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Clinical Trial
. 2024 Oct 15;79(4):888-900.
doi: 10.1093/cid/ciae215.

Safety and Immunogenicity of Accelerated Heterologous 2-Dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa

Betty Mwesigwa  1 , Fredrick Sawe  2   3 , Janet Oyieko  3   4 , Joel Mwakisisile  5 , Edna Viegas  6 , Gideon Akindiran Akintunde  2   7   8 , Josphat Kosgei  3   4 , Afoke Kokogho  2   7   8 , Nyanda Ntinginya  5 , Ilesh Jani  6 , Georgi Shukarev  9 , Jay W Hooper  10 , Steven A Kwilas  10 , Lucy A Ward  11 , Janice Rusnak  12 , Callie Bounds  11 , Rachel Overman  11 , Christopher S Badorrek  12 , Leigh Anne Eller  2   13 , Michael A Eller  2   13 , Christina S Polyak  2   13 , Amber Moodley  2   13 , Chi L Tran  2   13 , Margaret C Costanzo  2   13 , David J Leggat  2 , Dominic Paquin-Proulx  2   13 , Prossy Naluyima  1 , Dickson Nkafu Anumendem  14 , Auguste Gaddah  14 , Kerstin Luhn  9 , Jenny Hendriks  9 , Chelsea McLean  9 , Macaya Douoguih  9 , Hannah Kibuuka  1 , Merlin L Robb  2   13 , Cynthia Robinson  9 , Julie A Ake  2
Affiliations
Clinical Trial

Safety and Immunogenicity of Accelerated Heterologous 2-Dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa

Betty Mwesigwa et al. Clin Infect Dis. .

Abstract

Background: Shorter prophylactic vaccine schedules may offer more rapid protection against Ebola in resource-limited settings.

Methods: This randomized, observer-blind, placebo-controlled, phase 2 trial conducted in 5 sub-Saharan African countries included people without human immunodeficiency virus (HIV) (PWOH, n = 249) and people with HIV (PWH, n = 250). Adult participants received 1 of 2 accelerated Ebola vaccine regimens (MVA-BN-Filo, Ad26.ZEBOV administered 14 days apart [n = 79] or Ad26.ZEBOV, MVA-BN-Filo administered 28 days apart [n = 322]) or saline/placebo (n = 98). The primary endpoints were safety (adverse events [AEs]) and immunogenicity (Ebola virus [EBOV] glycoprotein-specific binding antibody responses). Binding antibody responders were defined as participants with a >2.5-fold increase from baseline or the lower limit of quantification if negative at baseline.

Results: The mean age was 33.4 years, 52% of participants were female, and among PWH, the median CD4+ cell count was 560.0 (interquartile range, 418.0-752.0) cells/μL. AEs were generally mild/moderate with no vaccine-related serious AEs or remarkable safety profile differences by HIV status. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody response rates in vaccine recipients were 99% for the 14-day regimen (geometric mean concentrations [GMCs]: 5168 enzyme-linked immunosorbent assay units [EU]/mL in PWOH; 2509 EU/mL in PWH) and 98% for the 28-day regimen (GMCs: 6037 EU/mL in PWOH; 2939 EU/mL in PWH). At 12 months post-dose 2, GMCs in PWOH and PWH were 635 and 514 EU/mL, respectively, for the 14-day regimen and 331 and 360 EU/mL, respectively, for the 28-day regimen.

Conclusions: Accelerated 14- and 28-day Ebola vaccine regimens were safe and immunogenic in PWOH and PWH in Africa. Clinical Trials Registration. NCT02598388.

Keywords: Ad.26.ZEBOV; Ebola virus; MVA-BN-Filo; immunogenicity; vaccine safety.

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Conflict of interest statement

Potential conflicts of interest. G. S., D. N. A., A. G., K. L., J. H., C. M., M. D., and C. R. were full-time employees of Janssen, Pharmaceutical Companies of Johnson & Johnson at the time of the study, and may own shares in Janssen, Pharmaceutical Companies of Johnson & Johnson. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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