Hopes of ending the world Aids epidemic have received a devastating blow after the first human trials showed a much-heralded new vaccine does not work.

The trials had raised hopes of fighting an epidemic that has claimed 28 million lives.

VaxGen said the vaccine did not offer general protection to Americans and Europeans.

But it was thought it could yet protect black and Asian people.

Results from VaxGen's trial of AidsVax show the vaccine reduced the rate of HIV infection by only 3.8% in men and women considered at high risk, VaxGen said in a statement.

"Overall what we see is the trial failed," VaxGen President Dr Donald Francis, told a conference call.

But he added: "There was a 500 person subset in this that showed clear efficacy. The challenge here is to see if this a statistical fluke."

Black and Asian people had a 67% lower rate of infection, the study showed.

Its trial of 5,400 volunteers had been running in the US and Holland since 1998.

The volunteers were made up of 5,000 homosexual or bisexual men and 400 women considered to be at high risk of getting HIV, the virus that causes Aids.

Each day nearly 15,000 men, women and children worldwide become infected with HIV.

Almost all end up with full-blown Aids, according to the International Aids Vaccine Initiative.

My comment:
This is deeply sad news hopefully one day a cure will appear.
There were an estimated 33,500 HIV infected adults aged 15 to 59 alive in the UK at the end of 2000. HIV prevalence by the end of 2003 is expected to be 40% higher than the 1999 level. Of the people estimated to be now living with HIV in the UK, about 30% are unaware of their infection.

2000 and 2001 saw the highest annual increases in new HIV diagnoses since records began. In 2000 there were 3,723 new HIV diagnoses reported, and in 2001 there were more than 4,160 new cases diagnosed.

The number of people living with HIV in the UK is increasing at around 10% per annum. HIV treatments which are currently delaying the onset of AIDS for many people with HIV, coupled with a steady stream of new HIV diagnoses, are behind this trend which is likely to continue.

Aids kills some 6,000 people each day alone in Africa - more than wars, famines and floods. Millions of children are orphans, many more live with HIV or Aids.

Useful links in learning about Aids:
http://www.tht.org.uk/ The Terrence Higgens Trust

http://www.nat.org.uk/ NAT

Get involved & be aware education is one key

I saw this article n the USA Today...and i was soo pleased to see that something is being done **finally** about the AIDS situation...hopefully more will b discovered...good post katt...

katt said:

Does anybody else find this part odd? What's so different on the inside? I am dying to know why this is so.

Sorry i'm not trying to jack your thread. I read this earlier and had meant to post it with that part highlighted.
Any work on aids is a positive step for all people.


Different edit
[This message was edited Mon Feb 24 17:09:16 PST 2003 by SuperC]

the reason that this works on different races at different levels is because of the immune systems in each race...some are more tolerant to change & others refuse 2 accept a new chemical/anit-body n2 it...this vaccine will b a basis for new drugs 2 grow on...and hopefully in our lifetimes we will see an end 2 the AIDS crisis

VaxGen Announces Initial Results of its Phase III AIDS Vaccine Trial

The study did not show a statistically significant reduction of HIV infection within the study population as a whole, which was the primary endpoint of the trial. However, the study did show a statistically significant reduction of HIV infection in certain vaccinated groups. Protection appeared to correlate with the higher level of vaccine-induced neutralizing antibodies observed in these groups, according to Michael Para, M.D., a principal investigator in the study.

The initial results reported in this news release are subject to additional analysis. A more detailed analysis is expected to be presented at the Keystone Symposia on HIV, March 29 to April 4. The full results of the trial will be reviewed with the U.S. Food and Drug Administration (FDA) over the coming months.

The results presented here are based on trial volunteers who received at least the primary course of three injections of either vaccine or placebo. Recognizing the limitations of subgroup analyses, the separate analysis of efficacy in subgroups was pre-specified in the statistical analysis plan. The statistical analysis plan was reviewed in advance by the FDA and its suggestions were incorporated prior to unblinding of the data.

• Item 1 The reduction of infection among the entire sample of volunteers, including all racial groups, was 3.8% (p-value = 0.76; n = 5,009).
  
• Item 2 There were 67% fewer HIV infections among ethnic minorities, other than Hispanic individuals, who received vaccine compared to placebo recipients (p-value <0.01; n = 498).
  
• Item 3 There were 78% fewer HIV infections among black volunteers who received vaccine compared to placebo recipients (p-value <0.02; n = 314).
  

Although the subgroup sample sizes were relatively small compared to the entire study sample, the results are statistically significant. With regard to ethnic minorities in the trial, there is less than a 1% possibility that the observed difference in infection rates could have occurred by chance. There is less than a 2% possibility that the observed difference in infection rates among black volunteers could have occurred by chance. In addition to the results in those receiving three doses, the reduction in infection in individuals who received at least one dose of vaccine or placebo were similar and also statistically significant. This analysis is known as "intent-to-treat".

Trial data indicate that black and Asian volunteers appeared to produce higher levels of antibodies against HIV. White and Hispanic volunteers appeared to develop consistently lower levels of protective antibodies following vaccination. VaxGen intends to conduct additional analyses to confirm if there was a direct correlation between the level of antibodies and the prevention of infection.

"This is the first time we have specific numbers to suggest that a vaccine has prevented HIV infection in humans," said Phillip Berman, Ph.D., VaxGen's senior vice president of Research and Development and inventor of the vaccine. "We're not sure yet why certain groups have a better immune response, but these preliminary results indicate that a surface-protein vaccine that stimulates neutralizing antibodies correlates with prevention of infection."

The results also indicate that AIDSVAX is well tolerated and has a high safety profile. Vaccine recipients had a slightly higher rate of pain, swelling and tenderness at the injection site compared to placebo recipients.

"We intend to continue development of this vaccine through licensure, including additional studies as necessary, for use in groups in which the vaccine demonstrated a significant reduction in infection," said Lance K. Gordon, Ph.D., chief executive officer of VaxGen. "In parallel, we will continue our work on the vaccine to make it more broadly effective."

An independent Data and Safety Monitoring Board (DSMB) consisting of prominent scientists, researchers, ethicists and a biostatistician oversaw the trial. "VaxGen's conduct of this trial lived up to the highest standards of scientific integrity," said Walter R. Dowdle, Ph.D., Chairman of the DSMB and former deputy director of the U.S. Centers for Disease Control and Prevention (CDC).

Dowdle is one of several independent researchers who have taken part in reviewing the trial data. The CDC participated in the statistical analysis, and the resulting data were reviewed by Dowdle and four independent clinical researchers: Donald Burke, M.D., from the Johns Hopkins School of Public Health; Neil Flynn, M.D., M.P.H. from the University of California at Davis; Donald Forthal, M.D., from the University of California at Irvine; and Michael Para, M.D., from Ohio State College of Medicine.

AIDSVAX is composed of a recombinant form of the protein (gp120) on the surface of HIV and is produced in mammalian cell culture. It includes two HIV subtype B antigens: MN and GNE8. The candidate vaccine cannot cause HIV infection since it contains no genetic material from the virus. Made through recombinant DNA technology, it contains non-infectious, genetically engineered proteins (rgp120) that mimic proteins on the surface of two strains of HIV subtype B. This subtype is prevalent in North America, Europe, Australia, Japan and Puerto Rico.

"Thanks to the dedication of thousands of trial volunteers, who are the real heroes here, we have gained extraordinary new insight into how to prevent HIV," said VaxGen President and co-founder Donald P. Francis, M.D., D.Sc. "We also owe a debt of gratitude to the investigators and their staff for their commitment to the project. The results from this groundbreaking effort will provide new insights into HIV and hopefully pave the way to ever more effective vaccines."

About the AIDSVAX B/B Phase III Trial

VaxGen's randomized, double-blind, placebo-controlled Phase III trial was designed in consultation with the FDA to test AIDSVAX B/B for safety and protective efficacy against the sexual transmission of HIV. The study volunteers included 5,108 men who have sex with men and 309 at-risk women, all of whom were meant to be HIV negative when they joined the trial. During the 36-month trial, a total of seven injections were administered at months 0, 1, 6, 12, 18, 24 and 30. The ratio of vaccine to placebo recipients was 2:1.

The trial was conducted in the United States, Canada, Puerto Rico and the Netherlands. Trial volunteers received regular counseling to avoid risks that could lead to HIV infection and were advised to assume that they may have received a placebo and that the vaccine might not be effective. A separate CDC study indicated that volunteers did not increase their risk behavior, and VaxGen's preliminary analysis of the trial data indicates that risk behavior was reduced in both the placebo and vaccine groups.

"If licensed, this vaccine could be an important tool to help prevent HIV infection, but it should not be considered a substitute for other risk-reducing practices," Dowdle said. "HIV prevention programs will continue to be very important."

VaxGen is nearing completion of its Phase III trial in Thailand, testing a formulation of AIDSVAX designed to protect against HIV subtypes B and E, and expects to announce results of that trial in the second half of 2003. Subtype E is prevalent in Southeast and East Asia and the Central African Republic. Unlike the AIDSVAX B/B trial, which tested the vaccine against sexual transmission of the virus, the trial in Thailand is testing the vaccine against infection acquired by injection drug use.

VaxGen is also in an early stage of developing a vaccine against HIV subtype C, prevalent in Sub-Saharan Africa, India and China. The company is committed to developing increasingly effective formulations of AIDSVAX that target all HIV subtypes.



AIDSVAX B/B Trial Statistics
Number of volunteers to complete three immunizations: 5,009
Placebo recipients: 1,679
AIDSVAX B/B recipients: 3,330
White volunteers: 4,185
Hispanic volunteers: 326
Non-white volunteers (Black, Asian, Other): 498
Black volunteers: 314

Annual study infection rate 2.7%

Approximate Efficacy (after at least 3 primary doses)
All volunteers: 3.8% (p-value = 0.76;
confidence interval: -23% to 24%)
Non-white volunteers: 67% (p-value < 0.01;
confidence interval: 30% to 84%)
Black volunteers: 78% (p-value < 0.02;
confidence interval: 29% to 93%)


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[This message was edited Wed Mar 5 8:38:52 PST 2003 by katt]

alex. i was far 2 slow again.

so sad

We have to realize that HIV is retrovirus and it connects the infected persons DNA. This is the difficulty in developing a vaccine. It will not be able to work on all strands of HIV.

Prevention, Prevention, Prevention.

As we cut the prevention dollars, more people will become infected.

This is very sad, I was hoping that the new vaccine would truly help and be effective for those who suffer. It is horrible to know so many millions have died and are dying because of that disease already.

Prevention is key and behavorial patterns have to change. Too many still have that "it can't happen to me" syndrome. Although I hope for the day when "no resident will say, I am sick" and there will be no more death and dying. I truly do hope in these times they find something to help limit or bring this epidemic to a hault.

SuperC said:

There are genetic differences between people indigenous to different areas/environments of the globe. Pointing this out can becomes shaky however when scientists with agendas try to divide the human race up by factors like "intelligence" etc.

A person can lieve very long years as HIV+ infected and do not become AIDS.

Treatment yes or not is a personal choice. Vaccine yes or not, would been also a personal choice.
I wouldn't use not the one, nor the other way to take over years hard medicines, they distroy my body and my immunsystem more and,maybe, faster as AIDS would or will do.

It is not in my sinn, do make propaganda against medicine.

I know somebody who's living since 20 years with HIV and without any treatments! - How can that work? Doctors and professors can't give an answer! Neither have they thought about it to make a statistik, of the how many from that kind, that I know are!!!

