• Type: Subunit vaccine
• Status: Clinical trial
• Host Species for Licensed Use: Human
• Antigen: F protein
• F protein gene engineering:
  • Type: Recombinant protein preparation
  • Description: A trimeric F glycoproteins from both major RSV subgroups (A and B) engineered for stability in the prefusion conformation is in clinical development in adults (Falsey et al., 2022).
  • Detailed Gene Information: Click Here.
• Adjuvant:
  • VO ID: VO_0000127
  • Description: (Falsey et al., 2022)
• Immunization Route: Intramuscular injection (i.m.)
• Description: A bivalent prefusion F vaccine (RSVpreF) containing trimeric F glycoproteins from both major RSV subgroups (A and B) engineered for stability in the prefusion conformation is in clinical development in adult (Falsey et al., 2022).

Human Response

• Vaccination Protocol: Patient was given a single 60-µg, 120-µg or 240-µg dose on day 0.
• Immune Response: Among older adults 65–85 years in the expanded cohort, RSV A 50% neutralizing GMTs in RSVpreF recipients increased from 1793–2734 before vaccination to 14 905–27 600 at 1 month postvaccination (Figure 3). RSV B neutralizing titers increased from 1635–2685 before vaccination to 15 169–30 071 at 1 month postvaccination. Postimmunization neutralizing titers were similarly high across RSVpreF dose levels and formulations; corresponding GMFRs were 7.2–13.2 for RSV A and 6.9–14.9 for RSV B across RSVpreF groups, and 1.1 for RSV A and 0.9 for RSV B for placebo recipients (findings were similar for older adults in the sentinel cohort.
• Side Effects: 124/490 of participants in the RSVpreF cohorts had local reactions within 14 days post–vaccination. The majority (82.2% [102/124]) of participants who reported local reactions rated them mild in severity; pain at the injection site was the most common (22.2% [109/490]) (Falsey et al., 2022).