To assess the safety and tolerability of recombinant Hepatitis EVaccine givenintramuscular in healthy adult male human subjects.
- Registration Number
- CTRI/2020/03/023769
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1)Male subjects aged between 18 and 45 years (both inclusive).
2)Body weight > 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive).
3)Ability to communicate effectively with study personnel.
4)Willingness to adhere to the protocol requirements.
5)Be able to give consent for participation in the trial.
6)Normal health as determined by personal medical history, clinical examination, and laboratory examinations data during screening (within the clinically acceptable range)
1)History of anaphylaxis or serious reactions to any vaccines
2)Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
3)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.
4)Subjects who have received immunoglobulins parenterally during the preceding 3 months.
5)Subjects who have received any vaccine in the preceding 6 months.
6)History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
7)History or presence of significant alcoholism or drug abuse within the past one-year.
8)History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.
9)Pulse less than 60/minute or more than 100/minute.
10)History of fever in last 2 weeks
11)Any clinically significant ECG abnormalities during screening.
12)Any clinically significant abnormal laboratory values during screening.
13)Any clinically significant chest X-Ray findings during screening.
14)Major illness during 3 months before the screening period.
15)Subjects who have participated in drug research studies within past 3 months.
16)Subjects who have donated one unit (350ml) of blood in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method assess the safety and tolerability of inactivated Hepatitis E Vaccine (Adsorbed) I.P. of M/s. Cadila Healthcare LtdTimepoint: Baseline and Day 28
- Secondary Outcome Measures
Name Time Method ILTimepoint: NIl