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Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine

Primary Purpose

Chikungunya

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Inactivated Chikungunya virus vaccine 20 mcg
Inactivated Chikungunya virus vaccine 30 mcg
Inactivated Chikungunya virus vaccine 10 mcg
Placebo
Sponsored by
Bharat Biotech International Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • King George Hospital
  • Medanta - The Medicity
  • KEM Hospital
  • Panchsheel Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

BBV87 - 10 mcg

Placebo

BBV87 -30 mcg

BBV87 -20 mcg

Arm Description

Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths (10, 20 and 30 mcg) administered intramuscularly on Day 0, 29 and 57

Placebo administered intramuscularly on Day 0, 29 and 57

Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57

Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57

Outcomes

Primary Outcome Measures

Occurrence of adverse events and Serious Adverse events post each dose
safety
Occurrence of adverse events and Serious Adverse events post each dose
safety
Occurrence of adverse events and Serious Adverse event 28 days after the last dose of vaccine
safety

Secondary Outcome Measures

Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Immunogenicity
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Immunogenicity
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Immunogenicity
Proportion of subjects with four fold seroconversion
Immunogenicity
Proportion of subjects with four fold seroconversion
Immunogenicity
Proportion of subjects with four fold seroconversion
Immunogenicity

Full Information

First Posted
July 17, 2017
Last Updated
October 26, 2020
Sponsor
Bharat Biotech International Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04603131
Brief Title
Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bharat Biotech International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
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 day1, day29, day57. Vaccine will be administered through intramuscular route.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBV87 - 10 mcg
Arm Type
Experimental
Arm Description
Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths (10, 20 and 30 mcg) administered intramuscularly on Day 0, 29 and 57
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered intramuscularly on Day 0, 29 and 57
Arm Title
BBV87 -30 mcg
Arm Type
Experimental
Arm Description
Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
Arm Title
BBV87 -20 mcg
Arm Type
Experimental
Arm Description
Inactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
Intervention Type
Biological
Intervention Name(s)
Inactivated Chikungunya virus vaccine 20 mcg
Intervention Description
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
Intervention Type
Biological
Intervention Name(s)
Inactivated Chikungunya virus vaccine 30 mcg
Intervention Description
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
Intervention Type
Biological
Intervention Name(s)
Inactivated Chikungunya virus vaccine 10 mcg
Intervention Description
3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
3 doses of Placebo administered intramuscularly on Day 0, 29 and 57
Primary Outcome Measure Information:
Title
Occurrence of adverse events and Serious Adverse events post each dose
Description
safety
Time Frame
Within 24 hrs
Title
Occurrence of adverse events and Serious Adverse events post each dose
Description
safety
Time Frame
7 Days,
Title
Occurrence of adverse events and Serious Adverse event 28 days after the last dose of vaccine
Description
safety
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Description
Immunogenicity
Time Frame
day 28
Title
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Description
Immunogenicity
Time Frame
day 56
Title
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Description
Immunogenicity
Time Frame
day 84
Title
Proportion of subjects with four fold seroconversion
Description
Immunogenicity
Time Frame
day 28
Title
Proportion of subjects with four fold seroconversion
Description
Immunogenicity
Time Frame
day 56
Title
Proportion of subjects with four fold seroconversion
Description
Immunogenicity
Time Frame
day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishna Mohan, PHD
Organizational Affiliation
Bharat Biotech International Limited
Official's Role
Study Director
Facility Information:
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
Country
India
Facility Name
Medanta - The Medicity
City
Gurgaon
State/Province
Haryana
Country
India
Facility Name
KEM Hospital
City
Mumbai
State/Province
Maharastra
Country
India
Facility Name
Panchsheel Hospital
City
Delhi
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine

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