At the 35th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global conference in Vienna, Austria, novel vaccines in clinical development were discussed.
One vaccine to note is Pfizer and Valneva’s Lyme borreliosis vaccine candidate, VLA15. Annually, Lyme disease is responsible for over 475,000 infections in the US and nearly 130,000 infections in Europe. Approximately 10–30% of patients develop severe symptoms such as Lyme carditis, Lyme neuroborreliosis, and Lyme arthritis, and 5–10% of patients exhibit persistent symptoms. At this time, there are no vaccines available to prevent Lyme disease in humans. VLA15 is a hexavalent, recombinant protein vaccine, which targets six Borrelia serotypes. VLA15 is currently in two Phase III studies, one of which is evaluating pediatric safety, and the other is a pivotal study for all individuals five years of age and older. The pivotal Phase III efficacy study is targeting the last subject’s last visit for Q4 2025. In VLA15’s Phase II studies, the vaccine was found to be generally safe and well-tolerated with the most common local reactions being pain and tenderness, and the most common systemic reactions being headache, muscle pain, and fatigue. Furthermore, seroconversion rates following the second booster dose were above 90% for all serotypes in all age groups, which was consistent with findings following the first booster dose.
Another vaccine of interest is Moderna’s mpox vaccine candidate, mRNA-1769. According to the US Centers for Disease Control and Prevention (CDC), the ongoing clade II 2022 mpox outbreak has been responsible for over 100,000 infections in 122 countries to date worldwide. A clade I outbreak has been ongoing in Central and Eastern Africa since 2024 and has been responsible for over 21,000 infections to date. Interim safety data from the ongoing Phase I/II trial reported that all dose levels exhibited an acceptable safety and tolerability profile, with the most common local reaction being pain at the injection site, and the most common systemic reactions being headache, fatigue, and myalgia. Interim immunogenicity results reported that mRNA-1769 induced increased levels of neutralising and binding antibodies against both the mpox virus and vaccinia virus, and strong CD4+ T-cell and moderate CD8+ T-cell responses were observed.
The development of an oral, live-attenuated cholera vaccine, PanChol, from Harvard Medical School was also discussed. Cholera is a severe diarrheal disease caused by the bacteria Vibrio cholerae, and spread through contaminated food and water. According to the World Health Organization (WHO), over 800,000 cholera cases and nearly 6,000 cholera deaths were reported from 33 countries in 2024. PanChol’s Phase I safety and immunogenicity study reported that the vaccine was safe and well-tolerated, as all of the dose levels reported no reactogenicity. Furthermore, 100% of trial participants seroconverted to two serotypes, Ogawa and Inaba, and all dose levels exhibited an approximate four-fold increase in titers. The next steps for PanChol include an upcoming booster study and a Phase Ib study in the cholera endemic region of Lusaka, Zambia.
Another vaccine to note is MinervaX’s Group B streptococcus (GBS) vaccine, MVX0006. Often, GBS does not cause any symptoms; however, in older adults, GBS can result in bacteremia, skin and soft tissue infections, osteomyelitis, pneumonia, and abscesses. MVX0006 is a protein-based vaccine that consists of two fusion proteins, GBS-NN and GBS-NN2, and an aluminium hydroxide adjuvant. In a Phase I study of MVX0006 in healthy older adults and obese/diabetic older adults, solicited adverse events were reported in up to 96% of study participants who received the vaccine, and unsolicited adverse events were reported in up to 75% of study participants who received the vaccine. The most commonly reported unsolicited adverse events were injection-site haemorrhage and nasopharyngitis. Overall, the vaccine was found to be generally well-tolerated when administered as three doses. Additionally, immune responses were observed against all five targeted GBS surface proteins after all three vaccine doses among both the healthy older adults and obese /diabetic older adults.
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