HIV (effect of HIV on the response to live attenuated intranasal influenza vaccine) MedDRA version: 20.1 Level: LLT Classification code 10020160 Term: HIV disease System Organ Class: 100000004862
Conditions
Interventions
Trade Name: FLUENZ tetra nasal spray suspension
Product Name: FLUENZ tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
Pharmaceutical Form: Nasal
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 – 49 HIV1 infected On antiretroviral therapy CD4 count of >200/mm3 (for at least 6 months, last available measurement within 3 months) Viral load undetectable (for at least 6 months, last available measurement within 3 months) History of having received at least one dose of trivalent inactivated influenza vaccine in the past Nonsmoker Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe egg allergy Hypersensitivity to gentamicin Pregnant or breastfeeding Chronic lung disease (e.g. bronchiectasis) A history of severe asthma or current active wheezing Other cause for immunosuppression (e.g. malignancy) or immunosuppressive medication Hepatitis B or C coinfection (as defined by a detectable HBSAg or HCV RNA) Planned close contact with severely immunocompromised individuals in 2 weeks following LAIV (e.g bone marrow transplant recipients) Recipient of any other vaccination within the last 4 weeks Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks. Individuals with a known and current history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range on a full blood count taken within the last 3 months. Current (active) participation in any clinical trial Inability to communicate in English or convey willingness to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do HIVinfected individuals have distinct differential early gene expression profiles following intranasal live attenuated influenza vaccine, when compared to age and sexmatched HIVnegative subjects, thus providing insights into the aberrant immunological response to live vaccines modulated by HIV infection? ;Secondary Objective: Are blood and pulmonary influenza specific Tcells detectable in HIV infected and HIV negative subjects following administration of live attenuated influenza vaccine?; Primary end point(s): Differential gene expression profiles after LAIV in HIV infected and HIV uninfected individuals ;Timepoint(s) of evaluation of this end point: Day 3 following administration of the live attenuated influenza vaccination (LAIV). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Influenza specific Tcell responses in blood (and in a subset of patients in lung). Antiinfluenza antibody titres in serum ;Timepoint(s) of evaluation of this end point: Day 7 - 28 | — |
Countries
United Kingdom
Contacts
Public ContactLeesley
Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed