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

NCT05732766 | Unknown Phase 3

• 1 other identifier: Hillchol®(BBV131) Safety
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 9

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.

Conditions

Cholera

Outcome Measures

Primary Outcomes (4)

• Immediate reaction

  Adverse reactions after administration of each dose

  Within 30 mins of 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.

  7-days

• unsolicited adverse events

  Incidence, intensity, and the causality of unsolicited adverse events during the 7-day followup period after each dose.

  7-days

• Serious Adverse Events (SAEs)

  Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.

  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)

Study Arms (3)

Group-I (Age: ≥18)

EXPERIMENTAL

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

Group-II (Age: ≥5 to <18)

EXPERIMENTAL

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

Group-III (Age: ≥1 to <5)

EXPERIMENTAL

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

Interventions

Hillchol vaccine BIOLOGICAL

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.

Group-I (Age: ≥18); Group-II (Age: ≥5 to <18); Group-III (Age: ≥1 to <5)

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (9)

King George Hospital, Visakhapatnam

Visakhapatnam, Andhra Pradesh, 530002, India

NOT YET RECRUITING

Rajarajeswari Medical College and Hospital

Kambīpura, Bangalore, 560074, India

NOT YET RECRUITING

All India Institute of Medical Sciences, Patna

Patna, Bihar, 801507, India

RECRUITING

Pt BD Sharma,PGIMS/UHS. Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

Jeevan Rekha Hospital, Belgaum

Belagavi, Karnataka, 590002, India

RECRUITING

Gillurkar Multispecialty Hospital

Nagpur, Maharashtra, 440024, India

RECRUITING

Malla Reddy Narayana Multi Speciality Hospital

Hyderabad, Telangana, 500055, India

NOT YET RECRUITING

Rana Hospital Pvt Ltd

Gorakhpur, Uttar Pradesh, 273001, India

RECRUITING

New Leelamani Hospital Pvt Ltd

Kanpur, Uttar Pradesh, 208001, India

RECRUITING

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dr.V.Krishna Mohan, PhD

CONTACT

04023480567; kmohan@bharatbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: February 4, 2023
• Primary Completion: March 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

IN (9)