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Promising Norwegian HIV vaccine Tested

Hemos posted more than 10 years ago | from the see-how-it-works dept.

Biotech 57

mkeke writes "The Norway Post is reporting: "A new Norwegian vaccine against HIV has attracted interest abroad, and is now being tested on 40 Norwegian HIV patients. The vaccine apparently helps to repair the patients' immune system, thus preventing the development of aids."
You can read it all here"

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57 comments

Woo Hoo! (-1, Flamebait)

Anonymous Coward | more than 10 years ago | (#6664339)

Just in time for the "release" of Panther and the G5!

Must...hold...in... (0, Funny)

pcbob (67069) | more than 10 years ago | (#6664392)

aw, what the heck, i've got too much karma:

"Promising Norwegian HIV vaccine" - GNAA must be really excited :)

article text (3, Informative)

witte (681163) | more than 10 years ago | (#6664479)

Promising Norwegian HIV vaccine tested

A new Norwegian vaccine against HIV has attracted interest abroad, and is now being tested on 40 Norwegian HIV patients.

-What we have seen so far, is that around 90 per cent of the patients have developed a new type of immunity which they did not have before joining the test project, says head of the project, Dag Kvale, Medical Director of the Ullevaal University Hospital in Oslo to TV2.

The vaccine, which has been developed by the Skien based company Bionor Immuno, apparently helps to repair the patients' immune system, thus preventing the development of aids, TV2 reports.

The patients will not be cured, but the new vaccine will possibly enable them to live with the virus without becoming sick with aids.

In September, representatives from the US National Health Institute will arrive in Norway to discuss the possibility for testing the vaccine on several thousand US HIV patients.

Unfortunately (-1, Flamebait)

BoomerSooner (308737) | more than 10 years ago | (#6664773)

It's only a matter of time till some big pharmaceutical company buys them out and jacks up the price of living for those with HIV.

Nothing better than squeezing every last dollar out of the ill. Too bad our society is one that doesn't care about a cause until it happens to them (or their family).

What a wonderful world. Don't forget to vote Republican to keep the status quo, we wouldn't want a Big Government (just a big spending one).

Interesting, but ... (5, Insightful)

MacEnvy (549188) | more than 10 years ago | (#6664491)

All the vaccine seems to do is allow people to continue to live with HIV for a longer time, without reaching full-blown AIDS. It's a nice step, but doesn't help with the main problem - that a significant portion of HIV cases are caused by ignorance and misbelief, especially in Africa. Furthermore, the places in Africa most hardly hit by HIV don't have enough money to buy cutting-edge treatments in the first place. They are too worried about food ...

It's too bad the details are so scarce in the article. It would be nice to know exactly what this vaccine does (enhance T-cells, etc?). For the moment, this news isn't very helpful to the majority of HIV sufferers. I suppose any progress is progress, though.

Re:Interesting, but ... (1)

isorox (205688) | more than 10 years ago | (#6665037)

Well thats all very well, however theres half a billion people in rich western countries countries that can contract aids from something as simple as a condom breaking. Now on Slashdot we are probably a very low risk demograhpic (its not transmitted by communal keyboard sharing), but people still can contract it via blood transfusions etc.

Re:Interesting, but ... (1)

tlotoxl (552580) | more than 10 years ago | (#6665710)

It's a nice step, but doesn't help with the main problem - that a significant portion of HIV cases are caused by ignorance and misbelief, especially in Africa.

I would think that the main problem is actually that AIDS is killing millions of people directly and ruining hundreds of millions of lives indirectly as the economy suffers or they lose their family and friends. Improved education and a proper cure would of course be better, but if HIV could be made non-life threatening, I think that would be a major advance.

I'm also curious about the details of the vaccine, though. Is it administered once or is it necessary to administer it at regular intervals? What are its side-effects? I guess it's quite early, but I look forward to hearing more about it.

Re:Interesting, but ... (1)

bill_mcgonigle (4333) | more than 10 years ago | (#6676040)

Improved education and a proper cure would of course be better, but if HIV could be made non-life threatening, I think that would be a major advance.

