News Scan for Apr 16, 2019

News brief

Ensesi and BARDA partner on needle-free flu vaccines

Enesi Pharma, a biotechnology company based in the United Kingdom, announced yesterday that it has partnered with the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) to develop new flu vaccines using its ImplaVax technology.

ImplaVax is a novel formulation and needle-free device that allows solid-dose vaccine to be delivered quickly under the skin. The goal is for health providers or even patients to administer vaccine disease using the simple reusable needle-free device. The company said the system has the potential to boost immune responses to vaccination and cut storage and distribution costs.

The project is part of BARDA's DRIVe (Division of Research, Innovation) initiative, which seeks and funds bold innovative solutions to transform health security, with an eye toward improving vaccine update, coverage, compliance, and preparedness. It will involve evaluating solid-dose formulations of marketed flu vaccines, along with in vitro tests to confirm titer generation, mechanical strength, and surety of implantation.

In vivo tests will compare efficacy and dosing regimens, including a comparison of solid-dose implants with placebo and vaccine administered by syringe.
Apr 15 Enesi Pharma press release

 

Phase 2 results promising for VLP chikungunya vaccine

Emergent BioSolutions today announced promising initial results for a phase 2 clinical study of its experimental chikungunya vaccine, a virus-like particle (VLP) product called CHIKV-VLP.

For the study, researchers evaluated safety and immunogenicity across a range of dosing regimens, the company said in a press release. Results suggest that, after a single dose, 98% of study participants had an antibody response by day 7. Also, the immune response persisted through study participants' 6-month visit, including those who got the one-dose regimen.

The dose-finding part of the study included 415 healthy adults at three US study sites. Subjects got a one- or two-dose series with or without an adjuvant over a 4-week period. Seroconversion occurred in 74% to 98% of subjects within 7 days of one dose and in all of them 28 days after the last dose. No significant safety problems were identified, suggesting that the vaccine was well tolerated.

Emergent said studies have shown VLP vaccines typically prompt higher neutralizing antibody titers needed to protect against chikungunya virus, which spreads to people from mosquitoes and causes symptoms such as joint pain, headache, muscle pain, joint swelling, and rash. Emergent licensed the vaccine from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. The Food and Drug Administration granted it fast-track designation in May 2018.

Abbey Jenkins, the company's senior vice president and head of its anti-infectives business unit, said, "Chikungunya virus infection represents a significant unmet medical need—having no vaccine or treatment available—despite its emergence as a global threat because of the highly debilitating nature of the associated disease and unprecedented magnitude of its spread."
Apr 16 Emergent BioSolutions press release

 

Northern Hemisphere flu drops, but a 2nd wave for some Asian locations

Flu activity continues to decline as the Northern Hemisphere pushes late into its flu season, though activity is still elevated in some countries, with a second wave of flu reported in some eastern Asia locations, the World Health Organization (WHO) said yesterday in its latest global flu update. The report includes data reported to Mar 31.

In Europe where both influenza A strains circulating with H3N2 a little more common, Bosnia, Herzegovina, Luxembourg, and Slovakia reported medium intensity activity. Flu levels are still above baseline in Estonia, Norway, and Moldavia.

Flu levels were low in central Asia and North Africa. For most of western Asia and the Middle East, virus activity is declining in most countries, except for Saudi Arabia, which reported a slight increase. Meanwhile, flu activity continues in East Asia but is decreasing, with influenza B as the dominant strain, which is typical for the latter part of the Northern Hemisphere season. Northern China has reported a second wave of flulike illness in recent weeks, as has South Korea.

Globally, of respiratory specimens tested the last half of March, 82% were influenza A and 17.8% were influenza B. Of subtyped influenza A strains, 40.6% were the 2009 H1N1 strain and 59.4% were H3N2.
Apr 15 WHO global flu update

Stewardship / Resistance Scan for Apr 16, 2019

News brief

Study ties good outcomes to following antibiotic prescribing guidelines

Adhering to antibiotic guidelines was associated with favorable outcomes in terms of mortality and length of hospital stay among patients in Norway, according to a study yesterday in Antimicrobial Resistance & Infection Control.

Norwegian, UK, and Swiss researchers assessed 1,756 patients receiving antibiotics under the care of pulmonary medicine, infectious diseases, and gastroenterology specialties in three university hospitals in western Norway. They analyzed data from 5 months in 2014 and classified patients into receiving care that was either adherent or non-adherent to Norwegian national guidelines.

The team found that 30-day mortality was 52% lower and in-hospital mortality 54% lower in the adherent compared with non-adherent patients. They also discovered a trend toward shorter hospital stays in the adherent group and a 17% higher chance of hospital discharge in the adherent group. Adherence to guidelines, however, was not associated with lower 30-day readmission rates.

The authors conclude, "This study builds on findings in previous studies, indicating that up-to-date, hospital antibiotic guidelines are safe and are associated with favourable clinical outcomes for inpatients. Antibiotic guidelines should be developed and regularly updated to ensure that they always promote best practice in the treatment of infectious diseases in the local context."
Apr 15 Antimicrob Resist Infect Control study

 

Hotel stay tied to superbug colonization after travel to LMICs

Staying in a hotel is associated with harboring antibiotic-resistant bacteria in travelers to low- and middle-income countries (LMICs), according to data presented yesterday at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam.

German investigators included 230 Germans who traveled outside of Europe in the cohort study. By analyzing stool samples, the scientists found that 53 of the travelers (23%) returned home colonized with extended-spectrum beta-lactamase–producing Enterobacteriaceae (ESBL-PE), with the highest risk tied to traveling to western, eastern, or southern Asia or to northern, middle, or eastern Africa.

Multivariate analysis determined that staying in a hotel in an LMIC raised the risk of ESBL-PE colonization more than fivefold. The risk doubled for travelers who booked a hotel for only part of their stay. The authors say their study is the first to make such a connection.

"Previous studies had already reported this for staying in a private accommodation, but it was unexpected that hotel might also be a risk factor," co-author Lynn Meurs, PhD, from the Robert Koch Institute in Berlin, said in an ECCMID news release. "Colonisation in itself does not lead to any health problems. However, there is a risk of infection with bacteria that patients are colonised with, especially in hospitalised patients."
Apr 15 ECCMID abstract
Apr 15 ECCMID poster
Apr 14 ECCMID news release

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