Quantitative benefit/risk assessment of the HPV vaccine for preventing anal cancer in males


logop95

Quantitative benefit/risk assessment of the HPV vaccine for preventing anal cancer in males

Human Papillomaviruses (HPVs) are the primary pathogens causing anal cancers, accounting for nearly 90% of global cases. The HPV-associated anal cancers and deaths are worryingly increasing in men but can be prevented with the quadrivalent HPV (qHPV) vaccine. P95 estimated the benefit-risk balance of qHPV vaccine use in males, applying a multicriteria decision analysis (MCDA). The qHPV vaccine was shown to have a satisfactory BR balance in males, and MCDA is identified as a practical decision-making tool in evaluating the BR balance of vaccines.

You can read the published manuscript here:

https://www.tandfonline.com/doi/full/10.1586/14760584.2016.1107480

 


Back to pharmacovigilance


Vulnerability bottleneck analysis (qualitative research)


logop95

Vulnerability bottleneck analysis (qualitative research)

This Project was commissioned by a steering committee to support the development of quality indicators on vulnerability. A mixed-methods approach was used, starting with a literature review and interviews with researchers, nurses and patient representatives, followed by the design and implementation of a questionnaire. A total of 170 responses were obtained and discussed in more detail in two focus groups. The project was completed with the development of a comprehensive report describing the results and advising on possible solutions and next steps. 

Further details (in Dutch) here:

https://www.kwaliteitwijkverpleging.nl/belastbaarheid-mantelzorg/knelpuntenanalyse-kwetsbaarheid-afgerond/ 

 


Back to consultancy


Conference reports (medical writing)


logop95

Conference reports (medical writing)

P95’s medical writers are frequently consulted to prepare meeting or conference reports for publication.

These are a few examples: 

IABS/DCVMN webinar on next-generation sequencing
(https://www.sciencedirect.com/science/article/pii/S1045105622000811

Virology, epidemiology, immunology and vaccine development of SARS-CoV-2, update after nine months of pandemic
(https://www.sciencedirect.com/science/article/pii/S1045105620301378?via%3Dihub

Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report
(https://www.sciencedirect.com/science/article/abs/pii/S1045105620300440?via%3Dihub

Report of the second international conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals
(https://www.sciencedirect.com/science/article/pii/S1045105620300634?via%3Dihub

Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019
(https://www.sciencedirect.com/science/article/pii/S1045105620300452?via%3Dihub

HPV board meeting: Overcoming barriers in HPV vaccination and screening programs
(https://www.sciencedirect.com/science/article/pii/S2405852116300957?via%3Dihub


Back to consultancy


Public health impact of low-dose aspirin on colorectal cancer, cardiovascular disease and safety in the UK (statistics/IT)


logop95

Public health impact of low-dose aspirin on colorectal cancer, cardiovascular disease and safety in the UK (statistics/IT)

An individual’s risk of cardiovascular disease and colorectal cancer may be decreased by prophylactic low-dose aspirin therapy. However, this therapy is also associated with adverse effects such as bleeding. To evaluate the expected population-level effect of low-dose aspirin prophylaxis, a micro-simulation model was built with data from UK governmental agencies and recent publications. The model demonstrated that the decrease in the incidence rate and the number of fatal cardiovascular disease and colorectal cancer events was larger than the increase in the incidence rate and number of fatal adverse effects in the UK population indicated for such prophylaxis. P95 contributed to the study design, data collection, model development, and study document writing and editing. 

You can read the published manuscript here:

https://www.sciencedirect.com/science/article/pii/S2352906721001391?via%3Dihub 


Back to consultancy


Effectiveness and safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil


logop95

Effectiveness and safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil

Mass vaccination can be an important tool to rapidly contain pathogens. In 2021, two doses of the recombinant COVID-19 vaccine ChadOx1-nCoV19 were offered to all 18–60-year-olds in Botucatu, Brazil, through a mass vaccination campaign. P95 contributed to a study that used this unique opportunity to assess the effectiveness and safety of the vaccine in real-world settings. The first and second vaccine doses were administered to 77,683 and 74,051 citizens, respectively. The effectiveness against COVID-19 disease of any severity was 74.5% after dose 1 and 81.3% after dose 2, which is comparable to the efficacy observed in clinical trials. Moreover, vaccination was well tolerated and did not raise safety concerns. Together, these results show the beneficial effect of this mass vaccination campaign in Botucatu. 

