Universal Influenza Vaccine Candidate to Begin Clinical Trial in United States

The National Institute of Allergy and Infectious Diseases (NIAID) — part of the National Institutes of Health (NIH) – has announced that it is sponsoring a Phase 2 clinical trial in the United States of an investigational universal influenza vaccine, developed to protect against multiple strains of the flu.

Following the 2017-2018 flu season in the United States, in which the country saw influenza-like illness reach their highest levels since the swine flu pandemic of 2009, public health officials have emphasized the need for a more effective influenza vaccine. In February 2018, the Centers for Disease Control and Prevention (CDC) reported interim estimates showing that the flu shot was about 36% effective overall at preventing flu illness from both influenza A and B viruses. In recent years, researchers have linked low flu vaccine effectiveness to egg-based vaccine production, finding that vaccine components for influenza A (H3N2) are prone to mutation when grown in eggs. H3N2 influenza dominated during much of the 2017-2018 season, causing a severe flu season which resulted in a reported 163 flu-related pediatric deaths.

Earlier this year, the US Food and Drug Administration (FDA) reported that cell-based flu vaccines were about 20% more effective than egg-based vaccines at preventing flu illness. In February 2018, NIAID announced its plan to develop a universal flu vaccine capable of offering broad protection against many strains of flu for multiple flu seasons, to replace the seasonal flu shot. Senator Ed Markey (D-Mass.) introduced a bill that month to fund the effort with $1 billion contributed over 5 years. On May 4, 2018, NIAID announced that it has begun a Phase 2 clinical trial of an experimental universal flu vaccine, known as M-001.

Israeli-based BiondVax Pharmaceuticals has developed and produced the M-001 flu vaccine candidate, which contains antigenic peptide sequences shared among many different influenza viruses. The experimental vaccine has been designed to offer protection from both current and emerging strains of the influenza virus, even the natural virus mutations that render the seasonal flu vaccine as ineffective. In 6 previous clinical trials involving 698 participants, BiondVax found that M-001 was safe, well-tolerated, and produced an immune response to a broad range of influenza strains.

NIAID’s new study is set to take place at 4 sites—all part of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs)—and will include 120 healthy volunteers ages 18 to 49 years. The volunteers will be vaccinated twice, the first time with either one dose of M-001 or a placebo, then receiving a second dose 22 days later. About 172 days later, all volunteers will receive a seasonal flu vaccine. Researchers will draw blood from the study participants to evaluate their immune response to both the experimental and seasonal vaccines.

In an interview with Contagion®, medical director of the National Foundation for Infectious Diseases William Schaffner, MD, Vanderbilt University professor of preventive medicine, said the previous trials and the new NIAID-sponsored study on M-001 are promising.

“This is a group of investigators who are well known to do rigorous vaccine-related research, and so we all hope this vaccine and many of the others are successful because we clearly need an improved influenza vaccine,” said Dr. Schaffner, noting that a phase 3 study would focus on M-001’s effectiveness in preventing influenza. He emphasizes that the new study focuses on young, healthy adults, so researchers will still need to evaluate the experimental vaccine’s safety and efficacy in infants, children, and elderly adults, who bear the brunt of influenza complications and mortality. “We’re all impatient but we have to curtail our impatience and be pleased that these studies are moving ahead.”