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

NCT04566484 | Terminated Phase 2 DMC

• 1 other identifier: InternationalVaccineI
• Study Type: interventional
• Target: 3,210
• Locations: 4 countries
• Sites: 4

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.

Conditions

Chikungunya

Outcome Measures

Primary Outcomes (2)

• Geometric mean titers (GMT) of neutralization antibody

  Geometric mean titers (GMT) of neutralization antibody measured by plaque reduction neutralization test (PRNT50 and/or micro-PRNT) at 28 days post second dose of BBV87/ Placebo

  28 days post second dose

• Proportion of participants with treatment emergent adverse events (TEAEs)

  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.

  On or after vaccination.

Secondary Outcomes (15)

• Seroconversion rates

  at 28 days post second dose of BBV87/ Placebo compared to baseline

• GMT of neutralization antibody

  at 28 days post first dose of BBV87/ Placebo

• Seroconversion rates

  at 28 days post first dose of BBV87/ Placebo compared to baseline

• GMT of neutralization antibody

  at 6 months (168 days) post second dose of BBV87/ Placebo (Part B and C only)

• Seroconversion rates

  At 6 months (168 days) post second dose of BBV87/Placebo compared to baseline (Part B and C only)

Other Outcomes (5)

• Number of Chikungunya cases

  During entire study period

• GMT of neutralization antibody

  At 14 days post first dose of BBV87/

• Seroconversion rates by PRNT50 at 14 days post first dose of BBV87/ Placebo compared to baseline (Part A only)

  At 14 days post first dose of BBV87/ Placebo

Study Arms (2)

BBV87vaccine(BBV87 20 µg/ BBV87 40 µg)

EXPERIMENTAL

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

Normal Saline

PLACEBO COMPARATOR

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

Interventions

BBV87 Chikungunya vaccine DRUG

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

BBV87vaccine(BBV87 20 µg/ BBV87 40 µg)

Normal Saline DRUG

Normal saline is the placebo

Normal Saline

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, any individual must meet the following 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 Criteria applicable to women and adolescents of childbearing potential
• Negative result on a pregnancy test (urine/serum) 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Any current or pre-existing health conditions (e.g., any major congenital defects, etc) which in the opinion of the investigator may affect the safety of the subject or the study endpoints.
• 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.
• Medical history of seropositivity for Human Immunodeficiency Virus (HIV) infection.
• 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
• Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks of the study vaccine administration, except emergency vaccination after any dose.
• Known history or allergy to vaccine components and excipients.
• 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

Sponsors & Collaborators

• International Vaccine Institute: lead

Study Sites (7)

Clínica de la Costa

Barranquilla, Atlántico, Colombia

Location

Centro de Atención en Investigación Médica (CAIMED).

Yopal, Casanare Department, Colombia

Location

Centro de Atencion y Diagnostico de Enfermedades Infecciosas (CDI).

Bucaramanga, Santander Department, Colombia

Location

Clínica San Agustín

San José, Costa Rica

Location

Centro de Estudios Clínicos Salud Avanzada. (CECLISA)

Guatemala City, Guatemala

Location

Centro de Vacunacion Internacional S.A. CEVAXIN

Panama City, Panama

Location

Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Chikungunya Fever

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sushant Sahastrabuddhe, MBBS, MPH

  Director, Chikungunya Program,International Vaccine Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: August 1, 2021
• Primary Completion: July 19, 2022
• Study Completion: May 31, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); PA (1); TH (1); GU (1)