Phase 1 trial of first MERS vaccine shows strong immune response
Results from the world's first phase 1 trial of a vaccine against MERS-CoV (Middle East respiratory syndrome coronavirus) demonstrated a strong immune response after two doses and a good safety profile. The trial involved 75 US Army volunteers and was published yesterday in The Lancet Infectious Diseases.
The study, conducted at Walter Reed Medical Center, assessed three doses of GLS-5300 MERS coronavirus vaccine, given to healthy adults ages 18 to 50 over a 3-month period. Twenty-five participants received 0.67 milligrams (mg) of the DNA vaccine, 25 got 2-mg injections, and the final group received 6 mg of the vaccine.
No major safety events were recorded, and seroconversion occurred in 59 (86%) of 69 participants and 61 (94%) of 65 participants after two and three vaccinations, respectively, the authors said. "There were no differences in immune responses between dose groups after 6 weeks. At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively," the authors wrote.
The authors concluded the data support the further development of GLS-5300 vaccine. In a commentary on the study, In-Kyu Yoon, PhD, and Jerome H. Kim, PhD, of the International Vaccine Institute in South Korea said, "Completion of the phase 1 trial of GLS-5300 represents an incremental but important step in the development of vaccines against emerging viral global threats."
Jul 24 Lancet Infect Dis study
Jul 24 Lancet Infect Dis commentary
Virginia notes uptick in Cyclospora illnesses
The Virginia Department of Health today announced a sharp increase in cyclosporiasis cases since mid-June in parts of Northern Virginia. To date there have been 15 cases, compared with 8 cases during the same time last year.
"Additionally, more than 40 people from two large businesses in the area have reported gastrointestinal illness, and are under investigation for suspected cyclosporiasis. A food or water source of this outbreak has not yet been identified, and the investigation is ongoing," the department said in a news release.
Cyclospora is a foodborne parasite that cases intestinal illness, and has been linked to fresh produce, including raspberries, basil, arugula, snow peas, mesclun lettuce, and cilantro. From 2000 to 2017, officials confirmed 39 Cyclospora outbreaks in the United States—all linked to fresh food.
Cyclospora causes watery diarrhea that can come and go until a patient seeks treatment.
Jul 23 Virginia Department of Health news release
CEPI, Themis announce chikungunya vaccine partnership
Valneva, a biotechnology company based in Norway and France, yesterday announced a new partnering agreement with the Coalition for Epidemic Preparedness Innovation (CEPI) worth up to $23.4 million to support manufacturing and late-stage development of a live-attenuated single-dose chikungunya vaccine (VLA1553).
In a statement, the company said the support from CEPI comes from the European Union (EU) Horizon 2020 program. As a step to ensure equitable access, the funding also includes a partnership to speed regulatory approval in regions where outbreaks occur as well as World Health Organization prequalification that would pave the way for broader use in lower- and middle-income countries.
As part of the deal, Valneva will maintain a stockpile of the vaccine and take steps to transfer manufacturing to partners in lower- and middle-income countries to boost vaccine access to populations at risk.
The investment is part of CEPI's third call for proposals through the EU Horizon 2020 program, which since January has resulted in $66 million in investments in two chikungunya vaccines and two Rift Valley fever vaccines. In June, Themis Bioscience and CEPI announce a partnership to support phase 3 development of the company's single-dose chikungunya vaccine (MV-CHIK).
CEPI was founded following West Africa's Ebola outbreak as a new way to fund and speed the development of new vaccine candidates against emerging infectious diseases, especially Middle East respiratory syndrome coronavirus (MERS-CoV), Nipah virus, and Lassa virus. It is supported by seven nations and a host of global health groups.
Jul 24 Valneva press release
Jul 25 CEPI press release
Jun 4 CIDRAP News scan "CEPI, Themis announce chikungunya vaccine partnership"
Maine doctors advised to test for Powassan after confirmed human case
The Maine Center for Disease Control & Prevention (Maine CDC) is warning physicians to consider testing certain patients for Powassan encephalitis (POW), a tick-borne disease, after a resident of southern Maine was hospitalized with the illness in late June.
The Maine CDC said doctors should consider testing for POW in any patient presenting with unexplained encephalitis, meningitis, or high fever (100.4°F or 38°C) during the summer and early fall.
POW is transmitted through infected Ixodes ticks. The illness can be serious and often requires hospitalization. Symptoms begin 1 week to 1 month after a tick bite and include fever, headache, vomiting, weakness, confusion, seizures, and memory loss.
Jul 24 Maine CDC advisory