By Julie Beal
To help illustrate the long history of DNA vaccine failure, this article will trace the history of clinical trials of genetic HIV vaccines. It’ll also take a look at the development of tests of infection in the 1980s which are being used to stage a fake pandemic in the years 2020 to 2021.
No vaccine can be deemed ‘safe’, and every vaccine is different. However, anyone looking for more information on the potential risks of the coronavirus vaccines should know that almost every aspect of them has been tested. This is important, not only because it casts light on what the coronavirus vaccines contain, but also because it shows just how much effort has gone into them. Essentially, groups like the Pox-Protein Public Private Partnership, set up by the Gates Foundation, NIH, GSK, and others, have been conducting large-scale experiments with genetic vaccines across Africa for years. This was in response to lots of ‘confirmed cases’ of Zika, Ebola, HIV, etc., and means thousands of people have now been dosed with various forms of synthetic DNA and mutant viruses designed and created in a lab.
The Pox-Protein Public-Private Partnership
Some of the biggest trials of genetic vaccines have been for HIV, which the Pox-Protein Public Private Partnership has spent the last ten years trying to get to market, without success. Known as the P5 for short, the group was set up in 2010 by the Bill & Melinda Gates Foundation, the National Institutes of Health, Sanofi Pasteur, GlaxoSmithKline (GSK), the South African Medical Research Council, the HIV Vaccine Trials Network (HVTN), and the US Military HIV Research Program. This was to continue the long-running RV144 trials of recombinant glycoprotein vaccines for HIV which date back to the early 1990s, with the development of AIDSVAX, a vaccine containing the recombinant glycoprotein gp160, which is a small molecular sequence said to be found on the surface of a HIV virus.
In 1993, gp160 was used in a phase I trial, and in 2002, trials of gp120 got to phase 3. However, throughout all the trials, the vaccines have shown only “modest protective efficacy”; namely, by failing to reduce ‘infection’ rates. Another trial was the STEP study (by Merck), which used three chimp ‘Ad5’ viruses that would get people to produce several different HIV proteins, but the study was stopped in 2007 because there were higher rates of HIV infection in the vaccinated group than in the placebo.
The increased rate of HIV infection occurred in men-who-have-sex-with-men who were uncircumcised and/or had pre-existing antibodies to Ad5. This phenomenon is still unexplained.
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The HVTN trial, begun in 2009, and sponsored by the NIH, used a vaccine expressing HIV proteins for the ‘prime’, then ‘boosted’ it with a viral vector expressing the same proteins, but the trial was stopped in 2013, because, yet again, “the vaccine regimen did not reduce the rate of HIV infection or mitigate the infection of those volunteers who had acquired HIV while on the trial.”
By this point, the P5 had gotten involved, and in 2015 various new approaches were tried, using viral vectors, proteins, and an adjuvant called MF59, in different combinations. (Note, MF59 is also being added to a number of coronavirus vaccines.) The first jab was a ‘priming’ vaccine (they used ALVAC-HIV by Aventis Pasteur) containing a canarypox virus vector, and the second was a ‘booster’ (AIDSVAX B/E by VaxGen), which contained subunits of the HIV surface glycoprotein gp120. However, after being tested on thousands of people in phase 3 trials across South Africa and Thailand, the trials were declared a failure. As usual, they were plagued with a lack of ‘immunogenicity’ – and adverse events were deemed unrelated to the vaccine.
Alarmingly, some of the vaccines were found to be contaminated with a kind of bacteria (Mycoplasma hyorhinis), which had come from pigs. In 2015, it was reported that 94 people had been injected with the contaminated vaccine, whilst taking part in a clinical trial for NYVAC-HIV-PT1. The Phase 1 trials took place in Switzerland and the USA (2012-2013). After announcing their latest failure in February (2020), the group are now focusing on the role of the microbiome (i.e. gut health – more on this below).
How did we get here?
Step back in time to 1984, and we find Anthony Fauci taking the helm of the NIH, the same year that HIV was ‘discovered’ by Robert Gallo. Fauci has overseen the agency throughout all of the trials of genetic vaccines, many of which have been initiated and sponsored by the NIH itself. 1984 was a world-changing turning point for the future of vaccines because a new virus called HIV was announced, leading to a change in the definition of both ‘virus’ and ‘infectivity’.
