2,000 children to get experimental malaria vaccine_Nature / BBC

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> ATTACHMENT part 2 message/rfc822

" VERACARE "

" Duane Alexander " ,

" Mark McClellan MD " ,

" Bernard A. Schwetz " ,

" Rosemary Roberts " ,

" Tommy Thompson " ,

CC:

2,000 children to get experimental malaria vaccine_Nature / BBC

Tue, 22 Jul 2003 18:11:01 -0400

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.ahrp.org

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

FYI

 

Malaria kills millions of African children yearly.

For many decades malaria vaccines have been sought but have

been dismal failures.

 

NATURE and BBC report that a vaccine experiment will be conducted

in 2,000 children in Mozambique--even though the vaccine's safety has

only been tested in adults in small phase I trials.

 

The sponsors are GlaxoSmithKline and the Malaria Vaccine Initiative

(MVI, funded by the Gates Foundation). In addition to the malaria

parasite protein, the vaccine contains " a fragment of hepatitis B "

and an adjuvant. Nature reports that the vaccine trial sponsors

(GSK and MVI) claim that in the adult tests the vaccine (RTS,S)

" protected up to 71% of adults from being infected with malaria. "

 

However in the next paragraph the article notes that Melinda Moree,

director of the MVI admits that " Chances of success are slim. We're

going to hear more about failures than successes....Even negative

results move us quite a way forward,' she says. "

 

BBC reports that in the adult trial the vaccine’s protective action

wore off after two months.

 

The experiment raises serious ethical concerns that need to be addressed

before 2,000 children are exposed to an experimental vaccine that the

sponsor admits is likely to fail:

 

1. What are the subjects' parents told about the vaccine?

 

2. Since the vaccine has not been tested in children before,

its safety in children has not been assured. Therefore this is

essentially a phase I safety trial. Why then, are 2,000 children

being exposed before its safety in children has been established?

 

3. If the efficacy rate in the small phase I adult trials was 71%

what led the sponsor to state that the vaccine's " chances of success are

slim " ?

 

4. What were the negative findings of the adult trials?

 

5. What is the adjuvant used with the vaccine?

 

6. What is the adjuvant's toxicity in humans--since it is not

licensed in the US?

 

7. What is the toxicity of the portion of the Hepatitis B virus that is

included, given that France halted its countrywide Hepatitis B

vaccination program several years ago due to serious neurologic

side effects in a minority of recipients?

 

8. Since the vaccines protective effect of the vaccine in the adult

safety trials wore off after just two months, does the sponsor and

those conducting the trial anticipate inoculating the children every two

months?

 

9. If so, what evidence is there that multiple shots are safe?

Shouldn't’t children’s exposure to an experimental vaccine be guided

by precautionary measures? Phase I (vaccine safety trials) do not

test multiple inoculations.

 

10. What is the ethical justification for a “trigger happy cowboy approach?”

Should scientists be allowed to take risky leaps without adequate

safety data and expose 2,000 children to an experimental vaccine

that the sponsor admits has “slim” chances for success?

 

 

Vera Hassner Sharav, President, AHRP

Meryl Nass, MD, Board member, AHRP

 

 

 

~~~~~~~~~~~~~

http://www.nature.com/nsu/nsu_pf/030707/030707-4.html

 

 

Two thousand kids to get experimental malaria jab

Largest ever test of malaria vaccine to begin in Africa.

9 July 2003

Tom Clarke

 

Malaria kills one million people a year in Africa.

© WHO

 

The most advanced test of a vaccine against malaria ever conducted in

children begins in Mozambique next week.

The hope is that immunization will become a primary weapon in the fight

against malaria, which kills 1 million Africans each year, most of them

toddlers and babies. Currently, drugs - to which resistance is rapidly

developing - and protections like bed nets are the only ways to control the

disease.

 

Two thousand children under five will take part in the trial, funded by the

Malaria Vaccine Initiative (MVI), an independent organization based in

Rockville, Maryland, which coordinates international efforts to develop

malaria vaccines, and drug giant GlaxoSmithKline. " This is the largest

malaria vaccine trial carried out in Africa to date, " says Pedro Alonso,

scientific director of the study's base, the Manhiça Health Research Centre

in Mozambique.

 

Tests with small numbers of volunteers have satisfied researchers that the

candidate vaccine - called RTS,S - is safe. The next stage, a phase 2 trial,

will now ask whether the vaccine actually prevents malaria in children.

Results should be available in 18 months.

 

RTS,S consists of a protein found on the surface of the malaria parasite at

the stage when a mosquito's bite injects it into the human body. It also

contains a fragment of the hepatitis B virus, too little to cause the

disease, but large enough to goad the body's immune system into recognizing

the malaria fragment.

 

A chemical mix called an adjuvant is the final ingredient. This tricks the

immune system into mounting a strong immune response to the vaccine, helping

it to remember the crucial parasite protein.

In tests in the Gambia, RTS,S protected up to 71% of adults from being

infected with malaria. If the vaccine has similar success in children it

must then pass further tests in babies. Those under a year old are excluded

from this trial for safety reasons but are at the highest risk of dying from

malaria.

 

Chances of success are slim, admits Melinda Moree, director of the MVI. Only

one of 80 current malaria vaccine concepts is estimated to succeed, she

explains: " We're going to hear more about failures than successes. " But a

clinical trial is the only way to find out what approaches do and don't

work. " Even negative results move us quite a way forward, " she says.

 

That RTS,S is in the most advanced stages of testing doesn't mean it is the

best candidate vaccine. It has been in development since the 1980s and has

the backing of a large company, says Adrian Hill at the University of

Oxford, UK.

 

Hill's team is working on a different approach using modified viruses to

carry malaria genes into the body; initial results are promising1. Around

nine other candidate vaccines are also in safety trials this year.

 

 

References

McConkey, S. J. et al. Enhanced T-cell immunogenicity of plasmid DNA

vaccines boosted by recombinant modified vaccina virus Ankara in humans.

Nature Medicine, published online, doi:10.1038/nm881 (2003).

 

© Nature News Service / Macmillan Magazines Ltd 2003

 

