A phase-I clinical study to assess the safety of Biological Es Inactived Polio vaccine in 18-45 yearold healthy male adults.

Phase 1

Completed

• Conditions: Preventive protection against Polio; Encounter for immunization,

• Registration Number: CTRI/2019/04/018474
• Lead Sponsor: Biological ELimited

Brief Summary

This is a single arm, open label Phase-I studyto demonstrate safety, reactogenicity & Immunogenicity of Biological E’sInactivated poliomyelitis vaccine (adsorbed) in 18-45 year-old adult malesubjects. A total of 24 adult male subjects will be administered asingle 0.5 mL dose of the test vaccine by Intra-muscular injection indeltoid muscle of the non-dominant arm.

Blood sample will be collected once atscreening and again 28 days after the single dose, for routine haematology,biochemistry parameters and serotype specific anti-Polio antibody assay. Vitalsigns will be recorded at all protocol specified visits for all subjects.

The total duration of the studyis 35 days for each subject (7 days for screening time and 28 days for followup post single dose).This study will be conducted in compliance with scheduleY, ICH and Indian good clinical practice guidelines in force.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Study Completion: 2020-01-24
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Healthy adult male volunteers ≥18 to ≤45 years of age at the time of vaccination; 2.
• Must have received primary polio vaccination series according to the Indian National Immunization Programme based on vaccination card or verbal information given by subjects during interview with investigator.
• Subject’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures; 4.
• Signed informed consent obtained prior to screening from subject; 5.
• Free of obvious health problems [with no significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or haematological functional abnormalities or illness that require medical therapy] as established by medical history, routine haematology and biochemistry parameters and clinical assessment;.

Exclusion Criteria

• Received IPV or OPV booster dose after the age of 12 years; 2.
• Abnormal pre-treatment laboratory haematology and biochemistry parameters which are clinically significant according to the investigator; 4.
• Known or suspected allergy against any of the vaccine components; 5.
• History of unusual or severe reactions to any previous vaccination; 6.
• Known or suspected immune deficiency either congenital or hereditary; 7.
• Systemic treatment with corticosteroids within one month before screening; 8.
• Blood donation within one month before screening; 9.
• History of any neurological disorder including epilepsy or febrile seizures or a family history of mental illness; 10.
• Any infectious disease or acute condition at the time of screening and/or inclusion; 12.
• Individuals with body temperature ≥100.4°F (≥38.0°C) within 3 days prior of intended study immunization; 13.
• Participation in another clinical trial within three months before screening; 14.
• Bleeding disorders or the usage of anticoagulants in the past 3 weeks; 15.
• History of any blood disorder (e.g. thalassemia, thrombocytopenia, disorders of the lymphocytes, anaemias, etc.) in the past 3 weeks; 16.
• Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months; 17.
• Any licensed or investigational drug or vaccine administered within 30 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine; 18.
• An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
• Inability or unwillingness to abide by the requirements of the study: • Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study;.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.Any clinically significant abnormal haematology and biochemistry laboratory parameters - At visit-1 & Visit-3. | 5. At all visits.
2.Proportion of subjects with local and systemic 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.Any clinically significant abnormal haematology and biochemistry laboratory parameters - At visit-1 & Visit-3. | 5. At all 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.Any clinically significant abnormal haematology and biochemistry laboratory parameters - At visit-1 & Visit-3. | 5. At all 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.Any clinically significant abnormal haematology and biochemistry laboratory parameters - At visit-1 & Visit-3. | 5. At all 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.Any clinically significant abnormal haematology and biochemistry laboratory parameters - At visit-1 & Visit-3. | 5. At all visits.

Secondary Outcome Measures

Name	Time	Method
Geometric mean fold rise (GMFR)	At day 28 as measured from baseline.
Proportion of subjects achieving seroconversion.	At day 28 post vaccination
Proportion of subjects achieving ≥2-fold and ≥4-fold increase in anti-Polio serotype specific antibody titre	At 28 days after single dose.
Geometric mean titre (GMT)	At day 28 post vaccination.

Trial Locations

Locations (1)

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

St. Theresa’s Hospital

🇮🇳Hyderabad, TELANGANA, India

Dr A Venkateshwar Rao

Principal investigator

09440040662

venky_gmc@yahoo.co.in