The first reports of a new illness were in 1981, when five men in New York presented with “the most devastating immune deficiency … ever seen” and were diagnosed with Pneumocystis carinii pneumonia, and three years later, Robert Gallo was said to have found the cause of the illness. However, he didn’t do this by isolating a virus, but by “showing that antibodies to the virus were found in the blood of 48 patients with AIDS or pre-AIDS but not in healthy controls”. This led to the development of a HIV antibody test called an ELISA, made available in 1985.
The discovery of HIV came at a time when there was a lot of experimentation going on with ‘dna creations’, such as use of nucleotide analogues, and the first genetic vaccines. For instance, a genetically engineered subunit vaccine was introduced in the early 1980s, made by injecting DNA into yeast to yield proteins in the form of “20- to 22-nm spherical or oval particles” (i.e. recombinant proteins as nanoparticles). In 1972, recombinant DNA (rDNA) was created for the first time, i.e. combining elements of DNA from different organisms which could then replicate inside another organism. For hepatitis alone, there were a variety of treatments being tried. Critics once blamed AIDS on Hepatitis B vaccinations given to gay men in the 1970s, some of which used the blood (‘serum’) of other people said to have the illness. Some people with hepatitis were given ‘human leukocyte interferon’ in the 1970s, too. It could by synthesized from scratch by stitching together “a 23-amino acid signal peptide followed by an interferon polypeptide of 165 amino acids”, then inserting it into a bacterial plasmid, and bringing it to life in E.coli bacteria, i.e. make it “biologically active”.
An article written in 2014, ‘Questioning the HIV–AIDS Hypothesis: 30 Years of Dissent’’, by Patricia Goodson (retracted in 2019), describes views which opposed the hard-won consensus, such as that of the inventor of the PCR test, Kary Mullis, who thought AIDS-like illnesses were due to latent viruses, which is supported by recent research on molecular mimicry and endogenous retroviruses. Even Montagnier and Gallo, each of whom announced discovery of HIV, have said it’s not necessarily the cause of AIDS.
Goodson’s article also includes some valuable information from a book by Celia Farber (‘Serious Adverse Events: An Uncensored History of AIDS – an exposé of the epidemic’s ethically questionable history’), which has an appendix written by Rodney Richards: “Richards – who helped to develop the first ELISA test for HIV – outlines the ‘evolution’ of CDC’s stances regarding the role of antibodies, infection, and HIV tests. First, the CDC aligned itself with the traditional view of antibodies signaling past/prior infection.” This makes sense because it had been long established that having antibodies in your blood means you haven’t got an active infection, but then,
In 1984, CDC scientists (mainstream) wrote:
A positive test for most individuals in populations at greater risk of acquiring AIDS will probably mean that the individual has been infected at some time with HTLV-III/LAV [the names originally used for HIV]. Whether the person is currently infected or immune is not known, based on the serologic test alone [(12), p. 378].
In 1986, the CDC moved toward a qualified claim, stating:
… patients with repeatedly reactive screening tests for HTLV-III/LAV antibody … in whom antibody is also identified by the use of supplemental tests (e.g., WB, immunofluorescence assay) should be considered both infected and infective.
Finally, in 1987, CDC adopted a non-qualified claim that antibodies signify active infection and/or illness:
“The presence of antibody indicates current infection, though many infected persons may have minimal or no clinical evidence of disease for years” [(16, 17), p. 509].
In the meantime, a new test had been developed by Mullis, called the polymerase chain reaction or PCR test (the one currently being used to test for the rona), and after using it to screen people thought to be at high risk for HIV infection, many tested positive despite being disease-free, so when they later became ill, this was said to be AIDS, and thus proof of the test’s validity. After the results were announced at the 4th International Conference on AIDS in 1988, people came to believe that HIV could be present in somebody without them having symptoms, whether antibodies were detected or not. Ever since then, if somebody tests positive for HIV with a PCR test, they can be deemed to be both infected and infectious, even if they have no symptoms. Mullis, who died in 2019, criticized the use of PCR as a way to identify an infected person:
PCR is intended to identify substances qualitatively, but by its very nature is unsuited for estimating numbers. Although there is a common misimpression that the viral-load tests actually count the number of viruses in the blood, these tests cannot detect free, infectious viruses at all; they can only detect proteins that are believed, in some cases wrongly, to be unique to HIV. The tests can detect genetic sequences of viruses, but not viruses themselves.
