Moderna starts clinical trials of the first two mRna vaccines against hiv

Based on the same platform used for Spikevax against Covid-19, vaccine candidates enter the first phase of human trials. A historic step, even if the times cannot be short

(photo: Mat Napo / Unsplash) Officially communicated last week in the databases of the US National Institutes of health, the clinical trials of phase 1 for a pair of HIV vaccines developed by Moderna. The Massachusetts biotechnology company, which became famous for being among the first developers of a messenger rna (mRna) vaccine against the new coronavirus Sars-Cov-2, is therefore also the first in the world to propose a vaccine formulation based on the same. technology and which aims to provide protection from the HIV virus and AIDS.

The news is not a total surprise, because already in January there was talk of these vaccines and on April 14th the company communicated to its investors that pre-clinical tests were underway on a long series of mRna vaccines targeting various viruses (including influenza), including three potential HIV candidates also developed thanks to a collaboration with the International Aids Vaccine Initiative (Iavi) and the Bill and Melinda Gates Foundation. Two of these three candidates have now completed the preliminary phase of the trial, and have been authorized for the start of the experimental human administration.

What is the phase 1 trial like?

According to the information made public, the phase 1 clinical trials will involve a total of 56 volunteers between 18 and 50 years old, all healthy and negative HIV test results. The goal of these first administrations is, as always, to verify the safety - and not yet the efficacy - of the vaccine formulation, although obviously the antibody response obtained will still be recorded on these people. The two vaccines, very similar to each other, have been called mRna-1644 and mRna-1644v2-Core, while there is no news of the third candidate announced for 2021 (mRna-1574) for now.

I volunteers will be divided into 4 different groups, in this case without blind protocols, who will receive respectively the first formulation, the second formulation and two slightly different mixes of the two formulations.

Times much longer than in Covid-19

Compared to the speed with which the clinical trials for Spikevax (the recently renamed Covid-19 vaccine, so recently renamed) have come to an end, in the case of HIV vaccines the experimentation will require a lot more time. In particular, there is talk of at least 10 months and more likely 2023 for the sole conclusion of phase 1, which will then have to be followed - if all goes well - phases 2 and 3. At best, according to pre-pandemic time statistics, approval will take 5 years.

The reason for this slower experimentation dynamic is not of a bureaucratic or clinical nature, but lies in circulation much less of the HIV virus in the population than what happened with Sars-Cov-2 in the past months. In fact, the bottleneck for clinical trials is the need to collect a sufficient amount of data on people infected with HIV after the start of the trial, to then compare the vaccinated group with the control group. Since, fortunately, becoming infected with HIV is much less frequent than Sars-Cov-2 and that for ethical reasons the volunteers involved in the experiment are not deliberately exposed to the virus, it will be necessary to wait a reasonable time before having sufficient data to request the marketing authorization for the vaccine. And it is difficult in this sense to make an a priori estimate of the times.

Still early to sing victory

On the one hand, the effectiveness of the messenger rna approach in vaccines against Covid -19 bodes well, on the other hand it is definitely premature to predict the outcome of the trials and the usability of the vaccine on a large scale. In fact, until now, all attempts to develop an HIV vaccine have been abandoned rather quickly, also due to the rapid and frequent mutations of the HIV virus, and the fact that the new vaccine technology (combined with a relatively recent of the immune response) can succeed where the previous ones have failed is essentially a gamble. In addition to the issues of safety and antibody response, it will be necessary to establish at what level the vaccine will be effective and protective against infection, and also how long it can guarantee the protection itself.

Although through vaccines l 'approach to the disease is completely different, in the case of the HIV virus (unlike Sars-Cov-2) we already have antiviral drugs available that guarantee excellent performance, so in retrospect it will be necessary to understand if and how much the vaccine can represent a real advantage in the fight against AIDS. On the good news front, however, it must be said that Moderna's HIV vaccines start from an excellent premise: the antigen that the mRna vaccine should encode, injected into another trial completed at the beginning of 2021 conducted without the technology. to mRna, resulted in a satisfactory immune response in 97% of cases.


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Topics

Hiv Vaccines Modern Vaccine globalData.fldTopic = "Hiv, Vaccines, Modern Vaccine"

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