AIDS vaccine Worse Than Useless?_ISS

AIDS vaccine Worse Than Useless?_ISS

Wed, 25 Jun 2003

An article published by the Institute of Science and Society (ISS locatedin the UK) cautions that experience thus far with 51 NIH-sponsored AIDSvaccinetrials (Phase I and II) belie the claimed positive findings made in anarticle in the currentissue of Vaccine, which concluded that there were no adverse effects in 3189HIVuninfected, healthy volunteers who were enrolled.

But Dr. Mae-Wan Ho the author of the ISS article (excerpt below) notes:”The only AIDS vaccine to have progressed past phase 3 trial, made byVaxGen,took 5 years and involved 5108 gay men and 309 women. Unfortunately, itprovedineffective, and may even be harmful.”

“In the 3003 white and Hispanic volunteers who received VaxGen’s vaccine,a higher proportion suffered breakthrough infections than in the 1508controls:6% vs 5%. Although the difference is not significant, it could indicate adangerous trend. But the company is not releasing further details on thetrialresults.”

Dr. Veljko Veljkovic, a prominent Hungarian AIDS scientist, points out: “This conclusion was based on analysis of many important parameters. Unfortunately, the key information – comparison of the health status between breakthrough infected vaccinated volunteers and control subjects who participated in these trials – was not reported, just as it was not reported by VaxGen in the results of their Phase III clinical trial.”

“Unless this information is reported, says Veljkovic, the companies andinstitutions that organized these clinical trials are in danger ofcommittinga scientific and ethical misconduct.”

Dr. Veljkovic and colleagues have repeated their call for an immediatemoratorium on the current clinical trials of HIV-1 gp120/160 vaccines.

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http://www.i-sis.org.uk/AVWTU.php

AIDS Vaccines Worse Than Useless?

The US administration is offering AIDS-ravaged nations support for fightingAIDS tied to the purchase of GM products. The main anti-AIDS strategy is aclass of vaccines that carries its own risks. Prominent AIDS researchershave called repeatedly for a moratorium as evidence of hazards accumulates.Dr. Mae-Wan Ho reports.

The complete document with references, is available in the ISIS memberssite.

George Bush has taken Europe to the World Trade Organisation over Europe’sde facto moratorium on GM imports. In the week of the G8 summit in Evian,France, Bush blasted Europe for perpetuating starvation in Africa byblocking US food aid with anti-GM policies, and announced his pledge of$15bn to combat AIDS globally, especially in Africa.

The UN Population Division reported earlier this year that by 2050, thepopulation of the hardest hit nations will have risen by 400 million lessthan previously estimated because of AIDS. “This estimate could be the firstsign that HIV-1 will cause extinction of human beings in this millenniumunless an effective AIDS vaccine is developed,” said a commentary by VeljkoVeljkovic and colleagues in the Lancet, published in February.

The only AIDS vaccine to have progressed past phase 3 trial, made by VaxGen,took 5 years and involved 5108 gay men and 309 women. Unfortunately, itproved ineffective, and may even be harmful.

In the 3003 white and Hispanic volunteers who received VaxGen’s vaccine, ahigher proportion suffered breakthrough infections than in the 1508controls: 6% vs 5%. Although the difference is not significant, it couldindicate a dangerous trend. But the company is not releasing further detailson the trial results.

A few days after Bush announced the AIDS package, US Congress was denouncedfor tying support for anti-AIDS research programmes in 50 countries to theiracceptance of GM products. This accusation came from Julio Sanchez,representative of Mesoamerican Trade. Introducing GM food to hungry,malnourished nations ravaged by AIDS is bad enough in terms of health risks,but AIDS research programmes are heavily concentrated towards vaccinedevelopment with a strategy that introduces its own health hazards, as isbecoming increasingly clear.

The gp120 protein is strongly immunogenic, which is why it is widely used invaccines, in the hope that the body will produce antibodies against theprotein and hence protect against the virus. But there have been manyworrying signs that this may have just the opposite effect.

For although the body mounts a strong immune reaction against the protein,and produces antibodies against it, those antibodies fail to protect againstthe virus. One main reason is that the virus is very mutable, and canreadily mutate to escape immune detection. In addition, the immune reactionmounted against the original gp120 undermines the effectiveness of theimmune system by over-stimulating it, so that it is less effective to copewith new infections.

A recombinant gp120 vaccine tested in HIV-negative individuals in phaseI/IItrails, was not effective in protecting against the disease. Not only that,participants in the trials had significant levels of circulating antibodiesagainst the vaccine before they became infected, and came down with AIDSdisease.

