News Release
Monday, May 15, 2023
A clinical trial of an experimental universal influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of the National Institutes of Health, has begun enrolling volunteers at Duke University in Durham, North Carolina. This Phase 1 trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.
The trial will enroll up to 50 healthy volunteers aged 18 through 49. Three groups of study participants (10 participants each) will be vaccinated with 10, 25 and 50 micrograms of the experimental vaccine, respectively. After evaluation of the data to determine an optimum dosage, an additional 10 participants will be enrolled to receive the optimum dosage. The study also will include a group of participants who will receive a current quadrivalent seasonal influenza vaccine. This will allow the researchers a point of direct comparison between the immunogenicity and safety of the candidate vaccine and available seasonal flu vaccines. Participants will be regularly evaluated to assess the vaccines safety (and, secondarily, its efficacy) and will receive follow-up appointments for up to one year after vaccination.
Seasonal influenza, or flu, kills thousands of people in the United States each year. The Centers for Disease Control and Prevention estimates that between 2010 and 2020, between 12,000 and 52,000 people died of flu in the United States annually. Although annual seasonal flu vaccines are valuable tools in controlling the spread and severity of influenza, they do not provide immunity against every flu strain. Each year, before the flu season begins, scientific experts must predict which influenza strains are likely to be most common during the upcoming months and then select three or four of these strains to include in the next seasonal flu vaccine. Vaccine manufacturers then need time to produce and distribute the vaccineduring which the dominant strains of the virus can change in unexpected ways, potentially decreasing the efficacy of the vaccine. An effective universal flu vaccine could eliminate these problems by protecting its recipients against a wide variety of strains and ideally providing durable long-term immunity, so people would not need to be vaccinated every year.
A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year, said Acting NIAID Director Hugh Auchincloss, M.D. Moreover, some strains of influenza virus have significant pandemic potential. A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic.
The early-stage trial is being conducted through the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, which was created by NIAID in 2019 to support the development of broadly protective and longer-lasting flu vaccines. It is the first investigational universal flu vaccine candidate to be tested by the CIVICs program, and was manufactured at the facilities of the Duke Human Vaccine Institute (DHVI), which is a part of the CIVICs program.
A similar vaccine developed by researchers at NIAIDs VRC already has shown positive results in early clinical trials. Both vaccines use a specific portion of a flu protein, hemagglutinin (HA), to induce a broad immune response against influenza. While one portion of the HA protein, known as the head, tends to change as the flu virus spreads and evolves, a more stable portion, known as the stem, evolves very slowly and is very similar across many different types of the flu virus. By using the HA stem as the basis for a vaccine, researchers hope to induce long-term immunity against a broad range of flu viruses. Unlike the VRCs earlier vaccine, the H1ssF-3928 mRNA-LNP vaccine candidate uses a messenger RNA (mRNA) platform. By developing and testing a variety of different platforms for a universal flu vaccine, researchers are more likely to find one that is both safe and provides strong and broad immunity against a variety of strains.
For more information about the clinical trial, visit clinicaltrials.gov using the identifier NCT05755620.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto 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.
About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
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Clinical trial of mRNA universal influenza vaccine candidate begins
Hundreds of seabirds found dead on Africas coast. Remains of endangered condors discovered in California. Dozens of dead Canada geese removed from a Markham park.
Around the world, a highly pathogenic H5N1 strain of avian influenza is killing wild birds in numbers never seen before.
This strain is unfortunately affecting wild birds quite severely and many, many species are getting severely ill and dying from this virus, said Brian Stevens, the wildlife pathologist for the Ontario and Nunavut branch of the Canadian Wildlife Health Cooperative, a group of scientific experts that monitor the health of wildlife.
Its very different from most other avian influenza viruses that weve come across.
The current outbreak of avian flu, which began in Europe in 2020 and reached North America a year later, is said to be one of the biggest in history.
Its estimated 200 million birds have died worldwide.
In Canada, the virus has killed an estimated 46,000 wild birds since monitoring began here in December 2021, although many more mortalities have likely gone undetected, said Christopher Sharp, a population management biologist with Canadian Wildlife Service, a branch of Environment and Climate Change Canada.
Wild birds pick up the virus from other birds when migrating in large numbers, but they dont typically die from it.
