Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 4 Issue 4 December 2015
http://jpids.oxfordjournals.org/content/current

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Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12–15 Months
Maurice A. Mufson, Clemente Diaz, Michael Leonardi, Christopher J. Harrison, Stanley Grogg,
Antonio Carbayo, Simon Carlo-Torres, Robert JeanFreau, Ana Quintero-Del-Rio, Gisele Bautista,
Michael Povey, Christopher Da Costa, Ouzama Nicholson, and Bruce L. Innis
J Ped Infect Dis (2015) 4 (4): 339-348 doi:10.1093/jpids/piu081
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Abstract
Background
M-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.
Methods
In 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.
Results
Seroresponse 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.
Conclusions
Immune 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 Registration NCT00861744; etrack; 111870

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Efficacy of a Tetravalent Dengue Vaccine in Children in Latin America
Rana F. Hamdy
Author Affiliations
Division of Infectious Diseases, The Children’s Hospital of Philadelphia
Received July 9, 2015.
Accepted August 1, 2015.
Villar L, Dayan GH, Arredondo-Garcia JL, et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med 2015; 372:113–23.
Extract
Dengue is a mosquito-borne disease caused by 1 of 4 virus serotypes from the flavivirus genus present in tropical and subtropical regions. This study reports the results from a phase 3 randomized, blinded, placebo-controlled efficacy trial of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) involving healthy children ages 9 to 16 years in 5 Latin American countries.
The study, sponsored by Sanofi Pasteur, took place in 22 centers in Colombia, Brazil, Mexico, Puerto Rico, and Honduras from June 2011 to March 2012. The investigational vaccine consists of 4 recombinant dengue vaccine viruses, which were constructed by replacing the genes that encode the premembrane and envelope proteins of the yellow fever 17D vaccine virus with those from wild-type dengue viruses…