If you don't have improved education or a cure then extending the lives of the infected is probably going to increase the overall infection rate.

Don't interpret that as a value judgement.

Re:Interesting, but ... (1)

0111 1110 (518466) | more than 10 years ago | (#6686373)

If you don't have improved education or a cure then extending the lives of the infected is probably going to increase the overall infection rate.

Which from the perspective of a shareholder in a pharmaceutical company with AIDS/HIV intellectual property is excellent news. If they can just prevent some rogue company from discovering a genuinely effective vaccine/cure for the virus itself they can keep raking in the profits until their patents expire.

Even the companies themselves will openly admit that they base research funding on potential profitability and that true vaccines (not theurapeutic, but preventative) are very risky investments due to the highly limited nature of the returns. Every patient only gets treated once. Life extending treatments OTOH, are possibly less costly and easier to discover and are far, far more profitable in the long run.

I'm generally surprised when I hear of any private company creating a new (preventative) vaccine on their own. It almost never happens because the potential for profit is just not as great. Any genuine cure or vaccine for HIV will only be discovered by government funded research.

Private companies will stick to working on better and better (just enough to be slightly better than the competition) therapies to extend the lives of their herds of cash cows.

Re:Interesting, but ... (1)

bill_mcgonigle (4333) | more than 10 years ago | (#6688937)

It's sad how insightful your response is.

Re:Interesting, but ... (1, Funny)

Anonymous Coward | more than 10 years ago | (#6665925)

The real problem is that we can't have sex with whoever we want. The disease is the problem, it's just exacebated by the fact that african's try to ignore it.

Re:Interesting, but ... (1)

lbreier (694155) | more than 10 years ago | (#6679613)

About poor countries who can't afford the ultra-expensive treatment there are interesting things like programs directed by the brazilian federal governmet that buy those medicines and distribute them for free. Althought it seems a good idea, the patent industry has almost shut down these programs. Beside the cientific frontier (on researching new treatments) and the educational frontier (enlightening citizens on how to prevent HIV), there is this political frontier everyone must be informed of and defend sick and poor people from the pharmaceutical patent industry.

Re:Interesting, but ... (1)

darkmeridian (119044) | more than 10 years ago | (#6680070)

This is really scary. HIV mutates at a incredibly rapid rate because it is a single-stranded retrovirus with no means of error checking. Imagining an entire population of people infected with HIV and not dying scares the bejesus out of me. I know this sounds cold, but mutating HIV in such a population could yield even more deadly derivatives.

Re:Interesting, but ... (1)

MacEnvy (549188) | more than 10 years ago | (#6681906)

That's a very good point - that making these people "immune" to the effects of AIDS could cause certain mutations to occur at a more frequent rate within the individuals affected.

I do find it amusing that you chose the wording "error checking". You must be a networking professional. Hooray for the 802.3 and LLC!

Thank god it's Norway (3, Insightful)

TripleA (232889) | more than 10 years ago | (#6664494)

and not some ultra-capitalist western cowboy-regime driven company who has come up with the vaccine. Thank's to the last part of Soviet, this vaccine may come to use even for the ones who need it the most (poor African and Asian countries) and not only the people who can afford it.

Re:Thank god it's Norway (1)

McWilde (643703) | more than 10 years ago | (#6664700)

Would you care to explain what you mean by "the last part of Soviet" and how this relates to Norway? As far as I know Norway has never been part of the Soviet Union or the Warsaw Pact.

Re:Thank god it's Norway (2, Informative)

TripleA (232889) | more than 10 years ago | (#6665256)

It's a reference to Swedish minister Bjorn Rosengren on a business trip to Norway 1999-09-23 having said (roughly translated) "Norway really is the last Soviet state".

And no, Norway has never been part of the Soviet Union.

Re:Thank god it's Norway (1)

Captain Large Face (559804) | more than 10 years ago | (#6665701)

What do you expect? Pharmaceutical companies to give away their products for free? These so called "ultra-capitalist western cowboy-regime driven compan[ies]" do actually have to pay for the research and development of these products, including getting the drug through length Q & A processes in each country in which they want to sell it. If certain countries actually paid their promised aid packages to third-world nations, then perhaps they might be able to afford the much-needed vaccines and medicines.

Re:Thank god it's Norway (1)

vidnet (580068) | more than 10 years ago | (#6668578)

In some countries, companies get research grants. The project in question is partially GAVI/Norwegian Research Council funded.

And in some countries, pharmaceutical companies produce pharmaceuticals rather than the highest possible surplus.

Re:Uhhhh, riiiiight (1)

DrWho520 (655973) | more than 10 years ago | (#6669600)

I think it is worth stating that the ultra-capitalist western cowboy-regime driven country that hosts these ultra-capitalist western cowboy-regime driven companies is the one thay ends up paying the majority of R&D costs for these drugs. Reguardless of who develops the drug, the price in the US can be 5 to 10 times as expensive as other countries. Just food for thought.

Re:Thank god it's Norway (1)

JavaLord (680960) | more than 10 years ago | (#6674952)

[and not some ultra-capitalist western cowboy-regime driven company who has come up with the vaccine. Thank's to the last part of Soviet, this vaccine may come to use even for the ones who need it the most (poor African and Asian countries) and not only the people who can afford it.

You couldn't possibly be talking about the same ultra-capitalist country who wants to give a 25 billion dollars [msnbc.com] to Africa while it's country is in the middle of a recession could you?

Yes, the big evil US empire that allows foreign workers to take US jobs via the H-1B [businessweek.com] and other liberal immigration/foreign labor laws, and who's pharmaceutical industry charges it's own citizens more money for prescription drugs [go.com] than foreign countries. If an HIV vaccine were found in the US, the US citizens would pay the most for us.

Yes, the ultra-capitalist western cowboy-regime driven nation has it out for you.

Re:Thank god it's Norway (1)

bill_mcgonigle (4333) | more than 10 years ago | (#6675756)

Listen to this guy when he starts cutting checks to those third world nations.

Re:Thank god it's Norway (1)

squee (34490) | more than 10 years ago | (#6676500)

except only 3 billion got funded, and efforts by USAID orgs to educate about condom use- the most effective aids prevention, even in africa - are stiffled.

as for those visas, they're also happen to be a huge boon in terms of cheep highly skilled labor for big campaign contributors [microsoft.com]

Re:Thank god it's Norway (1)

JavaLord (680960) | more than 10 years ago | (#6679308)

except only 3 billion got funded, and efforts by USAID orgs to educate about condom use- the most effective aids prevention, even in africa - are stiffled. as for those visas, they're also happen to be a huge boon in terms of cheep highly skilled labor for big campaign contributors [microsoft.com]
news sources? Something to back up your argument please? Yes, the visa's provide cheap labor for big companies at the expense of American citizens...Is that a good thing for America or bad?

Re:Thank god it's Norway (0)

Anonymous Coward | more than 10 years ago | (#6681055)

here's a news source to back up the skimping on aids money. maybe i was wrong.
maybe it was only 1.5 billion [truthout.org] . and maybe we havn't even paid up on our previous promises.
information about how effective condoms are used to be found at the cdc [house.gov]
this article from the villiage voice [truthout.org] is about the pressure nonprofits are feeling to conform to the bush admin's line. it also includes info on USAID orgs and the pressure they are experiencing in relation to aid prevention/contraception work abroad.

as for the visas, hard to say. i dont think it really matters either way for this admin. whats good for America as a whole is irrelevant to these folks. but it sure is good for corporate America.

Re:Thank god it's Norway (0)

Anonymous Coward | more than 10 years ago | (#6682307)

Sorry a democratic, librally slanted propaganda machine like truthout.org isn't a legit news source. Try finding one that isn't biased.

