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

• Published in: Clinical infectious diseases Vol. 79; no. 4; p. 888
• Main Authors: Mwesigwa, Betty, Sawe, Fredrick, Oyieko, Janet, Mwakisisile, Joel, Viegas, Edna, Akintunde, Gideon Akindiran, Kosgei, Josphat, Kokogho, Afoke, Ntinginya, Nyanda, Jani, Ilesh, Shukarev, Georgi, Hooper, Jay W, Kwilas, Steven A, Ward, Lucy A, Rusnak, Janice, Bounds, Callie, Overman, Rachel, Badorrek, Christopher S, Eller, Leigh Anne, Eller, Michael A, Polyak, Christina S, Moodley, Amber, Tran, Chi L, Costanzo, Margaret C, Leggat, David J, Paquin-Proulx, Dominic, Naluyima, Prossy, Anumendem, Dickson Nkafu, Gaddah, Auguste, Luhn, Kerstin, Hendriks, Jenny, McLean, Chelsea, Douoguih, Macaya, Kibuuka, Hannah, Robb, Merlin L, Robinson, Cynthia, Ake, Julie A
• Format: Journal Article
• Language: English
• Published: United States 15.10.2024
• Subjects: Adolescent; Adult; Africa South of the Sahara; Antibodies, Viral - blood; Ebola Vaccines - administration & dosage; Ebola Vaccines - adverse effects; Ebola Vaccines - immunology; Ebolavirus - immunology; Female; Hemorrhagic Fever, Ebola - immunology; Hemorrhagic Fever, Ebola - prevention & control; HIV Infections - immunology; HIV Infections - prevention & control; Humans; Immunization Schedule; Immunogenicity, Vaccine; Male; Middle Aged; Young Adult; Africa South of the Sahara; Ebola virus; vaccine safety; MVA-BN-Filo; Ad.26.ZEBOV; immunogenicity
• ISSN: 1537-6591
• DOI: 10.1093/cid/ciae215

Shorter prophylactic vaccine schedules may offer more rapid protection against Ebola in resource-limited settings. 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. 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. Accelerated 14- and 28-day Ebola vaccine regimens were safe and immunogenic in PWOH and PWH in Africa. Clinical Trials Registration. NCT02598388.