Hey! don't forget them! - What's about it?

If Africans and Asians are more affected as the big white world, then is this because of theyr social situation most!

The first, the very first could been to make that this Humans can lieve in a human situation. That they get theyr food and theyr house and the work, to find a live able life and bring body and soul in better position. I'm sure the numbers of the AIDS victims would fall quickly!

A person can lieve very long years as HIV+ infected and do not become AIDS.

Treatment yes or not is a personal choice. Vaccine yes or not, would been also a personal choice.
I wouldn't use not the one, nor the other way to take over years hard medicines, they distroy my body and my immunsystem more and,maybe, faster as AIDS would or will do.

It is not in my sinn, do make propaganda against medicine.

I know somebody who's living since 20 years with HIV and without any treatments! - How can that work? Doctors and professors can't give an answer! Neither have they thought about it to make a statistik, of the how many from that kind, that I know are!!!

Hey! don't forget them! - What's about it?

If Africans and Asians are more affected as the big white world, then is this because of theyr social situation is most cruel to lieve!

The first, the very first could been to make that this Humans can lieve in a human situation. That they get theyr food and theyr house and the work, to find a live able life and bring body and soul in better position. I'm sure the numbers of the AIDS victims would fall quickly!

hate it to ahve the last word!

what kind of error did? Did do an error? i didn't made it xtra! What was i thinking about... realize?

okay, i have to contribute my two cents...
i have been living with the HIV virus for a mere 4 months now, but i have already found what makes it bearable, and that is maintaining a positive attitude, and being surrounded by positive attitudes. i was going to a support group at first, but it was seriously bringing me down. my doctor told me that stress is one of the worst factors involved.

the following is a monologue i wrote and performed in a play in janurary called "did you say love?". we were instructed to write about what love means to us, and it is connected to this topic:

Enjoy!




