV131). Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to <18 and Group III: ≥1 to <5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart. Study Objectives: Primary Objectives: 1)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. End points: Immediate reaction: Within 30mins of administration of each dose. Incidence, intensity, and the causality of all solicited adverse events during the 7-day follow up period after each dose. Incidence, intensity, and the causality of unsolicited adverse events during the 7-day follow up period after each dose. Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period. Study design: In this study, a total sample size of 1800 participants will be enrolled in three age groups and administered with Hillchol® (BBV131). A) 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. B) 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. C)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. Eligibility Criteria: Inclusion Criteria: Participants /Legally acceptable representatives who have the ability to provide written informed consent. Participants of either gender of age ≥ 1 year. Expressed interest and availability to fulfill the study requirements. Willing to receive two doses of the vaccine at the specific study site. Willing to be contacted on the phone to assess adverse events and for study reminders. Agrees not to participate in another clinical study at any time during the study period. Exclusion: Any history of anaphylaxis in relation to vaccination. Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents. An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator. Participants with 38℃ or higher body temperature measured within 24 hours or at the time of investigational product dosing. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation. Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation. Other vaccination within 4 weeks before study initiation. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation. Participation in another clinical trial. History of cholera vaccinations or history of cholera diarrhea. Pregnancy, lactation or willingness/intention to become pregnant during the study. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). History of any psychiatric condition likely to affect participation in the study. Suspected or known current alcohol abuse is defined by an alcohol intake of greater than 42 units every week. 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. Study Procedure: Visit 1:Baseline (Day 0):If eligible, study participants will attend the OPD for a physical and general examination. A study vaccine will be administered. Following vaccination, participants will remain at the study site for at least 30 minutes to record any adverse events. Diary cards will be distributed to all the participants to record the adverse events after vaccination. Day 1-7: The study participants will be telephonically followed up by the site for the first 7 days to know their current health status . Visit 2 (Day 14+2):Study participants will return to the OPD for physical, and general examination. A study vaccine will be administered. Following vaccination, participants will remain at the study site for at least 30 minutes to record any adverse events. Diary cards will be distributed to all the participants to record the adverse events after vaccination. Day 15-21: The study participants will be telephonically followed up by the site for the first 7 days to know their current health status. Visit 3 (Day 28+2):Study participants will return to the OPD for physical and general examination. Diary cards will be collected from all the participants to record the adverse events after vaccination. Visit 4: (Day 56±7):Study participants will be contacted telephonically and followed up by the site to know their current health status and all the safety-related issues will be recorded. Visit 5 (Day 90±7):-Study participants will return to the OPD for physical and general examination. If any adverse events it will be recorded. Visit 6 (Day 180±7):Study participants will be contacted telephonically and followed up by the site to know their current health status and all the safety-related issues will be recorded. Unscheduled visits: If any subject develops any adverse or serious adverse event or is concerned about his/her health, they will be advised to visit the study site during the study follow-up period. All unscheduled visits and details of adverse events will be documented in the source document. Concomitant medications, if any, will also be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-I (Age: ≥18)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group-II (Age: ≥5 to <18)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group-III (Age: ≥1 to <5)
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Hillchol vaccine
Intervention Description
Hillchol® (BBV131) (The whole cell inactivated Stable Hikojima expressing both Inaba and Ogawa LPS) inactivated bacteria of a stable recombinant Vibrio cholerae O1 El Tor Hikojima serotype strain expressing approximately 50% each of Ogawa and Inaba O1 LPS antigens.
Primary Outcome Measure Information:
Title
Immediate reaction
Description
Adverse reactions after administration of each dose
Time Frame
Within 30 mins of administration of each dose
Title
solicited adverse events
Description
Incidence, intensity, and the causality of all solicited adverse events during the 7-day follow up period after each dose.
Time Frame
7-days
Title
unsolicited adverse events
Description
Incidence, intensity, and the causality of unsolicited adverse events during the 7-day followup period after each dose.
Time Frame
7-days
Title
Serious Adverse Events (SAEs)
Description
Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.
Time Frame
V- :1Baseline (Day 0),V- 2: (Day 14+2),V-3: (Day 28+2),V- 4: (Day 56±7),V-5: (Day 90±7) and V- 6: (Day 180±7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants /Legally acceptable representatives who have the ability to provide written informed consent. Participants of either gender of age > 1 year. Expressed interest and availability to fulfill the study requirements. Willing to receive two doses of the vaccine at the specific study site. Willing to be contacted on the phone to assess adverse events and for study reminders. Agrees not to participate in another clinical study at any time during the study period. Exclusion Criteria: Any history of anaphylaxis in relation to vaccination. Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents. An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator. Participants with 38℃ or higher body temperature measured within 24 hours or at the time of investigational product dosing. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation. Other vaccination within 4 weeks before study initiation. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation. Participation in another clinical trial. History of cholera vaccinations or history of cholera diarrhea. Pregnancy, lactation or willingness/intention to become pregnant during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.V.Krishna Mohan, PhD
Phone
04023480567
Email
kmohan@bharatbiotech.com
Facility Information:
Facility Name
King George Hospital, Visakhapatnam
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr.Narayana Rao Songa, MBBS,MD
Phone
7799348777
Email
narayanarao.kghamc@gmail.com
Facility Name
Rajarajeswari Medical College and Hospital
City
Kambipura
State/Province
Bangalore
ZIP/Postal Code
560074
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Arun Kumar, MBBS,MD
Phone
8904111627
Email
arunpatil2001@gmail.com
Facility Name
All India Institute of Medical Sciences, Patna
City
Patna
State/Province
Bihar
ZIP/Postal Code
801507
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Chandramani Singh, MBBS,MD
Phone
9931733280
Email
drcmsingh@aiimspatna.org
Facility Name
Pt BD Sharma,PGIMS/UHS. Rohtak
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Savita Verma, MBBS,MD
Phone
9812283746
Email
verma.savi@gmail.com
Facility Name
Jeevan Rekha Hospital, Belgaum
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Abhishek T Chavan, MBBS,MD
Phone
9113222185
Email
dr.abhishektchavan@gmail.com
Facility Name
Gillurkar Multispecialty Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440024
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr.Girish p Charde, MBBS,MD
Phone
9823606363
Email
girishdr123@gmail.com
Facility Name
Malla Reddy Narayana Multi Speciality Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500055
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr.Pradeep Reddy Mettu, MBBS,MD
Phone
8897242789
Email
mettupradeepreddy@gmail.com
Facility Name
Rana Hospital Pvt Ltd
City
Gorakhpur
State/Province
Uttar Pradesh
ZIP/Postal Code
273001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Vishal Tripathi, MBBS DCH
Phone
8700304154
Email
dr.vishaltripathi@gmail.com
Facility Name
New Leelamani Hospital Pvt Ltd
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Raghu Raj Singh, MBBS DCH
Phone
9555989176
Email
drraghurajsingh156@gmail.com

12. IPD Sharing Statement

Learn more about this trial

To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)

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