Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine
Phase-I Open Label, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Chikungunya Vaccine in Healthy Adults of 18 to 50 Years Age
1 other identifier
interventional
60
1 country
4
Brief Summary
Chikungunya vaccine is an inactivated virus vaccine. There will be three study arms and subjects will be vaccinated in a dose escalation manner.In each arm, vaccine will be administered on Day 1, Day 29, and Day 57. Vaccine will be administered through intramuscular route.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2017
CompletedFirst Submitted
Initial submission to the registry
July 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedOctober 28, 2020
October 1, 2020
10 months
July 17, 2017
October 26, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Occurrence of adverse events and Serious Adverse events post each dose
safety
Within 24 hrs
Occurrence of adverse events and Serious Adverse events post each dose
safety
7 Days,
Occurrence of adverse events and Serious Adverse event 28 days after the last dose of vaccine
safety
9 months
Secondary Outcomes (6)
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
day 28
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
day 56
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
day 84
Proportion of subjects with four fold seroconversion
day 28
Proportion of subjects with four fold seroconversion
day 56
- +1 more secondary outcomes
Study Arms (4)
BBV87 - 10 mcg
EXPERIMENTALInactivated Chikungunya virus vaccine (BBV87) in three dose strengths (10, 20 and 30 mcg) administered intramuscularly on Day 0, 29 and 57
Placebo
PLACEBO COMPARATORPlacebo administered intramuscularly on Day 0, 29 and 57
BBV87 -30 mcg
EXPERIMENTALInactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
BBV87 -20 mcg
EXPERIMENTALInactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
Interventions
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
Eligibility Criteria
You may qualify if:
- ≥18 and ≤50 yrs inclusive on the day of screening
- Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
- Medical history and physical examination without clinically significant findings at the time of screening
- Haematological and biochemical values either within institutional normal range and accompanied by physician approval
- Agree to keep a daily record of symptoms for the duration of the study
- Available for clinical follow-up throughout the study period via telephone contact as well as clinic visits
- Female specific criteria:
- If female of child bearing potential- have a negative urine pregnancy test result within 24 hrs of the scheduled first vaccination
You may not qualify if:
- Female specific criteria:
- Woman who is breast feeding or planning to become pregnant during the study period.
- General Criteria:
- History of suspected or confirmed Chikungunya fever
- (Case definition for Suspected Chikungunya: A subject meeting both the clinical and epidemiological criteria.
- Clinical criteria: acute onset of fever \>38.5°C and severe arthralgia/arthritis not explained by other medical conditions.
- Epidemiological criteria: residing or having visited epidemic areas, having reported transmission within 15 days prior to the onset of symptoms.
- Case definition for Confirmed Chikungunya:
- A subject meeting the laboratory criteria of positive ELISA test for CHIKV IgG.)
- Clinically significant abnormal clinical laboratory values including blood pressure(\>140 mmHg systolic and \>90 mmHg diastolic) when 3 measurements are taken 30 min apart , in seating position and at rest
- Body mass index (BMI) ≥ 25 \[BMI will be calculated as weight in Kilograms/(height in metres)2\]
- Test positive for HIV or Hepatitis B infection
- History of cardiovascular disease
- History of immune deficiency or autoimmune disease
- Have active or history of arthritis (joint swelling, pain, tenderness, warmth or erythema) within the last 6 months from date of screening
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Medanta - The Medicity
Gurgaon, Haryana, India
KEM Hospital
Mumbai, Maharashtra, India
Panchsheel Hospital
Delhi, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Krishna Mohan, PHD
Bharat Biotech International Limited
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2017
First Posted
October 26, 2020
Study Start
April 17, 2017
Primary Completion
January 30, 2018
Study Completion
July 30, 2018
Last Updated
October 28, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share