Paying the Toll

In my family, passion for anything other than the ways of God was the work of the Devil. Your sins were roadblocks barring your road to Heaven. God meets your needs, and you should NEVER question what he does or does not give you, lest he take it from you. We were raised to be humble God fearing suburbanite republicans, like my father and his father before him.
Can I get an amen from the congregation?
God, and therefore my father, really hated the 80s, when I was growing up. Rock music in that decade was the work of the devil, So we couldn’t even listen to Amy Grant, let alone to the Culture Club, George Michael, Prince, or Madonna like I so desperately wanted to. TV was full of vile representations of sex and greed and corruption, so it was nothing but religious propaganda like those asinine Davey & Goliath claymation cartoons for us. We were kept extremely guarded from the world and all it’s sinful ways.
But you can’t keep the river dammed up forever.
At the age of 11, within my father’s God fearing house, I found my one true passion, in the form of one of God’s most hated taboos.
I was introduced to the joys of being with a man by my own stepbrother. (dramatic gasp of shock) Wait it gets worse - we were listening to Def Leopard’s “Pour Some Sugar on Me” the first time we did it. Satan was just all over that room- coming out of the speakers, making the bed shake…
My stepbrother was two years older than I was, and while I realize now that this was not the best way to learn, he handed me the greatest gift I would ever know.
Sex.
The most truthful way I had ever expressed who I was.
And I hit the ground running.
When my family found out, they told me I was no longer a part of the family, and my stepbrother and I were placed in separate foster homes. I paid the toll to get away from my father, his family, and his god, and it was worth every cent.
With my stepbrother out of the picture, I started sleeping around with every experimental straight boy or not even realizing he is gay yet queer boy I could get my hands on. I was the neighborhood sex-machine in every place I lived.
And I was good at it too.
Good enough that they would keep coming back for more. And more. And more. I was getting all the appreciation and attention and love from these boys that I had never gotten from my cold and emotionally frozen family.
But eventually, I grew out of it. Or at least, I tried to.
While I was in high school, I grew weary of the incredible amount of sex I was having. I would go to a party, find someone to blow, and then afterwards, have a couple drinks or a couple of hits off a joint, and find someone new, and rinse and repeat, and rinse and repeat. It was not uncommon for me to end up sleeping with 5 or 6 guys in one weekend. But my heart yearned for something more.
I wanted a boyfriend.
Oh, I know what you’re thinking… “SOUNDS LIKE THE LAST THING THIS FAGGOT NEEDS IS ANOTHER BOYFRIEND, AM I RIGHT BOB?”
But I wanted something bigger.
Something with meaning.
Someone to fall asleep with.
Someone to wake up to.
Someone.
Anyone.
Anyone that I could love unconditionally, that would love me back… unconditionally.
But no one in my life had ever taught me to love. I didn’t have the first clue how to express love unless it was on my knees. I went on so many dates with so many guys, seeing every time some vision of us, monogamous and happy. But all they saw was a fantastic fuck with no return of phone call necessary.
After I graduated high school, I realized the problem was me. If I gave them what they wanted with no challenge, I would never begin to be able to keep them. So I stopped sleeping around so much, and refused to sleep with a guy until we were several dates in. But I didn’t know how to make it last. Once they got the sex they wanted, they moved on and settled down with more “respectable” boys.
I began to put on weight, and get more and more neurotic.
So I moved to Austin. I thought, “GO SOMEWHERE WHERE YOUR REPUTATION DOES NOT PRECEDE YOU, WHERE YOU CAN START ANEW”
And I met someone wonderful.
And I think he loves me.
We had been going out four months, and everything was beautiful. We talked nearly every day, the sex was incredible, but most importantly, he saw me for the person I am, not as the incredible blow jobs I could provide. We made a connection. We were monogamous. At the end of the road was a city of eternal love and passion and joy.
And then one day he got a letter from the CDC that someone had named him as a previous sexual contact that had tested positive for HIV.
We held one another close, and I assured him that his test would come back negative, thinking that our love was too strong for some stupid little virus.
And a week later he called me.
Positive.
I immediately got my test, and knew that there was no way that I was going to be positive.
I mean, after years and years of sleeping around with somewhere between oh…150-200 guys, I had stayed negative, and had been very cautious about STDs. The one time I really let my guard down, really opened my heart…
Positive.
After years of being promiscuous, no, being downright slutty… I got it from monogamy.
Irony is a bitch, isn’t he?
I tried to make it a non-issue, to make it just a small milestone within our relationship. I am a survivor. Along Life’s road, I had managed to survive religious persecution, physical abuse, mental abuse, verbal abuse, sexual molestation, rape, SURELY I could survive something this small in perspective.
But despite my best efforts the relationship crumbled. Consciously I was choosing very strongly to not blame him, I mean it’s not like he knew. But my sub-conscious knew that he had given it to me, and it killed my sex drive. I mean, how do you make love with the man who handed you your death sentence in the very act of loving him? How could I possibly look him in the face each day and not see my own impending death reflected in his eyes? So I did the chicken-shit thing… I disappeared without a trace. I couldn’t bring myself to say goodbye or tell him why.
So now I am on a medicine regime that’s giving me nausea, vomiting, and constant diarrhea for the next 10 months, but I like to think of it as Love’s Chemotherapy. Every time I take a pill, I think of it as putting some change into the tollbooth drop slot of life.
I stopped calling; I stopped seeing him, I stopped loving.
I lost my passion.
The only passion I ever really had.
Because it had cost me so much already.
My family, my well-being, my health, my very existence- all paid as toll, paid in full.
I still have hope. The field is narrowed, but I know that someday I will find someone who will also be positive, who will love me as much as I love him.
But for now, I am getting off the tollway. The price of love is more than I can afford at the moment.

Chris...thanks for being so brave We all still have a lot to learn and you just gave a lesson.