Re:Thank god it's Norway (1)

squee (34490) | more than 10 years ago | (#6686093)

"liberal media" isn't a worthy argument. its a label.
(a label really brought to the forefront by roger ailes, regan's propagana minister, who now heads Fox News)

those articles on truthout are not written by truthout. they are merely mirrored there.
try reading them.
as for waxman's site. the evidence is all there --thoroughly presented with sources.

present a rational counter argument, and maybe i'll be able to respond.
spout labels and i really have nothing else to say.

Re:Thank god it's Norway (0)

Anonymous Coward | more than 10 years ago | (#6696965)

Please, both articles on truthout link to libral sources, the first one links to a FRENCH newspaper. The other, to the village voice which is slanted WAY left. Trying finding a middle of the road source, at LEAST.

Re:Thank god it's Norway (1)

squee (34490) | more than 10 years ago | (#6698856)

if you want a transcript of fox news to point this stuff out, you're not going to find it. they wont bring up such stuff that critisizes the president. it wouldn't "be responsible".

yes, i had to look for stories about these issues in media that dares to critisize the president.

Again, you fail to adress ANY of the issues. But your labels have gotten uglier.

Do you dispute the facts in these articles?
If so,present your own that show specificaly otherwise. If not, then you again have just labeled me liberal and a french lover. and thats fine with me.

What do you wish to imply by yer "FRENCH" attack? I personaly am sick and fricken tired of all this jingoistic nationalist anti-frenchness going around this country. It smacks of the irrational behavior that has swept less fortunate countries in times of national weakness.

It's irrational It's embarrasing. It's kinda scary too.

Are the French obligated to support every American attack on any country in perpetuity in return for us saving thier ass in WWII? no. that's rediculous. It's embarrassing and unbecoming of this country to imply that.

At least they have a wide range of news media which represent the diverse interests of thier population, and a culture which encourages such dissent. It seems they might be holding on the ideals they learned from our revolution better than we have in the past couple years.

oh my god (-1, Troll)

korbatz (160895) | more than 10 years ago | (#6664505)

...they killed norwaypost (you...)!

looks like /. effect.

Anyway, it's promissing, even if the patients will never be cured.

after all, we will have the HUGE world sex party after the HIV vaccine developed.

Vaccine (4, Insightful)

nycsubway (79012) | more than 10 years ago | (#6664508)

Interesting use of the word vaccine. It seems that it actually helps stop the development of aquired immunodeficiency syndrome, but AIDS is not a virus.

HIV is the virus, but the 'vaccine' does not prevent HIV infection, it helps stop the effects of the HIV. I think they mean it's a vaccine in the sense that it can prevent AIDS.

An HIV infected person will still have HIV and can still transmit it to other people, even if they have had this vaccine.

Re:Vaccine (4, Insightful)

Alereon (660683) | more than 10 years ago | (#6664567)

The story is sparse on details, but it seems that it works to help prevent the onset of AIDS by allowing an individual to become partially immune to the immune-system-damaging effects of the HIV virus. Partially, since they still die eventually, but it helps. If, instead of a drug that acts on the virus itself, it stimulates an immune response, it would be classified as a vaccine, methinks.

Re:Vaccine (1)

meta-monkey (321000) | more than 10 years ago | (#6666393)

I also find it interesting that they use the word vaccine, when nobody really knows if HIV is a virus, or even exists. It's fascinating, but try it...go on google and type, say "polio virus image." You'll find dozens of scanning electron microscope images of the virus itself. Here it is attacking a cell...here it is with a special dye so you can see these structures...etc. Now try it with HIV. "HIV virus image." You'll find pictures of cultures that the author says are infected with HIV, and you'll find artists conceptions of the virus...but no actual virus.

It's never been isolated. It's difficult, but not THAT hard to isolate a virus. Get a culture going, put it in a centrifuge, spin it around, and things will seperate based on their densities. Do this for enough people who you know have the disease, and you'll find the criter they all have in common. Then culture it, and see what antibodies you find. You'd think with the hundreds of billions of dollars we've dumped into HIV research over 20 years, using the brightest minds in medicine, we'd have more than that.

