VSV-EBOPLUS has successfully acquired important information on the safety and immunogenicity signatures of the rVSV-ZEBOV-GP vaccine.
Two clinical studies with rVSV-ZEBOV-GP in Healthy Adults conducted in Switzerland (NCT02287480) and Gabon (PACTR201411000919191) were successfully extended to include 60 months visit to evaluate the persistence of the vaccine-induced immune response and its comparison between subjects in Europe and Africa.
The distribution of samples, collected from healthy adult subjects enrolled in the MSD-sponsored trial to evaluate the safety and immunogenicity of the rVSVΔG-ZEBOV Ebola Vaccine (NCT02314923), was successfully organized.
The clinical trial to evaluate the safety and immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus vaccine candidate in healthy children aged 1 to 12 years and in their relatives living in Lambaréné, Gabon (PACTR202005733552021) was conducted, enrolling 120 children and 163 relatives.
The one year antibody persistence to single-dose rVSV-ZEBOV-GP vaccination was demonstrated across dose ranges and settings, a key criterion in countries where booster vaccination would be impractical (Huttner A. et al. Lancet Infect Dis. 2018), and the long-term persistence of antibody responses after a single dose of rVSV-ZEBOV was characterized.
The natural Killer (NK) cell modulation and cytokine responses following human rVSV-ZEBOV-GP Ebolavirus vaccination was analysed, demonstrating that NK cells may contribute to the early protective efficacy in humans (Pejosky D. et al. NPJ Vaccines 2020).
Sera samples collected in paediatric study in Gabon and in the follow-up clinical trial in Geneva (from years 1 to 5) were analysed by Pseudovirion assay and the Serum-Neutralization Test (SNT).
It was Identified and cross-validated the transcriptomic signatures of immune response in 4 cohorts from different geographic and genetic backgrounds as well as identified signatures associated with immunogenicity and arthritis (Vianello E. et al The Lancet Microbe 2021).
Transcriptomic analysis allowed to identify an rVSVΔG-ZEBOV-GP-induced signature and it was demonstrated a direct correlation of blood transcriptomic changes with ZEBOV glycoprotein-specific antibody titres (Santoro F. et al. Vaccines (Basel). 2021), providing an important contribution to the identification of immune signatures.
The metabolomic profiles of the human immune response to rVSV-ZEBOV-GP vaccination at multiple time points were investigated, analyzing the changes in the amino acid metabolome induced by vaccination.
It was profiled the intracellular and circulating miRNome modulations at early timepoints after the administration of the rVSVΔG-ZEBOV-GP vaccine and miRNA signatures associated with the antibody response were identified.
A powerful computational tool “BioFeatS” specifically designed for integrative analyses, and an Internal Database and External Dashboard were developed, demonstrating their valuable use for people working on vaccine development, immunology, and public health, facilitating secure data exchange and easy visualization of complex biological information.
Sexual Dimorphism in Vaccine-Induced Immunity was investigated, integrating demographic information with omics data and immune responses.
