The SAVVY study is a Phase 2b trial evaluating the safety, tolerability, and immunogenicity of a Respiratory Syncytial Virus (RSV) vaccine in pregnant women and their infants.
The active ingredients in the RSV vaccine are 2 stabilized prefusion RSV F antigens, in equal amounts, from virus subgroups A and B.
Key study eligibility criteria include:
- 18 to 49 years of age
- Healthy and expecting a healthy baby
- Between 24 and 36 weeks of gestation on the day of planned vaccination
- Receiving prenatal standard of care
- Ultrasound at ≥ 18 weeks of pregnancy NOTE: If not performed at ≥ 18 weeks of pregnancy as part of prenatal standard of care, an ultrasound will be performed and reviewed as part of the screening visit
- BMI < 40 kg/m2 at screening
- Current pregnancy not from in vitro fertilization or other assisted reproductive technology
Up to 650 women will be randomized 1: 1: 1: 1: 1 to receive one of 2 dose levels of RSV Vaccine, formulated with or without aluminum hydroxide (Al[OH]3), or placebo (saline solution).
Eligible women will participate from enrollment during their pregnancy until approximately 12 months after delivery. Scheduled maternal study visits (8) include screening, vaccination, post-vaccination, and post-delivery visits. Maternal participants will answer questions and record their temperature and any vaccination-site swelling or redness in an electronic diary (e-diary) for 7 consecutive days at home beginning the day of vaccination.
Infants will participate from birth until approximately 12 months of age, with 5 study visits scheduled. Additional visits may be scheduled as needed.
For more information on maternal vaccines, please click on the link below.