All scientists have ever found are a bunch of non-specific antibodies, and when you test "HIV positive," all they're really saying is that you have several of these antibodies they think might result from HIV infection. None of the HIV tests (elisa, western blot) have ever even been approved by the FDA.

There are many scientists who doubt AIDS is actually caused by a virus, and may be something else entirely. Check virusmyth.net [virusmyth.net] for more information. Also, this interview [asu.edu] , with, among others, Dr. Peter Duesberg [berkeley.edu] , professor of biochemistry and molecular biology at UC Berkeley, makes some fascinating points about why AIDS may not be caused by a virus.

Re:Vaccine (2, Informative)

KnightNavro (585943) | more than 10 years ago | (#6667406)

It seems that finding an image [cmsp.com] of the HIV virus wasn't all that difficult.

Re:Vaccine (0)

Anonymous Coward | more than 10 years ago | (#6674341)

Dark mother! I hope someone will mod you down into smithereens! How uninformed can a human being be?? At least the moon hoax troll is funny.

How's your foot taste? (1)

NDPTAL85 (260093) | more than 10 years ago | (#6674843)

How hard did you search? I've even seen images of HIV virii in my HS textbooks over 5 years ago....

Re:Vaccine (1)

kramer2718 (598033) | more than 10 years ago | (#6673491)

This is a common technique when designing vaccines for HIV/AIDS. I've heard of several other HIV vaccines that got press as being able to suppress the disease.

IANAI (I am not an immunologist), but I think that one reason researchers are taking that path is that it's easier to do trials. One problem with preventative vaccines for HIV is that because HIV suppresses the immune system, vaccines for it can tend to do the same and several have actually caused the vaccine recipient to contract HIV. Furthermore, because there is no cure, we can't just expose people to HIV after giving them the vaccine. This would necessitate much larger trials in order to establish efficacy.

It's possible that this vaccine is a candidate to be a prentative vaccine but that testing it as a therapeutic vaccine is much easier and safer.

Sonner or later researchers will find a preventative vaccine and then we can all go back to our lives of promiscuity ... oh wait ... I'm posting to slashdot ... never mind.

Wording (4, Informative)

cam_macleod (59140) | more than 10 years ago | (#6664589)

Not to troll or complain, but isn't that technically a treatment, not a vaccine? Correct me if I'm wrong...

Re:Wording (4, Informative)

73939133 (676561) | more than 10 years ago | (#6665030)

A vaccine is something that stimulates the immune system with antigens. Most vaccines are preventive, but this one happens to be a therapeutic vaccine--you give it after the disease has already started. There are a few other examples of therapeutic vaccines.

Re:Wording (2, Insightful)

mattlary (595947) | more than 10 years ago | (#6676020)

A vaccine is not something that stimulates the immune system with antigens, but rather an administration of pathogens which enable the immune system to deal with the illness. I invite you to look at the definition [reference.com] as defined at Dictionary.com.

A true HIV vaccine would be given to individuals so that if they were to be exposed to HIV, their bodies would be able to fight off the virus.

Dosen't Matter (0, Offtopic)

Matt_Fisher (696201) | more than 10 years ago | (#6664803)

I am not to worried about what they call it. I am curious as to what the results are. Hopefully it's another big step forward to a cure!

40 people is a small sample size (1)

PIPBoy3000 (619296) | more than 10 years ago | (#6665739)

Though the results are promising, it's important to be careful extrapolating out to larger populations. 90% of 40 people is "significant", but it still a small sample size. Small effects can skew the results pretty badly.

It's nice to see AIDS vaccines working out, though. It's our best hope in the fight against the disease.

Re:40 people is a small sample size (1)

spike it (682080) | more than 10 years ago | (#6672506)

They tested 40 people in Norway, and with their promising results are now hoping to test THOUSANDS of Americans?? You've got to be kidding me...

Re:40 people is a small sample size (0)

Anonymous Coward | more than 10 years ago | (#6674992)

They tested 40 people in Norway, and with their promising results are now hoping to test THOUSANDS of Americans?? You've got to be kidding me...


yeah seriously, go test the thing in africa.

