Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18–45 years: Follow-up through Month 48 in a Phase III randomized study
| Autor: | Frank Struyf, Mark H. Einstein, Philippe Moris, Bradley Fox, Karen G. Swenson, Myron J. Levin, Bethany Hoffman, Marina Fernandez, Nahida Chakhtoura, Robert Yoachim, Grégory Catteau, Lan Lin, Mark M. Blatter, Cheryl A. Hansen, Sidney A. Funk, Archana Chatterjee, Terry D. Klein, David L. Fried, Mark Turner, Jacob Lalezari, Peter Takacs, Michael J. Noss, Michael W. Warren, Francis Dessy, Troy Thompson, Christopher V. Chambers, Rhoda S. Sperling, James H. Silverblatt, Gary Dubin, James Hedrick |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
CD4-Positive T-Lymphocytes safety Adolescent Immunology immunogenicity Antibodies Viral law.invention Young Adult Immune system Human Papillomavirus Recombinant Vaccine Quadrivalent Types 6 11 16 18 Randomized controlled trial law Humans Immunology and Allergy Medicine Papillomavirus Vaccines Human papillomavirus Gardasil® human papillomavirus Pharmacology Hpv human papillomavirus B-Lymphocytes business.industry Immunogenicity Gardasil virus diseases Middle Aged female genital diseases and pregnancy complications Vaccination Female HPV/Research Papers Cervarix business Immunologic Memory Cervarix® Follow-Up Studies medicine.drug |
| Zdroj: | Human Vaccines & Immunotherapeutics |
| ISSN: | 2164-554X 2164-5515 |
| DOI: | 10.4161/hv.36117 |
| Popis: | We previously reported higher anti-HPV-16 and -18 immune responses induced by HPV-16/18 vaccine compared with HPV-6/11/16/18 vaccine at Month 7 (one month after completion of full vaccination series) in women aged 18–45 y in an observer-blind study NCT00423046; the differences of immune response magnitudes were maintained up to Month 24. Here we report follow-up data through Month 48. At Month 48, in according-to-protocol cohort for immunogenicity (seronegative and DNA-negative for HPV type analyzed at baseline), geometric mean titers of serum neutralizing antibodies were 2.0- to 5.2-fold higher (HPV-16) and 8.6- to 12.8-fold higher (HPV-18) in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. The majority of women in both vaccine groups remained seropositive for HPV-16. The same trend was observed for HPV-18 in HPV-16/18 vaccine group; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably, particularly in the older age groups. In the total vaccinated cohort (regardless of baseline serological and HPV-DNA status), anti-HPV-16 and -18 neutralizing antibody levels induced by HPV-16/18 vaccine were higher than those induced by HPV-6/11/16/18 vaccine. CD4+ T-cell response for HPV-16 and HPV-18 was higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Memory B-cell responses appeared similar between vaccine groups. Both vaccines were generally well tolerated. Overall, the higher immune response observed with the HPV-16/18 vaccine was maintained up to Month 48. A head-to-head study incorporating clinical endpoints would be required to confirm whether the observed differences in immune response between the vaccines influence the duration of protection they provided. |
| Databáze: | OpenAIRE |
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