Four major mRNA vaccine clinical trials to watch in 2023.

Following the success of messenger RNA (mRNA) vaccines for COVID-19, there has been more investment in new trials. 

Recent positive clinical trials for melanoma and respiratory syncytial virus (RSV) have now shown that mRNA vaccines can prove effective in addition to the treatment of COVID-19, and the medical world has taken notice.

In 2023, four major studies on influenza, genital herpes, and melanoma showed how comprehensive mRNA vaccine technology could be. These include Moderna’s mRNA-1010, Pfizer’s modRNA vaccine for seasonal influenza, and Roche/BioNTech’s RO7198457 for advanced melanoma, and BioNTech’s BNT-163 for genital herpes lesions.

mrna trials

While most of the early clinical trials of mRNA vaccines were dominated by institutions and government agencies, the tables turned quickly. “MRNA technology is new and successful, and it looks like it’s going to be the next big breakthrough,” says Dr. Harvey Friedman of the University of Pennsylvania, who is researching mRNA vaccines against herpes. “The big pharmaceutical companies don’t want to be left out of this technology.”

According to the GlobalData clinical trials database, 85% of planned mRNA vaccine trials in 2023 will have industry sponsors, compared to only 34% of mRNA trials initiated in 2021 At the same time, overall investment in mRNA vaccine research has increased over the past decade. GlobalData is the parent company of Clinical Trials Arena.

mRNA vaccines work by instructing cells to code for certain proteins, which can then prevent infections by provoking an immune response or treat other diseases. As the industry accelerates the transition to mRNA vaccines, all eyes are on these four trials, expected in 2023.

mrna diseases


Pfizer and Modern Seasonal Influenza.


Two of the largest mRNA vaccine studies with 2023 values are related to seasonal influenza. First, immunogenicity data from Moderna’s phase III trial of mRNA-1010 (NCT05415462) in 6,102 patients is expected in the first quarter of 2023. The trial will test mRNA-1010 against an active reference vaccine, with the primary endpoints focusing on antibody titers and adverse events. (AE). 

The next phase III trial of Pfizer’s quadrivalent modRNA flu vaccine (NCT05540522) with 36,200 patients is expected to yield results in 2023. The primary endpoints measure the incidence of laboratory-confirmed cases of influenza, antibody titers, and side effects, all compared to the active vaccine.

Two vaccine trials are underway after the recent flu season proved unusually long. Meanwhile, some doctors are still waiting for the widespread combination vaccines against influenza and COVID-19.

Cancer mRNA vaccine trials

In the melanoma space, two major players have mRNA vaccine candidates in Phase II: Moderna/Merck and Co.’s mRNA 4157 and Roche/BioNTech’s RO7198457 (autogenous cevumerans). In December 2022, Moderna and Merck & Co. reported a positive top line in phase IIb. KEYNOTE-942 trials (NCT03897881) testing mRNA 45157/V940 in combination with Keytruda (pembrolizumab) as adjuvant therapy after complete tumour resection in advanced melanoma. Both companies said they plan to start a Phase III study in 2023.

Meanwhile, Roche and BioNTech want to conduct their own melanoma research. The 131-patient phase II IMCODE101 trial (NCT03815058), which tested RO7198457 against Keytruda alone, expecting results in 2023. The primary outcome measure is the progression-free survival (PFS) of patients in the open study after two months with previously untreated advanced melanoma.

BioNTech targets herpes

BioNTech is also testing an mRNA approach with a vaccine to prevent genital herpes. Data are expected in the second half of 2023 from the 108-participant BNT163 (NCT05432583) Phase I trial testing the safety and immunogenicity of the vaccine Herpesvirus as more than 70 proteins, which can make it difficult to select the correct mRNA targets, explains Friedman, who is working on the development of BNT163. “So far, our target selection looks good in mice and guinea pigs,” he says. “Now let’s see if it feels good to people.”

Meanwhile, Moderna has joined the race to develop a herpes mRNA vaccine and is expanding its mRNA pipeline with a vaccine against herpes simplex virus type 2 (HSV-2).


Next-Gen mRNA Vaccines

Pharma should examine these Key Results from mRNA Vaccine Trials In 2023, the entire field remains focused on infectious diseases. According to the GlobalData Clinical Trials Database, 70% of all ongoing mRNA vaccine trials are in the field of infectious diseases. Oncology is the most common therapeutic area, accounting for 12 percent of all ongoing mRNA vaccine trials.

Time will tell if mRNA vaccine technology takes a strong position in the field of cancer drug development, based on key results from melanoma mRNA studies. Meanwhile, mRNA vaccines are likely to continue fighting infectious diseases.

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