~~~~~~~~~~

 

http://news.bbc.co.uk/2/hi/health/3054734.stm

BBC

Malaria vaccine trial begins

 

Scientists hope they are moving closer to preventing deaths from malaria

with a trial to test a vaccine in children.

 

The mosquito carries the malaria parasite

Two thousand children aged one to four will be given the vaccine in a study

to measure how effective it is at preventing infection.

 

About 3,000 African children die of malaria every day.

 

A number of vaccines are being developed to prevent deaths and illness, but

research into this particular vaccine, created by pharmaceutical company

GlaxoSmithKline, is the most advanced.

 

" Each year, a million more children vanish from the face of the earth

because we don't have a vaccine. " Dr Melinda Moree, Malaria Vaccine

Initiative.

 

Trials in Europe, the US and Gambia and Mozambique have already suggested

the vaccine is safe and effective for adults.

 

This latest research, which will be carried out in an area where malaria is

endemic, will also check the vaccine is safe for small children to take.

 

The children will be monitored for up to 18 months, longer than previous

trials of the vaccine, to see if they develop the disease.

 

Prevention

 

In previous short-term trials of the vaccine, its effectiveness has appeared

to wear off after two months. It is hoped that its protection will last

longer in children.

 

If the trial is successful, further research will be needed.

 

Researchers estimate it could be between five and eight years until the

vaccine, RTS,S/AS02, is available, even if the trials are successful.

 

When a mosquito bites, it transmits an early form of the malaria parasite

called the sporozoite into the bloodstream.

 

From there, it moves to the liver, where the full parasite develops.

 

Researchers hope that by interrupting the life cycle of the parasite at the

early sporozoite stage, it will be possible to arm the immune system against

infection.

 

The vaccine is made from a surface protein from the sporozoite.

 

This is then combined with two substances which will trigger the immune

system to attack.

 

Delay

 

Dr Pedro Alonso, who is heading the study in Mozambique, said: " We are

looking at whether it could be delivered early in life in a programme where

it could be delivered to young infants. "

 

" Our team is committed to finding ways to prevent malaria from remaining the

number one killer of Africa's children.

 

" This trial is an important contribution to that effort and brings us that

much closer to the goal of immunising children against malaria. "

 

Dr Ripley Ballou, of GlaxoSmithKline, who has been involved in the

development of the vaccine, said: " We will be looking to see how many

children become infected, do they develop anaemia, or other complications of

malaria. "

 

Dr Melinda Moree, director of the Malaria Vaccine Initiative which is

backing the Mozambique research, said: " For each month of delay, 120,000

children die of malaria.

 

" Each year, a million more children vanish from the face of the Earth

because we don't have a vaccine. "

 

 

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which

has not always been specifically authorized by the copyright owner. Such

material is made available to advance understanding of ecological,

political, human rights, economic, democracy, scientific, moral, ethical,

and social justice issues, etc. It is believed that this constitutes a 'fair

use' of any such copyrighted material as provided for in section 107 of the

US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this

material is distributed without profit to those who have expressed a prior

general interest in receiving similar information for research and

educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use

copyrighted material for purposes of your own that go beyond 'fair use', you

must obtain permission from the copyright owner.

 

 

 

 

 

 

 

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To , e-mail to:

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[Guest guest]

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> http://www.ahrp.org

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

> FYI

>

> Malaria kills millions of African children yearly.

