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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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 |
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 |
Arm | Intervention/treatment |
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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.
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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. |
- 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.
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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 |
Inclusion Criteria:
- Participants /Legally acceptable representatives who have the ability to provide written informed consent.
- Participants of either gender of age > 1 year.
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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.
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
Contact: Dr.V.Krishna Mohan, PhD | 04023480567 | kmohan@bharatbiotech.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cholera Vibrio Infections Gram-Negative Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections |