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Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia (IVICHIK001)

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ClinicalTrials.gov Identifier: NCT04566484
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
International Vaccine Institute

Brief Summary:
This study has a Phase II with part A and part B and a Phase III with part C. This Adaptive seamless design will prospectively include planned modifications and incorporate both dose selection (parts A and B) and confirmation of the selected dose (part C) based on the accumulation of subjects' data within the entire study period as shown below. Part C will be randomized for immunogenicity subset and will be open label for safety cohort. The participants assigned to the control group from all parts (i.e, Part A, B and C) will be continuously followed up from the enrollment until the end of the study.

Condition or disease Intervention/treatment Phase
Chikungunya Drug: BBV87 Chikungunya vaccine Drug: Normal Saline Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3210 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Observer-blind in Phase 2 (parts A and B) and phase 3 in the immuno subcohort of Part C. It will be Open label in the safety cohort
Primary Purpose: Prevention
Official Title: A Phase II/III Adaptive Seamless Design, Randomized, Controlled Trial To Evaluate Safety And Immunogenicity of 2 Dose-Regimen Of BBV87 Chikungunya Vaccine In Healthy Subjects Aged 12 to 65 Years In Panama, Colombia, and Thailand
Estimated Study Start Date : December 23, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arm Intervention/treatment
Experimental: BBV87vaccine(BBV87 20 µg/ BBV87 40 µg)

The test article, inactivated Chikungunya virus vaccine 'BBV87', is available in a 2 mL clear glass USP Type 1 vial that contains a single dose of 0.5 mL of the vaccine as singlehuman dose (SHD). Vials are stoppered and sealed with tear-down aluminum seals.

• Route: BBV87 vaccine will be given to participants intramuscularly in the deltoid region of the upper arm. 0.5 mL of the investigational vaccine (BBV87 20 µg/ BBV87 40 µg) will be administered.

Drug: BBV87 Chikungunya vaccine
BBV87 Chikungunya vaccine is a whole virus inactivated vaccine formulated with 0.25 mg aluminum (as aluminum hydroxide) per single human dose.

Placebo Comparator: Normal Saline
Each 0.5 ml vial of placebo will contain normal saline.The placebo will be given to participants intramuscularly in the deltoid region of the upper arm.0.5 mL of placebo will be administered.
Drug: Normal Saline
Normal saline is the placebo




Primary Outcome Measures :
  1. Geometric mean titers (GMT) of neutralization antibody [ Time Frame: 28 days post second dose ]
    Geometric mean titers (GMT) of neutralization antibody measured by plaque reduction neutralization test (PRNT50) at 28 days post second dose of BBV87/ Placebo

  2. Proportion of participants with treatment emergent adverse events (TEAEs) [ Time Frame: On or after vaccination. ]
    Proportion of participants with treatment emergent adverse events (TEAEs) TEAEs are defined for this trial as any AEs/AESIs/SAEs that occur on or after vaccination.


Secondary Outcome Measures :
  1. Seroconversion rates [ Time Frame: at 28 days post second dose of BBV87/ Placebo compared to baseline ]
    Seroconversion rates (seroconversion is defined as a 4-fold rise in PRNT50 titers) at 28 days post second dose of BBV87/ Placebo compared to baseline

  2. GMT of neutralization antibody [ Time Frame: at 28 days post first dose of BBV87/ Placebo ]
    GMT of neutralization antibody measured by PRNT50 at 28 days post first dose of BBV87/ Placebo

  3. Seroconversion rates [ Time Frame: at 28 days post first dose of BBV87/ Placebo compared to baseline ]
    Seroconversion rates by PRNT50 at 28 days post first dose of BBV87/ Placebo compared to baseline

  4. GMT of neutralization antibody [ Time Frame: at 6 months (168 days) post second dose of BBV87/ Placebo (Part B and C only) ]
    GMT of neutralization antibody measured by PRNT50 at 6 months (168 days) post second dose of BBV87/ Placebo (Part B and C only)

  5. Seroconversion rates [ Time Frame: At 6 months (168 days) post second dose of BBV87/Placebo compared to baseline (Part B and C only) ]
    Seroconversion rates by PRNT50 at 6 months (168 days) post second dose of BBV87/ Placebo compared to baseline (Part B and C only) Seroconversion rates by PRNT50 at 6 months (168 days) post second dose of BBV87/Placebo compared to baseline (Part B and C only)

  6. GMT of Chikungunya-binding IgG titers [ Time Frame: At 28 days post second dose of BBV87/ Placebo ]
    GMT of Chikungunya-binding IgG titers by ELISA at 28 days post second dose of BBV87/ Placebo

  7. Seroconversion rates [ Time Frame: At 28 days post second dose of BBV87/ Placebo compared to baseline ]
    Seroconversion rates (seroconversion is defined as a 4-fold rise in Chikungunya-binding IgG titers by ELISA) at 28 days post second dose of BBV87/ Placebo compared to baseline

  8. GMT of Chikungunya-binding IgG titers [ Time Frame: At 28 days post first dose of BBV87/Placebo ]
    GMT of Chikungunya-binding IgG titers by ELISA at 28 days post first dose of BBV87/Placebo

  9. Seroconversion rates of Chikungunya-binding IgG titers [ Time Frame: At 28 days post first dose of BBV87/ Placebo compared to baseline ]
    Seroconversion rates of Chikungunya-binding IgG titers by ELISA at 28 days post first dose of BBV87/ Placebo compared to baseline

