Contact information
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RG_09-034
Study information
Scientific title
Response to routine immunisations in human immunodeficiency virus (HIV) infected adults: a cross-sectional cohort study
Acronym
AIR Study
Study hypothesis
The aim of this study is to investigate the level and duration of response to routine vaccinations in human immunodeficiency virus (HIV) infected adults compared with uninfected adults and how this relates to the function of the immune system in these individuals.
Ethics approval
National Research Ethics Committee - North Staffordshire Research Ethics Committee, 10/07/2009, ref: 09/H1204/53
Study design
Cross-sectional cohort study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact c.maclennan@bham.ac.uk to request a patient information sheet
Condition
Human immunodeficiency virus (HIV) infection
Intervention
Nationally-recommended immunisation against vaccine-preventable diseases for HIV-infected adults.
Cases:
At recruitment Pneumococcal, Men C, Hib, HepB, HepA and TetDipIPV vaccinations, depending on previous vaccination history and psychosocial factors questionnaire. Annual influenza vaccination. Vaccination response assessed by antibody titres. Booster vaccinations offered in case of sub-optimal response.
Controls:
As for cases, but no psychosocial factors questionnaire.
Duration of treatment and follow up (both arms): five years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Proportion of HIV-infected patients producing a response to Haemophilus influenzae type b conjugate vaccination of 1.0 ug per ml anti-polyribosyl phosphate antibodies (considered protective levels) at 1 month post-vaccination compared with HIV-uninfected control subjects.
Acute vaccination responses measured at baseline and one month post-vaccination with clinical laboratory serological assays for antibody titres.
Secondary outcome measures
1. Level of immune response to each vaccination at 1 month post-vaccination in study participants compared with control group and correlation of immune response to degree of immune suppression of each participant gauged by CD4 count
2. Duration of immune response to each vaccination through course of study
3. Correlation of immune response to psychosocial factors
4. Occurrence of any vaccine-preventable diseases during the course of the study
Acute vaccination responses measured at baseline and one month post-vaccination with clinical laboratory serological assays for antibody titres. Duration of immune response measured at four-monthly clinic visits (cases) and annual appointments (controls) over 5 year duration of study. Psychosocial factors measured at baseline and four months via a patient questionnaire. Vaccine-preventable disease occurrence measured through continuous follow in outpatient clinic over 5 year duration of study.
Overall trial start date
24/09/2009
Overall trial end date
24/09/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged over 18 years old, either sex
2. Informed consent given
3. Participant cases: proven HIV infection
4. Participant controls: proven absence of HIV-infection
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Participant cases: 1000; participant controls: 115
Participant exclusion criteria
1. Under 18 years of age
2. Informed consent withheld
3. HIV-status unknown
Recruitment start date
24/09/2009
Recruitment end date
24/09/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Centre for Immune Regulation
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Research and Commercial Services
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Birmingham (UK) - Clinical Immunology Service and University Hospital Birmingham Adult HIV Service
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary