Safety, tolerability and immunogenicity of PRV-101, a multivalent vaccine targeting coxsackie B viruses (CVBs) associated with type 1 diabetes: a double-blind randomised placebo-controlled Phase I trial
Authors' conclusion
The results indicate that the tested multivalent CVB vaccine is well tolerated and immunogenic, supporting its further clinical development.
Study context
- Population
- Healthy adults aged 18–44 years (17 men, 15 women), single study site in Finland
- Participants
- 32 adults
- Comparison
- PRV-101 vs placebo
- Low dosen = 12
- High dosen = 12
- Placebon = 8reference
- Primary endpoint
- Safety and tolerability
Methodological detailsdouble-blind, placebo-controlled, Phase I, single study site, Participants followed for another 24 weeks after the last injection
- Double-blind
- Placebo-controlled
- Phase I
- Single study site
- Participants followed for another 24 weeks after the last injection
Primary result
As reported in the abstract
Serious AEs
0
AEs leading to study treatment discontinuation
0
Treatment-emergent AEs related to study drug, placebo
37.5%
Treatment-emergent AEs related to study drug, PRV-101
62.5%
Further findings
Neutralising antibody responses · entire follow-up period
- Participants with protective titres ≥8 against all five serotypes
- >90%
- PRV-101 induced dose-dependent neutralising antibody responses against all five CVB serotypes in both high- and low-dose groups
Safety
Adverse events
- Serious AEs or AEs leading to discontinuation
- 0
- Treatment-related treatment-emergent AEs, placebo
- 37.5%
- Treatment-related treatment-emergent AEs, PRV-101
- 62.5%
Original publication
Safety, tolerability and immunogenicity of PRV-101, a multivalent vaccine targeting coxsackie B viruses (CVBs) associated with type 1 diabetes: a double-blind randomised placebo-controlled Phase I trial. Diabetologia. Published 19 February 2024. doi:10.
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