Track topics on Twitter Track topics that are important to you
As recommended by the Dutch Health Council, certain risk groups and health care workers in The Netherlands were vaccinated to prevent morbidity due to pandemic influenza A/H1N1. Adults were vaccinated twice with the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted surface-antigen vaccine Focetria® (Novartis). The vaccination campaign was executed by general practitioners.
The aim of the study is to verify whether HIV-infected individuals generate an adequate immune response after the first and after the second vaccination.
AIM OF THIS STUDY:
Primary objective: Do HIV-infected individuals mount a protective humoral response following vaccination for pandemic influenza A/H1N1 with the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted surface-antigen vaccine Focetria® (Novartis).
Secondary objective: 1) To evaluate the strength of the immune response in HIV-infected individuals compared to healthy volunteers. 2) To evaluate whether a second dose, administered at least 21 days after the first increases the proportion of HIV-infected individuals that have a titer above the threshold associated with protection. 3) To assess whether vaccination is associated with an increases in HIV-replication. 4) To assess whether very early antibody responses occur, which may may indicate immunological memory, for example due to cross reactivity from past influenza infection or vaccination.
This is not an interventional study. In this single-centre observational study we will monitor the immune response in a cohort of people who are to be vaccinated during the national vaccination campaign.
Population: The population base for this study consists of HIV-infected adult outpatients at our hospital and of healthy hospital employees. All Dutch and English speaking HIV-infected LUMC outpatients above 18 years of age, on a stable antiretroviral regimen or not yet in need of treatment, are sent a letter inviting them to take part. Healthy hospital employees are invited to take part with a letter, which is handed out upon vaccination. Inclusion is possible until three days after the first vaccination. Exclusion criteria are: use of systemic immunosuppressive medication, an ongoing infection, recent flu-like symptoms and pregnancy. The following characteristics are documented at baseline: age, gender, co-morbidity, medication, year of prior influenza vaccinations and year of diagnosis of HIV infection. All participants are requested to fill out standardized diary assessing flu-like symptoms and use of new medication during the 60 day follow-up.
Laboratory analysis: Lymphocyte counts are determined at baseline, prior to vaccination. A serum sample is taken prior to the first vaccination (day -30 to day 0), prior to the second vaccination (day 17-20) and after the second vaccination (day 60). Viral load is determined at baseline (day -30 to day 0) and after the second vaccination (day 5-7) in a subgroup of 10 persons with undetectable viral load at the preceding outpatient visit. Antibody responses are detected in duplicate for each sample by means of hemagglutination-inhibition (HI) assays according to standard methods at the Erasmus Medical Center in Rotterdam.
Statistical analysis: No formal sample-size calculation was performed. We intend to include a maximum of 100 subjects with HIV and 50 healthy hospital employees. The crude outcome estimates will be adjusted for variables that may influence the outcome (age, CD4 lymphocyte count, use of HAART, viral load).
Observational Model: Cohort, Time Perspective: Prospective
Leiden University Medical Centre
Leiden University Medical Center
Published on BioPortfolio: 2014-08-27T03:16:01-0400
Countries throughout the world are facing a growing non-communicable disease (NCD) burden. In developing countries, medicines to treat NCDs are often difficult to access or too expensive f...
This study will evaluate the safety, tolerability and immunogenicity of one or two 0.25mL or 0.5mL intramuscular injections of influenza vaccine compared with control vaccine in subjects 6...
The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, ...
This study is aimed to evaluate safety, tolerabilty and immunogenicity of three doses of Novartis Meningococcal B vaccine and of one dose of Novartis Menongococcal ACWY vaccine when adnmi...
The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would b...
EPH receptors are transmembrane receptor tyrosine kinases. Their extracellular domains bind specifically to ephrin A/B ligands, and this binding modulates the intracellular kinase activity. EPHs are k...
In Kenya, noncommunicable diseases (NCDs) account for 27% of all deaths. Adult Kenyans have an 18% chance of dying prematurely from cancers, diabetes, cardiovascular diseases or chronic respiratory di...
Clinicians working on first-in-human clinical studies need to be able to judge whether safety signals observed on an investigational drug were more likely to have occurred by chance or to have been ca...
T cells that are genetically modified to express chimeric antigen receptors (CARs) specific for CD19 show great promise for the treatment of relapsed/refractory acute lymphoblastic leukaemia (ALL). Th...
In recent years, chimeric antigen receptor (CAR) modified T cells have been used as a treatment for haematological malignancies in several phase I and II trials and with Kymriah of Novartis and Yescar...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Influenza or 'flu' is a respiratory illness associated with infection by influenza virus. Symptoms frequently include headache, fever, cough, sore throat, aching muscles and joints. There is a wide spectrum of severity of illness ranging from min...
Swine Flu - H1N1 influenza - H7N9
Swine flu is the common name given to a relatively new strain of influenza (flu) that caused a flu pandemic in 2009-2010. It is also referred to as H1N1 influenza (because it is the H1N1 strain of virus). The H1N1 flu virus will be one of the main vi...