Happe Myra, Hofstetter Amelia R, Wang Jing, Yamshchikov Galina V, Holman LaSonji A, Novik Laura, Strom Larisa, Kiweewa Francis, Wakabi Salim, Millard Monica, Kelley Colleen F, Kabbani Sarah, Edupuganti Srilatha, Beck Allison, Kaltovich Florence, Murray Tamar, Tsukerman Susanna, Carr Derick, Ashman Carl, Stanley Daphne A, Ploquin Aurélie, Bailer Robert T, Schwartz Richard, Cham Fatim, Tindikahwa Allan, Hu Zonghui, Gordon Ingelise J, Rouphael Nadine, Houser Katherine V, Coates Emily E, Graham Barney S, Koup Richard A, Mascola John R, Sullivan Nancy J, Robb Merlin L, Ake Julie A, Lyke Kirsten E, Mulligan Mark J, Ledgerwood Julie E, Kibuuka Hannah
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
NPJ Vaccines. 2024 Mar 29;9(1):67. doi: 10.1038/s41541-024-00833-z.
Ebola virus disease (EVD) is a filoviral infection caused by virus species of the Ebolavirus genus including Zaire ebolavirus (EBOV) and Sudan ebolavirus (SUDV). We investigated the safety and immunogenicity of a heterologous prime-boost regimen involving a chimpanzee adenovirus 3 vectored Ebola vaccine [either monovalent (cAd3-EBOZ) or bivalent (cAd3-EBO)] prime followed by a recombinant modified vaccinia virus Ankara EBOV vaccine (MVA-EbolaZ) boost in two phase 1/1b randomized open-label clinical trials in healthy adults in the United States (US) and Uganda (UG). Trial US (NCT02408913) enrolled 140 participants, including 26 EVD vaccine-naïve and 114 cAd3-Ebola-experienced participants (April-November 2015). Trial UG (NCT02354404) enrolled 90 participants, including 60 EVD vaccine-naïve and 30 DNA Ebola vaccine-experienced participants (February-April 2015). All tested vaccines and regimens were safe and well tolerated with no serious adverse events reported related to study products. Solicited local and systemic reactogenicity was mostly mild to moderate in severity. The heterologous prime-boost regimen was immunogenic, including induction of durable antibody responses which peaked as early as two weeks and persisted up to one year after each vaccination. Different prime-boost intervals impacted the magnitude of humoral and cellular immune responses. The results from these studies demonstrate promising implications for use of these vaccines in both prophylactic and outbreak settings.
埃博拉病毒病（EVD）是一种由埃博拉病毒属的病毒引起的丝状病毒感染，包括扎伊尔埃博拉病毒（EBOV）和苏丹埃博拉病毒（SUDV）。我们在美国（US）和乌干达（UG）针对健康成年人开展了两项1/1b期随机开放标签临床试验，研究了一种异源初免-加强免疫方案的安全性和免疫原性，该方案先用黑猩猩腺病毒3载体埃博拉疫苗[单价（cAd3-EBOZ）或二价（cAd3-EBO）]进行初免，随后用重组改良安卡拉痘苗病毒埃博拉疫苗（MVA-EbolaZ）进行加强免疫。美国试验（NCT02408913）招募了140名参与者，包括26名未接种过埃博拉病毒病疫苗的参与者和114名有cAd3-埃博拉疫苗接种经验的参与者（2015年4月至11月）。乌干达试验（NCT02354404）招募了90名参与者，包括60名未接种过埃博拉病毒病疫苗的参与者和30名有DNA埃博拉疫苗接种经验的参与者（2015年2月至4月）。所有测试的疫苗和方案均安全且耐受性良好，未报告与研究产品相关的严重不良事件。所引发的局部和全身反应原性大多为轻度至中度。异源初免-加强免疫方案具有免疫原性，包括诱导持久的抗体反应，每次接种后最早在两周时达到峰值，并持续长达一年。不同的初免-加强间隔影响体液和细胞免疫反应的强度。这些研究结果表明，这些疫苗在预防和疫情暴发情况下使用具有良好前景。
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