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- PMID: 22075170
- UKPMCID: 22075170
- DOI: 10.1016/S1470-2045(11)70287-X
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Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial.
Wheeler, Cosette M; Castellsagué, Xavier; Garland, Suzanne M; Szarewski, Anne; Paavonen, Jorma; Naud, Paulo; Salmerón, Jorge; Chow, Song-Nan; Apter, Dan; Kitchener, Henry; Teixeira, Júlio C; Skinner, S Rachel; Jaisamrarn, Unnop; Limson, Genara; Romanowski, Barbara; Aoki, Fred Y; Schwarz, Tino F; Poppe, Willy A J; Bosch, F Xavier; Harper, Diane M; Huh, Warner; Hardt, Karin; Zahaf, Toufik; Descamps, Dominique; Struyf, Frank; Dubin, Gary; Lehtinen, Matti;
The lancet oncology. 2012;13(1):100-10.
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Full-text held externally
- PMID: 22075170
- UKPMCID: 22075170
- DOI: 10.1016/S1470-2045(11)70287-X
Abstract
BACKGROUND: We evaluated the efficacy of the human papillomavirus HPV-16/18 AS04-adjuvanted vaccine against non-vaccine oncogenic HPV types in the end-of-study analysis after 4 years of follow-up in PATRICIA (PApilloma TRIal against Cancer In young Adults). METHODS: Healthy women aged 15-25 years with no more than six lifetime sexual partners were included in PATRICIA irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to HPV-16/18 vaccine or a control hepatitis A vaccine, via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites. The study was double-blind. The primary endpoint of PATRICIA has been reported previously; the present analysis evaluates cross-protective vaccine efficacy against non-vaccine oncogenic HPV types in the end-of-study analysis. Analyses were done for three cohorts: the according-to-protocol cohort for efficacy (ATP-E; vaccine n=8067, control n=8047), total vaccinated HPV-naive cohort (TVC-naive; no evidence of infection with 14 oncogenic HPV types at baseline, approximating young adolescents before sexual debut; vaccine n=5824, control n=5820), and the total vaccinated cohort (TVC; all women who received at least one vaccine dose, approximating catch-up populations that include sexually active women; vaccine n=9319, control=9325). Vaccine efficacy was evaluated against 6-month persistent infection, cervical intraepithelial neoplasia grade 2 or greater (CIN2+) associated with 12 non-vaccine HPV types (individually or as composite endpoints), and CIN3+ associated with the composite of 12 non-vaccine HPV types. This study is registered with ClinicalTrials.gov, number NCT00122681. FINDINGS: Consistent vaccine efficacy against persistent infection and CIN2+ (with or without HPV-16/18 co-infection) was seen across cohorts for HPV-33, HPV-31, HPV-45, and HPV-51. In the most conservative analysis of vaccine efficacy against CIN2+, where all cases co-infected with HPV-16/18 were removed, vaccine efficacy was noted for HPV-33 in all cohorts, and for HPV-31 in the ATP-E and TVC-naive. Vaccine efficacy against CIN2+ associated with the composite of 12 non-vaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), with or without HPV-16/18 co-infection, was 46·8% (95% CI 30·7-59·4) in the ATP-E, 56·2% (37·2-69·9) in the TVC-naive, and 34·2% (20·4-45·8) in the TVC. Corresponding values for CIN3+ were 73·8% (48·3-87·9), 91·4% (65·0-99·0), and 47·5% (22·8-64·8). INTERPRETATION: Data from the end-of-study analysis of PATRICIA show cross-protective efficacy of the HPV-16/18 vaccine against four oncogenic non-vaccine HPV types-HPV-33, HPV-31, HPV-45, and HPV-51-in different trial cohorts representing diverse groups of women. FUNDING: GlaxoSmithKline Biologicals.
Bibliographic metadata
- Wheeler, Cosette M
- Castellsagué, Xavier
- Garland, Suzanne M
- Szarewski, Anne
- Paavonen, Jorma
- Naud, Paulo
- Salmerón, Jorge
- Chow, Song-Nan
- Apter, Dan
- Kitchener, Henry
- Teixeira, Júlio C
- Skinner, S Rachel
- Jaisamrarn, Unnop
- Limson, Genara
- Romanowski, Barbara
- Aoki, Fred Y
- Schwarz, Tino F
- Poppe, Willy A J
- Bosch, F Xavier
- Harper, Diane M
- Huh, Warner
- Hardt, Karin
- Zahaf, Toufik
- Descamps, Dominique
- Struyf, Frank
- Dubin, Gary
- Lehtinen, Matti
- Denham, I
- Garland, S M
- Mindel, A
- O'Sullivan, M
- Skinner, S R
- Waddell, R
- De Sutter, P
- Poppe, W A J
- Tjalma, W
- De Carvalho, N S
- Naud, P
- Teixeira, J C
- Aoki, F Y
- Diaz-Mitoma, F
- Dionne, M
- Ferguson, L
- Miller, M
- Papp, K
- Ramjattan, B
- Romanowski, B
- Somani, R
- Apter, D
- Karppa, T
- Kudjoi, N
- Kyha-österlund, L
- Lehtinen, M
- Levanen, H
- Lönnberg, K
- Lunnas, T
- Niemi, L
- Paavonen, J
- Palmroth, J
- Petaja, T
- Rekonen, S
- Siitari-Mattila, M
- Tuomivaara, L
- Vilkki, M
- Belling, K H
- Gent, T
- Gieseking, F
- Grubert, T
- Harlfinger, W
- Höpker, W D
- Kohoutek, U
- Jensen-El Tobgui, S
- Merder, G
- Peters, K
- Schoenian, S
- Schulze, K
- Schwarz, T F
- Wackernagel, C
- Boselli, F
- Liverani, C A
- Salmerón, J
- Del Rosario-Raymundo, R
- Germar, M J
- Limson, G
- Villanueva, G
- Villanueva, S
- Zamora, J D
- Bajo, J
- Bayas, J
- Campins, M
- Castellsagué, X
- Castro, M
- RodrÃguez, L
- Chow, S N
- Yu, M H
- Yuan, C C
- Angsuwathana, S
- Jaisamrarn, U
- Cruickshank, M
- Hakim, E
- Kitchener, H
- Lewis, D
- Szarewski, A
- Ackerman, R
- Caldwell, M
- Chambers, C
- Chatterjee, A
- Civitarese, L
- Demars, L
- Ferris, D
- Fine, P
- Gall, S
- Hedrick, J
- Herzig, W
- Huh, W
- Klein, T
- Koltun, W
- Lalezari, J
- Lee, P
- Luber, S
- Martens, M
- Nebel, W
- Peterson, C
- Pitts, K
- Rosen, J
- Rosenfeld, W
- Scutella, M
- Seidman, L
- Sperling, M
- Sperling, R
- Stager, M
- Stapleton, J
- Swenson, K
- Thoming, C
- Twiggs, L
- Waldbaum, A
- Wheeler, C M
- Zbella, E
- Camier, A
- Colau, B
- Xhenseval, V
- Genevrois, S
- Issaka, Z
- Marius, P
- Martens, N
- Ouammou, T
- Peeters, P
- Rahier, M
- Smoes, N
- Spiessens, B
- Meurée, A
- Houard, N
- Dessy, F
- Poncelet, S
- Tonglet, A
- Van Hoof, C
- Vilain, A S
- Zahaf, T
- Zima, J
- Alt, E
- Iskaros, B
- Limaye, A
- Liu-Jarin, X
- Luff, R D
- McNeeley, M
- Provenzano, C
- Winkler, B
- Molijn, A
- Quint, W
- Struijk, L
- Van de Sandt, M
- Van Doorn, L J
- Catteau, G
- David, M-P
- Zahaf, T
- Declerck, L
- Dupin, J
- Maroye, J-L
- Kiviat, N
- Klugman, K P
- Nieminen, P
- Bergeron, C
- Eisenstein, E
- Marks, R
- Nolan, T
- Tay, S K