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SP0125
- Development stage
- Phase 2
- Lead developer
- Sanofi
- Modality
- Live Attenuated Vaccines → Live Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
- Administration
- Intranasal
01
Overview
**SP0125** is an intranasal live attenuated respiratory syncytial virus (RSV) vaccine candidate developed by Sanofi for preventing RSV infections in infants and toddlers. It is a temperature-sensitive attenuated strain designed to induce neutralizing antibodies (nAbs) and anti-RSV F IgGs, demonstrating high genetic stability and immunogenicity in Phase I/II trials where two doses elicited responses in 93% of participants, with 90% sustaining antibodies through the next RSV season in seronegative infants aged 6–24 months.[2][3] The program advanced to Phase III but was terminated after interim analysis showed insufficient efficacy despite an acceptable safety profile and no vaccine-associated enhanced respiratory disease.[4]
- Other names
- SP 0125SP0125SP-0125RSVt
02
Targets
RSV F (Respiratory syncytial virus fusion protein)
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