Federal ethics panel rejects proposal for human Zika challenge study
A federal ethics committee that reviewed a research proposal to experimentally infect humans with Zika virus to help gauge the best approach to a vaccine has rejected the application, according to a report posted last week and first reported today by Stat.
The expert panel, part of the National Institutes of Health (NIH), in December reviewed an application from the National Institute of Allergy and Infectious Diseases (NIAID) and Walter Reed Army Institute of Research.
In a 43-page report posted on the NIH Web site, the ethics panel said a human challenge study could be acceptable for studying the virus and vaccines against it in the future, but for now, studying the vaccine in regions where it is already spreading is a better option. The group also aired concerns about the potential risk to participants and others not involved in the study, such as sexual partners of the study subjects. Panelists also contended that there are other ways to develop vaccines that are reasonably protective.
Anna Durbin, MD, from Johns Hopkins University and a member of the team that proposed the human challenge study told Stat that a controlled human infection model could help streamline vaccine research, especially given that researchers face a closing window of opportunity to study the vaccine in a setting where researchers could more meaningfully gauge its protection. She added that among four main vaccine approaches, focusing on one that provides sterilizing immunity is a key goal.
Anthony Fauci, MD, NIAID director, told Stat that researchers can restructure their proposal to overcome the ethics obstacles.
Feb 28 Stat story
February NIH ethics panel report on Zika challenge studies
Sierra Leone study finds asymptomatic Ebola infections uncommon
Asymptomatic Ebola infections are uncommon even in highly exposed people and aren't likely to play a role in herd immunity, according to a seroprevalence study in Sierra Leone that used a new oral fluid immunoglobulin G test. A team led by researchers from Sierra Leone and Public Health England reported its findings yesterday in The Lancet Infectious Diseases.
After validating the test in survivors from Kerry Town Ebola treatment center and in controls from unaffected communities, the investigators tested household contacts of survivors. Results showed that the test was highly specific (100%) and highly sensitive (95.9%) in survivors.
Of 481 household contacts, 47.6% had high-level exposure such as contact with a corpse or contact with the body fluids of a sick patient. The researchers also found that 12% of them had some symptoms during the outbreak but were never diagnosed as having Ebola.
In Ebola-affected households, testing revealed asymptomatic infections in 2.3% of people and missed infections in 2.6%, suggesting that the levels of asymptomatic or missed illnesses are low.
The team concluded that asymptomatic infections don't seem to be a major contributor to herd immunity and that the noninvasive and easy-to-use test might be helpful for future investigations.
In a related commentary in the same issue, two researchers from the NIAID and the US Army Medical Research Institute of Infectious Diseases said the findings of the carefully conducted, well-controlled study cast doubt on earlier serosurveys from the 1980s and 1990s that implied high seroprevalence.
Though a single study doesn't settle the subclinical infection issue definitively, it does show that such illnesses aren't typical or widespread, the authors wrote. They added that the new swab-based test could be used to confirm or refute the earlier seroprevalence estimates.
Feb 27 Lancet Infect Dis abstract
Feb 27 Lancet Infect Dis commentary
Three new cases of MERS reported in Saudi Arabia
The Saudi Arabian Ministry of Health (MOH) announced three new cases of MERS-CoV yesterday, and two involved direct contact with camels.
The cases are from three different cities. A 74-year-old Saudi man from Bisha is in stable condition after presenting with symptoms of MERS-CoV (Middle East respiratory syndrome coronavirus) infection.
Two other patients are in critical condition, including a 76-year-old man from Hail who had direct contact with camels and a 29-year-old man from Riyadh whose disease is listed as primary, meaning it is unlikely he contracted the disease from another person.
The MOH observed another case on Feb 23. Information about that case, however, is in Arabic only on the MOH Web site, but the patient appears to be from Jeddah, according to a post from H5N1, an infectious disease news blog.
Former BARDA deputy director Hatchett named CEO of CEPI
Yesterday the interim board of the Coalition for Epidemic Preparedness Innovations (CEPI) announced Richard Hatchett, MD, as its new chief executive officer, the organization said today in a press release. His position will begin in April.
Hatchett most recently worked for the Biomedical Advanced Research & Development Authority (BARDA) at the US Department of Health and Human Services (HHS), where he served as deputy director and chief medical officer. In previous roles at HHS and at the White House, Hatchett helped respond to significant public health crises, including recent Ebola, MERS and Zika outbreaks.
In the release, interim CEPI CEO Professor John-Arne Rottingen said, "Richard Hatchett has just the right combination of scientific insight and governmental experience to lead CEPI. Adding to this, he is a pragmatic leader with great diplomatic skills, which is suitable for leading CEPI by engaging both private and public sector partners as well as civil society."
CEPI is an international partnership that launched in January at the World Economic Forum. Its goal is to streamline and advance the vaccine pipeline for public health threats; its first targets will be MERS (Middle East respiratory syndrome), Lassa fever, and Nipah.
Feb 28 CEPI news release
Jan 18 CIDRAP News Story "New $460 million effort takes aim at MERS, Lassa, Nipah"
First high-level Chinese biosecurity lab accredited
Late last week, the government of China announced that its first accredited high-level biosafety laboratory will be put into service. This is the first lab of its kind in Asia, which will be used to study class four pathogens (P4), which pose a high-risk of aerosolized, person-to-person transmission, according to People's Daily, the communist party newspaper in China.
The lab will allow Chinese researchers to study viruses such as Ebola, and is located in Wuhan, the capital of Hubei province.
"Virus prevention and control knows no borders. China has been shouldering its responsibility in global public health care security in an active manner," said lab director Yuan Zhiming.
The lab was modeled after a P4 facility in Lyon, France. The lab has a sewage disposal system, filtered air and water systems, waste processing, and other top biosafety standards. The lab will also serve as a United National reference laboratory, storing virulent pathogens in a protected environment.
Canada, Germany, Australia, the United States, the United Kingdom, South Africa, and some other nations also have P4 laboratories.
Feb 28 People's Daily story