The key difference from earlier outbreaks is that HPAI (highly pathogenic avian influenza) is circulating broadly in wild birds, said Sharp in an email. In addition, the current virus has led to significantly greater mortality in wild birds than what was previously experienced.
The impact of the virus could be lessened somewhat this year, he said, because its now been circulating for a year, which could give wild birds some immunity. There will, however, likely be infection in young birds that have never encountered the virus before or in older birds whose immunity has waned with time, said Sharp.
Canada has been hit with outbreaks of HPAI before.
But in the past, the virus has been most dangerous for domestic poultry, where it spreads through contact with wild birds or indirectly through fecal matter and contaminated water, soil and feed, according to the Canadian Food Inspection Agency, which monitors for the virus on farms.
It can have devastating consequences, according to the agency. Millions of poultry were culled on farms in Canada last year to stop the spread of the virus, which attacks the intestinal and respiratory tracks of the animals and spreads quickly among chickens and turkeys and is more lethal.
Nearly 7.5 million poultry have been affected in the current outbreak, according to the Canadian Food Inspection Agency, although the number of domestic birds affected this year is down more than a third compared to the same time period last year.
However the federal agency notes that Canada is still in the midst of the spring migration period, which lasts until June.
This means that there is still a possibility for the number of affected birds to increase in the coming months, said the agency. Its important to note that the ongoing response is unique in the number of detections, the geographical distribution of outbreaks and its long duration, which has extended beyond typical migratory periods.
Stevens said that avian influenza viruses, like human flu virus, mutate and change.
Presumably at some point this virus is going to change and that is going to lessen the virulence, said Stevens. And its going to be taken over by another strain of the virus that will then move to the population and hopefully not be as severe a strain.
But as I said, we havent come across a virus like this, he said, one that sticks around in the wild population as long as it has.
So I dont know when that is going to happen or how long were in for. But presumably at some point in the future this will lessen and we wont have to worry about it as much.
Scientists dont know the rate that the virus is killing wild birds because they dont know how many are infected.
For instance, more Canada geese died in the GTA this year compared to last year, including hundreds of dead geese that were removed from a Markham park this spring. The city hired a contractor to collect the birds, which were brought to a landfill and incinerated.
Canada geese seem to be more susceptible, said Stevens. We have people that contact us and say theres a handful of Canada geese that have died from this. But theres 50 others in the pond that seem to be fine.
So we dont know exactly how susceptible Canada geese are, said Stevens. But because they are out in parks where people are seeing them, theyre reported to us more than many other species.
There is no evidence that the geese are carriers. Instead, scientists believe dabbling ducks such as mallards are the carriers, because they dont appear to be symptomatic or die from infections.
This makes them more likely to be a key species group for moving the virus around on the landscape, said Sharp.
The strain has however killed other species including snow geese, tundra swans and trumpeter swans. And scavenger birds that feed on remains have also fallen prey to the virus, including bald eagles, red tailed hawks, great horned owls, turkey vultures and crows, said Stevens.
In May, the Canadian Wildlife Health Cooperative diagnosed the death of the first mammals in Ontario, red fox kits.
Across the country, the virus has been found in 110 mammals across 10 species, including scavenging species such as the red fox, striped skunk and mink, as well as in opportunistic marine mammals such as harbour seal and the Atlantic white-sided dolphin, according to Sharp.
Mammals infected with HPAI have been found in all provinces and territories, except for New Brunswick, Northwest Territories, and Nunavut, he said.
Its extremely rare for the virus to infect humans, or pets for that matter, although a domestic dog in Canada was confirmed in April this year to have died from the virus.
Pet owners are advised to keep cats indoors and dogs on a leash to limit contact with potentially infected wild birds or carcasses, and to minimize exposure to outside environments such as ponds where birds congregate. Pets shouldnt be given any raw meat from game birds or poultry. And people shouldnt feed or handle any wild bird by hand.
The Canadian Food Inspection Agency said dead, injured, or sick birds should be reported immediately to the relevant provincial or territorial authority, or the Canadian Wildlife Health Cooperative information line at 1-800-567-2033 or by using their online reporting tool.
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We havent come across a virus like this: Could dabbling ducks be the ...