Nonetheless, there has been enough media panic over various false-alarm ‘pandemics’ to ensure use of the tests has continued, especially to ‘diagnose’ HIV infection, whilst antibody tests showing protein particles and PCR tests showing small genetic sequences are classed as being proof of a whole virus, even though only fragments have been found.
However, the virologists and microbiologists who come up with the ideas for such vaccines are far removed from the sites of clinical trials, most of which take place on a large scale in Africa. On the whole, they seem to have blind faith in the integrity of such trials, the tests conducted, and the data reported from them. Rather than responding to reports of people getting sick and dying, scientists in labs now respond to constant reports of ‘cases’ of HIV, Ebola, etc., and this has led to the assumption that ‘cases = danger’. At the same time, clinical trials for DNA vaccines continued to grow, such that by 2017 there were said to be 162 DNA vaccine trials registered in the US. Another report in 2018 said there were an estimated 500 clinical trials using DNA vaccines.
Another area to keep an eye on is the potential for another shift in definitions. Since around 2008, key players in the HIV vaccine movement, such as Fauci, have been making the case for a reappraisal of vaccine approaches and immune correlates of protection. It is said that there are no correlates of protection for either HIV or Ebola, i.e. no measurable sign of immunity. Normally, vaccine makers aim to induce the production of neutralizing antibodies against viruses, and then, if successful, the vaccine can be deemed effective. However, when people are given a HIV vaccine, the neutralizing antibodies they produce may not “clear the infection” (as observed in blood samples), and subsequently, they may still test positive for HIV. An article published in 2014 made the case for a “new ‘old’ paradigm” whereby measurements of “functional non-neutralizing antibodies” are also considered when developing vaccines, noting “immune markers have the potential to expedite vaccine development”.
Nucleoside analogs (i.e. synthetic versions of the molecules used to make DNA) are sometimes used as antivirals, because they “block cellular division or viral replication by impairment [of] DNA/RNA synthesis or by inhibition of cellular or viral enzymes involved in nucleoside/tide metabolism.” Anti-virals have been around since the 1960s, and are a good example of just how long scientists have been meddling with DNA in the name of saving people from a virus. It began with a move towards biochemical pharmacology, rather than physiological pharmacology, such as when Prusoff synthesized a nucleoside analogue for the first time by making a chemical modification. Known as idoxuridine, (“a modified form of deoxyuridine”), it can be incorporated into the DNA replication of a virus because it’s “similar enough” to the real thing; “the iodine atom added to the uracil component blocks base pairing”. It was too toxic to be used as a drug, but Prusoff went on to develop another nucleoside analogue, which he licensed to Bristol-Myer-Squibb who named it Zerit and marketed it for the treatment of AIDS. The company also “reported 22 cases (including 7 deaths) worldwide of a stavudine-associated rapidly ascending neuromuscular weakness and respiratory failure mimicking Guillain–Barré syndrome”. Remdesivir, a prodrug of a modified adenine nucleoside analogue (called GS-441524) is now being suggested for the rona.
A little more history
The development of genetically engineered (i.e. recombinant) protein vaccines was ramped up throughout the 1980s and continues today. For instance, the flu vax Flublok, and the coronavirus vaccines by Sanofi/GSK and Novavax, use recombinant proteins. The first proof-of-concept DNA vaccine was tested on mice in 1990, and the first human trial of a DNA-based vaccine for HIV was in 1998. DNA vaccines, and gene therapy for specific diseases, use the same technology, i.e. they deliver genetically engineered viruses or plasmids encoding customised genetic sequences to the nucleus of cells. A 1995 report (‘Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues’) noted the increasing use of biotechnology in vaccines. There was a lot more vaccine research going on, and an increasing rise in applications to the FDA for new ‘biologics’. The report noted,
The modern vaccine industry looks more like the pharmaceutical industry and less like the earlier vaccine industry. The trend appears to be toward developing sophisticated products, often the result of recombinant DNA technology, that can be sold at prices approaching the higher prices of pharmaceuticals.
In 2000, the WHO reported on plans to test a genetic HIV vaccine in Uganda, delivered orally. Designed by Robert Gallo, the vaccine used “engineered salmonella bacteria to deliver genetic material encoding vaccine DNA to human cells.” The vaccine was developed by the International AIDS Vaccine Initiative, funded by the Rockefeller Foundation, the William H Gates Foundation, and UN agencies. Bill Gates has also contributed to funding trials of genetic vaccines, continuing the work begun by his father. The William H. Gates Foundation set up the Children’s Vaccine Program in 1998 (which went on to become GAVI), and since its launch in 2000, the Bill and Melinda Gates Foundation was funding research into DNA vaccines. For instance, the Johns Hopkins University School of Public Health and the University of Maryland School of Medicine got $20 million each to develop DNA vaccines for measles, such as “by placing genetic material from the measles virus inside weakened typhoid (Salmonella Typhi) bacteria or dysentery (Shigella) bacteria.”
