Dengue vaccine does well in trials: Sanofi

[Lite Beer]

Dengue vaccine does well in trials: Sanofi
The Nation

BANGKOK: -- Sanofi Pasteur has said that its work on a dengue vaccine, in the first of two pivotal phase-three efficacy studies, has achieved a "primary clinical endpoint".

The France-based company said this week the efficacy study showed a significant reduction in 56 per cent of dengue disease cases, with initial safety data consistent with the good safety profile observed in previous studies.

"Full analysis of the data will be undertaken in the coming weeks and reviewed by external experts prior to disclosure at an upcoming interna?tional scientific congress and publica?tion in a peer-reviewed journal later this year," it said.

Dengue is a threat to nearly half the world's population and a major public health priority in many countries in Asia and Latin America, where epi?demics occur.

"This achievement is the result of more than 20 years of work in the field of dengue, collaborating with investi?gators, volunteers, authorities, scien?tific experts and international organ?isations," Olivier Charmeil, president and chief executive of Sanofi Pasteur, said.

"Developing a dengue vaccine for the benefit of children and their par?ents is at the heart of our mission. Our goal is to make dengue the next vac?cine-preventable disease and to sup?port the WHO [World Health Organisation]'s ambition to reduce dengue mortality by 50 per cent and morbidity by 25 per cent by 2020."

Dr Maria Rosario Capeding, prin?cipal investigator at the Research Institute for Tropical Medicine in the Philippines, said it was the first time a dengue vaccine had successfully com?pleted a phase-three efficacy study.

"These significant clinical results, associated with the good safety profile of the vaccine, bring real hope to more than 100 million people affected each year by dengue, a disease without any specific treatment today," she said.

The results of this first, large-scale efficacy study will be further complemented by results in the third quarter from a second, large-scale study now being conducted in Latin America, including more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico, the company said.

-- The Nation 2014-05-03

[Thait Spot]

This is great news

Sent from my Nexus 4 using Thaivisa Connect Thailand mobile app

[issanaus]

Good news as far as it goes but does leave some question.

AFAIK there are 4 strains of Dengue Fever. Exposure to one will lead to an enhanced level of protection but leaves the person in a position where if they contact the other strains they will experience more sever symptoms.

Is my understanding correct ?????

If so is the vaccine effective against all strains?

If it is not effective against all strains will it lead to more sever reaction (if my original statement is correct) ?

[geriatrickid]

Please note the following;

1. It is a pediatric clinical trial: Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

2. The cinical trial is ongoing and will conclude in November 2017

3. The vaccine is a tetravalent which means it is for all 4 serotypes.

[wellred]

This is great news

[Cobragold]

Yes,

There are 4 strains of the fever, you get 1, you become immune only to that strain. But if you get another different strain, you will get the fever quite bad, subsequent strains can be life threatening and cause death.

[LukDod]

I can only hope that the trials on the mentioned vaccine....

...are _not_ based on the ridiculous claim by a Thai medical 'expert', made two weeks ago,

who said that that _homeopathic_ remedies would cure dengue fever. !!

[kriswillems]

A reduction of 56%? Is that a success? I mean, would you get the vaccination and pay for it if it decreases your risk with only 56%?

Also dengue fever is a very seasonal phenomenon. One year there's a lot of dengue fever, the other year not.

How can they be statistically sure this 56% reduction is not just a natural occurring seasonal variation.

Is it possible the the company is a bit too positive?

Edited May 3, 2014 by kriswillems

[kriswillems]

I can only hope that the trials on the mentioned vaccine....

...are _not_ based on the ridiculous claim by a Thai medical 'expert', made two weeks ago,

who said that that _homeopathic_ remedies would cure dengue fever. !!

The most effective malaria medicine was originally a homeopathic thing....(Artemisinin)

Edited May 3, 2014 by kriswillems

[ClutchClark]

I can only hope that the trials on the mentioned vaccine....

...are _not_ based on the ridiculous claim by a Thai medical 'expert', made two weeks ago,

who said that that _homeopathic_ remedies would cure dengue fever. !!

Do you even read the articles?

[ClutchClark]

A reduction of 56%? Is that a success? I mean, would you get the vaccination and pay for it if it decreases your risk with only 56%?

Would someone pay for 56% success? Ofcourse.

I am guessing you have never suffered from Breakbone Fever?

Besides, these vaccines will be paid for by NGO's and administered to children.

[stickylies]

I can only hope that the trials on the mentioned vaccine....

...are _not_ based on the ridiculous claim by a Thai medical 'expert', made two weeks ago,

who said that that _homeopathic_ remedies would cure dengue fever. !!

The most effective malaria medicine was originally a homeopathic thing....(Artemisinin)

Phytotherapy is not homeopathy.

[thepool]

<script type='text/javascript'>window.mod_pagespeed_start = Number(new Date());</script>

I can only hope that the trials on the mentioned vaccine....

...are _not_ based on the ridiculous claim by a Thai medical 'expert', made two weeks ago,

who said that that _homeopathic_ remedies would cure dengue fever. !!

The most effective malaria medicine was originally a homeopathic thing....(Artemisinin)

Phytotherapy is not homeopathy.

Exactly !

Homeopathy is the "science" of magic water and sugar pills -------------total Quackery !

[belg]

nice, the pharma will have something new to sell us ...

will thailand give it for free to all the kids, adults ? same same as the free tablets ?

[partington]

A reduction of 56%? Is that a success? I mean, would you get the vaccination and pay for it if it decreases your risk with only 56%?

Also dengue fever is a very seasonal phenomenon. One year there's a lot of dengue fever, the other year not.

How can they be statistically sure this 56% reduction is not just a natural occurring seasonal variation.

Is it possible the the company is a bit too positive?

It's not great, but it's far better than nothing. For a really effective vaccine you would want to see as close to 100% protection as possible, of course.

But these results mean that you could prevent more than half of the current number of cases of Dengue, and this is clearly a good start.

There is a suggestion in other news reports that though the vaccine was directed against all four strains of dengue, it is least effective against the most common strain.

The only way that this could have been discovered is by doing a clinical trial. Now that this is known future research can be directed towards increasing the efficacy against the resistant strain.

This is the only way you can progress: develop, test in trial, improve, test again.

People who do clinical trials do not somehow "forget" that dengue is seasonal, and that there is a variable chance of catching it. These trials are done by randomly allocating subjects to receive a placebo injection or the vaccine. The people receiving the injections, and the medical personnel giving them do not know who has got the vaccine and who got the salt solution until after the trial is over, when the code is broken by a third party. This is what "double blind" means.

So they are comparing people from the same populations at the same risk, selected at random to get the vaccine or the dummy.

[thepool]

<script type='text/javascript'>window.mod_pagespeed_start = Number(new Date());</script>

A reduction of 56%? Is that a success? I mean, would you get the vaccination and pay for it if it decreases your risk with only 56%?

Also dengue fever is a very seasonal phenomenon. One year there's a lot of dengue fever, the other year not.
How can they be statistically sure this 56% reduction is not just a natural occurring seasonal variation.

Is it possible the the company is a bit too positive?

It's not great, but it's far better than nothing. For a really effective vaccine you would want to see as close to 100% protection as possible, of course.

But these results mean that you could prevent more than half of the current number of cases of Dengue, and this is clearly a good start.

There is a suggestion in other news reports that though the vaccine was directed against all four strains of dengue, it is least effective against the most common strain.

The only way that this could have been discovered is by doing a clinical trial. Now that this is known future research can be directed towards increasing the efficacy against the resistant strain.

This is the only way you can progress: develop, test in trial, improve, test again.

People who do clinical trials do not somehow "forget" that dengue is seasonal, and that there is a variable chance of catching it. These trials are done by randomly allocating subjects to receive a placebo injection or the vaccine. The people receiving the injections, and the medical personnel giving them do not know who has got the vaccine and who got the salt solution until after the trial is over, when the code is broken by a third party. This is what "double blind" means.

So they are comparing people from the same populations at the same risk, selected at random to get the vaccine or the dummy.

A sound if simplistic response !

A 50% reported efficacy is indeed an achievement against one of the most challenging of mosquito born diseases.

A vaccination program based on the current results would be massively beneficial..

[attrayant]

nice, the pharma will have something new to sell us ...

Yes, that's awful. Publicly traded companies ought to give their products away for free.

[fab4]

Out of interest the Brits have been on this for a while but they've gone down a different route, with genetically modified mosquitoes. There's a 2 year field trial just started in Brazil. So if you're going to the World Cup, you could be safe..............or not

Brazilians welcome genetically-modified mosquito to help fight dengue fever

PRI's The World

Reporter John Otis

April 25, 2014 · 1:00 PM EDT

The new breed of Aedes aegypti has been given a lethal gene. The deadly flaw is kept in check in the lab, but the mosquitos soon die in the wild.

The strain, developed by the British company Oxitec, was the first genetically modified insect to be released in the wild — during small tests in 2010. The program underway in Jacobina is its first large-scale field test.

It starts in Moscamed's lab, where workers use water and strainers to separate the male mosquitos from the slightly larger females. The females, which bite, are destroyed, and the males — which don’t bite — are released into the wild from pickup trucks.

The Brazilian government has authorized the two-year trial. The hope is that the male GM mosquitos will mate with wild females and produce offspring that will die before they can reproduce .

Edited May 3, 2014 by fab4

[geriatrickid]

Phytotherapy is not homeopathy.

Wow. I'm impressed. One of the few times I am thoroughly excited that someone gets it and knows the difference. Usually, we are treated to idiots espousing pseudo science and advocating idiotic solutions e.g. (the TVF obsession with enemas and colonic "irrigation" etc.). Good job, and thank you.

[geriatrickid]

nice, the pharma will have something new to sell us ...

will thailand give it for free to all the kids, adults ? same same as the free tablets ?

The vaccine research is being facilitated and supported by multiple public health agencies/services around the world with the US NIH being a prominent backer. It is expected that in many countries the government will include the vaccine in subsidised or free "packages" for children It is in national interests to do so as the estimated annual case load is between 50-100 million in any given year and the costs of dengue infections are serious. Government vaccine supported programs typically negotiate low purchase prices for the drugs for these programs, cost plus a set % to allow the pharma company an opportunity to recoup its R&D and opportunity costs as well as to allow a fair profit. In case you forgot, when there is an international effort to contain a serious illness vaccines and treatments are delivered at no cost to at risk groups. Examples are polio & measles.

[geriatrickid]

A reduction of 56%? Is that a success? I mean, would you get the vaccination and pay for it if it decreases your risk with only 56%?

Also dengue fever is a very seasonal phenomenon. One year there's a lot of dengue fever, the other year not.

How can they be statistically sure this 56% reduction is not just a natural occurring seasonal variation.

Is it possible the the company is a bit too positive?

It's not great, but it's far better than nothing. For a really effective vaccine you would want to see as close to 100% protection as possible, of course.

But these results mean that you could prevent more than half of the current number of cases of Dengue, and this is clearly a good start.

There is a suggestion in other news reports that though the vaccine was directed against all four strains of dengue, it is least effective against the most common strain.

The only way that this could have been discovered is by doing a clinical trial. Now that this is known future research can be directed towards increasing the efficacy against the resistant strain.

This is the only way you can progress: develop, test in trial, improve, test again.

People who do clinical trials do not somehow "forget" that dengue is seasonal, and that there is a variable chance of catching it. These trials are done by randomly allocating subjects to receive a placebo injection or the vaccine. The people receiving the injections, and the medical personnel giving them do not know who has got the vaccine and who got the salt solution until after the trial is over, when the code is broken by a third party. This is what "double blind" means.

So they are comparing people from the same populations at the same risk, selected at random to get the vaccine or the dummy.

With all due respect, you are confusing the results of two clinical trials. The 2012 Phase II trial with 30% efficacy reported the issue with ineffectiveness against one serotype. This is the phase III trial and no analytical results have been released. What we have is an initial public statement which Sanofi was legally obliged to release because it is a publicly traded company. An error in reporting can have catastrophic results for a public company as shareholders can bring legal action for an inaccurate or delayed press release which impacts the company's share price. These suits are one of the leading causes of pharma company litigation and have added up to billions of dollars paid in settlements over the years.

[Maroon Watcher]

Good News 56% is better than 0.

Good start - lets hope it can evolve as viruses do

[Maroon Watcher]

talking of Mossies - the drought will keep the numbers down

But if evey one used a mosquito trap - there would be less desease carriers

I know this is not practical in country areas but even in Florida they have (had?)

mossie traps in trees

[partington]

A reduction of 56%? Is that a success? I mean, would you get the vaccination and pay for it if it decreases your risk with only 56%?

Also dengue fever is a very seasonal phenomenon. One year there's a lot of dengue fever, the other year not.

How can they be statistically sure this 56% reduction is not just a natural occurring seasonal variation.

Is it possible the the company is a bit too positive?

It's not great, but it's far better than nothing. For a really effective vaccine you would want to see as close to 100% protection as possible, of course.

But these results mean that you could prevent more than half of the current number of cases of Dengue, and this is clearly a good start.

There is a suggestion in other news reports that though the vaccine was directed against all four strains of dengue, it is least effective against the most common strain.

The only way that this could have been discovered is by doing a clinical trial. Now that this is known future research can be directed towards increasing the efficacy against the resistant strain.

This is the only way you can progress: develop, test in trial, improve, test again.

People who do clinical trials do not somehow "forget" that dengue is seasonal, and that there is a variable chance of catching it. These trials are done by randomly allocating subjects to receive a placebo injection or the vaccine. The people receiving the injections, and the medical personnel giving them do not know who has got the vaccine and who got the salt solution until after the trial is over, when the code is broken by a third party. This is what "double blind" means.

So they are comparing people from the same populations at the same risk, selected at random to get the vaccine or the dummy.

With all due respect, you are confusing the results of two clinical trials. The 2012 Phase II trial with 30% efficacy reported the issue with ineffectiveness against one serotype. This is the phase III trial and no analytical results have been released. What we have is an initial public statement which Sanofi was legally obliged to release because it is a publicly traded company. An error in reporting can have catastrophic results for a public company as shareholders can bring legal action for an inaccurate or delayed press release which impacts the company's share price. These suits are one of the leading causes of pharma company litigation and have added up to billions of dollars paid in settlements over the years.

Fair enough, I think you are right.

The problems with efficacy will have to be addressed though, whatever their source.

Edited May 3, 2014 by partington

[geriatrickid]

Fair enough, I think you are right.

The problems with efficacy will have to be addressed though, whatever their source.

You are correct too because the target level of efficacy is 80%. We can all agree that this is good news, a starting point for hopefully additional good news. Dengue is a horrible illness and anyone who had suffered it will attest to that. These things can be frustrating because they take so long to come to fruition. 20 years+ they have been working on a vaccine.