A new respiratory syncytial virus (RSV) vaccine candidate has achieved positive safety and immunogenicity results in a Phase I clinical study of RSV-naïve participants between the ages of six and 36 months.
MV-012-968 is being developed by Meissa Vaccines as a needle-free, adjuvant-free vaccine to protect infants and toddlers from RSV.
The study enrolled 79 participants at multiple sites in the US, with doses ranging from one dose of 103 PFU to two doses of 107 PFU, 28 days apart. At the highest dose tested, no serious adverse events related to vaccination were reported with no evidence of any lower respiratory tract symptoms, no Grade 2 or 3 fever observed, and low level, transient vaccine shedding detected.
All RSV-naïve infants and toddlers demonstrated a vaccine response to two doses of 107 PFU. Serum neutralising antibody responses to MV-012-968 were robust and comparable to the response seen with previous live attenuated RSV vaccine candidates that demonstrated high efficacy against medically-attended RSV disease.
Greater protection against RSV
Peter Wright, Professor of Pediatrics at Dartmouth Geisel School of Medicine, and a scientific advisor to Meissa, said: “While passive immunisation strategies such as monoclonal antibodies and maternal immunisation can protect infants against RSV, the duration of protection is limited. Active immunisation with a paediatric live attenuated RSV vaccine offers the possibility of greater protection and even limiting transmission. These goals have been hampered over the years by the challenge of balancing attenuation and potency. We suspect that locally stimulated immunity in the respiratory tract by a topically presented vaccine will be a component of a truly successful immunisation strategy.
“Now with next-generation vaccine technologies like Meissa’s, I am excited for the potential of a paediatric live attenuated RSV vaccine to advance and protect infants and toddlers. Meissa’s Phase I data are compelling and are consistent with strong preclinical data demonstrating potency despite heavy attenuation.”
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World