Another step on the long road (1)

gristlebud (638970) | more than 10 years ago | (#6666419)

It's really amazing how AIDS drugs have progresses.

It used to be that the doctors just pumped you full of antibiotics to keep infections away, then they created drugs to repress the virus, and now we can actuall repair the immune system.

This is a great example of how research and developement (or even the scientific method) needs to work. It may seem like things are progressing slowly, but compared to (say) the fight against malaria, thing are progressing much more rapidly.

Your sig (0)

Anonymous Coward | more than 10 years ago | (#6667063)

Better defs:

A friend is someone who will help you move.
A good friend is someone who will help you move a body.

Re:Another step on the long road (1)

tlotoxl (552580) | more than 10 years ago | (#6667621)

But isn't the (scientific) fight against malaria largely won? There are some strains of malaria that are drug resistant, but new drugs are quickly developed. The problem, as far as I understand it, isn't so much that we don't have effective drugs to fight malaria, but that they're simply not affordable to the third world where people need them the most.

Bill Gates saving the world (2, Interesting)

Jouni (178730) | more than 10 years ago | (#6669015)

I'm surprised this hasn't already been pointed out, but Bionor Immuno [med.uib.no] is a "partially GAVI/Norweigian Research Council funded project" and GAVI is largely launched with the $750M grant [med.uib.no] from Bill & Melinda Gates Foundation.

AIDS tamed with a helping hand form Bill? Stranger things could happen. I just can't imagine what they are. :-)

I applaud the research and accomplishments of the project!

Jouni

Re:Bill Gates saving the world (1)

Synithium (515777) | more than 10 years ago | (#6670345)

On scale Bill Gates is most likely the largest single donator to health charities in the world. Consistently....year after year....billions and billions of dollars.

It is possible to have a business face and a personal face that are largely different. Even though most of the money for this is generated through the Microsoft machine.

Re:Bill Gates saving the world (1)

Synithium (515777) | more than 10 years ago | (#6670406)

Wanted to back up my statment, this is from the Gates Foundation website (sorry for formatting):

Amounts in thousands

PROGRAM AREA 2002 2001
Global Health $506,984 $855,567
Education 413,121 177,944
Libraries 44,607 43,176
Pacific Northwest 121,874 36,511
Special Projects 70,141 33,403
Other:
Employee Matching Gifts/Sponsorships 738 356

$1,157,465 $1,146,957

The foundation has total net assets in excess of 37 billion.

Re:Bill Gates saving the world (0)

Anonymous Coward | more than 10 years ago | (#6723514)

Is this in real dollars or MS stock?

Re:Bill Gates saving the world (1)

JavaLord (680960) | more than 10 years ago | (#6675019)

If Bionor Immuno really does find a vaccine for HIV it will be the first Virus Bill slowed down rather than helped spread.

Re:Bill Gates saving the world (0)

Anonymous Coward | more than 10 years ago | (#6683605)

Rape half the world and administer treatment to a disease in 5 of your loudest neighbors and you're a hero....hmmmm...

Personally, I'd hang someone like that...and the family that they spawned...

Frustrating ... (1)

Mostly a lurker (634878) | more than 10 years ago | (#6672155)

I cannot find any references with details of this vaccine. Based on the Norway Post, it is impossible to see if this is significant. Does anyone have more information? Is there a patent application, for instance?

Small sample (1)

sakyamuni (528502) | more than 10 years ago | (#6679847)

A new Norwegian vaccine against HIV has attracted interest abroad, and is now
being tested on 40 Norwegian HIV patients.

What we have seen so far, is that
around 90 per cent of the patients have developed a new type of immunity which they did not have before joining the test project, says head of the project, Dag Kvale, Medical Director of the Ullevaal University Hospital in Oslo to TV2.

