https://www.nih.gov/news-events/news-releases/nih-launches-clinical-trial-mrna-nipah-virus-vaccine

Monday, July 11, 2022

NIH launches clinical trial of mRNA Nipah virus vaccine

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched an early-stage clinical trial evaluating an investigational vaccine to prevent infection with Nipah virus. The experimental vaccine is manufactured by Moderna, Inc., Cambridge, Massachusetts, and was developed in collaboration with NIAID’s Vaccine Research Center. It is based on a messenger RNA (mRNA) platform—a technology used in several approved COVID-19 vaccines. NIAID is sponsoring the Phase 1 clinical study, which is being conducted at the NIH Clinical Center in Bethesda, Maryland.

Nipah virus infection is a zoonotic disease, meaning that it is spread between animals and people. Fruit bats are the natural host for the virus. The first known Nipah outbreak occurred in 1998 in Malaysia and Singapore and resulted in 265 human cases and 105 deaths, and caused significant economic damage to the swine industry there. Since 1999, outbreaks have occurred annually in Asia, primarily in Bangladesh and India. The virus can cause mild-to-severe disease rapidly progressing from respiratory infection symptoms to encephalitis (brain swelling) leading to coma or death. An estimated 40% to 75% of people infected with Nipah virus die. Although most cases are transmitted via animals, person-to-person transmission can occur. Currently, there is no licensed vaccine or treatment for Nipah virus infection.

“Nipah virus poses a considerable pandemic threat because it mutates relatively easily, causes disease in a wide range of mammals, can transmit from person-to-person, and kills a large percentage of the people it infects,” said NIAID Director Anthony S. Fauci, M.D. “The need for a preventive Nipah virus vaccine is significant.”

NIAID’s Pandemic Preparedness Plan, published earlier this year, established a framework to study viruses of pandemic potential and prioritize research on prototype pathogens, such as Nipah virus. This is the first clinical trial using the prototype pathogen approach since the plan’s publication.

The experimental mRNA-1215 Nipah virus vaccine will be tested in a dose-escalation clinical trial to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults ages 18 to 60 years. Specifically, four groups of 10 participants each will receive two doses of the investigational vaccine via injection in the shoulder muscle four or 12 weeks apart. Group one (10 participants) will receive two 25-microgram (mcg) injections; group two will receive two 50-mcg injections; and group three will receive two 100-mcg injections, each four weeks apart. The vaccine dose for the fourth group of participants will be determined based on an interim analysis of the results from the three previous groups. The fourth group will receive two injections 12 weeks apart. Study participants will be evaluated through clinical observation and blood collection at specified times throughout the study and will be followed by clinical study staff through 52 weeks following their final vaccination.

For more information about the clinical trial, visit ClinicalTrials.gov using the study identifier NCT05398796.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

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https://www.path.org/articles/nipah-virus-film-contagion-vaccine/

Nipah virus has pandemic and bioterrorism potential. A vaccine candidate is undergoing Phase 1 trial.

In an interconnected world, viruses aren’t limited by borders. A small outbreak on one side of the globe can spread across continents and across oceans in a matter of hours. The COVID-19 pandemic is a sobering example of this reality, and though it may feel unprecedented, for infectious disease experts it isn’t a surprise. What’s more, it’s a reminder of the importance of shoring up global health security by advancing vaccines against diseases that have pandemic potential.

Because the next pandemic is never a question of “if.” It’s a question of “when.”

That’s why PATH is collaborating with the Coalition for Epidemic Preparedness Innovations (CEPI) and Auro Vaccines LLC, to develop a vaccine to protect against Nipah virus. That effort just reached a major milestone—the first clinical study of a Nipah virus vaccine candidate in humans. This is a monumental step toward protecting the world from a deadly disease for which there is currently no vaccine and no treatment beyond supportive care.

A looming threat

Nipah virus is a bat-borne virus that causes severe respiratory illness and encephalitis. It has the potential to cause widespread disease and death. It can be spread to humans from infected animals, infected food, or other infected persons, and has an estimated case fatality rate of 40 to 75 percent.

The virus was first identified in Malaysia in 1999 when an outbreak among pig farmers (pigs are susceptible to the disease and can transmit it to humans) killed 105 people and led to the slaughter of more than 1 million pigs. In addition to the tragic loss of life, it had a catastrophic impact on a community’s livelihood and the country’s economic security. Since, the disease has popped up throughout south and southeast Asia, particularly in India and Bangladesh, where outbreaks have occurred annually since 2001.

How do we break the pandemic potential of #nipahvirus and eliminate it as a global health threat? With strong partnership, innovative ideas, and a novel #vaccine.

However, the real extent of Nipah virus may be under-reported; initial symptoms are nonspecific and flu-like, which makes early diagnosis and control difficult. Many more countries are at risk, and global health agencies worry about the virus’s potential to spread unchecked. The US Centers for Disease Control and Prevention identifies Nipah virus as a pathogen with bioterrorism potential, and the World Health Organization included it on the 2018 R&D Blueprint list of priority diseases, citing it as one of the most important pathogens to monitor.

A vaccine is critical.

Advancing a new vaccine

The current Phase 1 study is investigating the safety and tolerability of a Nipah virus vaccine candidate. The study is the first in a series of studies that could one day lead to a stockpile of vaccine that would be used to control outbreaks.

The study began in February 2020 in healthy adult volunteers in Cincinnati, Ohio, USA. PATH is leading clinical development and conduct of the study; Auro Vaccines is the study sponsor and developer of the vaccine; and CEPI is providing funding. Results are expected in late 2022.

Efforts like this are critical to the health and safety of the global community—particularly to support those living in low- and middle-income countries, who often face underlying health conditions or limited access to health care. Without interventions, the pandemic threat of virulent diseases like Nipah virus remains. The numerous outbreaks of the virus (and the devastating results) are evidence enough of that, including a recent one in May 2018 in the Indian state of Kerala, where 23 people were infected in the span of a month—and only two people survived.

But it is not hopeless; if public and private sectors commit to working together and pooling their resources and expertise, we can equip the world with new tools to protect against the infectious diseases that have already cropped up, like Nipah virus—and the unknown pathogens that will arise in the future.

PATH and its partners have made that commitment.

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>Satan is not Jesus.

beliefs are not facts, so how are you SURE?