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CTRI Number  CTRI/2018/03/012558 [Registered on: 15/03/2018] Trial Registered Prospectively
Last Modified On: 25/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Single Arm Study 
Public Title of Study   "A first-in-human clinical trial to assess the overall safety and immune response with Typhoid conjugate vaccine of BE, against Typhoid disease in 18-45 year-old healthy adult male volunteers". 
Scientific Title of Study   An open label single arm phase-I study to evaluate safety, reactogenicity and immunogenicity of single intramuscular dose of Biological E’s Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine in 18-45 year-old healthy adults. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT039/TCV-Phase-I/CTP-02 Version:02 dated: 10.07.2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Venkateshwar Rao  
Designation  Consultant Physician- Dept. of General Medicine  
Affiliation  St. Theresa’s Hospital 
Address  St. Theresa’s Hospital, Sanathnagar, Hyderabad,Telangana, India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  09440040662  
Fax    
Email  venky_gmc@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhash Thuluva 
Designation  Vice President- Clinical Development 
Affiliation  Biological E.Limited 
Address  18/1&3, Azamabad, Hyderabad, Telangana,India

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  04067388087  
Fax  04027675309  
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Public Query  
Name  DrTSA Kishore 
Designation  Associate Vice President- Clinical Affairs & Pharmacovigilance 
Affiliation  Biological E.Limited 
Address  18/1&3, Azamabad, Hyderabad, Telangana India

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  04030214046  
Fax  04027675309  
Email  kishore.turaga@biologicale.com  
 
Source of Monetary or Material Support  
Biological E.Limited,18/1&3, Azamabad, Hyderabad, Telangana India 500020.  
 
Primary Sponsor  
Name  Biological ELimited 
Address  18/1&3, Azamabad, Hyderabad, Telangana India 500020 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Venkateshwar Rao  St. Theresa’s Hospital  Dept. of General Medicine, Room no:05,Ground floor, OPD block, Sanathnagar, Telangana,500018-India
Hyderabad
ANDHRA PRADESH 		 09440040662

venky_gmc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, St. Theresa’s Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Preventive protection against Typhoid fever  
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BioE’s Typhoid Conjugate Vaccine(Monovalent)- Single Human dose-0.5mL   1. Dose: 0.5 mL single dose 2. Frequency: One dose only 3. Route of administration: intramuscular injection in deltoid muscle of the non-dominant arm. 4. Total duration of therapy: 35 days (post single dose administration)  
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Adult male volunteers ≥18 to ≤45 years of age;
2.Signed voluntary informed consent obtained prior to screening from subject;
3.Individuals or their legally acceptable representative (LAR) who, after the nature of the study has been explained to them, have given written consent according to local regulatory requirements;
4.Subject or LAR’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
5.Individuals in good health as determined by the outcome of medical history, physical examination, routine haematological and biochemistry blood tests and clinical judgment of the investigator.
 
 
ExclusionCriteria 
Details  1.Individuals or LAR unwillingness or inability to understand and follow required study procedures, keep appointments, or is planning to relocate during the study period
2.Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines)
3.Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
4.Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
5.Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
6.Individuals with history of any illness 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.
7.Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
8.Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
9.Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
10.Individuals who have any malignancy or lymphoproliferative disorder.
11.Individuals with history of allergy or allergic reaction to any vaccine-related components.
12.Individuals participating in any clinical trial with another investigational product 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.Individuals who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine .
14.Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
15.Individuals who are part of study personnel or close family members to the personnel conducting this study.
16.Individuals with body temperature >100.4°F (>38.0°C) within 3 days of intended study immunization.
17.Individuals with history of substance or alcohol abuse within the past 2 years.
18.Any condition, which, in the opinion of the investigator may interfere with the evaluation of the study objectives.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety:
1.Proportion of subjects with solicited adverse reactions.
2.Proportion of subjects with unsolicited adverse events (AEs).
3.Medically attended and serious adverse events (SAEs),if any
4.Any clinically significant abnormal haematology and biochemistry laboratory parameters.
5.Clinically significant abnormal vital signs (Pulse, oral body temperature, Respiratory rate and Blood pressure) 		 1.during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) captured through subject diary.
2.during the post vaccination follow up period till day 28
3.during the post vaccination 28 day follow up period.
4.till day 28 post single dose vaccination
5.at all protocol specified visits  
 
Secondary Outcome  
Outcome  TimePoints 
Immunogenicity:
1.Anti-Vi specific IgG serum antibodies as measured by ELISA. 		 1.at day 0 pre vaccination and again at day 28 post vaccination.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   19/03/2018 
Date of Study Completion (India) 28/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a single arm, open label Phase-I study to demonstrate safety, reactogenicity & Immunogenicity of Biological E’s Typhoid Vi-CRM197 conjugate vaccine in 18-45 year-old adult male subjects. A total of 30 adult male subjects will be administered a single 0.5 mL dose of the test vaccine by Intra-muscular injection in deltoid muscle of the non-dominant arm. 

Blood sample will be collected once at screening and again 28 days after the single dose, for routine haematology and biochemistry parameters and for anti-Vi IgG typhoid antibody assay. Vital signs will be recorded at all protocol specified visits for all subjects.

The total duration of the study is 35 days for each subject (7 days for screening time and 28 days for follow up post single dose).The study will be conducted in compliance with schedule Y, ICH and Indian good clinical practice guidelines in force. 

 
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