Early-stage Yellow Fever Vaccine Trial Launched
Yellow fever has re-emerged as a public health threat in Africa
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has begun an early-stage clinical trial of an investigational vaccine designed to protect against yellow fever virus.
This Phase 1 clinical study is evaluating whether an experimental vaccine developed by the Danish biopharmaceutical company Bavarian Nordic is safe, tolerable and has the potential to prevent yellow fever virus infection.
Yellow fever virus is found in tropical and subtropical areas in South America and Africa. It caused an estimated 84,000 to 170,000 severe cases of disease and 29,000 to 60,000 deaths in 2013, according to the World Health Organization (WHO).
The virus is transmitted to people primarily through the bite of infected female Aedes aegypti mosquitoes. Mild cases of infection can cause fever, back pain, headache, nausea, vomiting, fatigue and weakness.
Most people recover, but approximately 15 percent of those infected develop severe disease manifested as yellow eyes and skin (jaundice), hemorrhage and shock, resulting in potentially fatal kidney, liver or heart conditions.
“Yellow fever has recently re-emerged as a major public health threat in parts of Africa. Although a vaccine exists to prevent this serious disease, it is currently in short supply, and it is not recommended for certain populations, such as pregnant women and people older than 60 years,” said NIAID Director Anthony S. Fauci, M.D.
“We must develop new options for preventing this terrible disease.”
As of July 21, 2016, the WHO has reported a total of 3,682 suspected yellow fever cases with 361 deaths in the African country of Angola. Meanwhile, another 1,798 suspected cases have been reported in the Democratic Republic of The Congo (DRC), including 85 deaths.
Cases with links to Angola have also been reported in Kenya and China.
More than 105 million people in Africa have been vaccinated against yellow fever in mass campaigns since 2006, according to the WHO. Despite this success, vaccine supplies are limited. In addition, in very rare cases, the current yellow fever vaccine can produce severe adverse complications, such as neurologic side effects, multiple organ system dysfunction and death.
For this reason, the vaccine should not be given to infants, the elderly, pregnant women and those with compromised immune systems.
Bavarian Nordic’s experimental yellow fever vaccine, dubbed MVA-BN-YF, is based on the company’s proprietary MVA-BN platform, which uses an attenuated (weakened) version of the Modified Vaccinia Ankara (MVA) virus as a vaccine vector to carry yellow fever virus genes into the body.
According to Bavarian Nordic, more than 7,600 people, including 1,000 individuals who are immunocompromised, have been safely vaccinated with MVA-BN-based vaccines.
The multi-site clinical trial will be conducted by NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs) at the University of Iowa in Iowa City and Saint Louis University in Missouri. Emory Vaccine Center in Decatur, Georgia will assist in evaluating data.
Additional details about the trial can be found at ClinicalTrials.gov using the identifier NCT02743455.
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