Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/1... more Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18–related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean fo...
Human papillomaviruses (HPV) infect epithelial cells, including the epithelium of mucous membrane... more Human papillomaviruses (HPV) infect epithelial cells, including the epithelium of mucous membranes. GARDASIL™ was approved for the prevention of genital warts, vaginal, vulvar and cervical cancer caused by HPV types 6, 11, 16 and 18. A competitive Luminex immunoassay (cLIA) has been developed to measure serum levels of virus‐like particle (VLP) type‐specific antibodies. The cLIA uses neutralizing, type‐specific, R‐phycoerythrin‐labeled monoclonal antibodies to monitor the antibody response to type‐specific, neutralizing epitopes on the VLPs. Antibody responses to two distinct neutralizing epitopes on VLP‐6 were characterized using monoclonal antibodies H6.M48 and H6.1C2. Both the H6.M48 and H6.1C2 mAbs bind to HPV‐6 VLPs. Competition assays showed that the H6.M48 and H6.1C2 bind to type‐specific, overlapping, neutralizing epitopes. Avidity analysis shows that the H6.1C2 binds to the HPV 6 VLP with greater avidity than the H6.M48 mAb. Sera from individuals with confirmed HPV‐6 infect...
Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, ... more Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18 L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrollment, the combined incidence of HPV 6/11/16/18-related persistent infection or disease was reduced in vaccine-recipients by 96% (two cases vaccine versus 46 placebo). There were no cases of HPV 6/11/16/18-related precancerous cervical dysplasia or genital warts in vaccine recipients, and six cases in placebo r...
Journal of the European Academy of Dermatology and Venereology, 2009
Background Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly eff... more Background Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly effective in preventing HPV 6/11/16/18‐related cervical and external genital disease. Herein, we evaluated the impact of the quadrivalent HPV 6/11/16/18 L1 VLP vaccine on prevention of HPV‐associated cervico‐genital lesions in a broad population of sexually active European women.Methods Female subjects (N = 9265) aged 16–24 with four or fewer lifetime sexual partners were enrolled and randomized to quadrivalent HPV vaccine or placebo. Subjects underwent cervicovaginal sampling for HPV DNA detection. Papanicolaou testing and anti‐HPV 6/11/16/18 serology testing was also performed.Results Vaccine efficacy against lesions representing immediate cervical cancer precursors (cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ) related to HPV 6/11/16/18 in the per‐protocol population was 100.0%[95% confidence interval (95% CI), 89.8–100.0]. Efficacy against external genital le...
The E4 and L1 gene products of human papillomavirus (HPV) types 6 and 11 are detected in variable... more The E4 and L1 gene products of human papillomavirus (HPV) types 6 and 11 are detected in variable amounts in condylomata acuminata. To study factors associated with detection of these proteins, biopsy specimens containing HPV-6 or -11 were analyzed for E4 protein, L1 protein, and HPV copy number. Seventeen of 50 women biopsied were pregnant. Nine men were also biopsied. Both the E4 and L1 proteins were found more frequently in lesions from pregnant women than from nonpregnant women or men. Both proteins were more often detected in lesions from women than from men. E4 gene products were more often detected in lesions in which L1 protein was detected and a higher HPV copy number was present. Detection of E4 gene products correlates with the detection of L1 protein in condylomata acuminata caused by HPV-6 or -11.
The prevalence of HPV infection in Latin America is among the highest in the world. A quadrivalen... more The prevalence of HPV infection in Latin America is among the highest in the world. A quadrivalent(types 6/11/16/18) human papillomavirus L 1 virus-like-particle vaccine has been shown to be 95-100% effective in preventing HPV 6/11/16/18-related cervical and genital ...
Staphylococcus aureus is a major cause of nosocomial infections worldwide, and the rate of resist... more Staphylococcus aureus is a major cause of nosocomial infections worldwide, and the rate of resistance to clinically relevant antibiotics, such as methicillin, is increasing; furthermore, there has been an increase in the number of methicillin-resistant S. aureus community-acquired infections. Effective treatment and prevention strategies are urgently needed. We investigated the potential of the S. aureus surface protein iron surface determinant B (IsdB) as a prophylactic vaccine against S. aureus infection. IsdB is an iron-sequestering protein that is conserved in diverse S. aureus clinical isolates, both methicillin resistant and methicillin sensitive, and it is expressed on the surface of all isolates tested. The vaccine was highly immunogenic in mice when it was formulated with amorphous aluminum hydroxyphosphate sulfate adjuvant, and the resulting antibody responses were associated with reproducible and significant protection in animal models of infection. The specificity of the...
Epidemiological studies and clinical trials of vaccines depend on the accurate measurement of ant... more Epidemiological studies and clinical trials of vaccines depend on the accurate measurement of antibodies within the polyclonal response to infection or vaccination. The assay currently used to measure the antibody response to vaccination with GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]--a quadrivalent vaccine used against human papillomavirus (HPV) types 6, 11, 16, and 18--is a competitive Luminex assay (cLIA) that uses multiplex technology to detect type-specific neutralizing antibodies against all four HPV types in a single serum sample. Here we describe how the cLIA was developed, as well as how the monoclonal antibodies (mAbs), used as competitors in the assay, were characterized. An enzyme-linked immunosorbent assay (ELISA) was used to screen eight previously-identified mAbs for their ability to bind to HPV virus-like particles (VLPs) in a type-specific and conformation-dependent manner. Four of these mAbs, H6.M48, K11.B2, H16.V5, and H18.J4, met our specifications and were shown to have the potential to neutralize HPV infection in hemagglutination inhibition and pseudovirus neutralization assays. The competitive immunoassay format was able to distinguish type-specific antibodies in the sera of nonhuman primates vaccinated with HPV VLPs, whereas a traditional direct-bind ELISA could not. In addition, the serum antibodies measured by the competitive assay are known to be neutralizing, whereas the ELISA does not distinguish neutralizing and nonneutralizing antibodies in a serum sample. By detecting antibodies to neutralizing epitopes, the competitive assay both demonstrates sero-conversion and provides a potential functional link between sero-conversion and protective immunity in response to vaccination with GARDASIL.
Human papillomavirus (HPV) types 6, 11, 16 and 18 L1 virus-like particles (VLPs) have been used t... more Human papillomavirus (HPV) types 6, 11, 16 and 18 L1 virus-like particles (VLPs) have been used to generate the prophylactic quadrivalent vaccine, Gardasil. There is a high degree of L1 homology between HPV types and it is likely that there is a substantial degree of surface exposed viral epitope similarity. An investigation of vaccine-induced antibody binding and neutralization was undertaken focusing on A7 species members, HPV 18 and 45. Polyclonal sera from Gardasil recipients and from HPV 18 L1 VLP recipients were evaluated. Vaccine-induced antibodies were found to cross-neutralize HPV 45 pseudovirions (PsV) in vitro. Examination of a panel of monoclonal antibodies made against L1 VLPs revealed the presence of conformational, neutralizing epitopes on the surface of VLPs that may be shared between HPV 18 and HPV 45. These data demonstrate that Gardasil(r) immunization induces antibodies capable of neutralizing HPV 18 PsV and HPV 45 PsV in vitro.
ABSTRACT In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL/SILGARD) clinical program, ... more ABSTRACT In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL/SILGARD) clinical program, 73% of women aged 16-26 were naïve to all vaccine HPV types. In these women, prophylactic administration of the vaccine was highly effective in preventing HPV 6/11/16/18-related cervical disease. Of the remaining women, 15% of had evidence of past infection with one or more vaccine HPV types (seropositive and DNA negative) at the time of enrollment. Here we present an analysis in this group of women to determine the efficacy of the HPV 6/11/16/18 vaccine against new cervical and external anogenital disease related to the same vaccine HPV type which had previously been cleared. Vaccine tolerability in this previously infected population was also assessed. 18,174 women were enrolled into 3 clinical studies. The data presented comprise a subset of these subjects (n = 2,617) who were HPV seropositive and DNA negative at enrollment (for >or=1 vaccine type). In each study, subjects were randomized in a 1:1 ratio to receive HPV 6/11/16/18 vaccine or placebo at day 1, month 2 and month 6 (without knowledge of baseline HPV status). Procedures performed for efficacy data evaluation included detailed genital examination, Pap testing, and collection of cervicovaginal and external genital specimens. Analyses of efficacy were carried out in a population stratified by HPV serology and HPV DNA status at enrollment. Subjects were followed for an average of 40 months. Seven subjects in the placebo group developed cervical disease, and eight subjects developed external genital disease related to a vaccine HPV type they had previously encountered. No subject receiving HPV 6/11/16/18 vaccine developed disease to a vaccine HPV type to which they were seropositive and DNA negative at enrolment. These results suggest that natural HPV infection-elicited antibodies may not provide complete protection over time, however the immune response to the HPV 6/11/16/18 vaccine appears to prevent reinfection or reactivation of disease with vaccine HPV types. Vaccine-related adverse experiences were higher among subjects receiving vaccine, mostly due to increased injection site adverse experiences.
Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/1... more Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18–related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean fo...
Acta Obstetricia et Gynecologica Scandinavica, 2008
Background. Long‐term efficacy evaluations of a quadrivalent HPV type 6/11/16/18 vaccine are ongo... more Background. Long‐term efficacy evaluations of a quadrivalent HPV type 6/11/16/18 vaccine are ongoing in the Nordic region. As there are limited epidemiological data on HPV infection in Norway, we determined prevalence and identified sociobehavioural correlates of HPV 6/11/16/18 infection in young Norwegian women. Methods. Norwegian (n = 898) women, aged 16–24 years, were enrolled in a 4‐year prospective study. At enrolment and at 6‐month intervals thereafter, an interview on behavioural data and a gynaecological examination were undertaken. Genital samples were tested for the L1, E6 and E7 genes of HPV‐6/11/16/18, and serum anti‐HPV‐6/11/16/18 levels were measured using a competitive Luminex immunoassay (cLIA). Results. DNA and seroprevalence of HPV 6, 11, 16 or 18 ranged from 0.9 to 16.3% and 2.6 to 16.2%, respectively; and most infected women (∼75%) were infected with only 1 type. Of the HPV DNA positive cases, 54.3, 50.0, 47.3 and 38.5% had detectable HPV 6, 11, 16 or 18 antibodi...
Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/1... more Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18–related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean fo...
Human papillomaviruses (HPV) infect epithelial cells, including the epithelium of mucous membrane... more Human papillomaviruses (HPV) infect epithelial cells, including the epithelium of mucous membranes. GARDASIL™ was approved for the prevention of genital warts, vaginal, vulvar and cervical cancer caused by HPV types 6, 11, 16 and 18. A competitive Luminex immunoassay (cLIA) has been developed to measure serum levels of virus‐like particle (VLP) type‐specific antibodies. The cLIA uses neutralizing, type‐specific, R‐phycoerythrin‐labeled monoclonal antibodies to monitor the antibody response to type‐specific, neutralizing epitopes on the VLPs. Antibody responses to two distinct neutralizing epitopes on VLP‐6 were characterized using monoclonal antibodies H6.M48 and H6.1C2. Both the H6.M48 and H6.1C2 mAbs bind to HPV‐6 VLPs. Competition assays showed that the H6.M48 and H6.1C2 bind to type‐specific, overlapping, neutralizing epitopes. Avidity analysis shows that the H6.1C2 binds to the HPV 6 VLP with greater avidity than the H6.M48 mAb. Sera from individuals with confirmed HPV‐6 infect...
Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, ... more Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18 L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrollment, the combined incidence of HPV 6/11/16/18-related persistent infection or disease was reduced in vaccine-recipients by 96% (two cases vaccine versus 46 placebo). There were no cases of HPV 6/11/16/18-related precancerous cervical dysplasia or genital warts in vaccine recipients, and six cases in placebo r...
Journal of the European Academy of Dermatology and Venereology, 2009
Background Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly eff... more Background Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly effective in preventing HPV 6/11/16/18‐related cervical and external genital disease. Herein, we evaluated the impact of the quadrivalent HPV 6/11/16/18 L1 VLP vaccine on prevention of HPV‐associated cervico‐genital lesions in a broad population of sexually active European women.Methods Female subjects (N = 9265) aged 16–24 with four or fewer lifetime sexual partners were enrolled and randomized to quadrivalent HPV vaccine or placebo. Subjects underwent cervicovaginal sampling for HPV DNA detection. Papanicolaou testing and anti‐HPV 6/11/16/18 serology testing was also performed.Results Vaccine efficacy against lesions representing immediate cervical cancer precursors (cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ) related to HPV 6/11/16/18 in the per‐protocol population was 100.0%[95% confidence interval (95% CI), 89.8–100.0]. Efficacy against external genital le...
