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

Abstract

One combined measles-mumps-rubella (MMR) vaccine without Human Serum Albumin (HSA) is currently licensed in the USA (M-M-R II; Merck, USA) and another has been developed (Priorix™ [MMR-RIT, GSK, Belgium]). In this follow-up study, children from USA or Puerto Rico, who had received one dose of M-M-R II or MMR-RIT at 12-15 months of age in the primary study (NCT00861744), were followed-up for 2 y post-vaccination. Anti-measles and anti-rubella antibodies were measured using Enzyme-Linked Immunosorbent Assay (ELISA), and anti-mumps antibodies using ELISA and plaque reduction neutralization (PRN) assays. Serious adverse events (SAEs) were recorded during the entire follow-up. The according-to-protocol (ATP) persistence cohort included 752 children (M-M-R II = 186, MMR-RIT = 566), who received primary vaccination at a mean age of 12.3 ( ± 0.67) months. 104 children were revaccinated with MMR-containing vaccines; therefore, serology results for timepoints after revaccination were excluded from the analysis. Seropositivity for measles (Year 1≥ 98.3%; Year 2≥ 99.4%) and rubella (Year 1≥ 98.9%; Year 2 = 100%) remained as high at Year 2 as at Day 42. Similarly, seropositivity for mumps determined by ELISA (Year 1≥ 90.1%; Year 2≥ 94.1%) and PRN assays (Year 1≥ 87.5%; Year 2≥ 91.7%) persisted. Thirty-three SAEs were recorded in 23 children; 2 SAEs (inguinal adenitis and idiopathic thrombocytopenic purpura) and one SAE (febrile convulsion) were considered as potentially related to MMR-RIT and M-M-R II, respectively. This study showed that antibodies against measles, mumps and rubella persisted for up to 2 y post-vaccination with either MMR vaccine in children aged 12-15 months, and that both vaccines were well-tolerated during the follow-up period.

• Authors: Andrea A Berry, Remon Abu-Elyazeed, Clemente Diaz-Perez, Maurice A Mufson, Christopher J Harrison, Michael Leonardi, Jerry D Twiggs, Christopher Peltier, Stanley Grogg, Antonio Carbayo, Steven Shapiro, Michael Povey, Carmen Baccarini, Bruce L Innis, Ouzama Henry
• Journal: Human vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 13 Issue 7 Pg. 1516-1522 (07 03 2017) ISSN: 2164-554X [Electronic] United States
• PMID: 28481690 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Neutralizing
• Antibodies, Viral
• Measles-Mumps-Rubella Vaccine

Topics

• Antibodies, Neutralizing (blood)
• Antibodies, Viral (blood)
• Drug-Related Side Effects and Adverse Reactions (epidemiology, pathology)
• Enzyme-Linked Immunosorbent Assay
• Follow-Up Studies
• Humans
• Immunization Schedule
• Infant
• Measles-Mumps-Rubella Vaccine (administration & dosage, adverse effects, immunology)
• Neutralization Tests
• Puerto Rico
• Time Factors
• United States
• Viral Plaque Assay