Condition category
Infections and Infestations
Date applied
22/01/2011
Date assigned
10/03/2011
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Calman MacLennan

ORCID ID

Contact details

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

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

http://www.birmingham.ac.uk/index.aspx

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

Publication citations

Additional files

Editorial Notes

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