The E4 and L1 gene products of human papillomavirus (HPV) types 6 and 11 are detected in variable... more The E4 and L1 gene products of human papillomavirus (HPV) types 6 and 11 are detected in variable amounts in condylomata acuminata. To study factors associated with detection of these proteins, biopsy specimens containing HPV-6 or -11 were analyzed for E4 protein, L1 protein, and HPV copy number. Seventeen of 50 women biopsied were pregnant. Nine men were also biopsied. Both the E4 and L1 proteins were found more frequently in lesions from pregnant women than from nonpregnant women or men. Both proteins were more often detected in lesions from women than from men. E4 gene products were more often detected in lesions in which L1 protein was detected and a higher HPV copy number was present. Detection of E4 gene products correlates with the detection of L1 protein in condylomata acuminata caused by HPV-6 or -11.
The prevalence of HPV infection in Latin America is among the highest in the world. A quadrivalen... more The prevalence of HPV infection in Latin America is among the highest in the world. A quadrivalent(types 6/11/16/18) human papillomavirus L 1 virus-like-particle vaccine has been shown to be 95-100% effective in preventing HPV 6/11/16/18-related cervical and genital ...
Staphylococcus aureus is a major cause of nosocomial infections worldwide, and the rate of resist... more Staphylococcus aureus is a major cause of nosocomial infections worldwide, and the rate of resistance to clinically relevant antibiotics, such as methicillin, is increasing; furthermore, there has been an increase in the number of methicillin-resistant S. aureus community-acquired infections. Effective treatment and prevention strategies are urgently needed. We investigated the potential of the S. aureus surface protein iron surface determinant B (IsdB) as a prophylactic vaccine against S. aureus infection. IsdB is an iron-sequestering protein that is conserved in diverse S. aureus clinical isolates, both methicillin resistant and methicillin sensitive, and it is expressed on the surface of all isolates tested. The vaccine was highly immunogenic in mice when it was formulated with amorphous aluminum hydroxyphosphate sulfate adjuvant, and the resulting antibody responses were associated with reproducible and significant protection in animal models of infection. The specificity of the...
Epidemiological studies and clinical trials of vaccines depend on the accurate measurement of ant... more Epidemiological studies and clinical trials of vaccines depend on the accurate measurement of antibodies within the polyclonal response to infection or vaccination. The assay currently used to measure the antibody response to vaccination with GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]--a quadrivalent vaccine used against human papillomavirus (HPV) types 6, 11, 16, and 18--is a competitive Luminex assay (cLIA) that uses multiplex technology to detect type-specific neutralizing antibodies against all four HPV types in a single serum sample. Here we describe how the cLIA was developed, as well as how the monoclonal antibodies (mAbs), used as competitors in the assay, were characterized. An enzyme-linked immunosorbent assay (ELISA) was used to screen eight previously-identified mAbs for their ability to bind to HPV virus-like particles (VLPs) in a type-specific and conformation-dependent manner. Four of these mAbs, H6.M48, K11.B2, H16.V5, and H18.J4, met our specifications and were shown to have the potential to neutralize HPV infection in hemagglutination inhibition and pseudovirus neutralization assays. The competitive immunoassay format was able to distinguish type-specific antibodies in the sera of nonhuman primates vaccinated with HPV VLPs, whereas a traditional direct-bind ELISA could not. In addition, the serum antibodies measured by the competitive assay are known to be neutralizing, whereas the ELISA does not distinguish neutralizing and nonneutralizing antibodies in a serum sample. By detecting antibodies to neutralizing epitopes, the competitive assay both demonstrates sero-conversion and provides a potential functional link between sero-conversion and protective immunity in response to vaccination with GARDASIL.
