CTRI/2019/07/019996 [Registered on: 02/07/2019] Trial Registered Prospectively
Last Modified On:
31/12/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Single Arm Study
Public Title of Study
A clinical study to assess the long-term immune response after primary vaccination and immune response after re-vaccination with typhoid conjugate vaccine
Scientific Title of Study
A prospective, open-label, multicenter, phase IV clinical study to evaluate the long term persistence of immunological response after primary vaccination with Typhoid Vi Conjugate Vaccine and response to booster dose vaccination with Typhoid Vi Conjugate Vaccine of M/s Cadila Healthcare Limited in healthy subjects
Trial Acronym
None
Secondary IDs if Any
Secondary ID
Identifier
18-02; Version No. 00; Dated 27/10/2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Study room, 1st floor, main hospital building, Department of Pediatrics, Gandhi Hospital, Musheerabad, Secunderabad –
500003 Hyderabad TELANGANA
9440424545
sivaram175@yahoo.com
Dr Ambrose Kumar Kandulna
GCS Medical College, Hospital and Research Centre
Room No. 13, Medicine OPD, Department of Medicine, GCS Medical College, Hospital and Research Centre, Opp. DRM office, Near Chamunda bridge, Naroda road, Ahmedabad – 380025 Ahmadabad GUJARAT
7698059533
drambrosek@gmail.com
Dr Sanjay Kumar Jangid
Hi-Tech Medical College & Hospital
Medicine OPD, Department of Medicine, Hi-Tech Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar -751025 Khordha ORISSA
Room No. 15, Ground floor, Department of Pediatrics, Parul Sewashram Hospital, Parul Institute of Medical Sciences & Research, Limda, Waghodia, Vadodara – 391760 Vadodara GUJARAT
9327214065
umasnayak@gmail.com
Dr Shrikant Sharma
SMS Medical College and Hospital, Jaipur
Medicine Unit VII, 2nd floor, Hospital building, Department of Medicine, SMS Medical College and Hospital, JLN Marg, Jaipur-302004 Jaipur RAJASTHAN
Ethics Committee, Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata – 700017, West Bengal
Approved
Ethics Committee, SMS Medical College and Attached Hospitals, JLN Marg, Jaipur – 302004, Rajasthan
Approved
Institutional Ethics Committee for Human Research, Parul Institute of Medical Sciences & Research, Limda, Waghodia, Vadodara – 391760, Gujarat
Submittted/Under Review
Institutional Ethics Committee, Gandhi Medical College and Hospital, Musheerabad, Secunderabad-500003, Telangana
Approved
Institutional Ethics Committee, GCS Medical College, Hospital & Research Centre, Opp. DRM office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad – 380025, Gujarat
Institutional Ethics Committee, Sparsh Hospitals and Critical Care Private Limited, Saheed Nagar, Bhubaneswar - 751007, Odisha
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Immunization against typhoid fever
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not applicable
Not applicable
Intervention
Typhoid Vi Conjugate Vaccine of M/s Cadila Healthcare Ltd
The subjects whose baseline anti-Vi IgG antibody titre is below the proposed seroprotective cut-off will be considered eligible to receive a single dose (0.5 ml) of the vaccine at visit 2 (day 0). The study vaccine will be administered as i.m. injection in the upper arm taking aseptic precautions
Inclusion Criteria
Age From
6.00 Month(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Subjects who had participated and completed the previously conducted phase II/III clinical study (Project No. 15-03) and had received the study vaccine before 3 years ± 3 months
2. Informed consent from adult subjects or from parents of the pediatric subjects. Additionally, assent from pediatric subjects of ≥7 years of age
3. Adult subjects or parents of pediatric subjects literate enough to fill the diary card
ExclusionCriteria
Details
1. History of typhoid fever or vaccination against typhoid fever after previous study
2. Subjects administered blood, blood containing products or immunoglobulins during the past 3 months
3. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
4. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
5. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
6. Participation in another clinical trial in the past 3 months
7. Subjects with history of alcohol or drug abuse in the past one year
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
-Long-term persistence of anti-Vi IgG antibodies
-Seroconversion rate 28 days post-vaccination
Day 0 and Day 28
Secondary Outcome
Outcome
TimePoints
-Seroconversion rate 10 days post-vaccination
-Geometric mean titre of anti-Vi IgG antibodies 10 days and 28 days post-vaccination as compared to the baseline
Day 10 and Day 28
Target Sample Size
Total Sample Size="236" Sample Size from India="236" Final Enrollment numbers achieved (Total)= "112" Final Enrollment numbers achieved (India)="112"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This phase IV clinical trial is an extension of previously conducted phase II/III clinical trial (Protocol No. 15-03; CTRI Registration No. CTRI/2016/05/006975). A total of 236 subjects who were enrolled (aged 6 months to 45 years at the time of enrollment) and who had completed the previous clinical trial will be enrolled in the current study around 3 years after their primary vaccination. This study is planned to evaluate the long-term persistence of anti-Vi IgG antibodies in the subjects who were vaccinated with Typhoid Vi conjugate vaccine in the previous clinical trial and also to evaluate the immunogenicity and safety of booster dose vaccination with Typhoid Vi conjugate vaccine I.P. of M/s Cadila Healthcare Ltd. The anti-Vi antibody titres will be evaluated using VaccZyme ELISA kits. After booster dose vaccination, seroconversion rate (defined as ≥4-fold rise in antibody titre as compared to the baseline titre) and geometric mean titre of antibodies will be evaluated at day 10 & day 28. The safety of the vaccine will be assessed by recording the adverse events occurring to the vaccinated subjects .