GSK Voluntarily Pauses Phase III Clinical Trials of RSV Maternal Vaccine Candidate GSK3888550A

News on February 18, 2022 /BioValleyBIOON/ --GlaxoSmithKline PLC.(GSK) recently announced that the company has voluntarily suspended enrollment and vaccination in the GRACE Phase III trial (NCT04605159), which is evaluating its maternal respiratory syncytial virus (RSV) vaccine (GSK3888550A vaccine). In addition, the company has also voluntarily paused two other trials.Clinical Trial(NCT04980391, NCT05229068), these trials are evaluating this candidate vaccine in pregnant women.

GRACE is a double-blind Phase III study evaluating the efficacy of a single dose of the unadjuvanted RSV maternal vaccine (GSK3888550A vaccine) administered via intramuscular injection to healthy pregnant women aged 18-49, for the prevention of RSV-associated lower respiratory tract infections (LRTI) in newborns. The study will also assess the safety of this vaccine in vaccinated mothers and their infants.

This decision was made based on the recommendation from the Independent Data Monitoring Committee (IDMC) following routine safety assessments. Monitoring safety signals is an integral part of the clinical development process for potential new vaccines.

This decision does not affect the ongoing RSV elderly vaccine (GSK3844766A vaccine) AReSVi 006 Phase III trial (NCT04886596). This trial is being conducted in the elderly population (≥60 years old) and is still ongoing, with data expected to be released in the first half of 2022.

GlaxoSmithKline PLC.Further updates on the RSV maternal vaccine will be provided at an appropriate time.RSV Maternal Vaccine (GSK3888550A) and RSV Elderly Vaccine (GSK3844766A) both contain the recombinant subunit prefusion RSV antigen (RSVPreF3), which is believed to trigger the desired immune response. The vaccine for the elderly also includes GSK's proprietary AS01 adjuvant system to enhance the immune response, as this population tends to have a weaker immune response to vaccination compared to younger individuals.

The above two vaccines are part of GSK's RSV vaccine project, which has tailored three RSV candidate vaccines for different populations (maternal vaccine, pediatric vaccine, and elderly vaccine), using different new technologies to protect the most vulnerable groups affected: infants and the elderly. All three candidate vaccines have received recognition in the United States.FDAFast Track Designation (FTD).

Vaccines preventing RSV can significantly reduce illness, doctor visits, and hospitalization rates among infants, young children, and the elderly, creating a substantial impact on the health and healthcare costs of the most vulnerable populations worldwide.

Respiratory Syncytial Virus (RSV) is a common and widespread cause of acute respiratory diseases. The virus is highly contagious and affects the lungs and respiratory tract. RSV infections occur in people of all ages, resembling a common cold for most young individuals, but it can be life-threatening for infants, immunocompromised individuals, and the elderly. Elderly people, as well as those with chronic heart disease, lung disease, or weakened immune systems, face an increased risk of severe infection. Currently, there is no vaccine to prevent RSV, and the medical community is limited to providing supportive care for patients.

Just recently, the United StatesFDAAwarded Bavarian Nordic Candidate Vaccine MVA-BN RSVBreakthrough Therapy Designation (BTD): For active immunization in individuals aged 60 years and older to prevent lower respiratory tract disease caused by RSV.MVA-BN RSV is a candidate RSV vaccine containing five unique RSV antigens designed to stimulate a broad immune response against all RSV subtypes (A and B), thereby mimicking the immune response observed after the body's natural reaction to RSV infection.The addition of five antigens differentiates MVA-BN RSV from other candidate RSV vaccines currently under development. (Bioon.com)

Source of the original text:GSK provides update on phase III RSV maternal vaccine candidate programme