> For many decades malaria vaccines have been sought but have

> been dismal failures.

>

> NATURE and BBC report that a vaccine experiment will be conducted

> in 2,000 children in Mozambique--even though the vaccine's safety has

> only been tested in adults in small phase I trials.

>

> The sponsors are GlaxoSmithKline and the Malaria Vaccine Initiative

> (MVI, funded by the Gates Foundation). In addition to the malaria

> parasite protein, the vaccine contains " a fragment of hepatitis B "

> and an adjuvant. Nature reports that the vaccine trial sponsors

> (GSK and MVI) claim that in the adult tests the vaccine (RTS,S)

> " protected up to 71% of adults from being infected with malaria. "

>

> However in the next paragraph the article notes that Melinda Moree,

> director of the MVI admits that " Chances of success are slim. We're

> going to hear more about failures than successes....Even negative

> results move us quite a way forward,' she says. "

>

> BBC reports that in the adult trial the vaccine's protective action

> wore off after two months.

>

> The experiment raises serious ethical concerns that need to be addressed

> before 2,000 children are exposed to an experimental vaccine that the

> sponsor admits is likely to fail:

>

> 1. What are the subjects' parents told about the vaccine?

>

> 2. Since the vaccine has not been tested in children before,

> its safety in children has not been assured. Therefore this is

> essentially a phase I safety trial. Why then, are 2,000 children

> being exposed before its safety in children has been established?

>

> 3. If the efficacy rate in the small phase I adult trials was 71%

> what led the sponsor to state that the vaccine's " chances of success are

> slim " ?

>

> 4. What were the negative findings of the adult trials?

>

> 5. What is the adjuvant used with the vaccine?

>

> 6. What is the adjuvant's toxicity in humans--since it is not

> licensed in the US?

>

> 7. What is the toxicity of the portion of the Hepatitis B virus that is

> included, given that France halted its countrywide Hepatitis B

> vaccination program several years ago due to serious neurologic

> side effects in a minority of recipients?

>

> 8. Since the vaccines protective effect of the vaccine in the adult

> safety trials wore off after just two months, does the sponsor and

> those conducting the trial anticipate inoculating the children every

two

> months?

>

> 9. If so, what evidence is there that multiple shots are safe?

> Shouldn't't children's exposure to an experimental vaccine be guided

> by precautionary measures? Phase I (vaccine safety trials) do not

> test multiple inoculations.

>

> 10. What is the ethical justification for a " trigger happy cowboy

approach? "

> Should scientists be allowed to take risky leaps without adequate

> safety data and expose 2,000 children to an experimental vaccine

> that the sponsor admits has " slim " chances for success?

>

>

> Vera Hassner Sharav, President, AHRP

> Meryl Nass, MD, Board member, AHRP

>

>

>

> ~~~~~~~~~~~~~

> http://www.nature.com/nsu/nsu_pf/030707/030707-4.html

>

>

> Two thousand kids to get experimental malaria jab

> Largest ever test of malaria vaccine to begin in Africa.

> 9 July 2003

> Tom Clarke

>

> Malaria kills one million people a year in Africa.

> © WHO

>

> The most advanced test of a vaccine against malaria ever conducted in

> children begins in Mozambique next week.

> The hope is that immunization will become a primary weapon in the fight

> against malaria, which kills 1 million Africans each year, most of them

> toddlers and babies. Currently, drugs - to which resistance is rapidly

> developing - and protections like bed nets are the only ways to control

the

> disease.

>

> Two thousand children under five will take part in the trial, funded by

the

> Malaria Vaccine Initiative (MVI), an independent organization based in

> Rockville, Maryland, which coordinates international efforts to develop

> malaria vaccines, and drug giant GlaxoSmithKline. " This is the largest

> malaria vaccine trial carried out in Africa to date, " says Pedro Alonso,

> scientific director of the study's base, the Manhiça Health Research

Centre

> in Mozambique.

>

> Tests with small numbers of volunteers have satisfied researchers that the

> candidate vaccine - called RTS,S - is safe. The next stage, a phase 2

trial,

> will now ask whether the vaccine actually prevents malaria in children.

> Results should be available in 18 months.

>

> RTS,S consists of a protein found on the surface of the malaria parasite

at

> the stage when a mosquito's bite injects it into the human body. It also

> contains a fragment of the hepatitis B virus, too little to cause the

> disease, but large enough to goad the body's immune system into

recognizing

> the malaria fragment.

>

> A chemical mix called an adjuvant is the final ingredient. This tricks the

> immune system into mounting a strong immune response to the vaccine,

helping

> it to remember the crucial parasite protein.

