Various Vaccine Clinical Trials by Moderna Move on to Later Stages
Five of the company’s vaccines are currently in Phase III.
At its Vaccines Day event, Moderna revealed various clinical and program updates concerning its mRNA pipeline. The company’s vaccine portfolio features 28 vaccines that combat latent, respiratory, and other pathogens.1
When it comes to virus-causing infections, all of these are currently undergoing clinical trials. A latent virus often does not cause obvious symptoms—existing in a resting state—which is a main quality in the Herpesviridae family. These viruses include:
- Cytomegalovirus (CMV): A common infectious cause of birth defects in the United States (one in 200 babies in the country are born with this infection) that has caused several billion dollars in annual healthcare costs. A Phase III trial known as CMVictory is in progress, which is measuring mRNA-1647 against primary CMV infection in women 16-40 years of age. The trial is a randomized, observer-blind, placebo-controlled study designed to evaluate the efficacy, safety and immunogenicity of mRNA-1647. The trial is fully enrolled with approximately 7,300 participants from 290 clinical sites globally.
- Epstein-Barr virus (EBV): A major cause of infectious mononucleosis (IM) in the United States that is responsible for more than 90% of yearly IM cases. Both EBV and IM are associated with a higher lifetime risk of certain cancers including gastric carcinoma, nasopharyngeal carcinoma, and various kinds of lymphoma. Moderna's EBV vaccine candidates are designed to tackle multiple EBV-associated conditions, including prevention of IM (mRNA-1189) and MS and post-transplant lymphoproliferative disorder, a subcategory of lymphoma in solid organ transplant patients (mRNA-1195). The Phase I trial for mRNA-1189 was created to test the safety, immunogenicity, and reactogenicity of various dose levels in participants ages 12-30 in the United States. The randomized, observer-blind, placebo-controlled study showed mRNA-1189 was immunogenic and generally well tolerated across all dose levels. The company is advancing mRNA-1189 toward a pivotal Phase III trial.
There are also ongoing trials for herpes simplex virus (HSV)—the main cause of genital herpes— and Varicella-Zoster virus (VZV)—also known as shingles—which are planning to begin Phase I/II trials and planning for Phase III respectively.
When it comes to enteric viruses, such as norovirus, it is highly contagious and a leading cause of diarrheal disease worldwide, as it is attributed to 18% of all acute gastroenteritis (AGE), and approximately 200,000 deaths annually. There is currently a randomized, observer-blind, placebo-controlled Phase I trial that tested the safety, reactogenicity and immunogenicity of trivalent (mRNA-1403) and pentavalent (mRNA-1405) norovirus vaccine candidates in 664 participants in both the 18-49 and 60-80 age ranges in the United States. Initial analysis suggested one dose of mRNA-1403 produces a “robust immune response,” and as result, a Phase III trial could be in the works.
Moderna also has a respiratory portfolio, which includes (but is not limited to COVID-19; Respiratory Syncytial Virus or RSV; and the flu.
"Our mRNA platform continues a remarkable track record across our broad vaccine portfolio. Today, we are excited to share that four vaccines in our pipeline have achieved successful clinical readouts across our respiratory, latent and other virus franchises," noted Stéphane Bancel, Moderna’s CEO. "With five vaccines in Phase III, and three more moving toward Phase III, we have built a very large and diverse portfolio addressing significant unmet medical needs. We are focused on execution to further build momentum across our pipeline and business, and to deliver for patients who are impacted by these infectious diseases.”
Reference
1. Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials. Moderna. News release. March 27, 2024. Accessed March 28, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Advances-Multiple-Vaccine-Programs-to-Late-Stage-Clinical-Trials/default.aspx
