Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months

Abstract

BackgroundM-M-RTMII (MMRII; Merck & Co) is currently the only measles-mumps-rubella (MMR) vaccine licensed in the United States. Another licensed vaccine would reinforce MMR supply. This study assessed the immunogenicity of a candidate vaccine (PriorixTM, GlaxoSmithKline Vaccines [MMR-RIT]) when used as a first dose among eligible children in the United States.MethodsIn this exploratory Phase-2, multicenter, observer-blind study, 1220 healthy subjects aged 12–15 months were randomized (3:3:3:3) and received 1 dose of 1 of 3 MMR-RIT lots with differing mumps virus titers (MMR-RIT-1 [4.8 log10]; MMR-RIT-2 [4.1 log10]; MMR-RIT-3 [3.7 log10] CCID50) or MMRII co-administered with hepatitis A vaccine (HAV), varicella vaccine (VAR) and 7-valent pneumococcal conjugate vaccine (PCV7). Immune response to measles, mumps, and rubella viruses was evaluated at Day 42 post-vaccination. Incidence of solicited injection site, general, and serious adverse events was assessed.ResultsSeroresponse rates for MMR vaccine viral components in MMR-RIT lots were 98.3–99.2% (measles), 89.7–90.7% (mumps), and 97.5–98.8% (rubella), and for MMRII were 99.6%, 91.1%, and 100%, respectively. Immune responses to HAV, VAR, and PCV7 were similar when co-administered with any of the 3 MMR-RIT lots or MMRII. There were no apparent differences in solicited or serious adverse events among the 4 groups.ConclusionsImmune responses were above threshold levels for projected protection against the 3 viruses from MMR-RIT lots with differing mumps virus titers. MMR-RIT had an acceptable safety profile when co-administered with HAV, VAR, and PCV7.Clinical Trials RegistrationNCT00861744; etrack; 111870

Gene expression differences among different MSI statuses in colorectal cancer

“…However, the underlying mechanism of FDXACB1 leading to MSI remains unknown. Some reviews speculated that such gene may contribute to the MSI by interfering MMR and functionally involving with the PD‐1/PD‐1L pathways, validating our prediction.…”

Immunogenicity and safety of the new MMR vaccine containing measles AIK-C, rubella Takahashi, and mumps RIT4385 strains in Japanese children: a randomized phase I/II clinical trial

“…It is reported that parotid gland swelling occurred in 0-1.8%, and that the incidence of symptoms related to aseptic meningitis was 0-0.1% following immunization with GSK-MMR containing RIT4385 in several clinical trials. 18,26,27 The actual incidence must be assessed in a post-marketing study; accordingly, no case of vaccineassociated aseptic meningitis was reported in a 2-year postmarketing study in Germany that involved 1,575,936 children who had received the GSK-MMR vaccine containing RIT4385. 27 There was no immediate reaction or serious ADR after vaccination with JVC-001, indicating that JVC-001 is safe and well tolerated.…”

Two-year antibody persistence in children vaccinated at 12–15 months with a measles-mumps-rubella virus vaccine without human serum albumin

“…The initial phase II, randomized, observer-blind study was conducted between June 2009 and July 2010 at 48 centers in the USA and 3 centers in Puerto Rico (NCT00861744) 13 . In this study, we continued to follow children for 2 y post-primary vaccination.…”

“…Currently there is only one MMR vaccine licensed in the USA (M-M-R II; Merck, USA), and any interruption to this single supply line could be a public health risk 3 . Another MMR vaccine, Priorix™ (MMR-RIT [RIT strain 4385]; GSK, Belgium), is licensed in over 100 countries 13 and has been shown to be immunogenic and well-tolerated in trials conducted in the USA 13-15 . Furthermore, as the MMR-RIT vaccine, like the current formulation of the M-M-R II vaccine, is manufactured without Human Serum Albumin (HSA) in accordance with the European Medicines Agency (EMA) guidelines, the theoretical risk of microbial contamination is reduced compared with previous formulations of the M-M-R II vaccine 16,17 …”