A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years
This study assessed long-term immunogenicity and safety following 3 doses of AS04-adjuvanted human papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) vaccine in females 10–14 years old. Girls included in the immunogenicity subset in the primary controlled, observer-blinded, randomized study (NC...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2019-08-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2019.1625644 |
| _version_ | 1797633619309625344 |
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| author | Tino F. Schwarz Li-Min Huang Alejandra Valencia Falko Panzer Cheng-Hsun Chiu Annabelle Decreux Sylviane Poncelet Naveen Karkada Nicolas Folschweiller Lan Lin Gary Dubin Frank Struyf |
| author_facet | Tino F. Schwarz Li-Min Huang Alejandra Valencia Falko Panzer Cheng-Hsun Chiu Annabelle Decreux Sylviane Poncelet Naveen Karkada Nicolas Folschweiller Lan Lin Gary Dubin Frank Struyf |
| author_sort | Tino F. Schwarz |
| collection | DOAJ |
| description | This study assessed long-term immunogenicity and safety following 3 doses of AS04-adjuvanted human papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) vaccine in females 10–14 years old. Girls included in the immunogenicity subset in the primary controlled, observer-blinded, randomized study (NCT00196924) who received 3 doses were invited for a 10-year follow-up (NCT00316706 and NCT00877877). Serum antibody responses against HPV-16/18 (vaccine types) and HPV-31/45 (non-vaccine types) were measured by enzyme-linked immunosorbent assay (ELISA) using type-specific VLP as coating antigens. Serious adverse events (SAEs) and pregnancy information were recorded. At Month (M) 120, all subjects (N = 418, according-to-protocol immunogenicity cohort) were seropositive for anti-HPV-16/18 antibodies. Geometric mean titers (GMTs) were 1589.9 ELISA Units [EU]/mL (95% confidence interval [CI]: 1459.8–1731.6) for anti-HPV-16 and 597.2 EU/mL (95% CI: 541.7–658.5) for anti-HPV-18 in subjects seronegative at baseline for the type analyzed. Post hoc mathematical modeling predicted a durability ≥50 years for anti-HPV-16 and anti-HPV-18. For the non-vaccine humoral type response, all initially seronegative subjects had seroconverted at M7, with anti-HPV-31 GMT of 2030.5 EU/mL (95% CI: 1766.2–2334.4) and anti-HPV-45 GMT of 2300.8 EU/mL (95% CI: 2036.8–2599.0). At M120, 87.7% and 85.1% remained seropositive for anti-HPV-31 with GMT of 242.9 EU/mL (95% CI: 201.4–293.0) and anti-HPV-45 with GMT of 204.7 EU/mL (95% CI: 170.0–246.6). During the 10-year follow-up, no SAEs or abnormal pregnancy outcomes were causally related to vaccination. Three doses of the AS04-HPV-16/18 vaccine induced high and sustained antibody response against HPV-16,18,31 and 45 in girls aged 10–14 years during the 10-year follow-up, with an acceptable long-term safety profile. |
| first_indexed | 2024-03-11T11:57:26Z |
| format | Article |
| id | doaj.art-12db5ea015de4256acac886bf78b7c59 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T11:57:26Z |
| publishDate | 2019-08-01 |
| publisher | Taylor & Francis Group |
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| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-12db5ea015de4256acac886bf78b7c592023-11-08T12:08:16ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2019-08-01157-81970197910.1080/21645515.2019.16256441625644A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 yearsTino F. Schwarz0Li-Min Huang1Alejandra Valencia2Falko Panzer3Cheng-Hsun Chiu4Annabelle Decreux5Sylviane Poncelet6Naveen Karkada7Nicolas Folschweiller8Lan Lin9Gary Dubin10Frank Struyf11Klinikum Würzburg Mitte, Standort JuliusspitalNational Taiwan University HospitalFundación de Santa Fe de BogotáPractice for Pediatric and Adolescent MedicineChang Gung University College of MedicineGSKGSKGSKGSKGSKGSKGSKThis study assessed long-term immunogenicity and safety following 3 doses of AS04-adjuvanted human papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) vaccine in females 10–14 years old. Girls included in the immunogenicity subset in the primary controlled, observer-blinded, randomized study (NCT00196924) who received 3 doses were invited for a 10-year follow-up (NCT00316706 and NCT00877877). Serum antibody responses against HPV-16/18 (vaccine types) and HPV-31/45 (non-vaccine types) were measured by enzyme-linked immunosorbent assay (ELISA) using type-specific VLP as coating antigens. Serious adverse events (SAEs) and pregnancy information were recorded. At Month (M) 120, all subjects (N = 418, according-to-protocol immunogenicity cohort) were seropositive for anti-HPV-16/18 antibodies. Geometric mean titers (GMTs) were 1589.9 ELISA Units [EU]/mL (95% confidence interval [CI]: 1459.8–1731.6) for anti-HPV-16 and 597.2 EU/mL (95% CI: 541.7–658.5) for anti-HPV-18 in subjects seronegative at baseline for the type analyzed. Post hoc mathematical modeling predicted a durability ≥50 years for anti-HPV-16 and anti-HPV-18. For the non-vaccine humoral type response, all initially seronegative subjects had seroconverted at M7, with anti-HPV-31 GMT of 2030.5 EU/mL (95% CI: 1766.2–2334.4) and anti-HPV-45 GMT of 2300.8 EU/mL (95% CI: 2036.8–2599.0). At M120, 87.7% and 85.1% remained seropositive for anti-HPV-31 with GMT of 242.9 EU/mL (95% CI: 201.4–293.0) and anti-HPV-45 with GMT of 204.7 EU/mL (95% CI: 170.0–246.6). During the 10-year follow-up, no SAEs or abnormal pregnancy outcomes were causally related to vaccination. Three doses of the AS04-HPV-16/18 vaccine induced high and sustained antibody response against HPV-16,18,31 and 45 in girls aged 10–14 years during the 10-year follow-up, with an acceptable long-term safety profile.http://dx.doi.org/10.1080/21645515.2019.1625644hpv-16/18 as04-adjuvanted vaccinehpv-31hpv-45non-vaccine typescross-reactivityimmunogenicity persistencesafetypredictive modeling |
| spellingShingle | Tino F. Schwarz Li-Min Huang Alejandra Valencia Falko Panzer Cheng-Hsun Chiu Annabelle Decreux Sylviane Poncelet Naveen Karkada Nicolas Folschweiller Lan Lin Gary Dubin Frank Struyf A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years Human Vaccines & Immunotherapeutics hpv-16/18 as04-adjuvanted vaccine hpv-31 hpv-45 non-vaccine types cross-reactivity immunogenicity persistence safety predictive modeling |
| title | A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years |
| title_full | A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years |
| title_fullStr | A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years |
| title_full_unstemmed | A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years |
| title_short | A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years |
| title_sort | ten year study of immunogenicity and safety of the as04 hpv 16 18 vaccine in adolescent girls aged 10 14 years |
| topic | hpv-16/18 as04-adjuvanted vaccine hpv-31 hpv-45 non-vaccine types cross-reactivity immunogenicity persistence safety predictive modeling |
| url | http://dx.doi.org/10.1080/21645515.2019.1625644 |
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