  10. GMT of Chikungunya-binding IgG titers [ Time Frame: At 6 months (168 days) post second dose of BBV87/ Placebo ]
    GMT of Chikungunya-binding IgG titers by ELISA at 6 months (168 days) post second dose of BBV87/ Placebo

  11. Seroconversion rates Chikungunya-binding IgG titers [ Time Frame: At 6 months (168 days)post second dose of BBV87/ Placebo vaccine compared to baseline (Part B and C only) ]
    Seroconversion rates Chikungunya-binding IgG titers by ELISA at 6 months (168 days) post second dose of BBV87/ Placebo vaccine compared to baseline (Part B and C only)

  12. Proportion of participants with solicited local and systemic adverse events within 7 days post vaccination [ Time Frame: Within 7 days post vaccination ]
    Proportion of participants with solicited local and systemic adverse events within 7 days post vaccination

  13. Proportion of participants with unsolicited adverse events within 28 days post vaccination [ Time Frame: Within 28 days post vaccination ]
    Proportion of participants with unsolicited adverse events within 28 days post vaccination

  14. Proportion of participants with Serious Adverse Events [ Time Frame: During entire study period ]
    Proportion of participants with Serious Adverse Events during entire study period

  15. Proportion of participants Adverse Events of Special Interest [ Time Frame: During entire study period ]
    Proportion of participants Adverse Events of Special Interest during entire study period transmission of chikungunya for the last 15 days)) confirmed by Real Time Polymerase Chain Reaction (RT-PCR) during entire study period


Other Outcome Measures:
  1. Number of Chikungunya cases [ Time Frame: During entire study period ]
    Number of Chikungunya cases [fever > 38.5 C and joint pain (usually incapacitating) with acute onset; and with epidemiological criterion (i.e., resident or visitor in areas with local

  2. GMT of neutralization antibody [ Time Frame: At 14 days post first dose of BBV87/ ]
    GMT of neutralization antibody measured by PRNT50 at 14 days post first dose of BBV87/Placebo (Part A only)

  3. Seroconversion rates by PRNT50 at 14 days post first dose of BBV87/ Placebo compared to baseline (Part A only) [ Time Frame: At 14 days post first dose of BBV87/ Placebo ]
    Seroconversion rates by PRNT50 at 14 days post first dose of BBV87/ Placebo compared to baseline (Part A only)

  4. GMT of Chikungunya-binding IgG titers by ELISA [ Time Frame: At 14 days post first dose of BBV87/ ]
    GMT of Chikungunya-binding IgG titers by ELISA at 14 days post first dose of BBV87/Placebo (Part A only).

  5. Seroconversion rates of Chikungunya-binding IgG titers [ Time Frame: At 14 days post first dose of BBV87/ Placebo compared to baseline (Part A only) ]
    Seroconversion rates of Chikungunya-binding IgG titers by ELISA at 14 days post first dose of BBV87/ Placebo compared to baseline (Part A only)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Part A first component : Healthy participants 18 to 65 years of age at enrollment. Good health is based on medical history and physical examination Part A second component, Part B and Part C: Healthy participants 12 to 65 years of age at enrollment. Good health is based on medical history and physical examination
  • Participants/Parent(s)/LAR who have voluntarily signed and dated informed consent/assent based on local regulation. In case of a public health emergency in which site visits is not permitted, the informed consent can be obtained in accordance with the local IRB/EC or local regulatory agency guidelines.
  • Participants/Parent(s)/LAR who are able to attend all scheduled visits and to comply with all trial procedures
  • Willing to give authorization for the use of blood samples to be stored and used for future research

Criteria applicable to women and adolescents of childbearing potential:

  • Negative result on a human chorionic gonadotropin pregnancy test on day of enrollment before receiving study products.
  • Agree to use effective birth control methods (or abstinence) during the duration of the study.

    • Adequate birth control is defined as follows, but not limited to: contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), and abstinence.

Note: If the subject during the pregnancy counseling process, answers yes to menopausal statuts with amenorrhea for at least 2 years, hysterectomy, or tubal ligation,therefore is not of childbearing potential.

Exclusion Criteria:

  • Participant with a congenital abnormality
  • Participants concomitantly enrolled or scheduled to be enrolled in another trial
  • Any female participant who is lactating, pregnant* or planning for pregnancy** during the course of study period
  • History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Screening visit
  • Documented thrombocytopenia
  • Medical history of uncontrolled coagulopathy or blood disorders.
  • Documented medical history of seropositivity for Human Immunodeficiency Virus (HIV) infection.
  • Documented medical history or suspected congenital or acquired immune function disorders.
  • Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone or equivalent for periods exceeding 10 days within the past 3 months ), cytotoxic or other immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
  • Receipt of blood or blood-derived products in the past 3 months
  • Participant who has received other vaccines from 1 month prior to test vaccination or planned to receive any vaccine within 1 month excluding a public health vaccination campaingn due to an outbreak
  • Known history or allergy to vaccines
  • Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
  • Participants/Parent(s)/LAR planning to move from the study area before the end of study period
  • Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily (part of a vulnerable population).
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • As per Investigator's medical judgment individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above
  • Employee of the study center directly involved with the proposed study or with study investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566484


Contacts
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Contact: LIBIA M HERNANDEZ, MD. MSc +573003188445 libia.hernandez@ivi.int
Contact: ANH WARTEL, MD. +821031402603 Anh.Wartel@ivi.int

Sponsors and Collaborators
International Vaccine Institute
Investigators
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Study Director: Sushant Sahastrabuddhe, MBBS, MPH Director, Chikungunya Program,International Vaccine Institute
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Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT04566484    
Other Study ID Numbers: InternationalVaccineI
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chikungunya Fever
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases