Details

Autor(en) / Beteiligte

• Baker, Jeffrey
• Aliabadi, Negar
• Munjal, Iona
• Jiang, Qin
• Feng, Ye
• Brock, Linda G.
• Cooper, David
• Anderson, Annaliesa S.
• Swanson, Kena A.
• Gruber, William C.
• Gurtman, Alejandra

Titel

Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18–49 years of age: Results of a randomized phase 3 study

Ist Teil von

• Vaccine, 2024-05, Vol.42 (13), p.3172-3179

Ort / Verlag

Netherlands: Elsevier Ltd

Erscheinungsjahr

2024

Quelle

MEDLINE

Beschreibungen/Notizen

• •RSVpreF immunogenicity, safety, and tolerability were evaluated in healthy adults.•Equivalence in immunogenicity was assessed across 3 RSVpreF lots.•All 3 RSVpreF lots elicited strong immune responses 1 month after vaccination.•Lot-pair comparisons met the 1.5-fold equivalence criterion for both RSV A and RSV B.•RSVpreF single doses were safe and well tolerated, with safety similar across lots. Bivalent RSV prefusion F subunit vaccine (RSVpreF), comprised of equal quantities of stabilized prefusion F antigens from the major circulating subgroups (RSV A, RSV B), is licensed for prevention of RSV-associated lower respiratory tract illness (LRTI) in older adults and for maternal vaccination for prevention of RSV-associated LRTI in infants. To support licensure and large-scale manufacturing, this lot consistency study was conducted to demonstrate equivalence in immunogenicity across 3 RSVpreF lots. This phase 3, multicenter, parallel-group, placebo-controlled, randomized (1:1:1:1), double-blind study evaluated immunogenicity, safety, and tolerability of RSVpreF in healthy 18–49-year-old adults. Participants received a single 120-µg injection of 1 of 3RSVpreF lots or placebo. Geometric mean ratio (GMR) of RSV serum 50 % neutralizing geometric mean titers obtained 1 month after vaccination were compared between each vaccine lot for RSV A and RSV B, separately. Equivalence between lots was defined using a 1.5-fold criterion (GMR 95 % CIs for every lot pair within the 0.667–1.5 interval). Safety and tolerability were assessed. Of 992participants vaccinated, 948 were included in the evaluable immunogenicity population. All 3 RSVpreF lots elicited strong immune responses, meeting the 1.5-fold equivalence criterion for all between-lot comparisons for both RSV A and RSV B. Across the 3 lots, RSV A and RSV B 50 % neutralizing geometric mean titers substantially increased from baseline (RSV A, 1671–1795; RSV B 1358–1429) to 1 month after RSVpreF vaccination (RSV A, 24,131–25,238; RSV B, 19,238–21,702), corresponding to ≥14-fold increases in 50 % neutralizing titers for both RSV A and RSV B from before to 1 month after vaccination. Single doses of RSVpreF were safe and well tolerated, with similar safety profiles across the 3 RSVpreF lots. These findings support the reproducibility of RSVpreF vaccine manufacturing with similar safety and reactogenicity profiles (NCT05096208).