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

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

      • Delhi, India
        • Panchsheel Hospital
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India
        • King George Hospital
    • Haryana
      • Gurgaon, Haryana, India
        • Medanta - The Medicity
    • Maharastra
      • Mumbai, Maharastra, India
        • KEM Hospital

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
PLACEBO_COMPARATOR: Placebo
Placebo administered intramuscularly on Day 0, 29 and 57
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
Within 24 hrs
Occurrence of adverse events and Serious Adverse events post each dose
Time Frame: 7 Days,
safety
7 Days,
Occurrence of adverse events and Serious Adverse event 28 days after the last dose of vaccine
Time Frame: 9 months
safety
9 months

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
Immunogenicity
day 28
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Time Frame: day 56
Immunogenicity
day 56
Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test
Time Frame: day 84
Immunogenicity
day 84
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

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

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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