The following is a summary of “Safety and immunogenicity of a messenger RNA-Based cytomegalovirus vaccine in healthy adults: results From a phase 1, randomized, clinical trial,” published in the March 2024 issue of Infectious Diseases by Fierro et al.
Researchers conducted a retrospective study assessing the safety, reactogenicity, and immunogenicity of mRNA-1647, a cytomegalovirus (CMV) vaccine based on mRNA, in adults, both CMV-seronegative and -seropositive.
They randomly assigned the participants to receive 30, 90, 180, or 300 µg of mRNA-1647 or placebo on 0-, 2-, and 6- month schedules with a follow-up of 12 months after the last dose.
The results showed 154 participants with 80 CMV-seronegative and 74 CMV-seropositive patients. Of all the participants, 118 received mRNA-1647, whereas 36 received a placebo. Mean age was 32.5 (8.6) years in the placebo group, 35.1(8.9) years in the mRNA-1647 group in phase B (63% and 64% female), and 42.5 (6.2) and 33.3 (8.7) years in phase C (2% and 16% female). No deaths or serious adverse events occurred. Most adverse reactions were of mild severity. mRNA-1647 induced increased immune responses in all groups.
Investigators concluded that phase 1 of the first-in-human trial shows mRNA-1647 to have an acceptable safety profile in adults and to elicit humoral and cellular immune responses.
Source: academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiae114/7628193