Status:
COMPLETED
Exploring Novel Mechanisms of Vaccine Failure LAIV Pilot Study
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Acquired Immune Deficiency Syndrome Virus
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
Brief Summary
Influenza ('flu) can cause severe infections, especially in people with weakened immune systems such as those with HIV. For this reason, yearly vaccination is recommended with the standard 'inactivate...
Detailed Description
The emerging field of systems vaccinology offers an unbiased, global approach to studying immune responses to vaccines, unlike the traditional reductionist approaches that focus on specific arms of th...
Eligibility Criteria
Inclusion
- Age18 - 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)
- Historyof having received at least one dose of trivalent inactivated influenza vaccine in the past
- Nonsmoker
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02266992
Start Date
September 1 2014
End Date
June 1 2015
Last Update
March 21 2016
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Foundation trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF