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dc.contributor.authorGambhira, Ratish
dc.contributor.authorGravitt, Patti E
dc.contributor.authorBossis, Ioannis
dc.contributor.authorStern, Peter L
dc.contributor.authorViscidi, Raphael P
dc.contributor.authorRoden, Richard B S
dc.date.accessioned2009-07-07T11:57:37Z
dc.date.available2009-07-07T11:57:37Z
dc.date.issued2006-12-01
dc.identifier.citationVaccination of healthy volunteers with human papillomavirus type 16 L2E7E6 fusion protein induces serum antibody that neutralizes across papillomavirus species. 2006, 66 (23):11120-4 Cancer Res.en
dc.identifier.issn0008-5472
dc.identifier.pmid17145854
dc.identifier.doi10.1158/0008-5472.CAN-06-2560
dc.identifier.urihttp://hdl.handle.net/10541/72746
dc.description.abstractOncogenic human papillomavirus (HPV) infection is a necessary cause of cervical cancer. Therefore, vaccination to prevent or eliminate HPV infection could reduce the incidence of cervical cancer. A fusion protein comprising HPV16 L2, E6, and E7 is a candidate combination preventive and therapeutic HPV vaccine. The L1- and L2-specific and neutralizing serum antibody titers and peripheral blood mononucleocyte antigen-specific proliferative responses generated by vaccination thrice at monthly intervals with HPV16 L2E7E6 were compared in two studies: a phase I randomized double-blind placebo controlled dose escalation trial in 40 healthy volunteers and a phase II trial of HPV16 L2E7E6 at the maximum dose in 29 women with high-grade anogenital intraepithelial neoplasia (AGIN). Vaccination of healthy volunteers induced L2-specific serum antibodies that were detected 1 month after the final vaccination (P(binomial) < 0.001). There was a significant trend to seroconversion for HPV16 and HPV18 neutralizing antibodies with increasing vaccine dose (P = 0.006 and P = 0.03, respectively). Seroconversion for HPV18 neutralizing antibodies showed a significant positive trend with increasing dose (P = 0.03) and was associated with seroconversion for HPV16 neutralizing antibodies (P(exact) = 0.04). The antigen-specific proliferative response of vaccinated healthy volunteers also showed a significant trend with increasing vaccine dose (P = 0.04). However, AGIN patients responded less effectively to vaccination than healthy patients for induction of HPV16 L2-specific antibody (P < 0.001) and proliferative responses (P < 0.001). Vaccination of healthy volunteers thrice with 533-mug HPV16 L2E7E6 at monthly intervals induced L2-specific serum antibodies that neutralized across papillomavirus species. Responses in AGIN patients were infrequent.
dc.language.isoenen
dc.subjectAnus Cancer
dc.subjectFemale Genital Cancer
dc.subject.meshAdult
dc.subject.meshAntibodies, Viral
dc.subject.meshAnus Neoplasms
dc.subject.meshCapsid Proteins
dc.subject.meshClinical Trials, Phase I as Topic
dc.subject.meshClinical Trials, Phase II as Topic
dc.subject.meshCross Reactions
dc.subject.meshDouble-Blind Method
dc.subject.meshEnzyme-Linked Immunosorbent Assay
dc.subject.meshFemale
dc.subject.meshGenital Neoplasms, Female
dc.subject.meshHuman papillomavirus 16
dc.subject.meshHuman papillomavirus 18
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshNeutralization Tests
dc.subject.meshOncogene Proteins, Viral
dc.subject.meshPapillomavirus Infections
dc.subject.meshPapillomavirus Vaccines
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshRecombinant Fusion Proteins
dc.subject.meshRepressor Proteins
dc.subject.meshTime Factors
dc.subject.meshVaccination
dc.titleVaccination of healthy volunteers with human papillomavirus type 16 L2E7E6 fusion protein induces serum antibody that neutralizes across papillomavirus species.en
dc.typeArticleen
dc.contributor.departmentDepartment of Pathology, The Johns Hopkins University, Baltimore, Maryland 21231, USA.en
dc.identifier.journalCancer Researchen
html.description.abstractOncogenic human papillomavirus (HPV) infection is a necessary cause of cervical cancer. Therefore, vaccination to prevent or eliminate HPV infection could reduce the incidence of cervical cancer. A fusion protein comprising HPV16 L2, E6, and E7 is a candidate combination preventive and therapeutic HPV vaccine. The L1- and L2-specific and neutralizing serum antibody titers and peripheral blood mononucleocyte antigen-specific proliferative responses generated by vaccination thrice at monthly intervals with HPV16 L2E7E6 were compared in two studies: a phase I randomized double-blind placebo controlled dose escalation trial in 40 healthy volunteers and a phase II trial of HPV16 L2E7E6 at the maximum dose in 29 women with high-grade anogenital intraepithelial neoplasia (AGIN). Vaccination of healthy volunteers induced L2-specific serum antibodies that were detected 1 month after the final vaccination (P(binomial) < 0.001). There was a significant trend to seroconversion for HPV16 and HPV18 neutralizing antibodies with increasing vaccine dose (P = 0.006 and P = 0.03, respectively). Seroconversion for HPV18 neutralizing antibodies showed a significant positive trend with increasing dose (P = 0.03) and was associated with seroconversion for HPV16 neutralizing antibodies (P(exact) = 0.04). The antigen-specific proliferative response of vaccinated healthy volunteers also showed a significant trend with increasing vaccine dose (P = 0.04). However, AGIN patients responded less effectively to vaccination than healthy patients for induction of HPV16 L2-specific antibody (P < 0.001) and proliferative responses (P < 0.001). Vaccination of healthy volunteers thrice with 533-mug HPV16 L2E7E6 at monthly intervals induced L2-specific serum antibodies that neutralized across papillomavirus species. Responses in AGIN patients were infrequent.


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