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An In vitro Model to Study Immune Responses of Human Peripheral Blood Mononuclear Cells to Human Respiratory Syncytial Virus Infection
Published on: December 10, 2013
Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination
Edward E Walsh1, Ann R Falsey1, Agnieszka M Zareba2
1Infectious Diseases Division, Department of Medicine, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York.
Insights
Revaccination with the bivalent RSV prefusion F (RSVpreF) vaccine was safe and generated an immune response in adults. Antibody levels after revaccination were similar to those after initial vaccination, indicating sustained protection.
Area of Science:
- Immunology
- Vaccinology
- Virology
Background:
- Respiratory syncytial virus (RSV) is a significant cause of respiratory illness.
- A bivalent RSV prefusion F (RSVpreF) vaccine is approved for individuals aged 60 and older.
- Previous studies indicated the RSVpreF vaccine is well-tolerated and elicits an immune response.
Purpose of the Study:
- To assess antibody persistence after initial RSVpreF vaccination.
- To evaluate the safety and immunogenicity of RSVpreF revaccination in adults.
- To compare immune responses between different age groups.
Main Methods:
- Healthy adults (18-49 and 65-85 years) received initial vaccination and revaccination 12 months later with placebo or RSVpreF.
- Geometric mean neutralizing titers (GMTs) against RSV-A and RSV-B were measured.
- Tolerability and safety were monitored throughout the study.
Main Results:
- Revaccination was well-tolerated with no safety concerns identified.
- Antibody responses after revaccination were lower than after initial vaccination but demonstrated an increase from pre-revaccination levels.
- Antibody levels 12 months after initial vaccination and revaccination were comparable.
Conclusions:
- The bivalent RSVpreF vaccine is safe and immunogenic upon revaccination in adults.
- Revaccination provides sustained antibody levels, suggesting potential for long-term protection.
- Further research may explore optimal revaccination schedules.
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).
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