A Seamless Phase II/III, Observer-blind, Multi-centre, Randomized Clinical Trial to Evaluate Immunogenicity and Safety of BBV87, an Inactivated Chikungunya Virus Vaccine in Healthy Subjects 12-65 Years of Age
The current study is designed to evaluate the safety, immunogenicity, and lot-to-lot consistency of the BBV87 40 μg vaccine in healthy subjects.This Phase III study is a randomized, observer blind, placebo-controlled, multi-centre, lot-to-lot consistency study with a two-dose schedule. Approximately, 1000 healthy subjects 12 to 65 years of age will be randomized irrespective of CHIKV serological status at Visit 1. Nine hundred subjects will be randomized equally among three lots of BBV87 40 μg. (Lot A, Lot B,and Lot C) while 100 subjects will be administered a placebo. Thus, approximately 1000 subjects will be randomized in allocation ratio 3:3:3:1 (BBV87 40 μg. Lot A: BBV87 40 μg. Lot B: BBV87 40 μg. Lot C: Placebo). Subjects will receive 40 μg dose strength of BBV87, based on the dose approved by the DSMB and CDSCO in the Phase II study. After Day 56, the DSMB will review the safety data during the study to safeguard the interests of trial subjects and assess the vaccine's safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,000
Inactivated Chikungunya Virus Vaccine (BBV87)
Placebo or normal Saline (0.9% )
All India Institute of Medical Sciences
Guwahati, Assam, India
NOT_YET_RECRUITINGAll India Institute of Medical Sciences
Patna, Bihar, India
NOT_YET_RECRUITINGGeometric mean titres of CHIKV antibodies estimation
Geometric mean titres of CHIKV antibodies estimated by PRNT50
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Seroconversion percentage
Percentage of subjects achieving seroconversion of CHIKV antibodies
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Geometric mean titres of CHIKV antibodies estimation of 3 lots
Geometric mean titres of CHIKV antibodies estimated by PRNT50 of three lots of BBV87 40 μg
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Geometric mean titres of CHIKV antibodies estimation
Geometric mean titres of CHIKV antibodies estimated by PRNT50
Time frame: 28 days following Dose 1 (Visit 2-DAY 28)
Seroconversion Percentage
Percentage of subjects achieving seroconversion of CHIKV antibodies
Time frame: 28 days following Dose 1 (Visit 2-DAY 56)
Adverse events
Occurrence, relationship and severity of local and systemic solicited AEs
Time frame: 7 days following each vaccination Dose 1 on day 0 and dose 2 on day 28
Adverse events and Serious adverse events
Occurrence, relationship and severity of unsolicited AEs and SAEs
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Related unsolicited AEs, all SAEs and AEs arthralgia, myalgia
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All India Institute of Medical Sciences
Raipur, Chhattisgarh, India
Redkar Hospital and Research Centre
Mumbai, Goa, India
RECRUITINGPGIMS
Rohtak, Haryana, India
NOT_YET_RECRUITINGIMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital
Bhubaneswar, Odisha, India
RECRUITINGJawahar Lal Nehru medical College
Ajmer, Rajasthan, India
NOT_YET_RECRUITINGSardar Patel Medical College
Bikaner, Rajasthan, India
NOT_YET_RECRUITINGGuru Teg Bahadur Hospital
Delhi, The National Capital Territory (nct) of Delhi, India
RECRUITINGAIIMS Rishikesh Department of Community Medicine
Rishikesh, Uttarakhand, India
NOT_YET_RECRUITINGOccurrence, relationship and severity of related unsolicited AEs, all SAEs and AEs arthralgia, myalgia occurring
Time frame: Post Visit 3 and up to end of study i.e., 11 months (approximately 334 days)