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

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ClinicalTrials.gov Identifier: NCT05732766

Recruitment Status : Recruiting

First Posted : February 17, 2023

Last Update Posted : February 17, 2023

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Sponsor:

Information provided by (Responsible Party):

Bharat Biotech International Limited

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.

Condition or disease	Intervention/treatment	Phase
Cholera	Biological: Hillchol vaccine	Phase 3

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Detailed Description:

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.
1. Willing to receive two doses of the vaccine at the specific study site.
2. 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1800 participants
Allocation:	Non-Randomized
Intervention Model:	Sequential Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Actual Study Start Date :	February 4, 2023
Estimated Primary Completion Date :	March 2023
Estimated Study Completion Date :	August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera Vaccines

Drug Information available for: Cholera Vaccine

Genetic and Rare Diseases Information Center resources: Cholera

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group-I (Age: ≥18) 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.	Biological: Hillchol vaccine 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.
Experimental: Group-II (Age: ≥5 to <18) 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.	Biological: Hillchol vaccine 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.
Experimental: Group-III (Age: ≥1 to <5) 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	Biological: Hillchol vaccine 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.

Outcome Measures

Primary Outcome Measures :

Immediate reaction [ Time Frame: Within 30 mins of administration of each dose ]
Adverse reactions after administration of each dose
solicited adverse events [ Time Frame: 7-days ]
Incidence, intensity, and the causality of all solicited adverse events during the 7-day follow up period after each dose.
unsolicited adverse events [ Time Frame: 7-days ]
Incidence, intensity, and the causality of unsolicited adverse events during the 7-day followup period after each dose.
Serious Adverse Events (SAEs) [ 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) ]
Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	1 Year to 99 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.
1. Willing to receive two doses of the vaccine at the specific study site.
2. 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05732766

Contacts

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Contact: Dr.V.Krishna Mohan, PhD	04023480567	kmohan@bharatbiotech.com

Locations

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India
King George Hospital, Visakhapatnam	Not yet recruiting
Visakhapatnam, Andhra Pradesh, India, 530002
Contact: Dr.Narayana Rao Songa, MBBS,MD 7799348777 narayanarao.kghamc@gmail.com
Rajarajeswari Medical College and Hospital	Not yet recruiting
Kambipura, Bangalore, India, 560074
Contact: Dr. Arun Kumar, MBBS,MD 8904111627 arunpatil2001@gmail.com
All India Institute of Medical Sciences, Patna	Recruiting
Patna, Bihar, India, 801507
Contact: Dr Chandramani Singh, MBBS,MD 9931733280 drcmsingh@aiimspatna.org
Pt BD Sharma,PGIMS/UHS. Rohtak	Recruiting
Rohtak, Haryana, India, 124001
Contact: Dr Savita Verma, MBBS,MD 9812283746 verma.savi@gmail.com
Jeevan Rekha Hospital, Belgaum	Recruiting
Belgaum, Karnataka, India, 590002
Contact: Dr Abhishek T Chavan, MBBS,MD 9113222185 dr.abhishektchavan@gmail.com
Gillurkar Multispecialty Hospital	Recruiting
Nagpur, Maharashtra, India, 440024
Contact: Dr.Girish p Charde, MBBS,MD 9823606363 girishdr123@gmail.com
Malla Reddy Narayana Multi Speciality Hospital	Not yet recruiting
Hyderabad, Telangana, India, 500055
Contact: Dr.Pradeep Reddy Mettu, MBBS,MD 8897242789 mettupradeepreddy@gmail.com
Rana Hospital Pvt Ltd	Recruiting
Gorakhpur, Uttar Pradesh, India, 273001
Contact: Dr Vishal Tripathi, MBBS DCH 8700304154 dr.vishaltripathi@gmail.com
New Leelamani Hospital Pvt Ltd	Recruiting
Kanpur, Uttar Pradesh, India, 208001
Contact: Dr Raghu Raj Singh, MBBS DCH 9555989176 drraghurajsingh156@gmail.com

Sponsors and Collaborators

Bharat Biotech International Limited

More Information

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Responsible Party:	Bharat Biotech International Limited
ClinicalTrials.gov Identifier:	NCT05732766
Other Study ID Numbers:	Hillchol®(BBV131) Safety
First Posted:	February 17, 2023 Key Record Dates
Last Update Posted:	February 17, 2023
Last Verified:	February 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Cholera Vibrio Infections Gram-Negative Bacterial Infections	Bacterial Infections Bacterial Infections and Mycoses Infections

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