The AIDS Crisis

Africa has been hit harder by HIV/AIDS than any other region of the world. Over 17 million Africans have died from AIDS, and another 28.1 million are infected with HIV, approximately 1.5 million of whom are children. Those statistics are awful enough, but there is more. There are currently 11 million AIDS orphans in Africa, and if we do not act urgently, there may be more than 25 million AIDS orphans in Africa by the end of this decade. Millions of children will have lost not only their parents, but their teachers, nurses and friends too. Employers are losing their workers, governments are losing their civil servants, families are losing their breadwinners. Poverty feeds the AIDS epidemic, the AIDS epidemic deepens poverty, and Africa is losing the potential to lift itself out.

Africa needs resources for AIDS prevention and education campaigns. Africans also need reliable access to AIDS medications. Treatment saves lives, reduces mother-to-child transmission of the disease, and helps provide an incentive for testing and counseling. Ensuring access to treatment gives reasons for hope and saves lives.

Treating AIDS patients in Africa has been a controversial topic because the costs are so high and getting the treatments to so many will be difficult. Of the 28 million infected, only 30,000 are currently on medication. Although in some instances drug companies have agreed to reduce the cost of some AIDS drugs to poor countries in crisis situations, there is a large gap between the reduced $300 annual cost of AIDS medications and the $8-$12 dollars per person annual health budget of many African governments. More must be done by pharmaceutical companies and governments to reduce the price of AIDS drugs and more must be done to get these drugs to the individuals who need them.

Determined African leadership can make a big difference in fighting AIDS. The governments of the affected countries have a huge role to play implementing the education programs and healthcare reforms necessary to reverse stop the spread of AIDS. This is possible when leaders are determined: Public education and prevention campaigns in Uganda cut infection rates from 14% of adults in the early 90's to 8% in 2000.

WHAT MUST HAPPEN

These countries cannot fight AIDS without our help. We need to ensure that Africa has the resources it needs to fight AIDS. In 2000, rich and poor governments together were only spending $500 million on AIDS in Africa. Awareness is growing now, but infection rates are growing faster.

UN Secretary General Kofi Annan has estimated that $7-10 billion per year is needed to fight AIDS around the world. Wealthy countries must move toward meeting their share of that target ($2.5 billion for the U.S., for example), and increase funding for AIDS prevention, education and treatment, as well as health care infrastructure, in countries across Africa.

We must act now to get Africa the money to effectively fight AIDS. The newly-established Global Fund for AIDS, Tuberculosis and Malaria is a significant step toward a large-scale international response to AIDS. But it urgently needs much more funding from rich countries.

So far, only $2.1 billion has been pledged to the Fund. It has awarded a first round of grants for $616 million over two years to proposals in 30 countries. However, in order to continue to reward the proposals coming in from poor country governments and non-governmental organizations in AIDS-stricken countries, donors need to pledge much more.

AIDS is not going to go away on its own. The longer we go without sufficiently investing in stopping the global epidemic, the further it will spread worldwide and the more expensive the global bottom line will be in the end.



www.datadata.org

applekisses said:

thank u for being so sweet all i can do is use it to teach. most people have never met someone positive, which is what makes a lot of people think it can not happen to them. i am living proof that it can. and it would be selfish of me to not use this to try to save others from the same fate

cborgman said:

awww... You're da bomb! Have you thought about working in an HIV clinic or center? I'm sure they need people like you!

applekisses said:

yes, i volunteer at the clinic i recieve my medications and whatnot from, because the state pays for all my stuff, so i give back that way. but even better, i am preaching the message subtley in my one man show, which opens this fall...

cborgman thankyou for telling us all what happened to you.
By writing this you may help others realise this disease can come to anyone.
Much Love and total respect to you

Thank you for confidence.

Sataninas said:

Hi sweetness.

Why haven't you contacted me?

xenon said:

I don't know.I'm sorry.
[This message was edited Wed Mar 12 8:34:52 PST 2003 by Sataninas]