'We haven't come across a virus like this': Could dabbling ducks be the link in avian flu's spread? Toronto Star
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Will the Dog Flu Jump to Humans?zhengshun tang - Getty Images
A Chinese study says that tracking the H3N2 canine influenza virus for 10 years has shown adaptions that allow the dog flu to recognize a human-like receptor.
The virus originally spawned from the bird flu and has stabilized within canines, although theres still no jump to humans.
Continued adaptation in mammals could mean an eventual threat to humans.
The so-called dog flu may be moving ever closer to infecting humans, according to a new Chinese study.
The H3N2 avian influenza virushighly contagious and lethal in the bird populationsuccessfully jump to dogs around 2006. And it hasnt gone away. Instead, according to a study published in eLife by scientists at the China Agricultural University, it is stabilizing and adapting to better recognize human-like receptors.
Our results showed that canines may serve as intermediates for the adaption of avian influenza viruses to humans, the study says. For a human population that lacks immunity to the canine version of the virus, thats cause for concern, the study warns.
The bird flu spreads quickly in avian populations, but without the ability to effectively infect mammals, the concern over human-to-human transmission has as yet remained relatively low. While it is still a risk for humans that encounter the avian flu, the receptor molecule infected by the virus doesnt pass the virus to other humans beyond the initial infection. That could all change with a successful adaption of the virus into a mammal, especially if that mammal is showing additional adaptation toward human transmission.
The changes in the canine virus apparently are making it better adapted to transmit within mammals, as you might expect after such a long period in dogs, James Wood, head of the department of veterinary medicine at the University of Cambridge, told The Telegraph. The virus does not seem to pose particularly worrying health threats to dogs. But Wood adds that, even though it may be good news that the virus has not yet hopped from dogs to other mammals, it might also mean that the virus just hasnt hit on the right mutation yet. One might be more concerned about the longer-term pandemic potential in other species, such as humans.
Story continues
The study tested 4,000 sick dogs and found that one in 20 had the H3N2 virus, although it was a version of the virus that had mutated to better match the genome sequence of a human virus.
Ian Jones, University of Reading professor of virology, tells The Telegraph that the adaption into a more mammal-like virus is natural because of the time it has spent in the canine population. At the moment, he says, I judge this data warrants attention but that the case for a threat is not clear.
The study calls for continuous surveillance and risk assessments related to the canine flu, citing no pre-existing human immunity. Jones, though, says humans may offer up some defenses against the virus. And Wood notes that even as the dog flu numbers increase, albeit slowly, theres no case of a human infected with the dog flu.
Just where the bird flu-turned-dog flu may go next isnt a sure thing, but scientists will be watching.
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With sniffles as a near-constant companion this fall and winter, and previously obscure viruses becoming household names in Colorado, youre not alone if you wondered whether this past year was normal.
Some pathogens like respiratory syncytial virus, or RSV, and streptococcus bacteria, or strep did damage that childrens hospitals called unprecedented. But the flu season was of about average severity, and a seeming cluster of unexplained hepatitis cases turned out to nothing out of the ordinary.
That doesnt mean fall and winter werent miserable for some, especially after two years with minimal viral spread. A January poll from the Kaiser Family Foundation found about 38% of people reported someone in their home had been sick from flu, COVID-19 or RSV in the previous month.
In some ways, thats a return to the way things were before the pandemic, said Dr. Sam Dominguez, a pediatric infectious disease specialist at Childrens Hospital Colorado.
An average toddler who attends daycare gets 10 to 12 respiratory viruses over the course of the six to eight months when they most commonly spread, but they had far fewer illnesses while people were masking and practicing social distancing earlier in the pandemic, he said.
Now that those measures are gone, respiratory viruses are back, he said.
The number of Colorado children who didnt get common viruses in 2020 and 2021 contributed to the massive number of RSV cases in fall 2022. At the peak in November, 295 children and 31 adults were admitted to hospitals with RSV in the Denver area. (The Colorado Department of Public Health and Environment doesnt collect statewide data on RSV.)
It really was the worst RSV season in my memory, Dominguez said.
Children under 1 were hit hardest, as is typical, but the average age of a hospitalized child was eight to nine months older as the virus found kids who werent previously infected, Dominguez said.For many respiratory diseases, including RSV, first infections tend to be the worst.
