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AzTrials

ChikungunyaPhase 1NCT04603131

Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine

A Phase 1 study testing Inactivated Chikungunya virus vaccine 20 mcg, Inactivated Chikungunya virus vaccine 30 mcg and Inactivated Chikungunya virus vaccine 10 mcg in people with Chikungunya, run by Bharat Biotech International Limited at 4 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Chikungunya
What is being tested?
Inactivated Chikungunya virus vaccine 20 mcg, Inactivated Chikungunya virus vaccine 30 mcg and Inactivated Chikungunya virus vaccine 10 mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
4 sitesIndia
Study dates
17 Apr 2017to 30 Jul 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ≥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

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

India4 sites

  • Panchsheel Hospital

    Delhi

  • Medanta - The Medicity

    Gurgaon, Haryana

  • KEM Hospital

    Mumbai, Maharashtra

  • King George Hospital

    Visakhapatnam, Andhra Pradesh

Other trials in India

About this study

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

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.

Read the 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.

Conditions
Chikungunya
Being tested
Inactivated Chikungunya virus vaccine 20 mcg, Inactivated Chikungunya virus vaccine 30 mcg, Inactivated Chikungunya virus vaccine 10 mcg, Placebo
Medical subject headings
Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inactivated Chikungunya virus vaccine 20 mcgBiological

    3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57

  • Inactivated Chikungunya virus vaccine 30 mcgBiological

    3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57

  • Inactivated Chikungunya virus vaccine 10 mcgBiological

    3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57

  • PlaceboBiological

    3 doses of Placebo administered intramuscularly on Day 0, 29 and 57

Study groups in NCT04603131
Study groupRoleWhat they receive
BBV87 - 10 mcgExperimentalInactivated Chikungunya virus vaccine (BBV87) in three dose strengths (10, 20 and 30 mcg) administered intramuscularly on Day 0, 29 and 57
Receives: Biological: Inactivated Chikungunya virus vaccine 10 mcg
PlaceboPlacebo comparatorPlacebo administered intramuscularly on Day 0, 29 and 57
Receives: Biological: Placebo
BBV87 -30 mcgExperimentalInactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
Receives: Biological: Inactivated Chikungunya virus vaccine 20 mcg
BBV87 -20 mcgExperimentalInactivated Chikungunya virus vaccine (BBV87) in three dose strengths administered intramuscularly on Day 0, 29 and 57
Receives: Biological: Inactivated Chikungunya virus vaccine 30 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of adverse events and Serious Adverse events post each dose

    safety

    Measured: Within 24 hrs

  2. Occurrence of adverse events and Serious Adverse events post each dose

    safety

    Measured: 7 Days,

  3. Occurrence of adverse events and Serious Adverse event 28 days after the last dose of vaccine

    safety

    Measured: 9 months

Secondary outcomes (6)

  1. Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test

    Immunogenicity

    Measured: day 28

  2. Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test

    Immunogenicity

    Measured: day 56

  3. Immunogenicity in terms of GMT estimated by 50 percent plaque reduction neutralization test

    Immunogenicity

    Measured: day 84

  4. Proportion of subjects with four fold seroconversion

    Immunogenicity

    Measured: day 28

  5. Proportion of subjects with four fold seroconversion

    Immunogenicity

    Measured: day 56

  6. Proportion of subjects with four fold seroconversion

    Immunogenicity

    Measured: day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start17 Apr 2017
  3. Primary completion30 Jan 2018
  4. Study completion30 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
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)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603131
Sponsor's protocol ID
BBIL/CHIKV/I/2014
Status last verified
Oct 2020
First submitted
17 Jul 2017
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Inactivated Chikungunya virus vaccine 20 mcg, Inactivated Chikungunya virus vaccine 30 mcg and Inactivated Chikungunya virus vaccine 10 mcg in people with Chikungunya, run by Bharat Biotech International Limited at 4 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of adverse events and Serious Adverse events post each dose (time frame: Within 24 hrs). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04603131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.

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