Intramuscular CodaVax-H1N1 in Healthy Adults
InfluenzaHumanThis study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants will be enrolled in autumn 2022 (southern hemisphere) and followed through the 2022 influenza season (Part A) or enrolled in autumn 2023 and followed through the 2023 influenza season (Part B). Participants will be screened within 28 days of randomization, and eligible participants in Part A will be enrolled into 1 of 3 sequential cohorts and randomised to receive a single dose of CodaVax-H1N1, placebo (normal saline), or licenced injectable seasonal influenza vaccine (Flucelvax Quad). Each subsequent cohort will include a higher dose of CodaVax H1N1 than the previous cohort, in addition to placebo and the licensed injectable seasonal influenza vaccine. In Part B, 24 eligible participants will be enrolled into 1 of 2 sequential cohorts and randomised to receive a single IM dose of CodaVax-H1N1 or placebo.
Immunogenicity of Alternative Annual Influenza Vaccination Strategies in Older Adults in Hong Kong...
InfluenzaHumanThis study allows to evaluate the strength and duration of immune responses between annual receipt of standard inactivated vaccine and alternative potent vaccines, including annual receipt of adjuvanted inactivated vaccine, annual receipt of high-dose inactivated vaccine, annual receipt of recombinant HA vaccine, and the alternate combinations of the former three vaccines over four years, for identifying improved vaccination strategies for influenza vaccination in older adults in a location experiencing a subtropical pattern in influenza activity.
Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
InfluenzaThis is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process.
Efficacy Study With QIVc in Pediatric Subjects
InfluenzaHumanThis phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
Tfh Dysfunction in HIV and Aging
Human InfluenzaThe purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people to understand how aging and HIV infection affect the immune responses (body defenses against infection) to the flu vaccine.
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With...
SARS CoV 2 InfectionInfluenza1 moreThis is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19. In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1 month after study treatment. Safety and immunogenicity of all participants will be assessed.
Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years
InfluenzaCommunity-acquired Pneumonia1 moreThis study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.
Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated...
InfluenzaHumanAs yet the investigators do not understand if there are biomarkers of immune protection after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the hypothesis that the T-bet expressing fraction of flu-specific B cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. In this study the investigators will be providing the LAIV to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the LAIV also protects after the intramuscular influenza vaccination. Update: We have amended this protocol to study the antigen-specific B cell populations that circulate after LAIV or IIV prime and LAIV or IIV boost.
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
InfluenzaInfluenza-like Illness1 moreA total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV)...
Respiratory Syncytial Virus InfectionsThe aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).