IDWeek

IDWeek

Source:

Falsey AR, et al. Abstract LB14. Presented at: IDWeek; Sept. 29-Oct. 3, 2021 (virtual meeting).

Disclosures: Falsey reports receiving grants from BioFire Diagnostics, Janssen, Merck and Pfizer and personal fees for serving on the data safety monitoring board for Novavax. Please see the study for all other author’s relevant financial disclosures.
October 02, 2021
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CYPRESS trial: RSV vaccine effective in older adults

Source:

Falsey AR, et al. Abstract LB14. Presented at: IDWeek; Sept. 29-Oct. 3, 2021 (virtual meeting).

Disclosures: Falsey reports receiving grants from BioFire Diagnostics, Janssen, Merck and Pfizer and personal fees for serving on the data safety monitoring board for Novavax. Please see the study for all other author’s relevant financial disclosures.
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An investigational respiratory syncytial virus vaccine was safe and effective against RSV-mediated lower respiratory tract disease among older adults, according to results from a phase 2 randomized controlled study called CYPRESS.

Ann R. Falsey

“The vaccine looked highly effective — 80% efficacy to prevent lower respiratory tract disease in older people,” Ann R. Falsey, MD, a professor of medicine at the University of Rochester School of Medicine, told Healio.

Despite the burden of RSV in the United States — researchers estimate that it causes 177,000 hospitalizations among adults aged 65 years or older each year — there is currently no licensed vaccine to protect against the disease.

Falsey and colleagues randomly assigned 5,800 adults aged 65 years or older in a 1:1 ratio to receive an adenovirus-based vaccine (Ad26.RSV.preF) or placebo. The primary endpoint was the first occurrence of PCR-confirmed lower respiratory tract disease (LRTD). The researchers broke LRTD into three case definitions and investigated the vaccine’s efficacy against each one:

  • three or more symptoms of lower respiratory tract infection (LRTI), which Falsey called “the most stringent definition;”
  • two or more symptoms of LRTI; and
  • two or more symptoms of LRTI or at least one symptom of LRTI combined with at least one systemic symptom.

The results of the CYPRESS trial, presented at IDWeek, showed that the vaccine’s efficacy was 80% (94.2% CI, 52.2%-92.9%) for the first case definition, 75% (94.2% CI, 50.1%-88.5%) for the second case definition and 69.8% (94.2% CI, 43.7%-84.7%) for the third.

According to the researchers, the vaccine was safe and well tolerated, with no safety signal observed — similar to what was reported in a previous study.

In her presentation, Falsey said the vaccine induced “an excellent humoral response” and “a robust and durable T-cell response.”

Falsey said her research team would like to study the vaccine in other populations, including adults with underlying cardiopulmonary disease and middle-aged adults with underlying conditions. However, she mentioned that COVID-19 has made things more complicated for researchers who are trying to develop a vaccine for a typically seasonal virus like RSV.

“What used to be straightforward for a wintertime virus is now quite complicated given the change in epidemiology we’re observing because of COVID,” she said in the interview. “The impact of COVID on the trial is, in my mind, difficult to predict. I think we know that eventually, all of the nasty respiratory pathogens that we’ve delt with for years will be back.”

Janssen announced in September 2019 that the FDA granted breakthrough therapy designation for Ad26.RSV.preF. The trial has entered phase 3 and is now called EVERGREEN.

“As someone who spent the last 20 years evaluating RSV in older adults and really defining that it’s a problem worth developing vaccine programs for, this is a pretty exciting moment,” Falsey said. “We’re very pleased with these positive results.”

References:

Falsey AR, et al. N Engl J Med. 2005;doi:10.1056/NEJMoa043951.

Falsey AR, et al. Abstract LB14. Presented at: IDWeek; Sept. 29-Oct. 3, 2021 (virtual meeting).

Janssen announces U.S. FDA breakthrough therapy designation for investigational prophylactic vaccine for the prevention of respiratory syncytial virus in older adults. https://www.jnj.com/janssen-announces-u-s-fda-breakthrough-therapy-designation-for-investigational-prophylactic-vaccine-for-the-prevention-of-respiratory-syncytial-virus-in-older-adults. Accessed Sept. 29, 2021.