None listed
Conditions
Interventions
Intervention1: Chikungunya virus vaccine: Purified inactivated Chikungunya virus antigen vaccine.Two dose strengths of investigational vaccine, BBV87. Low dose BBV87 and high dose BBV87 is administere
Sponsors
Bharat Biotech International Ltd
Bharat Biotech International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -Healthy male and female subjects aged between 12 to 65 years (both inclusive). -Subject or Subjectâ??s Parent should be willing to give voluntary written informed consent and/or assent prior to inclusion in the study. -Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. -Willing to consent to the storage and future use of biological samples for CHIKV related research. -Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child-bearing potential should be willing to follow effective birth control methods for at least 3 months after the last dose of vaccine.
Exclusion criteria
Exclusion criteria: -History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Screening visit. -Subject a known case of diabetes mellitus (Type 1 and 2). -History of degenerative neurological disease (e.g. Guillain Barre Syndrome, Multiple Sclerosis). -Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. -History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. -Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature >= 38°C or >= 100.4 °F) within 48 hours prior to vaccination. -Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease). -Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease). -Subjects who are pregnant or breast feeding. -Prior major surgery or any radiation therapy within 4 weeks of Screening visit. -Positive serologic test for HIV 1 and 2, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Investigator. -Current (within 14 days prior to Screening visit) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). -Receipt of licensed vaccines within 30 days prior to first vaccination. -Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. - Active addictive drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints. -Participating in another clinical trial within 30 days prior to Screening visit or planning to participate during the study -History of participation in Investigational Chikungunya virus vaccine trial. -Any other condition which in the opinion of the Investigator may affect subjectâ??s safety or participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogeneity 1.Immune Response following two doses: Geometric mean titres of CHIKV antibodies estimated by PRNT50 2.Safety and Tolerability: a.Occurrence, relationship and severity of local and systemic solicited adverse events (AE) b. Occurrence, relationship and severity of unsolicited AEs and serious adverse events (SAE) c.Occurrence, relationship and severity of related unsolicited AEs, all SAEs and AEs- arthralgia, myalgia Timepoint: Immunogeneity 1.Immune Response following two doses: Geometric mean titres of CHIKV antibodies estimated by PRNT50 2.Safety and Tolerability: a. occurring up to 7 days following each vaccination. b. occurring up to 28 days following Dose 2 (Visit 3) c. occurring post Visit 3 and up to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: 1.a.Immune Response following two doses: Percentage of subjects achieving seroconversion of CHIKV antibodies. 2.Immune Response following Single Dose a.Geometric mean titres of CHIKV antibodies estimated by PRNT50 b.Percentage of subjects achieving seroconversion of CHIKV antibodies.Timepoint: 1.28 days following Dose 2 (Visit 3) 2a.28 days following Dose 1 (Visit 2) 2b.28 days following Dose 1 (Visit 2) | — |
Countries
India
Contacts
Public ContactDr Krishna Mohan
Bharat Biotech International limited
Outcome results
None listed