Human papillomavirus (HPV) types 6, 11, 16 and 18 L1 virus-like particles (VLPs) have been used t... more Human papillomavirus (HPV) types 6, 11, 16 and 18 L1 virus-like particles (VLPs) have been used to generate the prophylactic quadrivalent vaccine, Gardasil. There is a high degree of L1 homology between HPV types and it is likely that there is a substantial degree of surface exposed viral epitope similarity. An investigation of vaccine-induced antibody binding and neutralization was undertaken focusing on A7 species members, HPV 18 and 45. Polyclonal sera from Gardasil recipients and from HPV 18 L1 VLP recipients were evaluated. Vaccine-induced antibodies were found to cross-neutralize HPV 45 pseudovirions (PsV) in vitro. Examination of a panel of monoclonal antibodies made against L1 VLPs revealed the presence of conformational, neutralizing epitopes on the surface of VLPs that may be shared between HPV 18 and HPV 45. These data demonstrate that Gardasil(r) immunization induces antibodies capable of neutralizing HPV 18 PsV and HPV 45 PsV in vitro.
ABSTRACT In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL/SILGARD) clinical program, ... more ABSTRACT In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL/SILGARD) clinical program, 73% of women aged 16-26 were naïve to all vaccine HPV types. In these women, prophylactic administration of the vaccine was highly effective in preventing HPV 6/11/16/18-related cervical disease. Of the remaining women, 15% of had evidence of past infection with one or more vaccine HPV types (seropositive and DNA negative) at the time of enrollment. Here we present an analysis in this group of women to determine the efficacy of the HPV 6/11/16/18 vaccine against new cervical and external anogenital disease related to the same vaccine HPV type which had previously been cleared. Vaccine tolerability in this previously infected population was also assessed. 18,174 women were enrolled into 3 clinical studies. The data presented comprise a subset of these subjects (n = 2,617) who were HPV seropositive and DNA negative at enrollment (for >or=1 vaccine type). In each study, subjects were randomized in a 1:1 ratio to receive HPV 6/11/16/18 vaccine or placebo at day 1, month 2 and month 6 (without knowledge of baseline HPV status). Procedures performed for efficacy data evaluation included detailed genital examination, Pap testing, and collection of cervicovaginal and external genital specimens. Analyses of efficacy were carried out in a population stratified by HPV serology and HPV DNA status at enrollment. Subjects were followed for an average of 40 months. Seven subjects in the placebo group developed cervical disease, and eight subjects developed external genital disease related to a vaccine HPV type they had previously encountered. No subject receiving HPV 6/11/16/18 vaccine developed disease to a vaccine HPV type to which they were seropositive and DNA negative at enrolment. These results suggest that natural HPV infection-elicited antibodies may not provide complete protection over time, however the immune response to the HPV 6/11/16/18 vaccine appears to prevent reinfection or reactivation of disease with vaccine HPV types. Vaccine-related adverse experiences were higher among subjects receiving vaccine, mostly due to increased injection site adverse experiences.
Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/1... more Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18–related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean fo...
Acta Obstetricia et Gynecologica Scandinavica, 2008
Background. Long‐term efficacy evaluations of a quadrivalent HPV type 6/11/16/18 vaccine are ongo... more Background. Long‐term efficacy evaluations of a quadrivalent HPV type 6/11/16/18 vaccine are ongoing in the Nordic region. As there are limited epidemiological data on HPV infection in Norway, we determined prevalence and identified sociobehavioural correlates of HPV 6/11/16/18 infection in young Norwegian women. Methods. Norwegian (n = 898) women, aged 16–24 years, were enrolled in a 4‐year prospective study. At enrolment and at 6‐month intervals thereafter, an interview on behavioural data and a gynaecological examination were undertaken. Genital samples were tested for the L1, E6 and E7 genes of HPV‐6/11/16/18, and serum anti‐HPV‐6/11/16/18 levels were measured using a competitive Luminex immunoassay (cLIA). Results. DNA and seroprevalence of HPV 6, 11, 16 or 18 ranged from 0.9 to 16.3% and 2.6 to 16.2%, respectively; and most infected women (∼75%) were infected with only 1 type. Of the HPV DNA positive cases, 54.3, 50.0, 47.3 and 38.5% had detectable HPV 6, 11, 16 or 18 antibodi...
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Papers by Janine Bryan