"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".

Phase 1

Completed

• Conditions: Preventive protection against Typhoid fever; Encounter for immunization,

• Registration Number: CTRI/2018/03/012558
• Lead Sponsor: Biological ELimited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-19
• Study Completion: 2018-05-28
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

• 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.
• 4.Individuals who have a previously ascertained or suspected disease caused by S.
• 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.
• 14.Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
• 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:	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
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
1.Proportion of subjects with solicited adverse reactions.	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
3.Medically attended and serious adverse events (SAEs),if any	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
4.Any clinically significant abnormal haematology and biochemistry laboratory parameters.	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
2.Proportion of subjects with unsolicited adverse events (AEs).	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 Measures

Name	Time	Method
Immunogenicity:	1.Anti-Vi specific IgG serum antibodies as measured by ELISA.

Trial Locations

Locations (1)

St. Theresa’s Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

St. Theresa’s Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr A Venkateshwar Rao

Principal investigator

09440040662

venky_gmc@yahoo.co.in