A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate the Non-inferiority of Immunogenicity and Safety of Hillchol® (BBV131)to Shanchol™ Along With Lot-to-lot Consistency of Hillchol®(BBV131).

NCT05507229 | Unknown Phase 3 DMC

• 1 other identifier: Hillchol®BBV131/2021
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 11

Brief Summary

A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the noninferiority 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 3(1350):1(450) ratio. In each group 600 participants will be enrolled and among 600 participants 450 participants will receive any lot of Hillchol® (BBV131) and 150 participants will receive Shanchol™. DSMB and report:After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group I, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group I and starting recruitment of participants for group II. After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group II, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group II and starting recruitment of participants for group III. After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131): 10-Lot-I, 10-Lot-II, 10-Lot-III and 10-shanchol) in the Group III, safety data of these subjects will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group III. A Final report will be generated, based on the safety and immunogenicity of the oral cholera vaccine (Hillchol®) will be notified to the Data safety monitoring board and Central Drugs Standard Control Organization (CDSCO), India.

Conditions

Cholera

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The proportion of participants achieving seroconversion against Ogawa serotype, 14 days after 2 doses of test or comparator vaccine. 2)The proportion of participants achieving seroconversion against Inaba serotype, 14 days after 2 doses of test or comparator vaccine.

  14 days after 2 doses of test or comparator vaccine

Secondary Outcomes (7)

• Secondary Outcome

  two weeks after 2 doses of Test or comparator vaccine

• Secondary Outcome

  two weeks after 2 doses of Test or comparator vaccine.

• Secondary Outcome

  Within 30 mins of administration of each dose.

• Secondary outcome

  during the 7-day follow-up period after each dose.

• Secondary Outcome

  during the 14-day follow-up period after each dose.

Study Arms (4)

Arm 1

EXPERIMENTAL

Hillchol®(BBV131) vaccine - (Lot-I ) administered to 450 subjects on day 0 and 14.

Biological: Hillchol vaccine

Arm 2

EXPERIMENTAL

Hillchol®(BBV131) vaccine - (Lot-II) administered to 450 subjects on day 0 and 14.

Biological: Hillchol vaccine

Arm 3

EXPERIMENTAL

Hillchol®(BBV131) vaccine - (Lot-III ) administered to 450 subjects on day 0 and 14 .

Biological: Hillchol vaccine

Arm 4

ACTIVE COMPARATOR

Shanchol Vaccine administered to 450 subjects on day 0 and 14

Biological: Shanchol Vaccine

Interventions

Hillchol vaccine BIOLOGICAL

HillChol®(BBV131) (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.

Arm 1; Arm 2; Arm 3

Shanchol Vaccine BIOLOGICAL

Shanchol™ (Killed Bivalent (O1 and O139) Whole Cell Oral Cholera Vaccine)

Arm 4

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants /Legally acceptable representatives who have ability to provide written informed consent.
• Participants of either gender of age \> 1 year.
• Expressed interest and availability to fulfil the study requirements.
• Willing to receive two dosesof 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.

You may not qualify if:

• Any history of anaphylaxis in relation to vaccination.
• Participant with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents.
• An individual 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 prior to study initiation
• Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
• Other vaccination within 4week prior to study initiation.
• Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to 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 as 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (11)

King George Hospital,Visakhapatnam

Visakhapatnam, Andhra Pradesh, 530002, India

Location

All India Institute of Medical Sciences,Patna

Patna, Bihar, India

Location

Aatman Hospital

Ahmedabad, Gujarat, India

Location

Pt BD Sharma,PGIMS/UHS. Rohtak

Rohtak, Haryana, 124001, India

Location

Jeevan Rekha Hospital ,Belgaum

Belagavi, Karnataka, India

Location

Khalatkar Hospital, Nagpur

Nagpur, Maharashtra, 440024, India

Location

Redkar Hospital and Research center,Goa

Goa, South Goa, India

Location

Indus Hospital

Hyderabad, Telangana, India

Location

Rana Hospital Pvt Ltd ,Gorakhpur

Gorakhpur, Uttar Pradesh, India

Location

Prakhar Hopsital Pvt Ltd,Kanpur

Kanpur, Uttar Pradesh, India

Location

National Institute of Cholera and Enteric Diseases,Kolkata

Kolkata, West Bengal, India

Location

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind Study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: February 22, 2022
• Primary Completion: July 30, 2022
• Study Completion: October 30, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

IN (11)