NIAID Launches Phase 1 Clinical Trial for Universal Influenza Vaccine

In May 2023, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), initiated a Phase 1 clinical trial for an experimental universal influenza vaccine named H1ssF-3928 mRNA-LNP. This trial, conducted at Duke University in Durham, North Carolina, aims to evaluate the vaccine's safety and its ability to induce an immune response.

The investigational vaccine utilizes messenger RNA (mRNA) technology to target the hemagglutinin (HA) protein's stem region, a component less prone to mutation across different influenza strains. By focusing on the HA stem, the vaccine aims to induce a broad and durable immune response.

The Phase 1 trial plans to enroll up to 50 healthy volunteers aged 18 to 49. Participants will receive varying dosages of the vaccine to determine the optimal dose for eliciting a robust immune response. The trial's primary objectives are to assess the vaccine's safety and immunogenicity.

This effort is part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, established by NIAID in 2019. CIVICs is a network of research centers working collaboratively to develop more durable, broadly protective, and longer-lasting influenza vaccines. The program includes Vaccine Centers, a Vaccine Manufacturing and Toxicology Core, Clinical Cores, and a Statistical, Data Management, and Coordination Center.

Duke University's Human Vaccine Institute (DHVI) is a key participant in the CIVICs program. DHVI's involvement spans vaccine design, manufacturing, and clinical testing. The institute's state-of-the-art facilities enable the production of high-quality vaccines for clinical trials.

Acting NIAID Director Hugh Auchincloss, M.D., emphasized the significance of this development:

"A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year."

Emmanuel “Chip” Walter, M.D., chief medical officer and director of the Duke Vaccine and Trials Unit at DHVI, highlighted the potential impact:

"During the course of a flu season, the influenza virus drifts, undergoing small, but significant changes that make current vaccines less effective. We are hopeful that this vaccine could offer protection across those sorts of changes."

The development of a universal influenza vaccine holds profound implications:

• Public Health Impact: A successful universal vaccine could significantly reduce the incidence of influenza-related illnesses and deaths, alleviating the burden on healthcare systems.

• Economic Benefits: By providing long-lasting protection, a universal vaccine could decrease healthcare costs associated with annual vaccinations and influenza-related hospitalizations.

• Pandemic Preparedness: Broad protection against various influenza strains would enhance global readiness for potential influenza pandemics.

This trial builds upon previous efforts to develop universal influenza vaccines. Notably, a similar vaccine developed by NIAID's Vaccine Research Center showed positive results in early clinical trials, demonstrating the potential of targeting the HA stem region.

The initiation of this Phase 1 clinical trial marks a significant step toward achieving a universal influenza vaccine. The collaborative efforts of NIAID, Duke University, and the broader CIVICs program underscore the commitment to advancing public health through innovative vaccine research.