Exploring novel mechanisms of vaccine failure and induction of pulmonary immunity following live attenuated influenza vaccination in HIV infected and uninfected individuals: a pilot study.

Phase 1

• Conditions: 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; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-001924-31-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Do HIVinfected individuals have distinct differential early gene expression profiles following intranasal live attenuated<br> 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?<br> ;Secondary Objective: Are blood and pulmonary influenza specific Tcells detectable in HIV infected and HIV negative subjects following administration of live attenuated influenza vaccine?;<br> Primary end point(s): Differential gene expression profiles after LAIV in HIV infected and HIV uninfected<br> individuals<br> ;Timepoint(s) of evaluation of this end point: Day 3 following administration of the live attenuated influenza vaccination (LAIV).

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Influenza specific Tcell responses in blood (and in a subset of patients in lung).<br> Antiinfluenza antibody titres in serum<br> ;Timepoint(s) of evaluation of this end point: Day 7 - 28