Need some quick cash and want to save the world? Just in time for Christmas, $1050 would surely come in handy. It’s almost free money when you look at what’s required: an overnight stay in a clinic, a follow-up appointment a week or so later.
“Enjoy free WiFi and food,” says the invitation from Linear, a clinical trial facility operating out of QEII Medical Centre in Perth, Western Australia.
But, yeah, there’s a catch: you’ll be taking part in a Phase 1 clinical trial in which you’ll be dosed with nasal drops made from chicken egg yolks containing antibodies that are designed to “provide temporary immunity to SARS-CoV-2.” (We’ll get back to that.)
A Phase 1 trial tests for safety. Some recruits have already been dosed. Two more cohorts are being recruited for late November.
You can read here how clinical drug trials are a form of paid work for many people in Australia, many of them young, plenty of them backpackers sick of picking grapes.
But really, this is the pointy end of finding treatments for the virus that has held the world hostage for nearly all of 2020.
Most of the focus in the media has been on the search for a silver bullet vaccine. But, given that we won’t see a vaccine where safety has been fully proven until 2022, researchers are looking at alternatives.
Nasal sprays are a growing area of research
University of Hong Kong researchers have developed a two-for-one nasal-spray vaccine for seasonal influenza and the SARS-CoV-2 virus. Phase 1 clinical trials start this month with 100 people, and will take at least a year.
The vaccine contains weakened flu viruses, including H1N1, H3N2, and B, with genetic segments of the COVID-19 spike protein. Entering the body via the nostrils, as does the coronavirus and the flu, the vaccine essentially mimics the infection process of a respiratory virus, and stimulates the immune response.
European and US researchers have just openly published a small study (not yet peer-reviewed) in which a nasal spray completely blocked the absorption of SARS-CoV-2, thereby protecting ferrets it was tested on.
Ferrets are used in respiratory disease research because, as with humans, they can catch viruses through the nose.
In this instance, according to a report in The New York Times, the spray was given to six ferrets, which were then divided into pairs and placed in three cages.
“Into each cage also went two ferrets that had been given a placebo spray and one ferret that had been deliberately infected with SARS-CoV-2 a day or two earlier.”
After 24 hours, none of the sprayed ferrets had caught the disease. All those given a placebo were sick. “Virus replication was completely blocked,” the authors wrote in a paper that has been submitted to Science.
Researchers from the University of Waterloo in Canada are working on a nasal-spray vaccine that floods healthy cells in the nasal cavity and lungs with virus-like particles that are designed to be harmless, but have a similar structure to SARS-CoV-2. This allows the body to produce a localised immune response to the corona-virus lookalike.
Melbourne-based biotech company, Ena Respiratory, is developing a novel nasal spray to boost the natural human immune system to fight common colds and flu.
In September, the company announced their treatment had significantly reduced the growth of the coronavirus in a study involving ferrets.
In a press release, the company said the “novel product, INNA-051… reduced viral replication by up to 96 percent in a gold-standard animal study.”
But what’s the point of taking it up the nose?
Shi-Hua Xiang is an associate professor at the Nebraska Center for Virology School of Veterinary Medicine and Biomedical Sciences,
University of Nebraska.
Dr Xiang is in the early stages of developing a bacterial delivery system for a COVID-19 nasal spray vaccine using bioengineered Lactobacillus – a safe, widely used bacteria found in yogurt and cheese – as a delivery system.
Dr Xiang believes that targeting the mucosal tissues of the nose and mouth “may provide more robust protection against COVID-19 than an injected vaccine because it would more closely mimic a natural COVID-19 infection, producing antibodies and immune cells in the key locations where the virus enters.”
The benefit here is that “mucosal vaccines induce immunity at the point of viral entry, controlling early infection before it becomes an established systemic infection.”
In other words, it knocks the virus on the head before it has a chance to take over the body.
But what about chicken-egg tests out of Perth?
Dr Daria Mochly-Rosen is president and founder of SPARK GLOBAL, Co-Director and Founder of SPARK at Stanford, and a professor of chemical and systems biology at Stanford University School of Medicine.
In an email to The New Daily, responding to questions, Dr Mochly-Rosen agreed that “the nose is where immune response is important … I also agree that injectable vaccine may not provide the same local response as the one triggered by the virus when delivered locally, in the nose.”
SPARK GLOBAL is a network of academic institutions around the globe that use a translational research model pioneered at Stanford in 2006. The program relies “on a large network of volunteer industry advisors to help translate breakthrough academic discoveries into products that benefit patients and society.”
The Phase 1 clinical trial running out of Perth at the Linear clinical facility is a SPARK GLOBAL project – and essentially it’s aiming to produce cheap, short-term and immediate protection against the coronavirus.
It’s not a traditional vaccine like the Nebraska project.
Dr Mochly-Rosen said an “active vaccine is a very different approach from ours; it will require to mount an immune response by the treated person, which will take several weeks; it can cause a local irritation; and its efficacy should be compared to injectable vaccine.”
The SPARK GLOBAL project is a passive vaccine. “We give subjects already active antibodies. It provide protection immediately, it is unlikely to cause nasal irritation and we have completed animal safety study and are currently conducting human safety study.”
On the upside, when formulated into nasal drops, the antibodies “can be self-administered at home or on the go.”
While they potentially provide immediate immunity, it won’t be long lasting – wearing off after approximately four hours.
Dr Mochly-Rosen saidn the nasal drops will not replace vaccines and measures such as wearing face masks, social distancing and washing hands.
“But they could play a vital role in keeping people safe while the medical community and governments around the world pursue all options for ending the pandemic,” she said.
Finally, this is where the chickens come in
- To produce the antibodies, egg-laying hens are first immunized with a key SARS-CoV-2 protein.
- The antibodies are passed to the hens’ eggs as IgY antibodies, extracted from the egg yolks, and formulated into nasal drops.
- When administered, antibodies in the drops coat the surfaces inside the nose and throat as a barrier against SARS-CoV-2.
- The use of chicken IgY antibodies has been shown to be safe and effective for multiple diseases. IgY are considered safe for humans when ingested, and the hens are never exposed to the actual virus.
- Because hens are widely available around the world, when immunized they provide a plentiful, inexpensive, and safe source of antibodies against the virus.
The trial is expected to be completed in December 2020. All going well, Phase 2 trials will begin next year.