Respiratory syncytial virus (RSV) vaccine! GSK maternal vaccine enters Phase 3 clinical study: can quickly induce strong immunity!

November 23, 2020 // -- GlaxoSmithKline (GSK) recently announced that the Phase 3 GRACE Study (NCT04605159), which evaluates the safety and effectiveness of its respiratory syncytial virus (RSV) candidate vaccine for maternal immunity (GSK3888550A vaccine), has begun to vaccinate subjects.
GRACE is a double-blind Phase 3 study that will be conducted in 10,000 pregnant women aged 18-49 and will assess the effectiveness of single-dose RSV maternal advent-free vaccine intramuscular immunity to pregnant women aged 18-49 years and prevent the effectiveness of RSV-related LRTI in newborns.
the study will also assess the safety of the vaccine among vaccinated mothers and their babies.
the study is expected to close in early 2024 and the interim results are expected to be released in the second half of 2022.
RSV is the leading cause of respiratory infections in infants and young children, such as fine bronchitis (inflammation and conggation of the small airways or trachea of the lungs) and viral pneumonia (an inflammatory state of the small airbags or follicles in the lungs).
currently, no vaccine for RSV is available.
estimates that 33 million RSV cases occur globally each year among children under the age of 5, of which about 3 million are hospitalized and about 120,000 die from infection-related complications.
RSV-related lower respiratory diseases (LRTI) have significant morbidity and mortality rates in infants under 6 months of age, with nearly half of paediatric hospitalizations (approximately 1.4 million cases) and deaths occurring in infants and young children under 6 months of age. "RSV is a heavy burden on young children, and a vaccine that protects them from it will represent significant progress in addressing the burden of RSV, preventing infant disease and family suffering, and reducing the social burden," said Emmanuel Hanon, senior vice president and head of vaccine research and development at
GSK.
to advance our RSV candidate vaccine portfolio based on reliable available data is an important step towards GSK's goal of reducing the burden of RSV-related diseases worldwide.
" RSV also poses a significant threat to the health of older people.
the United States alone, there are 177,000 hospitalizations and 14,000 deaths associated with RSV infection each year.
as the population ages, the incidence and mortality of respiratory infections, including RSV, will steadily increase.
last month, GSK released positive phase I/II safety, reactive and immunogenic data for its RSV vaccine for maternal immunity (GSK388550A vaccine) and elderly immunization (GSK3844766A vaccine).
two candidate vaccines contain recombinant sub-unit fusion pre-RSV antigens (RSVPreF3), which are believed to trigger the required immune response.
vaccines for the elderly also include GSK's proprietary AS01 adsition system to enhance the immune response, which tends to be weaker than in younger people.
maternal immunology candidate vaccine was tested in 502 healthy non-pregnant women, and three different doses of RSV candidate vaccine were tested against a placebo for monthly visits (8, 31 and 91 days after immunization).
data show that compared to the baseline: (1) candidate vaccines can rapidly enhance existing immunity at all dose levels, resulting in high levels of protective neutrality antibodies;
first batch of pregnant women will be released in 2021.
The vaccine candidates for the elderly were first tested in 48 healthy adults (18-40 years of age) and then in 1,005 healthy older adults (60-80 years of age), using different doses of antigens and adoses and compared with placebos.
1 month after immunization: (1) candidate vaccines induce strong body fluids and cellular immunity compared to baselines; The increase was nearly tenfold; (3) importantly, in older adults who were vaccinated, cellular immunity (RSVPreF3-specific CD4-T cells) was enhanced to reach a range similar to that observed in young people, although the initial baseline level observed in older adults was lower than in younger adults.
The two vaccines are part of the GSK RSV vaccine program, which uses different new technologies to protect the most vulnerable: infants and the elderly, with three RSV candidate vaccines tailored to different populations (mother vaccine, childhood vaccine, elderly vaccine).
all three vaccine candidates have been approved by the FDA for fast-track (FTD).
vaccine against RSV can significantly reduce disease, hospital visits and hospitalizations in infants, young children and the elderly, with a significant impact on the health and medical costs of the world's most vulnerable populations.
Based on available data and contacts with regulators, Phase 3 studies of RSV candidate vaccines for the elderly will be launched in the coming months, and phase I/II (RSV-negative infants) and Phase II (RSV sero-positive infants) studies for children are still ongoing.
() original source: GSK starts phase 3 study of RSV maternal candidate vaccine