The latest DNA vaccine failure
In May of this year, Dr Fauci co-authored an article which lamented the “futility” of the most recent trial, and the “disappointing” results, but championed “the range of vaccine platforms being used for anti‐SARS‐CoV‐2 candidate vaccines that have their origin in HIV vaccinology. The HIV vaccine field is clearly assisting in addressing this newly emergent pandemic and the National Institute of Allergy and Infectious Diseases (NIAID) is fostering these essential collaborations. For HIV Vaccine Awareness Day in 2020, we emphatically state that finding safe, effective and durable vaccines for HIV and COVID‐19 are NIAID’s top priorities. The world must have both.”
The authors were referring to the most recent abandoned experiment; in December, 2020, media reported that the Phase 2b/3 trial of HVTN 702 (also known as ‘Uhambo journey of hope’) had been stopped because, once again, more people got diagnosed with HIV in the vaccinated group than in the group that was given a placebo. The trial, conducted at 14 sites across South Africa, using ALVAC-HIV (vCP2438) and gp120/MF59 vaccines, involved six injections in six months, but later analysis found more people tested positive for HIV in the vaccinated group than in the placebo group.
What makes this trial stand out from all the others is that, in 2018, the researchers announced, “the composition of the human gut microbiome may inform how well an experimental HIV vaccine can elicit an immune response”. They said the type and amount of antibodies produced in response to vaccination “could be influenced by host-related factors such as antibody titers resulting from vaccination, host genetics (e.g., HLA type), health history, and microbiome.”
That’s not the kind of comment you normally see in a vaccine research report! But yes, these things are important for the maintenance of health, and to prevent disease. The gut microbiome is the name for the complex formed by the mass of organisms that help form the stomach; there are trillions of bacteria which are vital for our health, whilst some are simply tolerated, and others we have to get rid of. The balance between health and disease is a complex interplay between DNA and the environment it finds itself in. In fact, the ‘host-related factors’ the researchers describe are the same factors which can lead to an adverse vaccine reaction, and should be researched extensively, along with the other microbiomes in our bodies and the range of epigenetic factors which also affect health. However, the authors of this study just seem to be rationalising the antibody responses they recorded:
In a late breaker abstract presentation titled: Human gut microbiota are associated with HIV-reactive immunoglobulin at baseline and following HIV vaccination, James Kublin M.D. of the HIV Vaccine Trials Network (HVTN) explained that the human microbiome and immune system shape each other through lifelong interactions. He and his team used 16S ribosomal RNA sequencing of stool samples to understand the role of the human gut microbiome in modulating the immune response to two experimental HIV vaccines.
The microbiota composition of study participants, from the HVTN 096 clinical trial, was analyzed at baseline and then at two weeks and at six months post vaccination. …. Detection of antibodies directed against the envelope (Env) glycoprotein 41 (gp41) were generally much higher than baseline responses to other HIV Env antigens, which is consistent with there being cross-reactivity between responses to gp41 and other immunogens, potentially from commensal organisms such as E. coli. …. “We have further evidence that the microbiome is likely impacting vaccine responses, and that these responses may play a role in whether people are protected from HIV or not”, said James Kublin.
Host-related factors, e.g. microbiomes of the nose and throat, are indeed fundamental to ‘immunity’, whilst cross-reactivity can lead to a loss of immunity! This is crucial! But the only way to gain a clear understanding of these processes, and how balance is maintained, is to study them in natural human beings, rather than flooding them with genetic cocktails and then asking questions.
Unfortunately, however, the studies required are unlikely to be from the point of view of maintaining health, because vaccine trials focus on disease and the production of certain kinds of antibodies. Bill Gates has taken a keen interest in the microbiome, and there’s even an oral ronavax which is made using genetically modified probiotic bacteria to deliver plasmids secreting the spike protein! Literally all things natural are under threat from synthetic biology, especially if they’re patented.
Julie Beal’s previous 4-part chronicle of genetic vaccines is available HERE.
Top image credit: GSID.org
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