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This week, biotech company Moderna will launch human trials for its HIV vaccine. Its HIV vaccine will be the first of its kind to use messenger RNA (mRNA), an approach Moderna used in its effective vaccine against COVID-19.
Clinical trials will begin Aug. 19 and end around spring 2023, according to the National Institutes of Health Trials Register. They will involve 56 HIV negative participants aged 18 to 56. Participants will be given one or two forms of mRNA that cause the body to form defenses against HIV infection.
Related: Here’s Why COVID-19 Has A Vaccine After 1 Year And HIV Doesn’t Have One After Almost 40 Years
In the past, HIV vaccines used inactivated forms of the virus. However, previous trials have shown that these forms do not produce an immune response. In fact, researchers canceled a trial in Thailand in the 2000s after inactivated forms of the virus were found to increase the risk of getting HIV rather than preventing infections.
Instead, Moderna assays will contain one of two different types of mRNA: mRNA-1644 and mRNA-1644v2. These cause the body’s cells to develop a “protein peak” on their surface. These spikes are similar to those embedded by HIV on the surface of a cell when it begins to infect cells in order to reproduce. When the body recognizes the presence of the mRNA spike, it begins to produce antibodies to protect against infection.
MRNA can also make it easier for scientists to make changes to the vaccine.
“The mRNA platform facilitates the development of variant vaccines because it simply requires updating the coding sequences of the mRNA that encode the variant,” Rajesh Gandhi, MD, infectious disease physician at Massachusetts General Hospital and president of the HIV Medicine Association, said the medical website Very well.
This is particularly useful for HIV since the virus is known to have mutated into at least 16 known variants.
Moderna’s mRNA vaccines passed phase I testing earlier this year. Phase I trials test for safety by administering different doses and observing how the body and the drug interact. Phase II trials test the overall effectiveness of the vaccine, and phase III trials will compare the safety and effectiveness of the new vaccine with current HIV prevention drugs.
If the vaccine passes Phase III testing, Moderna can then submit its studies for US Food and Drug Administration (FDA) approval. Then the FDA will conduct phase IV trials for full scale testing and cost analysis.
If successful, the vaccine could then become widely available, helping to end an epidemic that has ravaged the world for more than 40 years.
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