Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Trial
Julie A. Ake,
Kristopher Paolino,
Jack N. Hutter,
Susan Biggs Cicatelli,
Leigh Anne Eller,
Michael A. Eller,
Margaret C. Costanzo,
Dominic Paquin-Proulx,
Merlin L. Robb,
Chi L. Tran,
Lalaine Anova,
Linda L. Jagodzinski,
Lucy A. Ward,
Nicole Kilgore,
Janice Rusnak,
Callie Bounds,
Christopher S. Badorrek,
Jay W. Hooper,
Steven A. Kwilas,
Ine Ilsbroux,
Dickson Nkafu Anumendem,
Auguste Gaddah,
Georgi Shukarev,
Viki Bockstal,
Kerstin Luhn,
Macaya Douoguih,
Cynthia Robinson
Affiliations
Julie A. Ake
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Kristopher Paolino
Clinical Trials Center, Center for Enabling Capabilities, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Jack N. Hutter
Clinical Trials Center, Center for Enabling Capabilities, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Susan Biggs Cicatelli
ICON Government and Public Health Solutions, Silver Spring, MD 20901, USA
Leigh Anne Eller
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Michael A. Eller
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Margaret C. Costanzo
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Dominic Paquin-Proulx
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Merlin L. Robb
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Chi L. Tran
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Lalaine Anova
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Linda L. Jagodzinski
Diagnostics and Countermeasures Branch, Center for Infectious Diseases Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA
Lucy A. Ward
Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA
Nicole Kilgore
Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA
Janice Rusnak
Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA
Callie Bounds
Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA
Christopher S. Badorrek
Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA
Jay W. Hooper
Virology Division, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD 21702, USA
Steven A. Kwilas
Virology Division, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD 21702, USA
Ine Ilsbroux
Janssen Research & Development, 2340 Beerse, Belgium
Dickson Nkafu Anumendem
Janssen Research & Development, 2340 Beerse, Belgium
Auguste Gaddah
Janssen Research & Development, 2340 Beerse, Belgium
Georgi Shukarev
Janssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands
Viki Bockstal
Janssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands
Kerstin Luhn
Janssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands
Macaya Douoguih
Janssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands
Cynthia Robinson
Janssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands
The safety and immunogenicity of the two-dose Ebola vaccine regimen MVA-BN-Filo, Ad26.ZEBOV, 14 days apart, was evaluated in people without HIV (PWOH) and living with HIV (PLWH). In this observer-blind, placebo-controlled, phase 2 trial, healthy adults were randomized (4:1) to receive MVA-BN-Filo (dose 1) and Ad26.ZEBOV (dose 2), or two doses of saline/placebo, administered intramuscularly 14 days apart. The primary endpoints were safety (adverse events (AEs)) and immunogenicity (Ebola virus (EBOV) glycoprotein-specific binding antibody responses). Among 75 participants (n = 50 PWOH; n = 25 PLWH), 37% were female, the mean age was 44 years, and 56% were Black/African American. AEs were generally mild/moderate, with no vaccine-related serious AEs. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody responder rates were 100% among PWOH and 95% among PLWH; geometric mean antibody concentrations were 6286 EU/mL (n = 36) and 2005 EU/mL (n = 19), respectively. A total of 45 neutralizing and other functional antibody responses were frequently observed. Ebola-specific CD4+ and CD8+ T-cell responses were polyfunctional and durable to at least 12 months post-dose 2. The regimen was well tolerated and generated robust, durable immune responses in PWOH and PLWH. Findings support continued evaluation of accelerated vaccine schedules for rapid deployment in populations at immediate risk. Trial registration: NCT02598388 (submitted 14 November 2015).
