Nasal Covid Vaccine Shows Promising Results in Early Clinical Trials

According to preliminary results from a Phase 1 clinical trial, the experimental nasal vaccine provided strong protection against Covid infection.

The vaccine, developed by startup Blue Lake Biotechnology Inc., was found to reduce the risk of symptomatic Covid infections by 86% over three months in people who received it as a booster dose. Booster shots in the US reduce symptomatic infections by 43% in people aged 18 to 49 within one to two months, according to a study published in November by the Centers for Disease Control and Prevention.

Clinical trial results provide an early but enticing glimpse of how the next generation Covid vaccine could be more effective in stopping the spread of the coronavirus.

Nasal vaccines may provide better protection against Covid compared to those given in the arm, scientists have said.

Because these vaccines are sprayed into the nose, they are thought to fire up the immune system faster against respiratory viruses. Essentially, nasal vaccines strengthen the immune defenses right where the virus enters the body, creating a more targeted line of defense.

The idea is to alert the immune system so that the virus “doesn’t even have a chance to gain a foothold,” said Dr. Benjamin Goldman-Israelow, an assistant professor of medicine at Yale School of Medicine who is not involved in the Blue Lake clinical trials.

Goldman-Israelow’s own animal studies have shown equally promising levels of protection. In a study published in Science in October, he and colleagues demonstrated that a nasal booster vaccine elicited a strong immune response in the upper respiratory tract and was more effective at blocking Covid infections than intramuscular vaccines.

Despite their promise, progress on nasal vaccines in the US has lagged behind other countries. While several nasal vaccine options are in development, most are in the preclinical stages. Apart from the Blue Lake vaccine, only one vaccine developed by researchers at Mount Sinai in New York has been tested in humans.

Nasal Covid vaccines have been approved in India, Iran and Russia, and two other vaccines are in use in China, along with an inhaled version that was approved in September for use as a booster dose. But so far, few details about their effectiveness have been made public.

Stage 1 results

The Phase 1 Blue Lake study included 72 participants aged 18 to 55 who had already received at least two doses of the mRNA vaccine, as well as unvaccinated healthy adults. The trial began in August 2021, and scientists will continue to collect data from participants until December.

The findings, which were published earlier this month, are still preliminary and more research is needed with more people before general conclusions can be drawn. But so far, the vaccine looks promising.

“When we ran the numbers, we had longer and better protection than mRNA vaccines – that’s very interesting,” said Biao He, founder and CEO of the Athens, Georgia-based startup and professor of infectious diseases at the University of Georgia College. . veterinary medicine.

“This is only Phase 1 and we need to do at least three phases, but we are very excited and excited about this,” he said.

The vaccine uses a type of parainfluenza virus coded for by the spike protein of the coronavirus to train the immune system to recognize it and fight it. The same parainfluenza virus, modified to not cause disease in humans, is also used in vaccines given to dogs to protect against kennel cough.

Once inhaled, pieces of the virus multiply inside the nasal cavity for several days in sufficient numbers to elicit an immune response without actually making the person sick.

Goldman-Israelow says this works by fine-tuning the way the respiratory system detects and identifies foreign invaders.

Unlike the more “sterile” environments in the bloodstream, the nose and lungs must look for specific danger signals in order to separate real threats from more harmless substances.

“Your lungs are always confronted with what you breathe in, and if they reacted very violently and had an intense immune response to everything they encountered, you would not be able to breathe,” Goldman-Israelow said.

He added that if the nasal vaccines are given as boosters, the body will already be prepared to recognize the coronavirus and thus could elicit a faster immune response at the site where the virus enters the body.

In their phase 1 trial, the researchers also documented fewer side effects from their vaccine compared to shots. Some people have reported flu-like symptoms such as arm aches, muscle aches and fever after Covid injections, but he said Phase 1 participants experienced mild or no side effects such as a runny nose.

“Side effects from other vaccines may have deterred some people from getting it, but in the trials we’ve done so far, our vaccine has been very well tolerated,” he said.

The researchers hope to begin the next phase of clinical trials soon, he said, and are aiming to expand the study to include about 400 participants from the US and Europe.

He said he hopes the more positive results will attract more funding to develop and test nasal vaccines — not just for Covid, but for other diseases as well.

If the current pace of vaccine development is any indication, there is reason to be optimistic, Goldman-Israelow said.

“Despite the huge anti-vaccination front, there are also many people who really want vaccines and protection,” he said. “There seem to be people who are interested in these things and they would like vaccines to work even better, and I think they have the potential to make them work better.”

AMENDMENT (February 24, 2023 5:06 pm ET): A previous version of this article misrepresented the results of the CDC mRNA booster study. It was 43% effective in people aged 18 to 49 for one to two months, and not in people aged 65 and under for three months.

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