149. Immunogenicity, Safety and Post-hoc Efficacy Assessment of the Adjuvanted Recombinant Zoster Vaccine in Adults with Hematologic Malignancies: A Phase 3, Randomized Clinical Trial
Session: Oral Abstract Session: Adult and Adolescent Vaccines
Thursday, October 4, 2018: 10:30 AM
Room: S 158

Background: Patients with hematologic malignancies treated with anticancer immunosuppressive therapies (ITs) are at increased risk of herpes zoster (HZ). In a previous report of this phase 3, observer-blind, multicenter trial (NCT01767467), the adjuvanted recombinant zoster vaccine (RZV) was shown to be immunogenic and well-tolerated in ≥18 years of age patients with hematologic malignancies who completed or were undergoing anticancer IT.1 Here we report end-of-study results from the same trial.

Methods: Participants were randomized 1:1 to receive 2 doses of RZV or placebo (PL) 1-2 months (M) apart, either ≥10 days before or after a cancer therapy cycle, or 10 days to 6 months after cancer therapy ended. Humoral and cell-mediated immune (CMI) responses were evaluated at 1M and 12M post-dose 2 (M2 and M13, respectively). Confirmatory objectives were to evaluate humoral response rate to RZV and to compare humoral immune responses to RZV and PL at M2 excluding either subjects with chronic lymphocytic leukemia and non-Hodgkin B-cell lymphoma (NHBCL), or only those with NHBCL. Efficacy against HZ was explored in a post-hoc analysis of confirmed HZ cases. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Serious AEs (SAEs), and potential immune-mediated diseases (pIMDs) were recorded throughout the study.

Results: Of the 562 (RZV: 283, PL: 279) treated participants, 415 (RZV: 217, PL: 198)/310 (RZV: 168, PL: 142) were included in the according-to-protocol (ATP) cohort for humoral immunogenicity/immune persistence. The ATP sub-cohort for CMI included 132 (RZV: 69, PL: 63) participants at M2 and 100 (RZV: 54, PL: 46) at M13. All confirmatory immunogenicity objectives were met (Table 1). RZV efficacy against HZ, assessed post-hoc, was 87.2% (Table 2). RZV was more reactogenic than PL. The occurrence of unsolicited AEs, SAEs and pIMDs was similar between the study groups (Table 3).

Conclusion: RZV induced robust humoral and cellular immune responses and showed an effect in the reduction of HZ incidence in patients with hematologic malignancies who completed or were undergoing anticancer IT. No safety concerns were identified.

1Oostvogels et al, IDWeek2017, abs 1344

Funding: GlaxoSmithKline Biologicals SA

 

Alemnew F. Dagnew, MD, MSc1, Osman Ilhan, MD2, Won-Sik Lee, MD, PhD3, Dariusz Woszczyk, MD, PhD4, Jae-Yong Kwak, MD, PhD5, Stella Bowcock, MA, MBBS6, Sang Kyun Sohn, MD7, Gabriela Rodriguez Macías, MD8, Tzeon-Jye Chiou, MD9, Dimas Quiel, MD10, Mickael Aoun, MD11, Maria Belen Navarro Matilla, MA, MBBS12, Javier De La Serna, MD13, Samuel Milliken, MBBS FRACP FRCPA14, John Murphy, MB15, Shelly A. McNeil, MD, FIDSA16, Bruno Salaun, PhD17, Emmanuel Di Paolo, MSc17, Laura Campora, MD18, Marta López-Fauqued, PhD18, Mohamed El Idrissi, MSc17, Anne Schuind, MD1, Thomas C. Heineman, MD, PhD19, Peter Van Den Steen, PhD18 and Lidia Oostvogels, MD20, (1)GSK, Rockville, MD, (2)Ankara University, Ankara, Turkey, (3)Inje University Busan Paik Hospital, Busan, Korea, Republic of (South), (4)University of Opole, Provincial Hospital, Opole, Poland, (5)Chonbuk National University Hospital, Jeonju, Korea, Republic of (South), (6)King’s College Hospital, London, United Kingdom, (7)School of Medicine, Kyungpook National University, Daegu, Korea, Republic of (South), (8)Gergorio Marañón Hospital, Madrid, Spain, (9)Taipei Veterans General Hospital, Taipei, Taiwan, (10)Complejo Hospitalario Dr. Arnulfo Arias Madrid, Panama, Panama, (11)Institut Jules Bordet, Brussels, Belgium, (12)Hospital Universitario Puerta de Hierro, Madrid, Spain, (13)Doce de Octubre Hospital, Madrid, Spain, (14)St Vincent’s Hospital, Sydney, Australia, (15)University Hospital Monklands, Airdrie, United Kingdom, (16)Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada, (17)GSK, Rixensart, Belgium, (18)GSK, Wavre, Belgium, (19)GSK, King of Prussia, PA, USA; Current affiliation: Halozyme Therapeutics, San Diego, CA, (20)GSK, Wavre, Belgium; Current affiliation: CureVac AG, Tübingen, Germany

Disclosures:

A. F. Dagnew, GSK: Employee and Shareholder , Salary .

O. Ilhan, None

W. S. Lee, None

D. Woszczyk, None

J. Y. Kwak, None

S. Bowcock, None

S. K. Sohn, None

G. R. Macías, None

T. J. Chiou, None

D. Quiel, None

M. Aoun, None

M. B. Navarro Matilla, None

J. De La Serna, None

S. Milliken, None

J. Murphy, GSK: Investigator , Research support .

S. A. McNeil, GSK group of companies: Grant Investigator , Research grant and Research support .

B. Salaun, GSK group of companies: Employee and Shareholder , Salary .

E. Di Paolo, GSK group of companies: Employee , Salary .

L. Campora, GSK group of companies: Employee and Shareholder , Salary .

M. López-Fauqued, GSK group of companies: Employee , Salary .

M. El Idrissi, GSK group of companies: Employee , Salary .

A. Schuind, GSK: Employee , Salary .

T. C. Heineman, GSK group of companies: Consultant , Employee and Shareholder , Consulting fee and Salary .

P. Van Den Steen, GSK: Employee and Shareholder , Restricted shares and Salary .

L. Oostvogels, GSK: Employee , Salary and Stock and stock options .

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