None listed
Conditions
Interventions
Intervention1: vaccine: trivalent (H1N1) inactivated influenza vaccine (Cadiflu-S) 0.5 ml intramusclarly stat dose only
Control Intervention1: Volunteer will not receive anything: Nil
Sponsors
Christian Medical College Vellore
Eligibility
Inclusion criteria
Inclusion criteria: Adult volunteers who are between 21 to 60 years old, who are in good health (as evaluated by physician by clinical history, examination, and investigations) who do not meet the exclusion criteria will be recruited
Exclusion criteria
Exclusion criteria: (1) Baseline HAI titres > 1:20 (2) Pregnant women [pregnancy will be ascertained in women of reproductive age group by menstrual history and urine testing if necessary] (3) Any vaccination received in the last two weeks (4) Volunteers who have been vaccinated against influenza in the last one year [as ascertained from volunteerâ??s recall or documentation if available] (5) Ongoing respiratory infections or respiratory infections in the last 1 month (6) Antibiotic usage within the last 2 weeks (7) Regular drug intake for any chronic illness or condition (including diabetes, hypertension) (8) Chronic respiratory conditions including COPD, asthma, ILD (9) Egg allergy (as per influenza vaccines patient leaflet). (10) Current regular (daily) smoker. (11) A long-term health problem with heart disease, lung disease (including asthma), kidney disease, neurologic disease, liver disease, metabolic disease (e.g., diabetes), or anaemia or another blood disorder (LAIV [Live Attenuated Influenza Vaccine] contraindications list). (12) Use of drugs for the treatment of rheumatoid arthritis, Crohnâ??s disease, or psoriasis or anticancer drugs; or radiation treatments (LAIV contraindications list). (13) Live with or expect to have close contact with a person whose immune system is severely compromised and who must be in protective isolation (e.g., an isolation room of a bone marrow transplant unit) (14) Hemoglobin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. After administration of inactivated vaccine and before challenge with nasal LAIV (day-0, day-3, day-7, day-14, day-30--0 hour): a. measurement of serum antibody levels (measured by ELISA or HAI responses) b. measurement of kinetics of plasma cells, memory B cells and effector T cells by immunophenotyping 2. After challenge with nasal LAIV vaccine (day 30 and at 7 time points between day-32 to day-44): a. measurement of kinetics of mucosal viral loads in MLF or NW.Timepoint: 1. After administration of inactivated vaccine and before challenge with nasal LAIV (day-0, day-3, day-7, day-14, day-30--0 hour): a. measurement of serum antibody levels (measured by ELISA or HAI responses) b. measurement of kinetics of plasma cells, memory B cells and effector T cells by immunophenotyping 2. After challenge with nasal LAIV vaccine (day 30 and at 7 time points between day-32 to day-44): a. measurement of kinetics of mucosal viral loads in MLF or NW. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. After administration of inactivated vaccine and before challenge with nasal LAIV (day-0, day-3, day-7, day-14, day-30--0 hour): a. Serum antibody levels estimated by microneutralization, neuraminidase inhibition b. Serum antibody effector function (ADP, ADCC) c. Measurement of kinetics of antigen-specific CD4 and CD8 T cells. 2. After challenge with nasal LAIV vaccine (day 30 and at all time points thereafter): a. Measurements in MLF or NW i. measurement of mucosal antibody levels (measured by ELISA, HAI, microneutralization, NAI responses) in MLF or NW. ii. measurement of inflammatory cytokine levels on day-30 before administration of nasal vaccine and 4 hours after administration (hour-0 and hour-4 samples on day-30). b. Measurements in blood (9 time points, day-30 to day-60) i. Serum antibody levels (measured by ELISA, HAI, microneutralization, NAI responses) ii. Serum antibody effector function (ADP, ADCC) iii. Kinetics of plasma cells and memory B cellsTimepoint: 1. After administration of inactivated vaccine and before challenge with nasal LAIV (day-0, day-3, day-7, day-14, day-30--0 hour) 2. After challenge with nasal LAIV vaccine (day 30 and at all time points thereafter): a b. Measurements in blood (9 time points, day-30 to day-60) | — |
Countries
India
Contacts
Public ContactBARNEY ISAAC T J
Christian Medical College
Outcome results
None listed