Response to routine immunisations in human immunodeficiency virus (HIV) infected adults

ISRCTN	ISRCTN95588307
DOI	https://doi.org/10.1186/ISRCTN95588307
Protocol serial number	RG_09-034
Sponsor	University of Birmingham (UK)
Funder	University of Birmingham (UK) - Clinical Immunology Service and University Hospital Birmingham Adult HIV Service

Submission date: 22/01/2011
Registration date: 10/03/2011
Last edited: 18/11/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Calman MacLennan
Scientific

MRC Centre for Immune Regulation
Institute of Biomedical Research
School of Immunity and Infection
College of Medicine and Dental Sciences
University of Birmingham
Edgabston
Birmingham
B15 2TT
United Kingdom

Study information

Primary study design	Observational
Study design	Cross-sectional cohort study
Secondary study design	Cross-section survey
Study type	Participant information sheet
Scientific title	Response to routine immunisations in human immunodeficiency virus (HIV) infected adults: a cross-sectional cohort study
Study acronym	AIR Study
Study objectives	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(s)	National Research Ethics Committee - North Staffordshire Research Ethics Committee, 10/07/2009, ref: 09/H1204/53
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	24/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1115
Key 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
Key exclusion criteria	1. Under 18 years of age 2. Informed consent withheld 3. HIV-status unknown
Date of first enrolment	24/09/2009
Date of final enrolment	24/09/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Centre for Immune Regulation

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.