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Anges starts Japan's 1st COVID-19 vaccine clinical trial on humans

9 Comments

Medical startup Anges Inc said Tuesday it has started Japan's first clinical trial on humans of a potential vaccine for the new coronavirus, aiming for government approval by the fall next year for its sale if the vaccine proves to be safe and effective.

The trial at Osaka City University Hospital begins with injecting the DNA vaccine into 30 healthy adults through early July. It will assess their data over eight weeks to see whether they have side effects from the vaccine or have developed antibodies against the disease.

The participants are grouped into two teams of 15, with one given larger amounts of the vaccine than the other. Each person receives two intramuscular shots of the vaccine.

If the initial phase of the clinical trial confirms the vaccine's safety, Anges will expand enrollment to around 400. If the next stage goes well, it hopes to obtain government approval between the spring and the fall of next year to produce and sell the vaccine.

Anges said the enrolled patients will be observed until July next year. It said it also plans a separate clinical trial of the vaccine at Osaka University.

The vaccine Anges has developed will inject a genetically engineered circular DNA into the body that produces "spike proteins," which are a characteristic of the coronavirus, according to the company. When such proteins are made, the body's immune system is stimulated to make antibodies against the virus.

Anges joins some 17 clinical tests of coronavirus vaccine candidates being conducted globally, including by U.S. biotechnology company Moderna Inc, British pharmaceutical giant AstraZeneca Plc and China's CanSino Biologics Inc, as the race accelerates.

In Japan, Shionogi & Co is also developing a vaccine but has yet to start a clinical test on humans.

Given the expected surge in demand, Japan is seeking to secure a stable supply of vaccines for people in the country. The government is pushing for homegrown vaccines and also negotiating with foreign companies such as AstraZeneca in an attempt to secure enough vaccines.

© KYODO

©2020 GPlusMedia Inc.

9 Comments
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I am not confident on this specific candidate to be successful, DNA vaccines have not yet proven to be effective in humans even after years of being tried because the plasmid DNA does not efficiently enter the cells by itself so most is degraded without ever being converted into proteins for the immune system to recognize.

The important part is that finally Japan joined the rest of the developed world and began doing clinical trials for new therapies using nucleic acids, as long as this vaccine candidate is safe for human use that still means a huge advancement for the country. Maybe in the near future more complicated delivery systems (and not just the "naked" DNA) can be tried and Japan can become again a country that can develop cures and treatments without having to depend always on discoveries from overseas.

8 ( +10 / -2 )

virusrex:

I'd just like to express my appreciation of your posts over recent months since the emergence of this virus. Obviously informed opinion, no hysteria, never any BS, I thank you for it.

Pity you're not able to be more positive about this particular initiative, but I note that there are 16 or so other vaccine tests being conducted globally. Let's hope someone comes up with something soon. Cheers.

11 ( +11 / -0 )

It's positive news but I think they need to take drastic action to speed things up. If a vaccine only becomes widely available by the fall of next year, it might be a bit late for many people. Worldwide, numbers are roughly doubling every month, and will probably be in the hundreds of millions by next year.

-4 ( +1 / -5 )

Geronimo, how do you accurately predict the long-term effects in humans, both potentially positive and negative, in a 'sped-up' few months' trial?

7 ( +7 / -0 )

Don't understand the protocol. Were participants screened for pre-existing conditions? Ethics of doing so aside, unless the subjects are all isolated, exposed to the virus in some uniform way after receiving the vaccine, and monitored to see how many fall ill, and how ill they become, how are the researchers going to determine the level of effectiveness, or lack thereof, of the two treatments? Otherwise, they could claim that because nobody got sick, it's 100% effective. Another article that raises more questions than it answers.

4 ( +4 / -0 )

Don't understand the protocol. Were participants screened for pre-existing conditions? Ethics of doing so aside, unless the subjects are all isolated, exposed to the virus in some uniform way after receiving the vaccine, and monitored to see how many fall ill, and how ill they become, how are the researchers going to determine the level of effectiveness, or lack thereof, of the two treatments? Otherwise, they could claim that because nobody got sick, it's 100% effective. Another article that raises more questions than it answers.

Clinical trials have specific phases which cannot be skipped. The first one examines if the vaccine is safe in a small number of healthy, normal individuals, the trials do not expect any of them to get infected and will only check if any unexpected side effect appears. Depending on the trial it can also assess the production of antibodies that can neutralize the virus but that is not the same as saying that they are protected.

A brief description of the phases from the CDC:

Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.

2 ( +2 / -0 )

In Russia they did already and soon will start to distribute to own citizens and later maybe abroad too.

But yes...JT "did not find" these news yet...

-4 ( +0 / -4 )

One has to be insane to want to be a guinea pig for especially a DNA vaccine. Who are these healthy individuals.? Are they inmates or some day labourers in nishi nari ward?

-2 ( +1 / -3 )

One has to be insane to want to be a guinea pig for especially a DNA vaccine. Who are these healthy individuals.? Are they inmates or some day labourers in nishi nari ward?

Of course not, just people not dominated by irrational fears that wish to help, the science is solid, a huge lot of data is available from animal experiments and from human trials in other countries that prove that properly designed DNA vaccines do not carry any significant risk. Statistically it can be proved that the clinical trial is not more risky than the possibility of catching COVID-19, logical rational people can understand that. Just a tiny bit of interest in helping controlling the pandemic is all that is needed for those people to volunteer.

Is for example more risky to be a nurse or a doctor, even without any pandemic active, but lots of people do it without being forced.

1 ( +1 / -0 )

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