Influenza and Emerging and Re-emerging Infectious Diseases Vaccine Studies

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

The NIAID Vaccine Research Center (VRC) Clinical Trials Program (CTP) completed enrollment of protocol VRC 326, a first-in-human study that is evaluating the safety, tolerability, and immunogenicity of a mosaic, hexavalent influenza vaccine, FluMos-v2, in healthy adults (NCT05968989). This vaccine was developed as a potential supraseasonal influenza vaccine that would protect against multiple circulating strains of influenza over several years, addressing the requirement to reformulate the influenza vaccine on an annual basis. An exploratory Part B of this protocol also evaluates the safety and tolerability of FluMos-v2 but in addition evaluates the germinal center vaccine-specific B cell responses after vaccination via fine needle aspiration of the draining lymph node on the side of vaccination. The VRC CTP initiated enrolled of two additional influenza vaccine trials, VRC 328 and VRC 329. VRC 328 evaluates the safety, tolerability, and immunogenicity of FluMos-v2 with and with adjuvant, ALFQ (Army Liposomal Formulation containing saponin QS-21), in healthy adult volunteers (NCT06863142). The goal of this study is to determine whether the addition of an adjuvant will enhance immune responses elicited by FluMos-v2, including the durability of these responses. The second study VRC CTP initiated, VRC 329, evaluates a pre-pandemic vaccine, SteMos1. VRC 329 is a phase 1, first-in-human study, evaluating a quadrivalent influenza HA stem vaccine, SteMos1, with and without ALFQ adjuvant in healthy adult volunteers (NCT07111078). The stem region of the influenza hemagglutinin (HA) protein contains the most conserved regions of the HA protein. The purpose of this vaccine is to induce broad, long-lasting immunity against many subtypes from Group 1 and Group 2 influenza viruses by targeting the conserved region of the HA stems. SteMos1 contains four HA stem antigens from Group 1(H2 and H5) and Group 2 (H7 and H10) subtypes. Each of these subtypes has the potential to cause a future influenza pandemic. In addition to the three ongoing trials described above, the VRC CTP completed data analysis of the results from phase 1 trial VRC 325, A First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared with a Licensed Inactivated Seasonal QIV (quadrivalent inactivated influenza vaccine) in Healthy Adults (NCT04896086). A manuscript reporting these results is in preparation. In addition to studies evaluating novel influenza vaccines, the VRC CTP completed data analysis of the results from a phase 1 first-in-human Nipah virus vaccine clinical trial conducted with healthy adult volunteers (NCT05398796). The manuscript has been submitted for publication and is under peer review. Nipah virus is a highly pathogenic zoonotic virus transmitted by fruit bats that causes severe respiratory and neurologic disease in humans and is transmitted from human-to-human. Given its pathogenicity and transmissibility, Nipah virus has the potential to cause significant outbreaks.