The 90% may seem like the treatment is a huge success. However, 40 patients is a very small sample size. It is exciting to hear that NIH will explore the possibility of a much larger trial. Several thousands of patients will provide more meaningful results.

this could lead to additional problems (1)

ReallyQuietGuy (683431) | more than 10 years ago | (#6683659)

think about it

lets say you have AIDS

are you a person who caught AIDS because of blood transfusions, operations, a cop who got bit by some infected addict, or are you someone who caught it from casual sex?

if the latter, are you going to be very careful with using condoms etc. (are you even going to TELL your partners/potential victims you have HIV? I mean, hey, you look healthy, and are they going to say "yes" to sex with you (even with a condom) when you've told them you have HIV? In which case, are you going to pass up on the chance to fuck them?)?

What if these victims don't have the resources to afford this same treatment that keeps you around as a disease vector?

Do a little searching! (1)

Syre (234917) | more than 10 years ago | (#6683902)

A bit of sleuthing came up with more details on the study. It was tested only on HIV patients, but it seemed to stimulate immune response, so perhaps it could be useful for those in high-risk groums who are not yet infected:

Name of project
IMMUNOTHERAPY OF HIV-INFECTED PATIENTS (CTN B-HIV-1/99)

Short name of project:
HIV Immunotherapy

Relevant keywords describing the project:
Immunisation, therapeutic vaccine, Phase I study, HIV, p24, peptides

Principal investigator
Name: Nina Langeland
Title/Position: Prof. Dr.med.
Telephone (work): +47 55 97 29 61
Fax number (work): +47 55 97 49 79
E-mail: nina.langeland@haukeland.no

Principal institution
Name: Haukeland University Hopital
Street name: Haukeland sykehus
P.O.Box:
Postal code: NO-5021
City: Bergen
Country: Norway

Project duration
Start of project period January , 2000
End of project period December , 2000

Names and institution of participating senior scientists
Dr. med. Nina Langeland (Haukeland Hospital), Dr. med. Birgitta Aasjoe (Haukeland Hospital), Dr. med. Vidar Lehmann (Haukeland Hospital)
Dr. Ingebjoerg Baksaas (Mericon AS), Dr. Knut Dahl (Mericon AS)
Birger Soerensen (Bionor AS), Dr. Jorgen Nyhus (Bionor AS)
-----

Main sponsors
Bionor AS, P.O.Box 1868 Gulset, NO-3703 SKIEN, Norway
-----

Brief project description ( background, aims and results so far )
Background A clinical trial was conducted and completed at Haukeland University Hospital, Bergen, Norway during 2000-2001. The study was approved by the Norwegian Medicines Control Authority and by the Ethics Committee of Health Region III in Norway. Study design The study was an open, single centre, phase I, uncontrolled study. 11 patients were enrolled. All had been HIV positive for several years. Nine patients were on HAART treatment, two patients received no specific HIV treatment. Primary Objectives The primary objective of the study was to determine safety and toxicity of immunisation with the Vacc-4x peptide mixture based on blood tests and adverse events reporting. Secondary Objectives The secondary objectives were to monitor immune response in terms of delayed type hypersensitivity (DTH) skin reaction, CD4 and CD8 cell counts, viral load, T-cell responses to individual synthetic p24 peptides and native analogues, and antibody responses to individual peptides and recombinant p24. Safety results No signs of toxicity and no clinically important adverse events following the Vacc-4x immunisation were observed. The adverse reactions reported were all of mild to moderate severity. No patients withdrew due to treatment-related adverse events or toxicological reactions. Painful injection was the most frequently reported adverse event, reported by 64% of the patients. Fatigue/vertigo or influenza-like symptom was reported after immunisation by 5 patients (45%). The results indicated that the therapeutic vaccine is safe and was well tolerated by all 11 enrolled patients. Immunological responses A positive DTH was measured for all patients indicating an activation of Th1 cells. An early and sustained increase in CD4 count for some patients on HAART was observed. The ELISPOT responses to synthetic and native peptides indicate production of new and virus specific CTLs that show cross reactivity back to native HIV proteins. No change observed in antibody production indicates that only cellular immunity has been activated, as expected.
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