Infectious Disease Daily Report: 01/19/2024
Cytomegalovirus Prophylaxis in Hematopoietic Cell Transplantation Recipients
A phase 2b, multicenter, open-label study investigated the pharmacokinetics, safety, and efficacy of letermovir in 28 adolescent allogeneic hematopoietic cell transplantation (allo-HCT) recipients (1). The study found that administration of adult letermovir doses in this adolescent cohort resulted in exposures within adult clinical program margins and was associated with safety and efficacy similar to adults. The proportion of participants with clinically significant CMV infection through week 24 post-HCT was 24%, comparable to 37.5% in the pivotal phase 3 study in adults. The trial registration number is NCT03940586.
Reference
Groll AH, Schulte JH, Antmen AB, Fraser CJ, Teal VL, Haber B, Caro L, McCrea JB, Fancourt C, Patel M, Menzel K, Badshah C. Pharmacokinetics, Safety, and Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Adolescent Hematopoietic Cell Transplantation Recipients. Pediatr Infect Dis J. 2024 Jan 19. doi: 10.1097/INF.0000000000004208. Epub ahead of print. PMID: 38241643.
COVID-19 Vaccination
A combined phase I/II and IIb randomized, double-blind, interventional clinical trial assessed the Convacell(®) COVID-19 vaccine in volunteers (1). The primary endpoints were the frequency of adverse effects and specific anti-N IgG titers. Phase I/II trials showed no severe adverse effects, 100% seroconversion by day 42, and sustained anti-N IgG levels for 350 days. Phase IIb results demonstrated significant increases in anti-N IgG and IFNγ(+)-producing PBMC quantities among 438 volunteers. Convacell(®) showed similar immunological efficacy in single and double dose regimens, including in elderly patients. The vaccine was found to be safe and highly immunogenic.
Reference
Rabdano S, Ruzanova E, Makarov D, Vertyachikh A, Teplykh V, Rudakov G, Pletyukhina I, Saveliev N, Zakharov K, Alpenidze D, Vasilyuk V, Arakelov S, Skvortsova V. Safety and Immunogenicity of the Convacell® Recombinant N Protein COVID-19 Vaccine. Vaccines (Basel). 2024 Jan 19;12(1):100. doi: 10.3390/vaccines12010100. PMID: 38276672.