None listed
Conditions
Interventions
Intervention1: Chikungunya vaccine (Inactivated) of HBI: 1.0 mL will be administered by intramuscular route in the deltoid region of the arm. The vaccine will be administered following 0, 28 days sche
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Subjects of 19 to 49 years of age. 2. Judged to be in good health on the basis of reported medical history, physical examination, laboratory investigations and clinical judgement of the investigator. 3. Plans to remain in the study area for the entire length of the trial. 4. Subject who has understood and provided written Informed Consent. 5. Subjects who are Seronegative for anti-CHIK IgG antibodies. 6. Negative Urine Pregnancy test for female subjects prior to each dose of vaccination.
Exclusion criteria
Exclusion criteria: 1. Participation in any other clinical trial in the four weeks preceding the trial vaccination. 2. Planned participation in any other clinical trial during the present trial period. 3. Subject who has a known history of allergy to any component of the vaccine. 4. Pregnancy or planning to become pregnant during the trial period, Lactation or unreliable contraception in female subjects. 5. Known or suspected primary or acquired disease of the immune system. 6. History of receiving or currently receiving allergy immunotherapy or immunosuppressive therapy except for using topical steroids. 7. Subjects on treatment with any hepatotoxic drug before receiving the vaccine during the last 90 days. 8. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction and autoimmune disease. 9. Having an active or history of arthritis (joint swelling, pain, tenderness, warmth or erythema). 10. History of suspected chikungunya, dengue or Japanese encephalitis. 11. History of contact with any confirmed case of COVID-19 or having tested positive for COVID-19 for less than a month. 12. Diabetes mellitus (type I or II), with the exception of a history of gestational diabetes. 13. Known or suspected acute respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis or any other respiratory problems (e.g. wheezing, shortness of breath). 14. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past one year or that is expected to require the use of oral or intravenous corticosteroids. 15. Any fever with temperature >= 38.0°C (100.4oF) in last 3 days. 16. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms. 17. Any known history or suspicion of thrombocytopenia or a bleeding disorder. 18. Known history or suspicion of HIV, HCV or Hepatitis B. 19. Any history of receipt of blood products in last 3 months. 20. Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days. 21. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1.Solicited/unsolicited local adverse events after each dose vaccination till Day 56 for Group I subjects and Day 84 for Group II subjects in each arm. 2.Solicited/unsolicited systemic adverse events after each dose vaccination till Day 56 for Group I subjects and Day 84 for Group II subjects in each arm. 3.Number of serious adverse events during the study period in each arm of each dosage group. Timepoint: Safety 1.Solicited/unsolicited local adverse events after each dose vaccination till Day 56 for Group I subjects and Day 84 for Group II subjects in each arm. 2.Solicited/unsolicited systemic adverse events after each dose vaccination till Day 56 for Group I subjects and Day 84 for Group II subjects in each arm. 3.Number of serious adverse events during the study period in each arm of each dosage group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity 1. Proportion of subjects achieving seroconversion and seroprotection in each arm of each dosage group on days 28, 56, 84 and 180 from the first dose of vaccination. 2. Geometric mean titres of antibodies in each arm of each dosage group on days 28, 56, 84 and 180 from the first dose of vaccination. Timepoint: Days 28, 56, 84 and 180 from the first dose of vaccination. | — |
Countries
India
Contacts
Public ContactDr S Sai Krishna
Human Biologicals Institute
Outcome results
None listed