呼吸道合胞病毒 z-bo 2020-10-23 414

　　GlaxoSmithKline (GSK) recently announced that its respiratory syncytial virus (RSV) vaccine candidate is well tolerated and immune to maternal immunity (GSK3888550A vaccine) and elderly immunity (GSK3844766A vaccine) in Phase I/II studies. Strong originality.

　　RSV is the main cause of respiratory infections in infants and the elderly, such as bronchiolitis (inflammation and congestion of the small airways or bronchioles of the lungs) and pneumonia (an inflammatory state of the small air sacs or alveoli in the lungs). Globally, RSV causes 3 million hospitalizations in children under 5 years of age each year; in the United States, RSV causes 177,000 hospitalizations in the elderly each year.

　　Both candidate vaccines contain recombinant subunit pre-fusion RSV antigen (RSVPreF3), which is believed to trigger the desired immune response. Vaccines for the elderly also include GSK’s proprietary AS01 adjuvant system to enhance the immune response, because the population’s immune response to vaccination is often weaker than that of young people.

　　The candidate vaccine for the elderly was first tested in 48 healthy adults (18-40 years old), and then tested in 1,005 healthy elderly (60-80 years old), using different doses of antigens and adjuvants, and Placebo for comparison. Interim data at 1 month after immunization showed: (1) Compared with baseline, the candidate vaccine induced strong humoral and cellular immunity; (2) Protective antibodies of the immune group (RSVPreF3-IgG and RSV-A neutralizing antibodies) Increased by nearly 10 times; (3) Importantly, the cellular immunity (RSVPreF3 specific CD4 T cells) of the vaccinated elderly people has been enhanced to reach a range similar to that of the young, although it is observed in the elderly The initial baseline level is lower than that of young people.

　　Maternal immunization candidate vaccines were tested in 502 healthy non-pregnant women. Three different doses of RSV candidate vaccines were tested for comparison with placebo, and monthly visits were conducted (day 8, 31 and 91 after immunization) ). The data shows that compared with baseline: (1) Candidate vaccines can rapidly enhance existing immunity at all dose levels, thereby producing high levels of protective neutralizing antibodies; (2) RSV- is observed on day 8. A and RSV-B neutralizing antibody titer increased 14 times.

　　These two vaccines are part of the GSK RSV vaccine project, which is tailored to different populations of three RSV candidate vaccines (maternal vaccine, childhood vaccine, and elderly vaccine), using different new technologies to protect the most affected vulnerable Crowd: babies and elderly. All three vaccine candidates have obtained Fast Track Qualification (FTD) from the US FDA.

　　Vaccines to prevent RSV can significantly reduce the rate of diseases, visits and hospitalizations in infants, young children, and the elderly, thus having a major impact on the health and medical costs of the most vulnerable people in the world.

　　Based on existing data and contacts with regulatory agencies, the Phase 3 study of RSV vaccine candidates for the elderly and mothers is under preparation and is expected to start in the next few months. Phase I/II of RSV vaccine candidates for children (RSV negative infants) ) And Phase II (RSV seropositive infants) studies are still in progress. The Phase I/II safety and immunogenicity data of RSV vaccine candidates in RSV seropositive infants will be announced at the European Society of Pediatric Infectious Diseases (ESPID) meeting from October 26 to 29, 2020.