Immune responses elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in previously vaccinated adult women |
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| Authors: | A.-B. Moscicki C.M. Wheeler B. Romanowski J. Hedrick S. Gall D. Ferris S. Poncelet T. Zahaf P. Moris B. Geeraerts D. Descamps A. Schuind |
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| Affiliation: | 1. University of California, Division of Adolescent Medicine, San Franscico, CA 94118, USA;2. University of New Mexico, Health Sciences Center, Albuquerque, NM 87131, USA;3. University of Alberta, Edmonton, AB T6G 2C8, Canada;4. Kentucky Pediatric and Adult Research, Bardstown, KY 40004, USA;5. University of Louisville, School of Medicine, Louisville, KY 40025, USA;6. Georgia Health Sciences University, Department of Family Medicine, Augusta, GA 30912, USA;g GlaxoSmithKline Vaccines, Rixensart B-1330, Belgium;h GlaxoSmithKline Vaccines, Wavre B-1300, Belgium;i GlaxoSmithKline Vaccines, King of Prussia, PA 19406, USA |
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| Abstract: | BackgroundVaccines are now available for the prevention of HPV-16/18-related cervical infections and pre-cancers, primarily targeting adolescent girls. Since the risk of HPV exposure potentially persists throughout a woman's sexual life, vaccine-derived immunity should be long-term. The current study, HPV-024 (NCT00546078, http://clinicaltrials.gov), assessed the immune memory in North American women who received three doses of HPV-16/18 AS04-adjuvanted vaccine 7 years earlier in HPV-001 (NCT00689741).MethodsWomen vaccinated in HPV-001 received a 4th-dose of the HPV-16/18 vaccine (024-4DV group, N = 65). Post 4th-dose immune responses were compared with post 1st-dose immune responses in cross-vaccination controls (024-3DV group, N = 50). Reactogenicity was compared between the 4th-dose and the 1st-dose administration.ResultsPre 4th-dose, 100% of subjects in the 024-4DV group remained seropositive for anti-HPV-16/18 antibodies (ELISA). Compared to pre 4th-dose, GMTs for anti-HPV-16 and anti-HPV-18 antibodies were respectively 9.3-fold and 8.7-fold higher at day 7, and 22.7-fold and 17.2-fold higher at month 1. Compared to post 1st-dose, GMTs for anti-HPV-16 and anti-HPV-18 were respectively 80.5-fold and 205.4-fold higher at day 7, and 11.8-fold and 20.5-fold higher at month 1. Furthermore, 68.2% and 77.3% of women had HPV-16/18 specific memory B-cells, respectively, pre 4th-dose, rising to 100% one month post 4th-dose vaccination. The 4th-dose was generally well tolerated.ConclusionA 4th-dose of HPV-16/18 AS04-adjuvanted vaccine triggered a rapid and strong anamnestic response in previously vaccinated women, demonstrating vaccine-induced immune memory. |
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| Keywords: | AE, adverse event ATP, according-to-protocol CD40L, CD40 ligand CI, confidence interval CMI, cell-mediated immune CVS, cervico-vaginal secretion DNA, deoxyribonucleic acid ELISA, enzyme-linked immunosorbent assay Gmean, geometric mean GMT, geometric mean titre HPV, human papillomavirus HPV-001, the primary vaccination study (NCT00689741) HPV-007, the follow-up study of HPV-001 (NCT00120848) HPV-010, clinical study NCT00423046 HPV-024, the current study (NCT00546078) HPV-16/18 vaccine, HPV-16/18 AS04-adjuvanted vaccine IFN-γ, interferon-gamma IL-2, interleukin 2 LiPA, Line Probe Assay NA, North America/North American NOAD, new onset autoimmune disease NOCD, new onset chronic disease PBNA, pseudovirion-based neutralisation assay PCR, polymerase chain reaction SAE, serious adverse event SD, standard deviation TNF-α, tumour necrosis factor-alpha TVC, total vaccinated cohort US, United States 024-3DV, subjects receiving 3 vaccine doses in HPV-024 024-4DV, subjects receiving a 4th vaccine dose in HPV-024 |
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