News Scan for Oct 25, 2019

First US flu deaths in kids
Oral HPV in young women
Promising rapid TB test
Animal virus surveillance program ends
Trial of new anthrax vaccine

CDC reports first 2 pediatric flu deaths of the 2019-20 flu season

In its weekly flu update today, the US Centers for Disease Control and Prevention (CDC) reported the first pediatric flu deaths of the new season and noted that the nation's flu activity increased slightly last week but is still at low levels.

Both of the pediatric flu deaths occurred during the week ending Oct 12. One was linked to an unsubtyped influenza A virus, and the other was related to an influenza B Victoria-lineage virus.

Meanwhile, clinic visits for flulike illness rose slightly, to 2.4%, up from 1.7% the week before. The percentage of respiratory specimens that tested positive for flu at clinical labs, however, was 2.4%, down from 3.4% the previous week.

The low level of flu activity so far is similar to recent previous seasons, but the CDC said there are a few hot spots. Louisiana and Puerto Rico are reporting high flulike illness activity, a marker that reflects clinic visits for the disease. Most parts of the country are reporting sporadic or local flu activity, but the viruses are widespread in Maryland and regional in Louisiana.

So far, H3N2 and influenza B Victoria strains are circulating at similar levels this season.
Oct 25 CDC FluView report


Study finds oral HPV common in young women, but less so in vaccinees

A 10-year study that included oral rinse sampling in sexually active female adolescents seen at a large healthcare center in New York found that human papillomavirus (HPV) in the oral cavity is common in sexually active patients and that HPV vaccination was linked to a decline in oral cavity HPV detections. A research team based at Albert Einstein College of Medicine in the Bronx, New York, reported its findings today in JAMA Network Open.

The clinic offered free healthcare, including HPV vaccination. The study took place from October 2007 to March 2017. Along with oral rinse samples, researchers also collected specimens from cervical and anal swabs and information on sexual behavior. The team did follow-up tests on the participants every 6 months until they reached age 25.

Of baseline oral rinse samples from 1,259 participants, HPV DNA was found in 6.2%. The team found a significant decrease of oral HPV detection with time since participants first engaged in sexual activity, independent of age or cervical HPV detection. Also, detection of HPV types covered by the quadrivalent vaccine was significantly lower in those who had received one vaccine dose at study enrollment compared with those who were unvaccinated.

Researchers concluded that the data don't strongly support a sexual transmission model for oral HPV acquisition, though detection was highest soon after sexual activity began. They also said concurrent HPV detection in cervical and oral cavity samples suggests that the anogenital region may be a source of the virus and that autoinoculation may play a transmission role.

In a related editorial, two experts said the study answers important questions about HPV. They note that the findings are similar to oral rinse HPV prevalence in adults and suggest that patients clear the virus quickly. They also noted that the association between the vaccine and clinical protection is strong. The authors are Rachel Katzenellenbogen, MD, with Indiana University School of Medicine, and Kenneth Fife, MD, PhD, with SAFE Health in Los Angeles. The two added that the study lays the groundwork for studying HPV in young men.
Oct 25 JAMA Netw Open abstract
Oct 25 JAMA Netw Open editorial


Rapid molecular TB assay shows promise in diagnosing children

Chinese researchers report today in Pediatrics that a rapid, automated molecular test for tuberculosis offers good diagnostic value in children compared with traditional bacteriologic and other molecular tests.

Children account for 10% to 15% of all tuberculosis cases globally, but modeling estimates indicate many cases are not identified or reported, partly due to poor access to diagnostics, the challenge of obtaining samples, and low bacterial loads. Molecular tests like the Xpert Mycobacterium tuberculosis and rifampicin (MTB/RIF) Ultra assay using bronchoalveolar lavage fluid (BALF) are a promising alternative. But while the Ultra assay has been gradually introduced for diagnosing tuberculosis in adults, there are little data about its diagnostic value in pulmonary tuberculosis in children.

To test the accuracy of the Ultra assay in children, researchers with the Beijing Pediatric Research Institute and Beijing Children's Hospital enrolled 93 children with pulmonary tuberculosis and 128 children with respiratory tract infections. The sensitivity of Ultra in all pulmonary tuberculosis cases was 70%—nearly twice as high as that of bacteriologic tests (37%)—and 91% in bacteriologically confirmed tuberculosis cases. Ultra could detect Mycobacterium tuberculosis in 58% of cases with negative culture or acid-fast–staining results. The specificity was 98%. There was no significant difference in sensitivity between samples with a BALF volume ≤1 and >1 millilters (66% vs 73%; P = .50; odds ratio [OR], 0.71).

Among 164 children for which Ultra and the Xpert MTB/RIF assay were simultaneously performed, sensitivity was 80% and 67%, respectively, indicating good agreement (к = 0.84). An additional 6 children were identified as Ultra-positive but Xpert-negative. The positive rate decreased from 93% to 63% after 1 month (P = .01; OR , 0.12) and to 71% after 2 months (P = .03; OR, 0.18) of antituberculosis treatment.

Despite the promising results, the authors of the study note that the current cost of the Ultra assay is a prohibitive factor in its implementation as a point-of-care test, especially in low-income countries where there is a high burden of tuberculosis. "To be financially viable in low-income countries, a large increase in tuberculosis funding and/or a further reduction in the price of the Ultra test would be needed," they write.
Oct 25 Pediatrics study


Expired funding shutters 10-year zoonotic virus surveillance project

A 10-year-old program called Predict that searches for potential zoonotic virus threats is winding down because its federal funding has not been renewed, triggering concern among some experts that the world will be less prepared for the next epidemic or pandemic, the New York Times reported today.

The program is run by the US Agency for International Development (USAID) and has cost $207 million, according to the report. Since its launch it has collected more than 140,000 virus samples and identified more than 1,000 new viruses, including a new Ebola strain. Predict has also trained 5,000 people in African and Asian nations and has built or bolstered 60 medical research labs, primarily in developing countries.

USAID's former emerging threats director, Dennis Carroll, told the Times that the program was being shelved because of "the ascension of risk-averse bureaucrats" and a rising discomfort with an economic aid agency funding cutting-edge science. He noted that the two former presidential administrations were "enormously supportive" of Predict.

Irene Koek, acting assistant administrator of USAID's global health bureau, told the Times that USAID is proud of Predict's work and that the program is closing because it reached the end of a 10-year funding cycle. She added that similar research will be part of future budget requests, but so far, the details are still in planning stages.
Oct 25 NY Times story


New anthrax vaccine candidate cleared for phase 1 trial

The US Food and Drug Administration has cleared an investigational new drug application for BlueWillow Biologics' BW-1010, a next-generation anthrax vaccine. The vaccine will be tested in a phase 1 clinical trial, which will begin enrollment this year.

BW-1010 is an intranasal vaccine that delivers a recombinant protective antigen for anthrax in an oil-in-water adjuvant (immune booster). The delivery system offers unique protection against respiratory infections and elicits both systemic and mucosal immunity, BlueWillow said this week in a press release.

"The BlueWillow/PBL anthrax vaccine has the potential to provide significant advantages over the current injectable vaccine," said BlueWillow CEO Dave Peralta in the release. "Animal studies have demonstrated BW-1010 is safe and elicits protection against anthrax after just one or two vaccinations."

Anthrax is considered a possible risk to national security and public health by the US government, which stores millions of doses of the current injectable anthrax vaccine in the Strategic National Stockpile. The current vaccine requires three doses and antimicrobial therapy.
Oct 23 BlueWillow press release

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