title: A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18-26 years.
abstract: Intradermal administration of human papillomavirus (HPV) vaccines could be dose-sparing and cost-saving. This pilot randomized study assessed Cervarix(®) and Gardasil(®) administered either intramuscularly or intradermally, in different doses (full-dose or reduced to 20%) by different methods (needle and syringe or PharmaJet needle-free jet injection device). Following an initial reactogenicity study of 10 male subjects, sexually naïve women aged 18-26 years were randomized to the eight study groups to receive vaccine at 0, 2 and 6 months. 42 female subjects were enrolled and complete data were available for 40 subjects. Intradermal administration of either vaccine raised no safety concerns but was more reactogenic than intramuscular administration, although still tolerable. All subjects demonstrated a seroconversion (titre≥1:320) by Day 95. Further evaluation of intradermal HPV vaccination and its potential for cost reduction in resource poor settings is warranted.
authors.affiliation: Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong Special Administrative Region. tony-nelson@cuhk.edu.hk
authors.forename: E Anthony S
authors.initials: EA
authors.lastname: Nelson
authors.forename: Hugh Simon
authors.initials: HS
authors.lastname: Lam
authors.forename: Kai C
authors.initials: KC
authors.lastname: Choi
authors.forename: Wendy C S
authors.initials: WC
authors.lastname: Ho
authors.forename: L W Eva
authors.initials: LW
authors.lastname: Fung
authors.forename: Frankie W T
authors.initials: FW
authors.lastname: Cheng
authors.forename: Rita Y T
authors.initials: RY
authors.lastname: Sung
authors.forename: Michael
authors.initials: M
authors.lastname: Royals
authors.forename: Paul K S
authors.initials: PK
authors.lastname: Chan
mesh_terms: D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D010865:Pilot Projects; D014611:Vaccination / Q000379:methods*; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18
keywords: 1% 4-[2-hydroxyethyl]-1-piperazine ethanesulfonic acid; 3-O-desacyl-4′-monophosphoryl lipid A; ASO4; DMEM; Dulbecco's modified Eagle's medium; FBS; GMT; HEPES; HPV; Human papillomavirus; ID; IM; Intradermal; NAM; PBNA; SAE; SEAP; Vaccine; fetal bovine serum; geometric mean titre; human papilloma virus; intradermal; intramuscular; neutralization assay medium; pseudovirion-based neutralization assay; secreted alkaline phosphatase; serious adverse events