- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603131
Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine
October 26, 2020 updated by: Bharat Biotech International Limited
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
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This is an open label phase I study for assessing the safety, tolerance and immunogenicity of 3 escalated doses of the test vaccine, BBV87.
The study design has four treatment groups - 3 test groups and a control placebo group with 15 subjects in each group.
However, the groups will be divided into three study arms: each arm will have 15 subjects of the test vaccine group and 5 subjects of the placebo group.
The randomization will be done in a way that allots 5 subjects of the placebo group to each test dose group.
All subjects will be screened (via medical history, physical examination and laboratory investigations) to establish the eligibility criteria.
This includes negative antibodies, CHIKV IgG, by ELISA method.
The test vaccine and placebo will be administered as 3 doses at 28 days interval on day 1±2, 29±2, and 57±2.
Vaccine administration will be performed as an in-patient procedure.
Subjects will be admitted in CPU 24 hrs prior to vaccine administration, and will be shifted to MICU for vaccination and observed for 48 hrs; and will be discharged upon completion of all clinical monitoring procedures.
Laboratory and biochemical tests will be performed as part of clinical monitoring before discharge, and 24 hrs after vaccine administration.
Following vaccination, all participants will be monitored throughout the study period for adverse events with daily telephone contacts (for 7 days after each vaccine, and then weekly), interim clinic visits, subject diary cards, and haematological & biochemical laboratory tests.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Delhi, India
- Panchsheel Hospital
-
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Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, India
- King George Hospital
-
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Haryana
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Gurgaon, Haryana, India
- Medanta - The Medicity
-
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Maharastra
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Mumbai, Maharastra, India
- KEM Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥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
Exclusion Criteria:
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
- Have an active or history of malignant conditions including haematological malignancy
- Have a history of degenerative neurological disease (e.g. GuillainBarre Syndrome, multiple sclerosis)
- Have received any vaccination within 4 weeks prior to the vaccination in this study
- Have received blood transfusion or immunoglobulin within 30 days prior to vaccination in this study
- Have a history of serious reactions to any vaccines that preclude receipt of study vaccinations as determined by the investigator
- Have asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
- Have diabetes mellitus (type I or II), with the exception of history of gestational diabetes
- Have received any investigational drug in 6 weeks prior to screening
- Is currently participating in any form of clinical trial that involves intervention.
- Is likely to participate in any other clinical trial during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BBV87 - 10 mcg
Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths (10, 20 and 30 mcg) administered intramuscularly on Day 0, 29 and 57
|
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
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PLACEBO_COMPARATOR: Placebo
Placebo administered intramuscularly on Day 0, 29 and 57
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3 doses of Placebo administered intramuscularly on Day 0, 29 and 57
|
EXPERIMENTAL: BBV87 -30 mcg
Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
|
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
|
EXPERIMENTAL: BBV87 -20 mcg
Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
|
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of adverse events and Serious Adverse events post each dose
Time Frame: Within 24 hrs
|
safety
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Within 24 hrs
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Occurrence of adverse events and Serious Adverse events post each dose
Time Frame: 7 Days,
|
safety
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7 Days,
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Occurrence of adverse events and Serious Adverse event 28 days after the last dose of vaccine
Time Frame: 9 months
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safety
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9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Time Frame: day 28
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Immunogenicity
|
day 28
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Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Time Frame: day 56
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Immunogenicity
|
day 56
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Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Time Frame: day 84
|
Immunogenicity
|
day 84
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Proportion of subjects with four fold seroconversion
Time Frame: day 28
|
Immunogenicity
|
day 28
|
Proportion of subjects with four fold seroconversion
Time Frame: day 56
|
Immunogenicity
|
day 56
|
Proportion of subjects with four fold seroconversion
Time Frame: day 84
|
Immunogenicity
|
day 84
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Krishna Mohan, PHD, Bharat Biotech International Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 17, 2017
Primary Completion (ACTUAL)
January 30, 2018
Study Completion (ACTUAL)
July 30, 2018
Study Registration Dates
First Submitted
July 17, 2017
First Submitted That Met QC Criteria
October 23, 2020
First Posted (ACTUAL)
October 26, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 28, 2020
Last Update Submitted That Met QC Criteria
October 26, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBIL/CHIKV/I/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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