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

Response to routine immunisations in human immunodeficiency virus (HIV) infected adults: a cross-sectional cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN95588307
Enrollment
1115
Registered
2011-03-10
Start date
2009-09-24
Completion date
Unknown
Last updated
2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) infection Infections and Infestations Human immunodeficiency virus (HIV)

Interventions

Nationally-recommended immunisation against vaccine-preventable diseases for HIV-infected adults. Cases: At recruitment ? Pneumococcal, Men C, Hib, HepB, HepA and TetDipIPV vaccinations, depending o

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Under 18 years of age 2. Informed consent withheld 3. HIV-status unknown

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026