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Moderna’s many mRNA vaccines will gradually enter clinical trials

Moderna’s many mRNA vaccines will gradually enter clinical trials. Moderna will use mRNA technology to conduct phase 1 trials of influenza and HIV vaccines this year, and begin a key phase 3 study of its cytomegalovirus (CMV) candidate vaccine.

Moderna's many mRNA vaccines will gradually enter clinical trials

Phase 1 studies of RSV vaccine candidates are also underway.

As part of Vaccine Day this week, the company updated its vaccine development schedule and announced the results of early mRNA vaccine trials.

HIV vaccine: mRNA-1644 and mRNA-1574

Moderna is expected to start three phase 1 clinical trials for the two HIV vaccine candidates mRNA-1644 and mRNA-1574 in 2021.

mRNA-1644 is a novel approach to human HIV vaccine strategy, designed to trigger the human body to produce broad-spectrum neutralizing HIV-1 antibodies (bNAb). It was developed in collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation (BMGF). The candidate’s first phase of research will use iterative human testing to validate the method. Antigens and a variety of novel antigens will be used for germline targeting and immunofocusing.

The second method is mRNA-1574, which is currently being evaluated by the National Institutes of Health (NIH), which includes a variety of natural trimeric antigens.

Candidate mRNA influenza vaccine: mRNA-1010

Moderna’s influenza program is evaluating multiple drug candidates, including multiple antigen combinations for the four seasonal viruses recommended by the WHO.

In addition, it also hopes to explore potential combination vaccines against influenza, SARS-CoV-2, RSV and human interstitial pneumonia virus (hMPV).

The effective rate of influenza vaccines currently on the market is 40-60%: Moderna believes that its mRNA technology can be improved. It also said that its technology has several advantages over egg-based vaccine production: not only has it made progress in production, but it is also targeted in vaccines against strains (egg-based production may lead to unexpected vaccine viruses. Antigen changes).

RSV vaccine candidate: mRNA-1345

This week, Moderna also released an interim analysis of its Phase 1 study of its RSV vaccine candidate mRNA-1345.

A single dose of mRNA-1345 vaccine of 50μg (N=19) or 100μg (N=20) is generally tolerated in young people (18-49 years old).

The vaccine showed increased RSV neutralizing antibodies in seropositive young people. As expected, all participants had neutralizing antibodies at baseline. A single vaccination of mRNA-1345 at the dose level of 50 or 100 μg can increase the titers of neutralizing antibodies against RSV-A and RSV-B serotypes without significant dose response.

Dr. Jacqueline Miller, Senior Vice President of Infectious Diseases at Moderna, said: “These first phase interim data show that mRNA-1345 can trigger a strong neutralizing antibody response. I am encouraged. We will continue to seek RSV vaccines to protect the most vulnerable. The population-young children and the elderly-reducing RSV infection is also a major issue that needs to be solved. We will also explore the possibility of combining mRNA-1345 with other respiratory virus vaccines.”

There is currently no approved respiratory syncytial virus vaccine.

CMV vaccine: mRNA-1647

Moderna’s CMV vaccine is its most advanced mRNA vaccine candidate: it will enter this year’s Phase 3 pivotal study of 8,000 seronegative women aged 16-40 in the United States, Europe and Asia Pacific.

In the week seven months later, Moderna has released the intermediate phase 2 data of the vaccine mRNA-1647. Among the participants who received 3 doses of CMV seronegative, the geometric mean titer (GMT) of neutralizing antibodies against epithelial cell infection was at least 20 times higher than the baseline GMT of the CMV seropositive group; while neutralizing antibodies against fibroblast infection The GMT was close to the baseline GMT of the CMV seropositive group.

Among CMV-positive participants, the neutralizing antibody GMT for epithelial cell infection increased to at least 6.8 times higher than baseline, while the neutralizing antibody GMT for fibroblast infection increased to about 2 times higher than baseline.

mRNA-1647 is a vaccine that combines 6 types of mRNAs in a vial. They encode two antigens located on the surface of CMV: 5 types of mRNAs encoding subunits that form membrane-bound pentameric complexes and one type of mRNA encoding the whole Long membrane-bound glycoprotein B (gB) mRNA. Both pentamer and gB are necessary conditions for CMV to infect the epithelial surface of the barrier and enter the human body.

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