Publications by authors named "P M Mendelman"
As infants suffer significant morbidity and mortality due to norovirus-related acute gastroenteritis (AGE), we assessed four formulations of the bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in Panamanian and Colombian infants. 360 infants aged 6 weeks to 5 months were randomly allocated to 8 groups to receive three doses of HIL-214 or two doses of HIL-214 and one dose of placebo (Days 1, 56 and 112), where HIL-214 doses contained 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.
View Article and Find Full Text PDFArticle Synopsis
- - The study involved a dose-finding trial for the HilleVax bivalent vaccine (HIL-214) in children aged 6 months to 4 years across Panama and Colombia, with 120 participants per age cohort.
- - Participants were divided into four groups receiving different vaccine formulations, and responses to the vaccine were measured at multiple intervals, showing significant antibody responses particularly after the second dose, especially in the younger cohort.
- - The vaccine was well-tolerated with mild side effects reported, and the antibody levels remained elevated for at least 210 days post-vaccination, indicating potential for further development to protect young children from norovirus.
Article Synopsis
- Young children can experience significant health issues from norovirus gastroenteritis, prompting a study on the TAK-214 bivalent vaccine in kids aged 1-8 years.
- The phase 2 study involved 120 children from Finland, Panama, and Colombia who received different formulations of the vaccine, with results showing it was well-tolerated and led to strong immune responses.
- After two doses, the vaccine induced durable immunity against norovirus with high seroresponse rates, confirming that TAK-214 is a promising candidate for preventing this illness in young children.
Background: We performed this first-in-human efficacy trial of Takeda's bivalent norovirus vaccine candidate (TAK-214) against moderate or severe acute gastroenteritis (AGE) in healthy adults.
Methods: This double-blind, randomized, placebo-controlled phase 2b trial was conducted over two winter seasons in 18-49 year-old US Navy recruits. Participants were randomized (1:1) to receive intramuscular injections of saline placebo (N = 2,357) or TAK-214 [15 μg GI.
Article Synopsis
- The study evaluated the long-term immunity and safety of two bivalent norovirus vaccines in a clinical trial involving 454 adults, over a year after the initial vaccination.
- No safety concerns were identified, with antibody levels remaining elevated compared to baseline, even 365 days post-vaccination.
- The memory probe vaccination successfully boosted antibody levels, indicating an immune memory response, particularly for the GI.1 strain of the virus.