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- PMID: 21858807
- UKPMCID: 21858807
- DOI: 10.1002/ijc.26362
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Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18.
Szarewski, A; Poppe, W A J; Skinner, S R; Wheeler, C M; Paavonen, J; Naud, P; Salmeron, J; Chow, S-N; Apter, D; Kitchener, H; Castellsagué, X; Teixeira, J C; Hedrick, J; Jaisamrarn, U; Limson, G; Garland, S; Romanowski, B; Aoki, F Y; Schwarz, T F; Bosch, F X; Harper, D M; Hardt, K; Zahaf, T; Descamps, D; Struyf, F; Lehtinen, M; Dubin, G;
International journal of cancer. Journal international du cancer. 2012;131(1):106-16.
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Full-text held externally
- PMID: 21858807
- UKPMCID: 21858807
- DOI: 10.1002/ijc.26362
Abstract
In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix(®), GlaxoSmithKline Biologicals) was highly efficacious against HPV-16/18 infections and precancerous lesions in women HPV-16/18 deoxyribose nucleic acid (DNA) negative and seronegative at baseline. We present further data on vaccine efficacy (VE) against HPV-16/18 in the total vaccinated cohort including women who may have been exposed to HPV-16/18 infection before vaccination. In women with no evidence of current or previous HPV-16/18 infection (DNA negative and seronegative), VE was 90.3% (96.1% confidence interval: 87.3-92.6) against 6-month persistent infection (PI), 91.9% (84.6-96.2) against cervical intraepithelial neoplasia (CIN)1+ and 94.6% (86.3-98.4) against CIN2+ [97.7% (91.1-99.8) when using the HPV type assignment algorithm (TAA)]. In women HPV-16/18 DNA negative but with serological evidence of previous HPV-16/18 infection (seropositive), VE was 72.3% (53.0-84.5) against 6-month PI, 67.2% (10.9-89.9) against CIN1+, and 68.8% (-28.3-95.0) against CIN2+ [88.5% (10.8-99.8) when using TAA]. In women with no evidence of current HPV-16/18 infection (DNA negative), regardless of their baseline HPV-16/18 serological status, VE was 88.7% (85.7-91.1) against 6-month PI, 89.1% (81.6-94.0) against CIN1+ and 92.4% (84.0-97.0) against CIN2+ [97.0% (90.6-99.5) when using TAA]. In women who were DNA positive for one vaccine type, the vaccine was efficacious against the other vaccine type. The vaccine did not impact the outcome of HPV-16/18 infections present at the time of vaccination. Vaccination was generally well tolerated regardless of the woman's HPV-16/18 DNA or serological status at entry.
Bibliographic metadata
- Szarewski, A
- Poppe, W A J
- Skinner, S R
- Wheeler, C M
- Paavonen, J
- Naud, P
- Salmeron, J
- Chow, S-N
- Apter, D
- Kitchener, H
- Castellsagué, X
- Teixeira, J C
- Hedrick, J
- Jaisamrarn, U
- Limson, G
- Garland, S
- Romanowski, B
- Aoki, F Y
- Schwarz, T F
- Bosch, F X
- Harper, D M
- Hardt, K
- Zahaf, T
- Descamps, D
- Struyf, F
- Lehtinen, M
- Dubin, G
- Denham, I
- Garland, S
- Mindel, A
- O'Sullivan, M
- Skinner, S R
- Waddell, R
- Naud, P
- Teixeira, J C
- De Sutter, P
- Poppe, W A J
- Tjalma, W
- Aoki, F Y
- Diaz-Mitoma, F
- Dionne, M
- Ferguson, L
- Miller, M
- Papp, K
- Ramjattan, B
- Romanowski, B
- Somani, R
- Apter, D
- Astikainen, S
- Karppa, T
- Kekki, M
- Keranen, H
- Kudjoi, N
- Kuortti, M
- Kupari, M
- Kyha-Osterlund, L
- Isaksson, R
- Lehtinen, M
- Levanen, H
- Liljamo, T
- Loonberg, K
- Niemi, L
- Paavonen, J
- Palmroth, J
- Petaja, T
- Rekonen, S
- Romppanen, U
- Siitari-Mattila, M
- Tuomivaara, L
- Vilkki, M
- Belling, K H
- Gent, T
- Grubert, T
- Harlfi nger, W
- Holst, A
- Hopker, W D
- Tobgui, S Jensen-El
- Merder, G
- Peters, K
- Schoenian, S
- Schulze, K
- Schwarz, T F
- Wackernagel, C
- Boselli, F
- Mojana, G
- Salmeron, J
- Benitez, G
- Crisostomo, C
- Rosario- Raymundo, R Del
- Germar, M J
- Limson, G
- Raymundo, J
- Remollino, M C
- Villanueva, G
- Villanueva, S
- Zamora, J D
- Zamora, L
- Bajo, J
- Bayas, J
- Campins, M
- Castellsagué, X
- Castro, M
- Centeno, C
- Cruzet, F
- Rodriguez, L
- Torne, A
- Vidart, J A
- Chow, S-N
- Yu, M H
- Yuan, C C
- Huang, S-C
- Ho, H-N
- Chen, R-J
- Lin, H-H
- Chu, T-Y
- Angsuwathana, S
- Jaisamrarn, U
- Wilawan, K
- Abdulhakim, U K E
- Cruickshank, M
- Kitchener, H
- Lewis, D
- Pavel, I
- Robinson, J
- Szarewski, A
- Ackerman, R
- Ault, K
- Bennett, N
- Caldwell, M
- Chambers, C
- Chatterjee, A
- Civitarese, L
- Demars, L
- De Santis, T
- Downs, L
- Ferris, D
- Fine, P
- Gall, S
- Harper, D M
- Hedrick, J
- Herzig, W
- Hiraoka, M
- Huh, W
- Kamemoto, L
- Klein, T
- Koltun, W
- Kong, A
- Lalezari, J
- Lee, P
- Leeman, L
- Luber, S
- Martens, M
- Michelson, J
- 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
- Yardley, M
- Zbella, E
- Kiviat, N
- Klugman, K P
- Nieminen, P
- Bergeron, C
- Eisenstein, E
- Karron, R
- Marks, R
- Nolan, T
- Tay, S K
- Albers, S
- Bollaerts, P
- Camier, A
- Colau, B
- De Breyne, A
- Genevrois, S
- Issaka, Z
- Martens, N
- Peeters, P
- Smoes, N
- Spiessens, B
- Tavares, F
- Tonglet, A
- Vanden-Dunghen, S
- Vilain, A S
- Ward, K R
- 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
- Doorn, L J Van
- Poncelet, S
- Xhenseval, V