title: Impact of smoking on the quantity and quality of antibodies induced by human papillomavirus type 16 and 18 AS04-adjuvanted virus-like-particle vaccine - a pilot study.
abstract: BACKGROUND
  The AS04-adjuvanted bivalent L1 virus-like-particle (VLP) vaccine (Cervarix™) against infection with human papillomavirus (HPV) types 16/18 holds great promise to prevent HPV16/18 infections and associated neoplasias, but it is important to rule out significant co-factors of the neoplasias like smoking.
  
  
  METHODS
  We conducted a pilot study to compare the quantity and quality of HPV16/18 antibody response at baseline and 7 months post vaccination in 104 non-smoking and 112 smoking female participants vaccinated at 0, 1 and 6 months with Cervarix™ (55 and 48 study participants) or with Hepatitis A vaccine (HAVRIX™) (48 and 64 participants, respectively). These 216 women were a sub-sample of 4808 baseline 16- to 17-year old Finnish women initially enrolled in the double-blind, randomized controlled phase III PATRICIA trial. Following end-of-study unblinding in 2009 they were randomly chosen out of all the participants of the three major Finnish PATRICIA study sites in the Helsinki metropolitan area (University of Helsinki, N = 535, and Family Federation Finland, N = 432) and Tampere (University of Tampere, N = 428). Following enrolment, serum samples were collected at month 0 and month 7 post 1st vaccination shot, and were analysed for levels and avidity of IgG antibodies to HPV16 and HPV18 using standard and modified (4 M urea elution) VLP ELISAs.
  
  
  RESULTS
  We found that at month 7 post vaccination women who smoked (cotinine level > 20 ng/ml) had levels of anti-HPV16/18 antibodies comparable to those of non-smoking women. Low-avidity HPV16/18 IgG antibodies were observed in 16% of the vaccinated women, and active smoking conferred a three-fold increased risk (95% CI 1.0-9.3) of having the low-avidity antibodies.
  
  
  CONCLUSIONS
  Our data suggest that while smoking does not interfere with the quantity of vaccine-induced peak IgG levels, it may affect the avidity of IgG induced by HPV16/18 vaccination.
authors.affiliation: School of Health Sciences, University of Tampere, Tampere, Finland. bazanyanengo@yahoo.co.uk.
authors.forename: Proscovia B
authors.initials: PB
authors.lastname: Namujju
authors.forename: Emma
authors.initials: E
authors.lastname: Pajunen
authors.forename: Aline
authors.initials: A
authors.lastname: Simen-Kapeu
authors.forename: Lea
authors.initials: L
authors.lastname: Hedman
authors.forename: Marko
authors.initials: M
authors.lastname: Merikukka
authors.forename: Helja-Marja
authors.initials: HM
authors.lastname: Surcel
authors.forename: Reinhard
authors.initials: R
authors.lastname: Kirnbauer
authors.forename: Dan
authors.initials: D
authors.lastname: Apter
authors.forename: Jorma
authors.initials: J
authors.lastname: Paavonen
authors.forename: Klaus
authors.initials: K
authors.lastname: Hedman
authors.forename: Matti
authors.initials: M
authors.lastname: Lehtinen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood*; D000915:Antibody Affinity; D004311:Double-Blind Method; D005260:Female; D005387:Finland; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D030041:Hepatitis A virus / Q000276:immunology; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage*; D010865:Pilot Projects; D012307:Risk Factors; D012907:Smoking; D002583:Uterine Cervical Neoplasms / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D014611:Vaccination; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D014761:Viral Hepatitis Vaccines