| CTRI Number |
CTRI/2025/07/090155 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A phase-I clinical study to assess the safety of Biological Es Typhoid vaccine in 18-55 year old healthy adults. |
|
Scientific Title of Study
|
A prospective multicentre, open label, Phase-I study to evaluate the safety and immunogenicity of Biological E’s Bivalent Typhoid and Paratyphoid A conjugate vaccine administered to 18-55 years-old healthy adults in India. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT086/Bi-TCV-Phase-I/CTP-01 VersionNo:1.0 dated 09.12.24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhash Thuluva |
| Designation |
Sr. Vice President- Clinical development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, Room no:5,2nd floor, Road No.35,Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
|
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Thuluva |
| Designation |
Sr. Vice President- Clinical development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, Room no:5,2nd floor, Road No.35,Jubilee Hills
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
|
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Subba Reddy GV |
| Designation |
Associate Vice President- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, Room no:2,2nd floor, Road No.35,Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216240 |
| Fax |
|
| Email |
subbareddy.gunneri@biologicale.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Biological E.Limited |
| Address |
18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biological ELimited |
Plot No 1, Phase 11, Kolthur Village, Shameerpet, Medchal-Malkajgiri District, Telangana -500 078. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiva Narang |
GTB Hospital |
Department of General Medicine,
GTB Hospital, 6th Floor, Room No::26B,Tahirpur Road, GTB Enclave, Dilshad Garden- 110095
East
DELHI |
09899838807
shivanarang@gmail.com |
| Dr P J Srinivas |
King George Hospital |
Department of Community Medicine,
King George Hospital,1st Floor of OPD, Collectorate Junction, Maharani Peta - 530002
Visakhapatnam
ANDHRA PRADESH |
09949001578
pjsrinivas.kghamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Guru Teg Bahadur Hospital Ethics Committee |
Approved |
| IEC King George Hospital, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BE’s Typhoid and Paratyphoid A conjugate vaccine (Bivalent) |
0.5mL of BEs Bivalent Typhoid and Paratyphoid A conjugate vaccine administered intramuscularly on Day 1 |
| Comparator Agent |
Typhoid Conjugate Vaccine (Monovalent) TYPHIBEV |
0.5mL of BEs TYPHIBEV vaccine administered intramuscularly on Day 1 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and non-pregnant female subjects between 18-55 (both inclusive) years of age at the time of vaccination.
2. Subject who after the nature of the study has been explained to them, have given written informed consent according to local regulatory requirements prior to performance of any study specific procedure.
3. Subject’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
4. Individuals in good health as determined by medical history, physical examination and laboratory investigations, based on clinical judgment of the investigator.
5. Participant seronegative for human immunodeficiency virus, hepatitis B, and hepatitis C at screening.
6. Negative urine pregnancy test for female subjects of childbearing potential at screening.
7.Female participants of non-childbearing potential
|
|
| ExclusionCriteria |
| Details |
1. Individuals with a previously ascertained or suspected disease caused by Salmonella Typhi or Salmonella Paratyphi A.
2. Individuals with history of household contact with and or intimate exposure to an individual with laboratory confirmed S. Typhi or S. Paratyphi A infection
3. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines);
4. Individuals with body temperature greater than or equal to 100.4°F (38.0°C) within 3 days of intended study vaccine administration.
5. Individuals with any progressive unstable or uncontrolled clinical conditions according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
6. Subject’s unwillingness or inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period;
7. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
8. Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment or alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids in the previous 30 days;
9. Subjects with receipt of immunoglobulins and or any blood derived products, or bone marrow transplantation, in the 90 days preceding vaccination or planned administration during the study period.
10. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks;
11. History of allergy, hypersensitivity or allergic reaction to any vaccine-related component; including diphtheria toxoid containing vaccines;
12. Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
13. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives.
14. Subject who had significant acute or chronic infections requiring systemic antibiotics treatment within the past 14 days of study vaccine administration.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Number and Percentage of participants with solicited administration-site events.
2. Number and Percentage of participants with solicited systemic events.
3. Number and Percentage of participants with unsolicited adverse events.
4. Number and Percentage of participants with any serious adverse event (SAE).
5. Number and Percentage of participants with Medically Attended AEs, AEs/SAEs leading to withdrawal from the study.
|
1. during 60 minutes’ post vaccination observation period and 6 subsequent days in adults.
2.during 7 days after vaccination, on the day of vaccination and the 6 subsequent days.
3.during 29 days after vaccination, on the day of vaccination and 28 subsequent days, adults.
4.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults.
5.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of participants achieving anti-Vi antigen IgG antibody concentrations greater than or equal to 2.0 microgram per ml |
before single vaccination (Day 1) and 28 days after single vaccination (Day 29) |
| Percentage of participants achieving anti-Vi antigen IgG antibody concentrations greater than or equal to 4.3 microgram per ml |
before single vaccination (Day 1) and 28 days after single vaccination (Day 29) |
| Percentage of participants achieving at least 4-fold increase in Anti-O:2 IgG antibody concentrations |
at 28 days after single vaccination (Day 29) compared to single vaccination baseline |
| Geometric mean concentration (GMC) of anti-Vi antigen Immunoglobulin G (IgG) antibody concentrations |
before single vaccination (Day 1), 28 days after single vaccination (Day 29) |
| Geometric mean Fold Rise (GMFR) in anti-Vi antigen Immunoglobulin G (IgG) antibody concentrations |
after single vaccination, (Day 29) compared to pre-vaccination |
| GMC of Anti-O:2 IgG antibody concentrations |
before single vaccination (Day 1), 28 days after single vaccination (Day 29). |
| Geometric mean Fold Rise (GMFR) in Anti-O:2 IgG antibody concentrations |
after single vaccination, (Day 29) compared to pre-vaccination |
| Geometric mean titres (GMT) of serum bactericidal activity (SBA) against Salmonella Paratyphi A |
at baseline (Day 0) and at day 28 after single vaccination |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective open label, Phase-I study to assess safety and immunogenicity of Bivalent Typhoid and Paratyphoid A conjugate vaccine administered as a single dose to healthy adults in India. The target population in this study would be healthy adults of either gender, aged between 18-55 years at the time of vaccination.
A total of 90 adult subjects will be recruited into one of the two treatment arms in 2:1 ratio to receive a single dose of either the Bivalent Typhoid and Paratyphoid A conjugate vaccine (test arm) or Bio E’s monovalent TCV vaccine (comparator or control arm), intramuscularly.
The study will be conducted in compliance with NDCT Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct. |