HIV mRNA Vaccines Continue to Fail in Clinical Trials

Messenger ribonucleic acid (mRNA) vaccines are being described as a “new era in vaccinology.”¹ Research is underway to develop mRNA shots for not only coronaviruses but also C. difficile, hepatitis C, influenza, malaria, norovirus, cancer and more² — despite the fact that all mRNA shots are likely ineffective and/or dangerous.

The most recent mRNA failure was a phase 1 trial of Moderna’s mRNA human immunodeficiency virus (HIV) injection. Larger trials were halted after a high rate of “puzzling skin side effects” occurred.

“We are taking this very seriously,” Carl Dieffenbach, head of the Division of AIDS at the National Institute of Allergy and Infectious Diseases (NIAID), told Science.³ Although all HIV mRNA shots have failed to pass even the initial trials, researchers plan to repeat the phase 1 trial using a lower dose.

High Rates of Skin Reactions Halt HIV mRNA Shot Trials

Trials of mRNA-based HIV immunogens are being conducted in partnership by the International AIDS Vaccine Initiative (IAVI), Moderna, the HIV Vaccine Trials Network (HVTN), the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation.⁴

In a series of phase 1 trials, 7% to 18% of participants⁵ who received the experimental shots experienced skin reactions, including hives, itchiness or hives caused by scratching. In a news release, IAVI largely downplayed the concerning outcome, stating:⁶

“Most of these events were mild or moderate, and managed with simple allergy medications. There were no serious adverse events reported. Participants who experienced skin events were provided all medical care necessary and were monitored closely.

IAVI and partners are actively working to investigate the potential causes of these skin events. We have brought in an interdisciplinary team of external experts, including allergists and immunologists, to further assess the skin events.

In the interest of transparency and clarity, IAVI and partners have presented preliminary data on immune responses and safety at scientific conferences and look forward to continuing our discussion of these results.”

However, the setback highlights the continued failures in the race to create an mRNA HIV shot. “We would be moving more quickly if this finding had not been observed,” IAVI head Mark Feinberg told Science.⁷

Problems Plague mRNA HIV Shots

To create the shot, researchers have been injecting “different mRNAs, encoding various pieces of HIV’s surface protein or the entire molecule, over the course of several months.”⁸ The idea is to trigger the creation of broadly neutralizing antibodies, or bNAbs.

BNAbs are immune system proteins that have the unique ability to fight a wide range of strains of a virus. In terms of HIV, bNAbs are of particular interest because HIV is highly variable, with numerous strains circulating globally. Derek Lowe, a medicinal chemist, wrote:⁹

“Moderna has been working for some years now on a possible HIV vaccine using their mRNA technology, which is an ambitious goal. There have been numerous attempts at this over the decades, and needless to say none of them have worked out yet. There is almost certainly not going to be a single-shot vaccine targeting a single antigen — the situation is too complex for that.

Since the virus comes in many different strains, the hope has been that some sort of more comprehensive vaccine protocol might be able to induce broadly neutralizing antibodies that could take on all comers.”

Most antibodies target specific virus strains, but bNAbs can neutralize many strains of HIV, making them a powerful tool in the fight against this virus. While people with HIV sometimes develop their own bNAbs, no vaccine has done so.¹⁰

The idea in creating bNAbs through mRNA technology for HIV is to deliver instructions for creating proteins that resemble parts of the HIV envelope. This would, in theory, stimulate the immune system to produce bNAbs that can neutralize a wide range of HIV strains, offering a broad protection against the virus. As reported by Bloomberg:¹¹

“Creating an mRNA vaccine for HIV is trickier than making the kind of SARS-CoV-2 shots we’ve become familiar with. The mRNA COVID vaccines deliver the recipe for the spike protein … This causes immune cells to produce neutralizing antibodies against COVID, much as they would do if they had experienced a COVID infection.

With HIV, there’s no such simple recipe. HIV’s equivalent to the spike protein — its envelope glycoprotein — is wilier. It hides its vulnerable aspects, making it difficult for immune cells to generate antibodies against it. An even bigger problem is that HIV starts to mutate within hours of infecting someone …

HIV behaves like ‘a swarm of slightly different viruses’ … People with HIV rarely develop neutralizing antibodies, and in the very few who do, the antibodies take years to evolve — far too long for them to effectively fight the virus. The immune system can’t keep up.

But what if the immune system could be given a head start? That’s the idea behind the Moderna/IAVI vaccine … The researchers will administer a series of shots to try to coax the immune system along that years-long process ahead of time so that when it is exposed to HIV, it can spring into action.”

Skin Problems May Be Early Warning for an Immune Response

While the Moderna HIV shot reportedly generated “impressive antibodies that were moving toward bNAbs,”¹² the high rate of skin problems it triggered are suggestive of a greater problem. Lowe went so far as to describe them as an “early warning radar for general immune response”:¹³

“A significant number of vaccine recipients (ten to fifteen percent in some cases) have shown various sorts of skin reactions (hives, etc.) These almost always resolve, but it is a warning.

Skin reactions are sort of an early warning radar for general immune response (thus the skin tests for various allergens), and the worry is that these might well become worse on further dosing (or be harbingers of other immune problems in different organ systems). It’s definitely worth a closer look.

I have to point out that this side effect rate is much higher than has been seen with the coronavirus mRNA vaccines (thus the alarm bells), but skin reactions are not unknown there, either … No one is quite sure if it’s the mRNA species themselves that set off the response here, or if it’s something about the formulation (the lipid nanoparticles).”

“Potentially more worrisome, however, would be if the problem is tied to a cumulative effect from multiple mRNA shots,” Science reported.¹⁴ It’s important to point out that while all HIV mRNA shots have failed, we’re to believe COVID-19 mRNA shots passed safety and efficacy studies with flying colors and the technology is thereby “proven” safe and effective.

But as noted by Canadian oncologist and cancer researcher Dr. William Makis, “The more mRNA shots you take, the greater the immune system damage, the greater your risk of impaired cancer surveillance and hence, the greater your risk of turbo cancer.”¹⁵