None listed
Conditions
Interventions
Intervention1: JENVAc: The JE vaccine (BBIL?S) is purified inactivated vaccine, containing the JEV strain isolated from a clinical case of JE infection from an endemic area in India. The strain was ad
Sponsors
Bharat Biotech Intl Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy volunteers of 50 to 1 years age group (inclusive) without significant medical history or abnormal findings at screening 2.Willing to give signed written Informed Consent. 3.Available for all study related visits and procedures for the entire duration of the study, without any known exposure to JE prior to the first screening visit based on previous clinical history.
Exclusion criteria
Exclusion criteria: 1. Subjects with the age less than 1 and above 50 years. 2. Fever of any origin of duration more than 3 days within one month prior to screening or on the day of screening. 3. History of malaise, head ache, anorexia at the time of screening or during the administration of the vaccine under study. 4. Past history of JE infection. 5. Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, hematological or immune disorders. 6. Past history of / current allergic diseases. 7. Any confirmed or suspected immunosuppressive or immunodeficient condition 8. Use of any marketed or investigational or herbal medicine or non registered drug or vaccine for JE or other vaccine in the past 2 months. 9. Clinically relevant abnormal hematology or biochemistry values in the opinion of the investigator. 10. Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol. 11. Intention to travel out of the area prior to final or follow-up Visit on day 56±2. 12. Previous history of hypersensitive reaction to vaccine or Vaccine component.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving 4-fold or greater neutralizing antibody titer in subjects seropositive at baseline (â?¥1:10) at day 28±2 after a single dose of vaccination. Proportion of participants that are seronegative at baseline (1:10) will require a PRNT50 titer of â?¥1:10 to meet the criteria for seroconversion at day 28±2 after a single dose of vaccination.. GMT in each group on day 0 and day 28±2. Timepoint: GMT at 0 and 28±2 day. 4-fold 56±2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited and unsolicited local and systemic AEs within 28 days and 56 days of post vaccination on day 0, 28±2 and 56±2. Occurrence of vaccine-associated SAEs throughout the course of the study. Proportion of participants achieving 4-fold or greater neutralizing antibody titer at day 56±2 after two doses of vaccination Timepoint: AEs day 0, 28±2 and 56±2 4-fold conversion 56±2 | — |
Countries
India
Contacts
Public ContactDrA Singh
Outcome results
None listed