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A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine

Edward E Walsh1, Ann R Falsey1, Daniel A Scott2

  • 1Department of Medicine, Infectious Diseases Division, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York, USA.

The Journal of Infectious Diseases
|December 21, 2021
PubMed

Insights

A new bivalent prefusion F vaccine (RSVpreF) shows promise for preventing respiratory syncytial virus (RSV) in infants through maternal immunization. The RSV vaccine was safe and generated strong neutralizing antibody responses in adults.

Area of Science:

  • Immunology
  • Vaccinology
  • Virology

Background:

  • Human respiratory syncytial virus (RSV) poses a significant health challenge, with maternal immunization identified as a potential prevention strategy.
  • Current prophylactic options for RSV are limited, highlighting the need for novel vaccine candidates.

Purpose of the Study:

  • To evaluate the safety and immunogenicity of a bivalent prefusion F vaccine (RSVpreF) in adults.
  • To assess different dosages and formulations of the RSVpreF vaccine, including the addition of aluminum hydroxide (Al(OH)3).

Main Methods:

  • A phase 1/2 randomized, placebo-controlled study involving 618 adults aged 18-49.
  • Participants received placebo or varying doses of RSVpreF (60, 120, or 240 µg) with or without Al(OH)3.
  • Safety assessments included local and systemic reactions, with serious adverse events monitored for 12 months postvaccination. Immunogenicity was measured by virus-neutralizing titers.

Main Results:

  • RSVpreF was generally safe and well-tolerated, with most adverse events being mild to moderate. No vaccine-related serious adverse events were reported up to 12 months.
  • All RSVpreF formulations induced significantly higher virus-neutralizing titers against RSV subgroups A and B compared to placebo at 1 month postvaccination.
  • Geometric mean fold rises (GMFRs) at 1 month were 10.6-16.9 for RSV A and 10.3-19.8 for RSV B, exceeding historical responses to postfusion F vaccines. Titers remained elevated at 12 months.

Conclusions:

  • The bivalent prefusion F vaccine (RSVpreF) is safe, well-tolerated, and elicits robust neutralizing antibody responses in adults.
  • These findings support the continued development of RSVpreF for maternal immunization to protect infants against RSV.
  • The vaccine is currently under evaluation in a pivotal phase 3 study for its efficacy in maternal immunization programs.
Abstract

Keywords:
F proteinimmunogenicitymaternal vaccinationneutralizing responsesrespiratory syncytial virussafetyvaccine

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