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A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of a Replication-Defective Herpes Simplex Virus (HSV) Type 2 Vaccine, HSV529, in Adults With or Without HSV Infection.
Dropulic, Lesia K; Oestreich, Makinna C; Pietz, Harlan L; Laing, Kerry J; Hunsberger, Sally; Lumbard, Keith; Garabedian, Doreen; Turk, Siu Ping; Chen, Aiying; Hornung, Ronald L; Seshadri, Chetan; Smith, Malisa T; Hosken, Nancy A; Phogat, Sanjay; Chang, Lee-Jah; Koelle, David M; Wang, Kening; Cohen, Jeffrey I.
Afiliação
  • Dropulic LK; Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.
  • Oestreich MC; Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.
  • Pietz HL; Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.
  • Laing KJ; Department of Medicine, School of Medicine, University of Washington.
  • Hunsberger S; Biostatistics Research Branch, NIAID, NIH, Rockville.
  • Lumbard K; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.
  • Garabedian D; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.
  • Turk SP; Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.
  • Chen A; Global Biostatistics and Programming, Pennsylvania.
  • Hornung RL; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.
  • Seshadri C; Department of Medicine, School of Medicine, University of Washington.
  • Smith MT; Department of Medicine, School of Medicine, University of Washington.
  • Hosken NA; Department of Medicine, School of Medicine, University of Washington.
  • Phogat S; New Vaccines Portfolio Strategy and Execution, Pennsylvania.
  • Chang LJ; Global Clinical Sciences, Sanofi Pasteur, Swiftwater, Pennsylvania.
  • Koelle DM; Department of Medicine, School of Medicine, University of Washington.
  • Wang K; Department of Laboratory Medicine, School of Medicine, University of Washington.
  • Cohen JI; Department of Global Health, School of Medicine, University of Washington.
J Infect Dis ; 220(6): 990-1000, 2019 08 09.
Article em En | MEDLINE | ID: mdl-31058977
BACKGROUND: Herpes simplex virus 2 (HSV2) causes genital herpes in >400 million persons worldwide. METHODS: We conducted a randomized, double-blinded, placebo-controlled trial of a replication-defective HSV2 vaccine, HSV529. Twenty adults were enrolled in each of 3 serogroups of individuals: those negative for both HSV1 and HSV2 (HSV1-/HSV2-), those positive or negative for HSV1 and positive for HSV2 (HSV1±/HSV2+), and those positive for HSV1 and negative for HSV2 (HSV1+/HSV2-). Sixty participants received vaccine or placebo at 0, 1, and 6 months. The primary end point was the frequency of solicited local and systemic reactions to vaccination. RESULTS: Eighty-nine percent of vaccinees experienced mild-to-moderate solicited injection site reactions, compared with 47% of placebo recipients (95% confidence interval [CI], 12.9%-67.6%; P = .006). Sixty-four percent of vaccinees experienced systemic reactions, compared with 53% of placebo recipients (95% CI, -17.9% to 40.2%; P = .44). Seventy-eight percent of HSV1-/HSV2- vaccine recipients had a ≥4-fold increase in neutralizing antibody titer after 3 doses of vaccine, whereas none of the participants in the other serogroups had such responses. HSV2-specific CD4+ T-cell responses were detected in 36%, 46%, and 27% of HSV1-/HSV2-, HSV1±/HSV2+, and HSV1+/HSV2- participants, respectively, 1 month after the third dose of vaccine, and CD8+ T-cell responses were detected in 14%, 8%, and 18% of participants, respectively. CONCLUSIONS: HSV529 vaccine was safe and elicited neutralizing antibody and modest CD4+ T-cell responses in HSV-seronegative vaccinees. CLINICAL TRIALS REGISTRATION: NCT01915212.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas Virais / Herpes Genital / Vacinação / Herpesvirus Humano 2 / Herpes Simples Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas Virais / Herpes Genital / Vacinação / Herpesvirus Humano 2 / Herpes Simples Idioma: En Ano de publicação: 2019 Tipo de documento: Article