Response to routine immunisations in human immunodeficiency virus (HIV) infected adults: a cross-sectional cohort study
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.
National Research Ethics Committee - North Staffordshire Research Ethics Committee, 10/07/2009, ref: 09/H1204/53
Cross-sectional cohort study
Primary study design
Secondary study design
Patient information sheet
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Human immunodeficiency virus (HIV) infection
Nationally-recommended immunisation against vaccine-preventable diseases for HIV-infected adults.
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.
As for cases, but no psychosocial factors questionnaire.
Duration of treatment and follow up (both arms): five years.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
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
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
Recruitment end date
Countries of recruitment
Trial participating centre
MRC Centre for Immune Regulation
University of Birmingham (UK)
Research and Commercial Services
University of Birmingham (UK) - Clinical Immunology Service and University Hospital Birmingham Adult HIV Service
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)