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[PMID]: | 28954299 |
[Au] Autor: | Safaeian M; Sampson JN; Pan Y; Porras C; Kemp TJ; Herrero R; Quint W; van Doorn LJ; Schussler J; Lowy DR; Schiller J; Schiffman MT; Rodriguez AC; Gail MH; Hildesheim A; Gonzalez P; Pinto LA; Kreimer AR; Costa Rica HPV Vaccine Trial (CVT) Group |
[Ad] Endereço: | Roche Molecular Diagnostics, Pleasanton, CA; National Cancer Institute, National Institutes of Health, Bethesda, MD; HPV Immunology Laboratory, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD; Agencia Costarricense de Investigaciones Biomédicas (ACI |
[Ti] Título: | Durability of Protection Afforded by Fewer Doses of the HPV16/18 Vaccine: The CVT Trial. |
[So] Source: | J Natl Cancer Inst;110(2), 2018 Feb 01. | [Is] ISSN: | 1460-2105 |
[Cp] País de publicação: | United States |
[La] Idioma: | eng |
[Ab] Resumo: | Background: Previously, we demonstrated similar human papillomavirus (HPV)16/18 vaccine efficacy estimates and stable HPV16/18 antibody levels four years postvaccination in a nonrandomized analysis of women who received a varying number of doses of the bivalent HPV16/18 vaccine. Here we extend data to seven years following initial vaccination. Methods: We evaluated HPV16/18-vaccinated women who received one (n = 134), two (n 0/1 = 193, n 0/6 = 79), or three doses (n = 2043) to a median of 6.9 years postvaccination. Cervical HPV DNA was measured with the SPF10- DEIA-LiPA PCR system; HPV16/18-specific antibody levels were measured using enzyme-linked immunosorbent assays (n = 486). Infection and immunological measures were compared across vaccine dose groups. Prevalent HPV infection at year 7 was also compared with an unvaccinated control group (UCG). All statistical tests were two-sided. Results: Among women in the three-dose, two-dose 0/6 , two-dose 0/1 , and one-dose groups, cumulative incident HPV16/18 infection rates (No. of events/No. of individuals) were 4.3% (88/2036, 95% confidence interval [CI] = 3.5% to 5.3%), 3.8% (3/78, 95% CI = 1.0% to 10.1%), 3.6% (7/192, 95% CI = 1.6% to 7.1%), and 1.5% (2/133, 95% CI = 0.3% to 4.9%; P = 1.00, .85, .17 comparing the two-dose 0/6 , two-dose 0/1 , and one-dose groups to the three-dose group, respectively). The prevalence of other carcinogenic and noncarcinogenic HPV types, excluding HPV16/18/31/33/45, were high and not statistically different among all dose groups, indicating that the low incidence of HPV16/18 in the one- and two-dose groups was not due to lack of exposure. At seven years, 100% of participants in all dose groups remained HPV16 and HPV18 seropositive. A non-statistically significant decrease in the geometric mean of the HPV16 antibody levels between years 4 and 7 was observed among women in the three-dose group: -10.8% (95% CI = -25.3% to 6.6%); two-dose (0/6 months) group: -17.3% (95% CI = -39.3% to 12.8%), two-dose (0/1 month) group: -6.9% (95% CI = -22.1% to 11.2%), and one-dose group: -5.5% (95% CI = -29.7% to 27.0%); results were similar for HPV18. Conclusions: At an average of seven years of follow-up, we observed similar low rates of HPV16/18 infections and slight, if any, decreases in HPV16/18 antibody levels by dose group. |
[Mh] Termos MeSH primário: |
Papillomavirus Humano 16/imunologia Papillomavirus Humano 18/imunologia Vacinas contra Papillomavirus/administração & dosagem Vacinas contra Papillomavirus/imunologia
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[Mh] Termos MeSH secundário: |
Adolescente Adulto Anticorpos Antivirais/sangue Anticorpos Antivirais/imunologia Colo do Útero/virologia DNA Viral/genética Feminino Papillomavirus Humano 16/genética Papillomavirus Humano 18/genética Seres Humanos Infecções por Papillomavirus/imunologia Infecções por Papillomavirus/prevenção & controle Infecções por Papillomavirus/virologia Doenças do Colo do Útero/imunologia Doenças do Colo do Útero/prevenção & controle Doenças do Colo do Útero/virologia Adulto Jovem
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[Pt] Tipo de publicação: | CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL |
[Nm] Nome de substância:
| 0 (Antibodies, Viral); 0 (DNA, Viral); 0 (Papillomavirus Vaccines); 0 (human papillomavirus vaccine, L1 type 16, 18) |
[Em] Mês de entrada: | 1710 |
[Cu] Atualização por classe: | 180308 |
[Lr] Data última revisão:
| 180308 |
[Sb] Subgrupo de revista: | IM |
[Da] Data de entrada para processamento: | 170928 |
[St] Status: | MEDLINE |
[do] DOI: | 10.1093/jnci/djx158 |
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