Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.
Lee, Andrew W;
Liu, Ken;
Lhomme, Edouard;
Blie, Julie;
McCullough, John;
Onorato, Matthew T;
Connor, Laurie;
Simon, Jakub K;
Dubey, Sheri;
VanRheenen, Susan;
+23 more...Deutsch, Jonathan;
Owens, Abigail;
Morgan, Amy;
Welebob, Carolee;
Hyatt, Donna;
Nair, Sunita;
Hamzé, Benjamin;
Guindo, Oumar;
Sow, Samba O;
Beavogui, Abdoul H;
Leigh, Bailah;
Samai, Mohamed;
Akoo, Pauline;
Serry-Bangura, Alimamy;
Fleck, Suzanne;
Secka, Fatou;
Lowe, Brett;
Watson-Jones, Deborah;
Roy, Céline;
Hensley, Lisa E;
Kieh, Mark;
Coller, Beth-Ann G;
PREVAC Study Team;
(2024)
Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 78 (4).
pp. 870-879.
ISSN 1058-4838
DOI: https://doi.org/10.1093/cid/ciad693
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BACKGROUND: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older. METHODS: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR. RESULTS: In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2. CONCLUSIONS: A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).
