PMID- 33005887
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220417
IS  - 2590-1362 (Electronic)
IS  - 2590-1362 (Linking)
VI  - 6
DP  - 2020 Dec 11
TI  - Immunogenicity and safety of concurrent or sequential administration of live, 
      attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) and 
      measles-mumps-rubella vaccine in infants 9-12 months of age in the Philippines: A 
      non-inferiority Phase 4 randomized clinical trial.
PG  - 100074
LID - 10.1016/j.jvacx.2020.100074 [doi]
LID - 100074
AB  - INTRODUCTION: Japanese encephalitis (JE) virus is the leading cause of viral 
      encephalitis across temperate and tropical zones of Asia. The live attenuated SA 
      14-14-2 JE vaccine (CD-JEV) is one of three vaccines prequalified by the World 
      Health Organization (WHO) to prevent JE. When incorporating a new vaccine into a 
      country's Expanded Program on Immunization (EPI), it is important to show that 
      the new vaccine can be administered concurrently with other routine pediatric 
      vaccines without impairing the immune responses or changing the safety profiles 
      of the co-administered vaccines. This Phase 4 open-label study evaluated the 
      safety and immunogenicity of measles-mumps-rubella (MMR) vaccine co-administered 
      with CD-JEV. METHODS: The study randomized 628 healthy Filipino children aged 
      between 9 and 10 months to receive MMR and CD-JEV concurrently or separately. MMR 
      immunogenicity was measured 56 days after MMR vaccination using a measles plaque 
      reduction neutralization test (PRNT), anti-mumps immunoglobulin G (IgG) 
      enzyme-linked immunosorbent assay (ELISA), and anti-rubella IgG ELISA, 
      respectively. Neutralizing antibody against JE virus was measured 28 days after 
      CD-JEV vaccination using PRNT. Safety was assessed through solicitation of 
      immediate reactions, adverse events (AEs) within 14 days of vaccination, 
      unsolicited AEs occurring within 28 days, and serious adverse events (SAEs) 
      during participation in the study. RESULTS/CONCLUSIONS: During the study, no 
      post-vaccinal encephalitis cases or related SAEs were reported in either group. 
      Concurrent immunization with CD-JEV and MMR vaccines was not associated with any 
      unusual safety signals when compared with sequential immunization. No significant 
      differences between the regimens were seen in seropositivity or serology 
      titer/concentration results for any of the antigens. Co-administration of CD-JEV 
      and MMR was non-inferior to single administration of either vaccine.
CI  - (c) 2020 The Author(s).
FAU - Capeding, Maria Rosario
AU  - Capeding MR
AD  - Research Institute for Tropical Medicine, 9002 Research Drive, Filinvest 
      Corporate City, Alabang, Muntinlupa City, Manila 1781, Philippines.
FAU - Alberto, Edison
AU  - Alberto E
AD  - Research Institute for Tropical Medicine, 9002 Research Drive, Filinvest 
      Corporate City, Alabang, Muntinlupa City, Manila 1781, Philippines.
FAU - Feser, Jodi
AU  - Feser J
AD  - PATH, PO Box 900922, Seattle, WA 98109, USA.
FAU - Mooney, Jessica
AU  - Mooney J
AD  - PATH, PO Box 900922, Seattle, WA 98109, USA.
FAU - Tang, Yuxiao
AU  - Tang Y
AD  - PATH, PO Box 900922, Seattle, WA 98109, USA.
FAU - Audet, Susette A
AU  - Audet SA
AD  - US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 
      20993, USA.
FAU - Beeler, Judy A
AU  - Beeler JA
AD  - US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 
      20993, USA.
FAU - Ellison, Damon W
AU  - Ellison DW
AD  - Armed Forces Research Institute of Medical Sciences, 315/6 Rajvithi Road, Bangkok 
      10400, Thailand.
FAU - Zhang, Lei
AU  - Zhang L
AD  - Chengdu Institute of Biological Products Co., Ltd., 379, 3rd, Jinhua Road, 
      Jinjiang District, Chengdu 61002, China.
FAU - Letson, G William
AU  - Letson GW
AD  - PATH, PO Box 900922, Seattle, WA 98109, USA.
FAU - Neuzil, Kathleen M
AU  - Neuzil KM
AD  - PATH, PO Box 900922, Seattle, WA 98109, USA.
FAU - Marfin, Anthony A
AU  - Marfin AA
AD  - PATH, PO Box 900922, Seattle, WA 98109, USA.
LA  - eng
PT  - Journal Article
DEP - 20200814
PL  - England
TA  - Vaccine X
JT  - Vaccine: X
JID - 101748769
PMC - PMC7509462
COIS- L Zhang is employed by the manufacturer of the vaccine, Chengdu Institute of 
      Biological Products Co., Ltd. All other authors declare no competing interests.
EDAT- 2020/10/03 06:00
MHDA- 2020/10/03 06:01
PMCR- 2020/08/14
CRDT- 2020/10/02 05:47
PHST- 2020/05/19 00:00 [received]
PHST- 2020/08/08 00:00 [revised]
PHST- 2020/08/11 00:00 [accepted]
PHST- 2020/10/02 05:47 [entrez]
PHST- 2020/10/03 06:00 [pubmed]
PHST- 2020/10/03 06:01 [medline]
PHST- 2020/08/14 00:00 [pmc-release]
AID - S2590-1362(20)30021-8 [pii]
AID - 100074 [pii]
AID - 10.1016/j.jvacx.2020.100074 [doi]
PST - epublish
SO  - Vaccine X. 2020 Aug 14;6:100074. doi: 10.1016/j.jvacx.2020.100074. eCollection 
      2020 Dec 11.