title: Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial.
abstract: There is an urgent need for a novel vaccine that is effective against human Enterovirus 71 (EV71) outbreaks. A double-blind, randomized controlled study was to evaluate the safety and immunogenicity of a human EV71 vaccine in healthy adults, children and infants. The vaccine dosages were 200 U and 400 U for children and adults, and 100 U, 200 U and 400 U for infants. Subjects were randomized to receive different dosages of the vaccine or placebo. Adults received intramuscular injection on Days 0, 14 and 28. Children and Infants received on Days 0, 28 and 56. The novel human EV71 inactivated vaccine was well tolerated and highly immunogenic in healthy volunteers, especially in infant populations. For immune response, the seropositive rates (with titers ≥≥1:8) of neutralizing antibody [NTAb] increased to 100% for all dosage groups after the second vaccination. For NTAb seronegative infants before vaccination, after one dose, the NTAb GMTs were 29.7 (95% CI, 13.1-67.2), 10.1 (95% CI, 6.6-15.3), and 27.4 (95% CI, 14.3-52.2) in the 100 U, 200 U, and 400 U vaccine groups, respectively; after two doses, the GMTs were 114.1 (95% CI, 44.5-292.4), 159.5 (95% CI, 49.3-515.3), and 509.0 (95% CI, 181.3-1429.1), respectively.
  
  
  BACKGROUND
  ClinicalTrial.gov identifier: NCT01273246 and NCT01273233.
authors.affiliation: The Center for Disease Control and Prevention of the Guangxi Zhuang Autonomous Region, China.
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Li
authors.forename: Zheng-Lun
authors.initials: ZL
authors.lastname: Liang
authors.forename: Qiang
authors.initials: Q
authors.lastname: Gao
authors.forename: Li-Rong
authors.initials: LR
authors.lastname: Huang
authors.forename: Qun-Ying
authors.initials: QY
authors.lastname: Mao
authors.forename: Shu-Qun
authors.initials: SQ
authors.lastname: Wen
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.forename: Wei-Dong
authors.initials: WD
authors.lastname: Yin
authors.forename: Rong-Cheng
authors.initials: RC
authors.lastname: Li
authors.forename: Jun-Zhi
authors.initials: JZ
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D029821:Enterovirus A, Human / Q000276:immunology*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D010919:Placebos; D014765:Viral Vaccines