Post Hoc Analysis of the PATRICIA Randomized Trial of the Efficacy of Human Papillomavirus Type 16 (HPV-16)/HPV-18 AS04-Adjuvanted Vaccine against Incident and Persistent Infection with Nonvaccine Oncogenic HPV Types Using an Alternative Multiplex Type-Specific PCR Assay for HPV DNA
| Autor: | Tino F. Schwarz, Terry D. Klein, Archana Chatterjee, Rachel Skinner, Willy Poppe, Paulo Naud, Klaus Peters, Maria Julieta Maria Julieta Germar, Brigitte Desiree Alberte Colau, Marie Pierre David, Cosette M. Wheeler, M. Rowena Del Rosario-Raymundo, Song Nan Chow, Jorma Paavonen, Wim Quint, Leen Jan Van Doorn, Jorge Salmerón, Frank Struyf, Julio Cesar Teixeira, Gary Dubin, Genara Limson, David J. M. Lewis, Brian Ramjattan, Francisco Diaz-Mitoma, Suzanne M. Garland, Xavier Castellsagué, Wiebren A.A. Tjalma, Diane M. Harper, Matti Lehtinen, Anco Molijn |
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| Přispěvatelé: | HPV PATRICIA Study Group |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Microbiology (medical) Adolescent Genotype Clinical Biochemistry Immunology Aluminum Hydroxide Biology Polymerase Chain Reaction law.invention Young Adult Papillomavirus Vaccines Adjuvants Immunologic law medicine Humans Immunology and Allergy Multiplex Papillomaviridae Polymerase chain reaction Vaccines Intraepithelial neoplasia Papillomavirus Infections Cancer medicine.disease biology.organism_classification Vaccine efficacy Virology 3. Good health Lipid A Treatment Outcome DNA Viral Female Human medicine |
| Zdroj: | Clinical and vaccine immunology |
| ISSN: | 1556-679X 1556-6811 |
| Popis: | The efficacy of the human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against cervical infections with HPV in the Pa pilloma Tri al against C ancer i n Young A dults (PATRICIA) was evaluated using a combination of the broad-spectrum L1-based SPF 10 PCR-DNA enzyme immunoassay (DEIA)/line probe assay (LiPA 25 ) system with type-specific PCRs for HPV-16 and -18. Broad-spectrum PCR assays may underestimate the presence of HPV genotypes present at relatively low concentrations in multiple infections, due to competition between genotypes. Therefore, samples were retrospectively reanalyzed using a testing algorithm incorporating the SPF 10 PCR-DEIA/LiPA 25 plus a novel E6-based multiplex type-specific PCR and reverse hybridization assay (MPTS12 RHA), which permits detection of a panel of nine oncogenic HPV genotypes (types 16, 18, 31, 33, 35, 45, 52, 58, and 59). For the vaccine against HPV types 16 and 18, there was no major impact on estimates of vaccine efficacy (VE) for incident or 6-month or 12-month persistent infections when the MPTS12 RHA was included in the testing algorithm versus estimates with the protocol-specified algorithm. However, the alternative testing algorithm showed greater sensitivity than the protocol-specified algorithm for detection of some nonvaccine oncogenic HPV types. More cases were gained in the control group than in the vaccine group, leading to higher point estimates of VE for 6-month and 12-month persistent infections for the nonvaccine oncogenic types included in the MPTS12 RHA assay (types 31, 33, 35, 45, 52, 58, and 59). This post hoc analysis indicates that the per-protocol testing algorithm used in PATRICIA underestimated the VE against some nonvaccine oncogenic HPV types and that the choice of the HPV DNA testing methodology is important for the evaluation of VE in clinical trials. (This study has been registered at ClinicalTrials.gov under registration no. NCT00122681.) |
| Databáze: | OpenAIRE |
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