> In tests in the Gambia, RTS,S protected up to 71% of adults from being

> infected with malaria. If the vaccine has similar success in children it

> must then pass further tests in babies. Those under a year old are

excluded

> from this trial for safety reasons but are at the highest risk of dying

from

> malaria.

>

> Chances of success are slim, admits Melinda Moree, director of the MVI.

Only

> one of 80 current malaria vaccine concepts is estimated to succeed, she

> explains: " We're going to hear more about failures than successes. " But a

> clinical trial is the only way to find out what approaches do and don't

> work. " Even negative results move us quite a way forward, " she says.

>

> That RTS,S is in the most advanced stages of testing doesn't mean it is

the

> best candidate vaccine. It has been in development since the 1980s and has

> the backing of a large company, says Adrian Hill at the University of

> Oxford, UK.

>

> Hill's team is working on a different approach using modified viruses to

> carry malaria genes into the body; initial results are promising1. Around

> nine other candidate vaccines are also in safety trials this year.

>

>

> References

> McConkey, S. J. et al. Enhanced T-cell immunogenicity of plasmid DNA

> vaccines boosted by recombinant modified vaccina virus Ankara in humans.

> Nature Medicine, published online, doi:10.1038/nm881 (2003).

>

> © Nature News Service / Macmillan Magazines Ltd 2003

>

> ~~~~~~~~~~

>

> http://news.bbc.co.uk/2/hi/health/3054734.stm

> BBC

> Malaria vaccine trial begins

>

> Scientists hope they are moving closer to preventing deaths from malaria

> with a trial to test a vaccine in children.

>

> The mosquito carries the malaria parasite

> Two thousand children aged one to four will be given the vaccine in a

study

> to measure how effective it is at preventing infection.

>

> About 3,000 African children die of malaria every day.

>

> A number of vaccines are being developed to prevent deaths and illness,

but

> research into this particular vaccine, created by pharmaceutical company

> GlaxoSmithKline, is the most advanced.

>

> " Each year, a million more children vanish from the face of the earth

> because we don't have a vaccine. " Dr Melinda Moree, Malaria Vaccine

> Initiative.

>

> Trials in Europe, the US and Gambia and Mozambique have already suggested

> the vaccine is safe and effective for adults.

>

> This latest research, which will be carried out in an area where malaria

is

> endemic, will also check the vaccine is safe for small children to take.

>

> The children will be monitored for up to 18 months, longer than previous

> trials of the vaccine, to see if they develop the disease.

>

> Prevention

>

> In previous short-term trials of the vaccine, its effectiveness has

appeared

> to wear off after two months. It is hoped that its protection will last

> longer in children.

>

> If the trial is successful, further research will be needed.

>

> Researchers estimate it could be between five and eight years until the

> vaccine, RTS,S/AS02, is available, even if the trials are successful.

>

> When a mosquito bites, it transmits an early form of the malaria parasite

> called the sporozoite into the bloodstream.

>

> >From there, it moves to the liver, where the full parasite develops.

>

> Researchers hope that by interrupting the life cycle of the parasite at

the

> early sporozoite stage, it will be possible to arm the immune system

against

> infection.

>

> The vaccine is made from a surface protein from the sporozoite.

>

> This is then combined with two substances which will trigger the immune

> system to attack.

>

> Delay

>

> Dr Pedro Alonso, who is heading the study in Mozambique, said: " We are

> looking at whether it could be delivered early in life in a programme

where

> it could be delivered to young infants. "

>

> " Our team is committed to finding ways to prevent malaria from remaining

the

> number one killer of Africa's children.

>

> " This trial is an important contribution to that effort and brings us that

> much closer to the goal of immunising children against malaria. "

>

> Dr Ripley Ballou, of GlaxoSmithKline, who has been involved in the

> development of the vaccine, said: " We will be looking to see how many

> children become infected, do they develop anaemia, or other complications

of

> malaria. "

>

> Dr Melinda Moree, director of the Malaria Vaccine Initiative which is

> backing the Mozambique research, said: " For each month of delay, 120,000

> children die of malaria.

>

> " Each year, a million more children vanish from the face of the Earth

> because we don't have a vaccine. "

>

>

> FAIR USE NOTICE: This may contain copyrighted (© ) material the use of

which

> has not always been specifically authorized by the copyright owner. Such

> material is made available to advance understanding of ecological,

> political, human rights, economic, democracy, scientific, moral, ethical,

> and social justice issues, etc. It is believed that this constitutes a

'fair

> use' of any such copyrighted material as provided for in section 107 of

the

> US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this

> material is distributed without profit to those who have expressed a prior

> general interest in receiving similar information for research and

> educational purposes. For more information go to:

> http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use

> copyrighted material for purposes of your own that go beyond 'fair use',

you

> must obtain permission from the copyright owner.

>

>

>

>

>