Bibliographic Details
| Title: |
Safety and Immunogenicity of Accelerated Heterologous 2-Dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa. |
| 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 |
| Source: |
Clinical Infectious Diseases; 10/15/2024, Vol. 79 Issue 4, p888-900, 13p |
| Subject Terms: |
PATIENT safety, DRUG side effects, RESEARCH funding, VACCINE effectiveness, HIV-positive persons, STATISTICAL sampling, BLIND experiment, CD4 lymphocyte count, ENZYME-linked immunosorbent assay, RANDOMIZED controlled trials, DESCRIPTIVE statistics, VACCINE immunogenicity, VIRAL vaccines, EBOLA virus, DRUG tolerance, EVALUATION |
| Geographic Terms: |
SUB-Saharan Africa |
| 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. [ABSTRACT FROM AUTHOR] |
|
Copyright of Clinical Infectious Diseases is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
Complementary Index |
