A5068710810- Viral gastroenteritis research and epidemiology
- Vaccine Coverage and Hesitancy
- SARS-CoV-2 and COVID-19 Research
- Cervical Cancer and HPV Research
- Pharmacovigilance and Adverse Drug Reactions
- Respiratory viral infections research
- Viral Infections and Immunology Research
- Heparin-Induced Thrombocytopenia and Thrombosis
- Intramuscular injections and effects
- Pneumonia and Respiratory Infections
- Influenza Virus Research Studies
- Systemic Lupus Erythematosus Research
- Herpesvirus Infections and Treatments
- Diphtheria, Corynebacterium, and Tetanus
- Gastrointestinal disorders and treatments
- Bacterial Infections and Vaccines
- Urinary Tract Infections Management
- Health Systems, Economic Evaluations, Quality of Life
- Animal Virus Infections Studies
- Pediatric Pain Management Techniques
- Clinical practice guidelines implementation
- Cytokine Signaling Pathways and Interactions
- NF-κB Signaling Pathways
- Acute Kidney Injury Research
- Computational Drug Discovery Methods
Janssen (Belgium)
2025
Janssen (United States)
2025
University Medical Center Utrecht
2019-2023
Heidelberg University
2021-2023
University Hospital Heidelberg
2021-2023
GlaxoSmithKline (Belgium)
2015-2021
GlaxoSmithKline (India)
2019
University of Liège
2003
In May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world of COVID-19 vaccines. Within this project, study aimed generate background incidence rates 41 adverse events special interest (AESI) contextualize potential safety signals detected following administration A dynamic cohort conducted using a distributed data network 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United...
To assess the risk of autoimmune disease (AD) in 9–25 year-old women within 1 year after first AS04-HPV-16/18vaccine dose, a retrospective, observational database cohort study was conducted using CPRD GOLD. From GOLD 4 cohorts (65,000 subjects each) were retrieved: exposed female (received ≥1 AS04-HPV-16/18 vaccine dose between Sep2008–Aug2010) and 3 unexposed cohorts: historical (Sep2005–Aug2007), concurrent male, male. Co-primary endpoints confirmed neuroinflammatory/ophthalmic AD other...
The public-private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key allow proper monitoring assessment. goals this study were compute age-, sex-, calendar-year stratified nine autoimmune diseases in seven databases from four countries assess validity by comparing with published data.Event calculated for following outcomes: acute...
Abstract Background Little is known about the risk of invasive E. coli disease (IED) after elective urologic procedures with or without antibiotic prophylaxis. This study aimed to estimate IED selected in patients prophylaxis, and controls who had no nor other procedures.Table 1.Patient demographic clinical characteristics Methods The Komodo Research Database (01/01/2021–06/30/2023) was used identify ≥60 years old prostate biopsy, endoscopy, nephrostomy (index: first procedure date), a 1:3...
Little is known about the risk of invasive E. coli disease (IED) after elective urologic procedures. We estimated IED selected procedures in patients with or without antibiotic prophylaxis, and controls no other surgical The Komodo Research Database (01/01/2021-06/30/2023) was used to identify ≥ 60 years old urological (index: first procedure date) randomly random date). Patients were classified into two cohorts based on whether not they received prophylaxis within 14 days prior index date....
To complement and support routine pharmacovigilance, Janssen conducted rapid real-world data analyses for near real-time safety monitoring of the COVID-19 vaccine to contextualize potential signals. Analyses were performed in four U.S. healthcare claims databases (February 2022-May 2023) using standardized algorithms three exposures, 56 outcomes, 93 negative controls. Three self-controlled case series two comparative cohort variants conducted, each with consideration multiple at-risk periods...
We assessed the risk of spontaneous abortion (SA) after inadvertent exposure to HPV-16/18-vaccine during pregnancy using an observational cohort design. The study population included women aged 15–25 years registered with Clinical Practice Research Datalink General OnLine Database in United Kingdom (UK), who received at least one dose between 1st September 2008 and 30th June 2011. Exposed had first day gestation 30 days before 45 (90 for extended period) any dose. Non-exposed 120 days–18...
As part of a regulatory commitment for post-licensure safety monitoring live, oral human rotavirus vaccine (RV1), this study compared the incidence rates (IR) intussusception, acute lower respiratory tract infection (LRTI) hospitalization, Kawasaki disease, convulsion, and mortality in RV1 recipients versus inactivated poliovirus (IPV) concurrent (cIPV) recent historical (hIPV) comparison cohorts. Vaccine were identified 2 claims databases from August 2008 – June 2013 (RV1 cIPV) January 2004...
Investigational and marketed vaccines are increasingly evaluated, manufacturers required to put in place mechanisms monitor long-term benefit-risk profiles. However, generating such evidence real-world settings remains challenging, especially when rare adverse events assessed. Planning of an appropriate study design is key conducting a valid study. The aim this paper illustrate how feasibility assessments support the generation robust pharmacoepidemiological data.Following initiative...
Abstract Monitoring the real-life effectiveness of respiratory syncytial virus (RSV) products is major public health importance. This generic protocol for a test-negative design study aims to address currently envisioned approaches RSV prevention (monoclonal antibodies and vaccines) these among target groups: children, older adults, pregnant women. The approach was chosen allow flexibility in adapting specific setting. includes severe acute infection (SARI) (ARI), both due RSV, as end...
Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk adverse events following immunisation that were not identified could be estimated pre-licensure. The aim this perspective paper is to describe authors' experience in design and conduct twelve PASS contributed evaluation benefit-risk real-world settings. We challenges learnings from selected rotavirus, malaria, influenza, human papillomavirus measles-mumps-rubella-varicella assessed potential theoretical risks,...
This post-hoc analysis of data from a matched cohort study investigated the risk febrile convulsions (FC) 5–12 days post-first dose measles-mumps-rubella-varicella vaccine (MMRV) in low-risk population, compared to measles-mumps-rubella (MMR) and varicella (V) vaccines administered separately. The population excluded children with personal history FC (Scenario 1) or/and family (≥1 parent/sibling) 2). Incidence post-MMRV Scenario 2 (excluding at children) (36.3–49.5/100,000) post-MMR+V whole...
Abstract Several immunization products are currently being developed against respiratory syncytial virus (RSV) for children, pregnant females, and older adults, some have already received authorization. Therefore, studies to monitor the effectiveness of these needed in following years. To assist researchers conduct postmarketing studies, we a generic protocol register-based cohort evaluate product RSV-specific nonspecific outcomes. study on basis this protocol, can use any relevant databases...
(2021). Association between rotavirus gastroenteritis and intussusception: suggested evidence from a retrospective study in claims databases the United States. Human Vaccines & Immunotherapeutics: Vol. 17, No. 1, pp. 269-277.
Abstract A Microsporum canis recombinant 31.5 kDa keratinase and a M . crude exo‐antigen were tested as vaccines in an experimental infection model guinea pigs. Animals vaccinated subcutaneously three times at two‐week intervals with either the keratinase, or adjuvant alone. Cutaneous challenge was performed blindly. Both humoral cellular‐specific immune responses to antigens evaluated every 14 days, while blind evaluation of clinical lesion development fungal persistency skin monitored...
Evidence on vaccine effectiveness (VE) may encourage vaccination and help fight the reemergence of measles mumps in Europe. However, limited data exist real-life individual measles, rubella (MMR) vaccines. This study evaluated VE GSK's MMR ("Priorix") against mumps.This retrospective, case-control used UK from Clinical Practice Research Datalink GOLD linked to Hospital Episode Statistics database identify children 1-13 years old diagnosed with or January 2006 December 2018. Cases were...