Effectiveness and safety data were described in two publications:  

https://www.ncbi.nlm.nih.gov/pubmed/36311567 

https://www.sciencedirect.com/science/article/pii/S0264410X22010106?via%3Dihub 


Back to consultancy


Decrease in norovirus infections in Germany following COVID-19 containment measures (epidemiology)


logop95

Decrease in norovirus infections in Germany following COVID-19 containment measures (epidemiology)

The preventive measures put in place to contain COVID-19 infections likely affected the spread of other pathogens, such as norovirus, a highly infectious virus that causes diarrheal disease. Between 2020-2021, P95 collaborated with a large laboratory in Germany to assess the effect of COVID-19 containment measures on the presence of norovirus. Data from routine testing for norovirus were analyzed and reported at P95. Compared to 2018–2019, the proportion of norovirus-positive stool samples was significantly lower in 2020, hovering around 0% from May to December. This likely reflects the impact of COVID-19 containment measures adopted since March 2020.  

You can read the published manuscript here:

https://www.ncbi.nlm.nih.gov/pubmed/33581238 


Back to consultancy


Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in Europe and Latin America


logop95

Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in Europe and Latin America

The mRNA vaccines against SARS-CoV-2 have protected billions of people worldwide, but the novel variants of concern (VoC) could escape the vaccine-acquired immunity. P95 participated in the safety monitoring of the phase 2b/3 HERALD study to weigh the efficacy and safety of the unmodified mRNA COVID-19 vaccine candidate, CVnCoV. In this 40,000-person trial across ten countries in Europe and Latin America, CVnCoV was found to be 48% efficacious against symptomatic COVID-19. Systemic adverse events were more frequent in the CVnCoV group than in the placebo group. Judging the fast-changing COVID-19 vaccine landscape with the emergence of VoC, the researchers recommended halting activities on CVnCoV and aiming to develop next-generation vaccine candidates. 

You can read the published manuscript here: 

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00677-0/fulltext 

 


Back to pharmacovigilance


Economic burden of varicella in Europe


logop95

Economic burden of varicella in Europe

Varicella is a highly contagious infection that yearly isolates millions of children at home for over a week. This causes a high morbidity and economic burden, which can greatly be prevented with vaccination. P95 collaborated on a systematic review that first estimated the number of cases of varicella across Europe and the cost of varicella at more than 600 million euros annually across 31 European countries in the absence of universal vaccination.

Full results can be accessed in the following publications: 

https://www.cambridge.org/core/journals/epidemiology-and-infection/article/systematic-review-of-varicella-seroprevalence-in-european-countries-before-universal-childhood-immunization-deriving-incidence-from-seroprevalence-data/EDACE2F4EA61A98B0EBBFDCBAB6AB34C 

https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-017-2445-2https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-12343-x 


Back to SLRs


Lyme disease systematic reviews


logop95

Lyme disease systematic reviews

Lyme disease, a tick-borne infection, has been increasing in incidence and expanding to new regions, partly due to climate change. Since 2020, P95 has been collaborating on a major systematic literature review of studies on Lyme disease. Publications and grey literature sources have been searched for data on Lyme incidence, epidemiology, hospitalization and clinical manifestations, among other outcomes. Data are being compiled for different regions of the World. This major study is expected to result in several publications and congress communications.

A first publication is already available, and three others are expected to be published soon: 

https://www.sciencedirect.com/science/article/abs/pii/S1877959X22001418


Back to SLRs


Under-ascertainment of Respiratory Syncytial Virus infection in adults due to diagnostic testing limitations


logop95

Under-ascertainment of Respiratory Syncytial Virus infection in adults due to diagnostic testing limitations

In 2022, the P95 team collaborated on a systematic review and meta-analysis to quantify testing under-ascertainment of adult respiratory syncytial virus (RSV) infection. A total of 8066 unique references were screened, of which 154 met the inclusion criteria. The analysis showed that RT-PCR, particularly singleplex testing, is the most sensitive RSV diagnostic test in adults and that accuracy can be improved by assessing ≥3 specimen types. 

https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiad012/6994132?login=false 

 


Back to SLRs