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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.
Hum Vaccin Immunother. 2014; 10(12):3455-65.HV

Abstract

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.

Authors+Show Affiliations

a Montefiore Medical Center; Albert Einstein College of Medicine; Department of Obstetrics & Gynecology and Women's Health ; Bronx , NY USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25483700

Citation

Einstein, Mark H., et al. "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." Human Vaccines & Immunotherapeutics, vol. 10, no. 12, 2014, pp. 3455-65.
Einstein MH, Levin MJ, Chatterjee A, et al. 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. Hum Vaccin Immunother. 2014;10(12):3455-65.
Einstein, M. H., Levin, M. J., Chatterjee, A., Chakhtoura, N., Takacs, P., Catteau, G., Dessy, F. J., Moris, P., Lin, L., Struyf, F., & Dubin, G. (2014). 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. Human Vaccines & Immunotherapeutics, 10(12), 3455-65. https://doi.org/10.4161/hv.36117
Einstein MH, et al. 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. Hum Vaccin Immunother. 2014;10(12):3455-65. PubMed PMID: 25483700.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Einstein,Mark H, AU - Levin,Myron J, AU - Chatterjee,Archana, AU - Chakhtoura,Nahida, AU - Takacs,Peter, AU - Catteau,Grégory, AU - Dessy,Francis J, AU - Moris,Philippe, AU - Lin,Lan, AU - Struyf,Frank, AU - Dubin,Gary, AU - ,, PY - 2014/12/9/entrez PY - 2014/12/9/pubmed PY - 2015/10/16/medline KW - 50 μg) adsorbed on aluminum salt (500 μg Al(OH)3) KW - ANOVA, analysis of variance KW - AS04, Adjuvant System containing 3-O-desacyl-4’-monophosphoryl lipid A (MPL KW - ATP, according-to-protocol KW - CI, confidence interval KW - CMI, cell-mediated immune KW - CVS, cervicovaginal secretion KW - Cervarix® KW - ED50, effective dose producing 50% response KW - ELISA, enzyme-linked immunosorbent assay KW - GM, geometric mean KW - GMR, geometric mean (titer) ratio KW - GMT, geometric mean titer KW - Gardasil® KW - HPA, Health Protection Agency KW - HPV, human papillomavirus KW - IgG, immunoglobulin G KW - MSC, medically significant condition KW - NOAD, new onset autoimmune disease KW - NOCD, new onset chronic disease KW - PBMC, peripheral blood mononuclear cells KW - PBNA, pseudovirion-based neutralization assay KW - SAE, serious adverse event KW - TVC, total vaccinated cohort KW - VLP, virus-like particle KW - human papillomavirus KW - immunogenicity KW - nAb(s), neutralizing antibody(ies) KW - safety SP - 3455 EP - 65 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 10 IS - 12 N2 - 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/25483700/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_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.36117 DB - PRIME DP - Unbound Medicine ER -