The primary and secondary objectives and end points to RSV001
| End point measures | ||
|---|---|---|
| Primary objective: vaccine safety and tolerability | Solicited and unsolicited symptoms recorded daily for 1 week after each vaccine dose | Oral temperature Solicited symptoms: headache, nausea and/or vomiting, malaise, myalgia and arthralgia Local injection site adverse events: pain and/or tenderness, erythema, induration and swelling Local nasal site adverse events: pain and/or tenderness, irritation and discharge Any other event not listed above (unsolicited symptoms) |
| Nursing observations obtained at all visit attendances | Resting heart rate, resting respiratory rate, systolic and diastolic blood pressure and oral temperature | |
| Safety bloods obtained at scheduled visit attendances | Haematology: haemoglobin, total white cell count, platelet count, haematocrit, red cell count, mean cell volume, mean haemoglobin, mean haemoglobin concentration, neutrophil count, lymphocyte count, monocyte count, eosinophil count and basophil count Biochemistry: sodium, potassium, urea, amylase, C reactive protein, creatinine, bilirubin, alanine transaminase, alkaline phosphatase and albumin | |
| Secondary objective: vaccine immunogenicity | Antibody response to vaccination | Serum antibody response to RSV F antigen Serum antibody response capable of RSV neutralisation |
| Cellular immune response to vaccination | Quantification of circulating vaccine-induced antibody secreting B-cells (IgA and IgG) against RSV F antigen Quantification of circulating vaccine-induced T-cell responses against RSV antigens F, N and M2–1 | |
| Exploratory immunology | Nasal and salivary antibody response to vaccination CD4+ and CD8+ T-cell subset response to vaccination Cytokine response to vaccination Gene expression changes after vaccination Any further exploratory immunology to detect vaccine-related immune responses |
RSV, respiratory syncytial virus.