Response to routine immunisations in human immunodeficiency virus (HIV) infected adults
| ISRCTN | ISRCTN95588307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95588307 |
| Secondary identifying numbers | RG_09-034 |
- 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
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
| Study design | Cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact c.maclennan@bham.ac.uk to request a patient 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 | 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 study start date | 24/09/2009 |
| Completion date | 24/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Participant cases: 1000; participant controls: 115 |
| 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
- England
- United Kingdom
Study participating centre
MRC Centre for Immune Regulation
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Research and Commercial Services
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.birmingham.ac.uk/index.aspx |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
University/education
University of Birmingham (UK) - Clinical Immunology Service and University Hospital Birmingham Adult HIV Service
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.
