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Clinical Trial
. 2024 Oct 16;230(4):e905-e916.
doi: 10.1093/infdis/jiae185.

Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination

Edward E Walsh  1 , Ann R Falsey  1 , Agnieszka M Zareba  2 , Qin Jiang  2 , Alejandra Gurtman  3 , David Radley  3 , Emily Gomme  3 , David Cooper  3 , Kathrin U Jansen  3 , William C Gruber  3 , Kena A Swanson  3 , Beate Schmoele-Thoma  4
Affiliations
Clinical Trial

Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination

Edward E Walsh et al. J Infect Dis. .

Abstract

Background: Respiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well tolerated and immunogenic in a phase 1/2 study. We evaluated antibody persistence after initial vaccination and safety and immunogenicity after revaccination from this study.

Methods: Healthy adults were randomized to receive initial vaccination and revaccination 12 months later with either placebo or RSVpreF (240 µg with or without aluminum hydroxide). RSV-A and RSV-B geometric mean neutralizing titers (GMTs) were measured through 12 months after both vaccinations. Tolerability and safety were assessed.

Results: There were 263 participants revaccinated (18-49 years old, n = 134; 65-85 years old, n = 129). Among 18- to 49-year-olds and 65- to 85-year-olds, geometric mean fold rises (GMFRs) for both RSV subgroups (RSV-A, RSV-B) 1 month after initial RSVpreF vaccination were 13.3 to 20.4 and 8.9 to 15.5, respectively, as compared with levels before initial vaccination; corresponding GMFRs 12 months after initial vaccination were 4.1 to 5.0 and 2.6 to 4.1. GMFRs 1 month after revaccination vs levels before revaccination were 1.4 to 2.3 and 1.4 to 2.2 for 18- to 49-year-olds and 65- to 85-year-olds. Peak GMTs after revaccination were lower than those after initial vaccination. GMTs 12 months after initial vaccination and revaccination were similar, with GMFRs ranging from 0.7 to 1.6. No safety signals occurred.

Conclusions: RSVpreF revaccination was immunogenic and well tolerated among adults. Clinical Trials Registration. NCT03529773 (ClinicalTrials.gov).

Keywords: RSVpreF; immunogenicity; neutralizing responses; respiratory syncytial virus; safety; vaccine.

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Conflict of interest statement

Potential conflicts of interest. E. E. W. reports receiving grants from Pfizer, Merck Sharp and Dohme, and Janssen and serving in unpaid consultancy roles for Janssen, Merck, Moderna, and Pfizer. A. R. F. reports receiving grant funding from Pfizer Inc, Merck, Janssen, BioFire Diagnostics, Vax Co, and CyanVac and consulting fees from Gilead, GlaxoSmithKline, Icosavax, and Novavax. A. M. Z., Q. J., A. G., D. R., E. G., D. C., K. U. J., W. C. G., K. A. S., and B. S.-T. are current or former employees of Pfizer Inc and may hold stock or stock options. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Study design. Left deltoid, right deltoid, and deltoid of nondominant arm refer to the deltoid muscle. Al(OH)3, aluminum hydroxide; RSVpreF, respiratory syncytial virus prefusion F vaccine; SIIV, seasonal inactivated influenza vaccine.
Figure 2.
Figure 2.
Disposition of participants: A, 18 to 49 years old; B, 65 to 85 years old. Al(OH)3, aluminum hydroxide; RSVpreF, respiratory syncytial virus prefusion F vaccine; SIIV, seasonal inactivated influenza vaccine.
Figure 3.
Figure 3.
RSV-A and RSV-B neutralizing titers. A, RSV-A titers in participants 18−49 years of age; B, RSV-B titers in participants 18−49 years of age; C, RSV-A titers in participants 65−85 years of age; and D, RSV-B titers in participants 65−85 years of age. Samples from different time points were tested separately. Geometric mean titers and 95% CIs are also provided in Supplementary Table 1. Associated geometric mean fold rises are provided in Supplementary Tables 2 and 3. Different reagents were used between month 1 and the subsequent time points. Revaccination was administered 12 months after initial vaccination (the x-axis is not to scale). Al(OH)3, aluminum hydroxide; M, month; revax, revaccination; RSV-A, respiratory syncytial virus subgroup A; RSVpreF, respiratory syncytial virus prefusion F vaccine; SIIV, seasonal inactivated influenza vaccine; vax1, initial vaccination.
Figure 4.
Figure 4.
Local reactions within 14 days after initial vaccination and revaccination in participants (A) 18 to 49 and (B) 65 to 85 years of age. Al(OH)3, aluminum hydroxide; D1, initial vaccination; D3, revaccination; RSVpreF, respiratory syncytial virus prefusion F vaccine; SIIV, seasonal inactivated influenza vaccine.
Figure 5.
Figure 5.
Systemic events within 14 days after initial vaccination and revaccination in participants (A) 18 to 49 and (B) 65 to 85 years of age. Al(OH)3, aluminum hydroxide; D1, initial vaccination; D3, revaccination; RSVpreF, respiratory syncytial virus prefusion F vaccine; SIIV, seasonal inactivated influenza vaccine.
Figure 6.
Figure 6.
Summary of adverse events occurring (A) 1 month and (B) 12 months after vaccination in participants 18 to 49 and 65 to 85 years of age. Al(OH)3, aluminum hydroxide; RSVpreF, respiratory syncytial virus prefusion F vaccine; SIIV, seasonal inactivated influenza vaccine.
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References

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