| CTRI Number |
CTRI/2024/08/072503 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A phase 1 study to assess the safety and tolerability of bivalent typhoid and paratyphoid a conjugate vaccine (btpt) of M/s Zydus Lifesciences ltd., India in healthy, adult human subjects |
|
Scientific Title of Study
|
An Open-label, Single-treatment, Single-period, Single dose, clinical phase 1 study to assess the safety and tolerability of bivalent typhoid and paratyphoid a conjugate vaccine (btpt) of M/s Zydus Lifesciences ltd., India in healthy, adult human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BTPT 1001 Version No. 02 dated 16th May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krunal Prajapati |
| Designation |
Sr.Manager |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Centre, Zydus Lifesciences Ltd, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya,
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Krunal.G.Prajapati@ZydusLife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krunal Prajapati |
| Designation |
Sr.Manager |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Centre, Zydus Lifesciences Ltd, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya,
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Krunal.G.Prajapati@ZydusLife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krunal Prajapati |
| Designation |
Sr.Manager |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Centre, Zydus Lifesciences Ltd, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya,
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Krunal.G.Prajapati@ZydusLife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Ltd., Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad- 382481, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Ltd |
| Address |
M/s Zydus Lifesciences Limited, Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47, 49 & 50, Sarkhej-Bavla N. H. No. 8A, Opp. Ramdev Masala, Village: Changodar, Tal.: Sanand, Dist.: Ahmedabad – 382213, State: Gujarat, (India), |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krunal Prajapati |
Zydus Research Centre |
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village Moraiya, 382213
Ahmadabad
GUJARAT |
02717665555
Krunal.G.Prajapati@ZydusLife.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee, Riddhi Medical Nursing Home, A/101 Jalaram Plaza, Jawahar chowk, Maninagar, Ahmedabad - 380008, Gujarat, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Typhoid Conjugate Vaccine |
Dose : 0.5 ml
Route:Intramuscular injection
Frequency :- Once
Duration :- Single time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and non-pregnant, non-lactating female subjects aged between 18 and 50 years (Both inclusive).
2.Ability to communicate effectively with study personnel.
3.Willingness to adhere to the protocol requirements.
4.Be able to give written informed consent for participation in the trial.
5.Normal health as determined by personal medical/surgical history, vital signs, physical examination, Chest X-ray PA view (only if clinically indicated), ECG and laboratory assessment data during screening (within the clinically acceptable range).
6.Male subjects and female subjects of childbearing potential must agree to use effective contraception till study completion.
7.Subject should be literate to understand study requirement. |
|
| ExclusionCriteria |
| Details |
1.Any hypersensitivity reaction or History of anaphylaxis or serious adverse event with previous receipt of tetanus and/or diphtheria toxoid containing vaccines.
2.Subjects with known hypersensitivity to any component of the study vaccine.
3.Household contact with known exposure to an individual with laboratory confirmed S. Typhi or S. Paratyphi A.
4.Subjects who are taking immunostimulant therapy (e.g., interferons) or immunosuppressant medications (e.g., corticosteroids, cytotoxic drugs or antimetabolites, etc.).
5.Subjects who are known to be suffering from diseases which can affect immune competence e.g., diabetes, immunodeficiency disorders or known to be HIV positive.
6.Subjects who have received immunoglobulins parenterally during the preceding 3 months.
7.Subjects who have received any type of typhoid vaccine in last 3 years.
8.Subjects who have received any vaccine in preceding one month of dosing and who are planning to take vaccine during study period.
9.History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, gynaecological or any other body system involvement which interferes with safety assessment as per investigator discretion.
10.History or presence of alcoholism or drug abuse within the past one-year.
11.History or presence of significant smoking (more than 10 cigarettes per day)
12.Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.
13.Pulse less than 60/minute or more than 100/minute.
14.History of fever or any other infection in last 2 weeks of enrollment
15.Any clinically significant ECG abnormalities at screening.
16.Any clinically significant abnormal laboratory values during screening.
17.Subjects who have participated in clinical research studies within past 3 months.
18.A positive urine drugs of abuse test or positive alcohol test at check-in.
19.For female subjects, positive serum β-hCG level or urine pregnancy test at the screening or check-in visit.
20.Female subjects with history of pregnancy or lactation in the past 3 months.
21.Female subjects with history of less than 1 year of menopause and not using adequate anti-fertility measures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety and tolerability of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine given intramuscularly in healthy adult human subjects. |
Baseline to Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the immunogenicity of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine given by intramuscular route in healthy subjects. |
Baseline to Day 28 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| Date of Study Completion (India) |
25/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Zydus Lifesciences Ltd has already developed and commercialized S. Typhi conjugate vaccine (ZyVac®TCV) in India. To cover the range of enteric fever causing agents, a combination vaccine of typhoid and paratyphoid A conjugate vaccine has been developed. In this combination vaccine, Vi Polysaccharide of S. typhi is conjugated with tetanus toxoid and O specific Polysaccharide of S. Paratyphi A conjugated with diphtheria toxoid. Both conjugates were formulated using suitable excipients and preservative. Drug substance is tested and released as per the quality control specification. After that it is formulated and converted to the drug product. Drug product is also tested and released as per the quality control specification.The acute and repeated dose toxicity studies were carried out to demonstrate the safety and tolerability of the Bivalent Typhoid and Paratyphoid A Conjugate Vaccine and to identify the inherent toxicities of formulation, toxicities of impurities and contaminants or toxicities that may result from interactions between the vaccine components. Using this formulation, animal studies were performed and vaccine immunogenicity and safety was determined. In preclinical toxicity (PCT) studies, the bivalent Typhoid and Paratyphoid conjugate vaccine was found to be safe & immunogenic. The proposed route of administration of the vaccine is intramuscular (IM). |