Researchers are still trying to sort out whether children who got their first infection later were more likely to become severely ill, or whether the country essentially compressed three respiratory seasons worth of hospitalizations into one, Dominguez said.
Thats the million-dollar question, he said.
Its not clear yet if RSV will return to a more normal pattern this fall, though the sheer number of children infected over the past season suggests there wont be a large pool thats susceptible, Dominguez said.
The U.S. Food and Drug Administration approved an RSV vaccine for adults 60 and up on Wednesday, and is expected to approve a second vaccine for adults and a new antibody product for children, which would reduce severe cases, he said.
Colorado sounded the alarm about unexplained hepatitis in children in May 2022, but new cases tapered off as the year went on. The state health department has identified 32 cases of liver inflammation in children without a clear cause since October 2021.
The rate of pediatric hepatitis cases wasnt above what would be expected in normal times, state epidemiologist Dr. Rachel Herlihy said. Unexplained hepatitis is a rare phenomenon, and before late 2021, it didnt get much attention.
It still isnt entirely clear what caused the hepatitis cases, though the leading theory is that children who were infected with adeno-associated virus 2 and another virus at the same time may have been more likely to develop the condition.
The flu season has been moderate in Colorado, with most hospitalizations between early November and mid-January. Influenza A hit early and petered out relatively quickly, while influenza B has yet to cause a significant wave.
Its still possible there could be a spring flu wave, as happened in 2022, but thats looking less likely, Herlihy said. This year, the flu vaccine was a good match for the circulating strains and a relatively high percentage of people chose to get it, which limited the number of severe illnesses, she said.
It certainly wont go on record as a particularly severe season, she said.
The Centers for Disease Control and Prevention have counted 145 flu deaths among children nationwide this season a return to prepandemic levels. One child died during the 2020-2021 season, and 45 did during the 2021-2022 season.
Colorado has recorded one pediatric flu death so far this season a school-aged child in the Denver area, according to the state health department.
Neither Colorado nor the CDC counts adult flu deaths as they happen.
While many of the disease waves have passed, Colorado kids are still experiencing about three to four times the usual number of cases of invasive group Astreptococcus infections, which is unprecedented, Dominguez said.
There are fewer cases now than there were in March, but its too early to say the tide has turned, he said.
Im trying to be optimistic that we might be ending that wave, he said.
The state health department recorded 28 cases of invasive strep A in children and two deaths in 2022, with most occurring in November and December far higher than the usual pace of one or two cases per month. Adults also have had an above-average rate of invasive infections, Herlihy said.
Most people develop strep throat or mild skin infections when infected with strep A, but sometimes the bacteria gets into the bloodstream or the nervous system, or destroys tissue around a wound.
An unusually high number of kids have gotten strep throat, so its not clear if the increase in severe cases simply reflects the number of total infections, Dominguez said. The CDC is running genetic analysis to see if a more-severe strain is circulating, but so far it hasnt found any sign of that, he said.
The risk of invasive strep A is higher if someone is infected with a respiratory virus at the same time. That doesnt seem to be the only factor, though, because invasive strep A cases have remained high even as circulation of viruses has gone down, Herlihy said.
While theres no vaccine against group A strep, keeping children up-to-date on their other shots gives the bacteria fewer opportunities to piggyback off another infection, Dominguez said. Its also important to use hygiene practices like handwashing, he said.
Parents should also be vigilant for symptoms like prolonged fever, difficulty breathing, worsening respiratory symptoms, rapidly spreading rashes, or a child refusing to eat or move, Dominguez said.
If you can recognize and treat group A strep sooner, the outcomes are better, he said.
One bright spot over the last year was that an expected increase in paralysis cases in children never happened.
The condition, known as acute flaccid myelitis, followed a pattern of hitting children hard every other year from 2014 to 2018. There was no spike in 2020, though, and doctors were concerned that it would return last year.
Acute flaccid myelitis is thought to be triggered by an infection with a virus called enterovirus D68, but the number of paralysis cases remained low in 2022, despite the widespread circulation of that virus. At Childrens Hospital Colorado, there was a significant increase in patients who had EV-D68 in late summer, but only four of them developed acute flaccid myelitis, Dominguez said.
One theory is that the strain circulating in 2022 happened to be one that is far less likely to cause paralysis, Dominguez said.
It would be great if we got lucky and the current strain continues, he said.
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