October 12, 2016
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RSV vaccine shows promise in phase 1 trial

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A respiratory syncytial virus vaccine induced a rapid immune response and was associated with acceptable adverse events among healthy young men in a phase 1 trial, according to researchers in Canada.

“In this first-in-humans study the safety, reactogenicity and immunogenicity of a RSV vaccine for pregnant women, containing purified recombinant RSV glycoprotein F engineered to preferentially maintain pre-fusion conformation (RSV-PreF), was evaluated,” Joanne M. Langley, MD, FRCPC, of the Canadian Center for Vaccinology at IWK Health Centre and Nova Scotia Health District Authority, and colleagues wrote.

The researchers randomly assigned 128 healthy men aged 18 to 44 years to 10 μg, 30 μg or 60 μg of RSV-PreF antigen (GlaxoSmithKline Vaccines) with or without an aluminum hydroxide adjuvant, or placebo at three sites in Canada. The median age of participants was 32 years, and 60.9% were white.

Patients assigned to 30 μg RSV-PreF with aluminum hydroxide adjuvant, 60 μg RSV-PreF with adjuvant and 60 μg RSV-PreF without adjuvant experienced the greatest RSV neutralizing antibody responses, according to the researchers.

Thirty days after vaccination, participants who responded to the vaccine had RSV-A neutralizing antibody titer ratios of at least 1:512, and 70% had titers of no less than 1:1,024, with titers increasing 3.2- to 4.9-fold.

Injection site pain (81.3%) and fatigue (43.8%) were the most common adverse events. Severe fatigue occurred among three participants in the vaccine group compared with 33 controls (11.8%-25%). Eight participants in the vaccine group and one control patient reported fever.

In combination with other recent data, this study showed important recent developments in RSV vaccines, Janet A. Englund, MD, a professor of pediatric infectious diseases at the University of Washington and Seattle Children’s Research Institute, and Helen Y. Chu, MD, MPH, assistant professor of allergy and infectious diseases at the University of Washington, wrote in an accompanying editorial.

“This is an exciting time for the RSV field,” they wrote. “Long the neglected back-room orphan virus mentioned only as the cause of annual outbreaks of bronchiolitis in infants, we have new hope that successful collaborations among academicians, clinicians, governmental and international agencies, foundations, regulatory bodies, and the pharmaceutical industry will defeat this important pathogen which impacts both the young and old at all levels of society.” – by Andy Polhamus

 

Disclosures: This trial was supported by GlaxoSmithKline Biologicals SA. Langley reports receiving research funding from the Canadian Institutes of Health Research, GlaxoSmithKline, Immunovaccine, Novavax, Pan Provincial Vaccine Enterprise (Prevent), Pfizer, the Public Health Agency of Canada and Sanofi Pasteur. Englund reports consulting for Pfizer, being a member of the GlaxoSmithKline DSMB for influenza antivirals and receiving research support for clinical trials from Alios BioPharma, Gilead Sciences, GlaxoSmithKline, Novavax and Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.