The first clinical trial of a nasal vaccine against Alzheimer’s disease begins

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It is the culmination of nearly 20 years of research. the Brigham and Women’s Hospital of Boston, has just announced that it is starting a clinical trial to test the safety and efficacy of a new nasal vaccine. This vaccine, formulated from a substance that stimulates immunity (Protollin), is intended to prevent and slow the progression of Alzheimer’s disease, a form of dementia that affects more than 50 million people in the world. world.

Alzheimer’s disease is the most common cause of dementia. It results from an accumulation of amyloid deposits and the progressive degeneration of neurons; it is characterized by impaired memory and executive functions, impaired reasoning skills, and disorientation. To date, there is no treatment, but research in this area, which has been particularly prolific in recent years, has made it possible to better understand the disease, in particular its risk factors and the physiological mechanisms involved.

This Phase 1 trial will involve 16 participants, aged 60 to 85, all with early-stage Alzheimer’s disease, but in good general health. They will receive two doses of the vaccine one week apart, the hospital said. Like any phase 1 trial, the objective here is to determine the safety and tolerance of the nasal vaccine. Researchers will also assess the effects of Protollin on the participants’ immune response.

An adjuvant that stimulates the immune system

The vaccine uses the immune modulator Protollin, an experimental intranasal agent that stimulates the immune system, which can help fight certain diseases. A study published in 2004 has shown that this adjuvant, combined with influenza antigens, increases serum immunoglobulin levels up to 250-fold compared to immunization with antigens alone. Composed of proteins derived from bacteria, it has already been used safely in humans as an adjuvant for other vaccines.

Scientists hope that similarly, it can activate the body’s immune system to target beta-amyloid protein plaques – one of the hallmarks of Alzheimer’s disease. ” The immune system plays a very important role in all neurological diseases Said Howard Weiner, who led the research. If this trial proves successful, the researchers believe this new approach could potentially help treat other neurodegenerative diseases.

Protollin is developed, manufactured and marketed by I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical, two Chinese pharmaceutical companies (which are also funding this trial). The product has been designed to activate the white blood cells found in the lymph nodes located on the sides and back of the neck (hence the method of administration by nasal spray), so that they migrate to the brain and eliminate beta-amyloid plaques. ” Over the past 20 years, there has been growing evidence that the immune system plays a key role in the elimination of beta-amyloid. This vaccine harnesses a new arm of the immune system to treat Alzheimer’s disease Said Tanuja Chitnis, professor of neurology at Brigham and Women’s Hospital and principal investigator of the trial.

This first historic trial on humans will provide an opportunity for the research team to measure the effect of nasal protollin on the immune response, in particular its effects on white blood cells, by examining cell surface markers, genetic profiles and functional tests. ” If clinical trials in humans show the vaccine to be safe and effective, it could represent a non-toxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s disease in people. people at risk », explique Howard Weiner.

Several treatments under development

According to National Institute on Aging, Alzheimer’s disease is the sixth leading cause of death in the United States. In France, nearly a million people are affected by the disease and it is estimated that 225,000 new cases are diagnosed each year. Researchers around the world have been working for years on the development of new drugs to treat or slow Alzheimer’s disease. Very often, experimental drugs can eliminate amyloid plaques but do not resolve the symptoms of very handicapping patients on a daily basis, namely their loss of autonomy and reduced cognitive abilities.

Recently, researchers have developed treatment and vaccine for the disease. Tested only on mice, their products seem very promising. Their approach differs from other experimental treatments in that they target a very specific form of the beta-amyloid protein. If their results are very encouraging, it will probably unfortunately take years of research before having a treatment for humans.

In June, the Food and Drug Administration approved the first new drug against Alzheimer’s disease in 20 years: it is Aduhelm (or aducanumab), developed by the American laboratory Biogen in collaboration with the Japanese company Eisai Co.; it was designed to destroy the amyloid plaques that build up in the brain. Namely, in 2019, Biogen announced the end of its two phase 3 clinical trials, following negative results. Then six months later, the lab announced that his treatment was ultimately effective for a subset of participants.

The FDA’s decision therefore sparked controversy, especially following warnings from independent advisers that the drug had not been shown to actually help slow the disease. It would also carry the risk of serious side effects. The European Medicines Agency has so far opposed the treatment – it is expected to make its final decision in mid-December. According to CBS News, the FDA has asked Biogen to conduct a follow-up study to confirm the drug’s benefits; if this study is inconclusive, the American authority could withdraw it from the market.

Source : Brigham and Women’s Hospital

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