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.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2018/03/012558
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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 LARâ??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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: <br/ ><br>1.Proportion of subjects with solicited adverse reactions. <br/ ><br>2.Proportion of subjects with unsolicited adverse events (AEs). <br/ ><br>3.Medically attended and serious adverse events (SAEs),if any <br/ ><br>4.Any clinically significant abnormal haematology and biochemistry laboratory parameters. <br/ ><br>5.Clinically significant abnormal vital signs (Pulse, oral body temperature, Respiratory rate and Blood pressure)Timepoint: 1.during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) captured through subject diary. <br/ ><br>2.during the post vaccination follow up period till day 28 <br/ ><br>3.during the post vaccination 28 day follow up period. <br/ ><br>4.till day 28 post single dose vaccination <br/ ><br>5.at all protocol specified visits
- Secondary Outcome Measures
Name Time Method Immunogenicity: <br/ ><br>1.Anti-Vi specific IgG serum antibodies as measured by ELISA.Timepoint: 1.at day 0 pre vaccination and again at day 28 post vaccination.