The vaccine could also be dangerous. A vaccine based on the gp120 from thestrain SF2, actually suppressed the production of antibodies that couldneutralise the later infecting virus, while boosting the production ofuseless antibodies that were specific for the vaccine strain, SF2. In otherwords, gp120 acts as a molecular decoy to disarm the body’s antiviralresponse, leaving it more vulnerable, and increasing the likelihood of rapiddisease progression in those vaccinated that later became infected. Thisphenomenon is called “deceptive imprinting” of the immune system.

Were those effects predictable in advance of the clinical trials? Veljkovicand his colleagues answer a definite yes.

First of all, the part of the gp120 molecule that plays the dominant role inprovoking an immune response is the V3 loop. The V3 loop and flankingregions are similar in base sequence and structure to the antigen-bindingregion of the human immunoglobulin (Ig) (antibody protein). And it has beenproposed since the early 1990s that this immunoglobulin-like domain in gp120may interfere with the immune regulatory network. This is strongly supportedby later observations that the anti-V3 and anti-Ig antibodies of healthyindividuals are similar in structure, and that antibodies reacting to V3 arepresent in sera that are HIV-negative.

In 1999, Howard Urnovitz and colleagues identified a mysterious case of AIDSin a French woman with no risk factors. Analysis of the isolated HIV viralenvelope showed that it had homology to sequences found on at least 14different human chromosomes. This opened a whole new can of worms. Was thisrare strain of HIV-1 the result of genetic recombination (reshuffling) inthe human genome, similar to that found in veterans suffering from Gulf Warsyndrome (see “Dynamic genomics”, this series)? Antibodies to humanendogenous retroviruses were found in the urine of patients with clinicalAIDS. Thus, vaccinating against HIV-1 may be tentamount to vaccinatingpeople against their own genes (see “Endogenous retroviruses & chronicdisease”, this series). Does that mean genetic reshuffling and retroviralelements in the human genome may have a key role to play in AIDS disease, asin Gulf War Syndrome and other chronic disease?

Another piece of evidence implicating genetic recombination is that the V3loop and its flanking regions are located between recombination signalssimilar to those found in human immunoglobulins, and also similar to the Chirecombination hotpots found in many viruses and bacteria. Consequently, theimmunologically dominant region of gp120 may be involved in recombining withhuman immunoglobulin genes resulting in autoimmune responses, and may alsorecombine with co-infecting viruses and bacteria to generate new pathogens.Evidence of such recombination has subsequently been found in the sera ofAIDS patients.

Many other observations have linked gp120 with auto-antibodies that reactagainst the body’s own cells and enhance the infectivity of HIV-1, and thoseresearchers have also issued warnings against AIDS vaccines.

In fact, warnings against AIDS vaccines go back to Albert Sabin, one of themost prominent viral vaccine developers of the 20th century. “The availabledata provide no basis for testing any HIV vaccine in human beings eitherbefore or after infection,” Sabin stated.

The current issue of Vaccine carries an article evaluating the long-termsafety of a range of AIDS vaccines involving 3189 HIV uninfected, healthyvolunteers who were enrolled into 51 NIAID (NIH) – sponsored Phase I and IIclinical trials. It concluded that there were no adverse effects. Veljkovicremarks, “This conclusion was based on analysis of many importantparameters ….Unfortunately, the key information – comparison of the healthstatus between breakthrough infected vaccinated volunteers and controlsubjects who participated in these trials – was not reported, just as it wasnot reported by VaxGen in the results of their Phase III clinical trial.”

Unless this information is reported, says Veljkovic, the companies andinstitutions that organized these clinical trials are in danger ofcommitting a scientific and ethical misconduct.

It is pertinent to point out that transgenic DNA in GM food and feed alsocarry recombination hotspots, such as the ones associated with the CaMV 35Spromoter and the left and right borders of the Agrobacterium T-DNA used asvector to introduce transgenic DNA into the plant genome. Theserecombination hotspots enhance horizontal gene transfer and recombination.Furthermore, as Veljkovic said, the recombination hotspots in transgenic DNAmay interact with the recombination signals flanking the V3 loop of thegp120 gene in AIDS vaccines to generate yet more exotic viruses.

Veljkovic and his colleagues have repeated their call for an immediatemoratorium on the current clinical trials of HIV-1 gp120/160 vaccines.

The complete document with references, is available in the ISIS memberssite. Full details here

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