Background: This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Methods: Overall, 1197 subjects were randomized 2:2:2:2:1; 1194 were vaccinated with 1 dose of 1 of 3 lots ofrVSVΔG- ZEBOV-GP (2 × 107 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 108 pfu, n = 264; high-dose group), or placebo (n = 133). Daily temperatures and adverse events (AEs) were recorded days 1 to 42 postvaccination. Solicited AEs included injection-site AEs from days 1 to 5, and joint pain, joint swelling, vesicular lesions (blisters), and rashes from days 1 to 42. Serious AEs (SAEs) were recorded through 6 months postvaccination. Results: Fever (≥38.0°C) was observed in 20.2% of combined lots (3.2% with ≥39.0°C), 32.2% of high-dose (4.3% with ≥39.0°C), and 0.8% of placebo (0.8% with ≥39.0°C). Incidences of AEs of interest (days 1-42) were arthralgia (17.1% combined lots, 20.4% high-dose, 3.0% placebo), arthritis (5.1% combined lots, 4.2% high-dose, 0.0% placebo), and rash (3.8% combined lots, 3.8% high-dose, 1.5% placebo). Twenty-one SAEs and 2 deaths were reported, all assessed by investigators as unrelated to vaccine. Conclusions: rVSVΔG-ZEBOV-GP was generally well-tolerated, with increased rates of injection-site and systemic AEs compared to placebo, and no vaccine-related SAEs or deaths. These findings support the use of rVSVΔG-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Clinical Trials Registration: NCT02503202.
RCT Entities:
Background: This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Methods: Overall, 1197 subjects were randomized 2:2:2:2:1; 1194 were vaccinated with 1 dose of 1 of 3 lots of rVSVΔG- ZEBOV-GP (2 × 107 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 108 pfu, n = 264; high-dose group), or placebo (n = 133). Daily temperatures and adverse events (AEs) were recorded days 1 to 42 postvaccination. Solicited AEs included injection-site AEs from days 1 to 5, and joint pain, joint swelling, vesicular lesions (blisters), and rashes from days 1 to 42. Serious AEs (SAEs) were recorded through 6 months postvaccination. Results: Fever (≥38.0°C) was observed in 20.2% of combined lots (3.2% with ≥39.0°C), 32.2% of high-dose (4.3% with ≥39.0°C), and 0.8% of placebo (0.8% with ≥39.0°C). Incidences of AEs of interest (days 1-42) were arthralgia (17.1% combined lots, 20.4% high-dose, 3.0% placebo), arthritis (5.1% combined lots, 4.2% high-dose, 0.0% placebo), and rash (3.8% combined lots, 3.8% high-dose, 1.5% placebo). Twenty-one SAEs and 2 deaths were reported, all assessed by investigators as unrelated to vaccine. Conclusions: rVSVΔG-ZEBOV-GP was generally well-tolerated, with increased rates of injection-site and systemic AEs compared to placebo, and no vaccine-related SAEs or deaths. These findings support the use of rVSVΔG-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Clinical Trials Registration: NCT02503202.
Authors: Jason A Regules; John H Beigel; Kristopher M Paolino; Jocelyn Voell; Amy R Castellano; Zonghui Hu; Paula Muñoz; James E Moon; Richard C Ruck; Jason W Bennett; Patrick S Twomey; Ramiro L Gutiérrez; Shon A Remich; Holly R Hack; Meagan L Wisniewski; Matthew D Josleyn; Steven A Kwilas; Nicole Van Deusen; Olivier Tshiani Mbaya; Yan Zhou; Daphne A Stanley; Wang Jing; Kirsten S Smith; Meng Shi; Julie E Ledgerwood; Barney S Graham; Nancy J Sullivan; Linda L Jagodzinski; Sheila A Peel; Judie B Alimonti; Jay W Hooper; Peter M Silvera; Brian K Martin; Thomas P Monath; W Jay Ramsey; Charles J Link; H Clifford Lane; Nelson L Michael; Richard T Davey; Stephen J Thomas Journal: N Engl J Med Date: 2015-04-01 Impact factor: 91.245
Authors: Ana Maria Henao-Restrepo; Ira M Longini; Matthias Egger; Natalie E Dean; W John Edmunds; Anton Camacho; Miles W Carroll; Moussa Doumbia; Bertrand Draguez; Sophie Duraffour; Godwin Enwere; Rebecca Grais; Stephan Gunther; Stefanie Hossmann; Mandy Kader Kondé; Souleymane Kone; Eeva Kuisma; Myron M Levine; Sema Mandal; Gunnstein Norheim; Ximena Riveros; Aboubacar Soumah; Sven Trelle; Andrea S Vicari; Conall H Watson; Sakoba Kéïta; Marie Paule Kieny; John-Arne Røttingen Journal: Lancet Date: 2015-08-03 Impact factor: 79.321
Authors: Stephen B Kennedy; James D Neaton; H Clifford Lane; Mark W S Kieh; Moses B F Massaquoi; Nancy A Touchette; Martha C Nason; Dean A Follmann; Fatorma K Boley; Melvin P Johnson; Gregg Larson; Francis N Kateh; Tolbert G Nyenswah Journal: Clin Trials Date: 2016-01-14 Impact factor: 2.486
Authors: Marc-Alain Widdowson; Stephanie J Schrag; Rosalind J Carter; Wendy Carr; Jennifer Legardy-Williams; Laura Gibson; Durodami R Lisk; Mohamed I Jalloh; Donald A Bash-Taqi; Samuel A Sheku Kargbo; Ayesha Idriss; Gibrilla F Deen; James B W Russell; Wendi McDonald; Alison P Albert; Michelle Basket; Amy Callis; Victoria M Carter; Kelli R Clifton Ogunsanya; Julianne Gee; Robert Pinner; Barbara E Mahon; Susan T Goldstein; Jane F Seward; Mohamed Samai; Anne Schuchat Journal: MMWR Suppl Date: 2016-07-08
Authors: Junerlyn Agua-Agum; Benedetta Allegranzi; Archchun Ariyarajah; R Bruce Aylward; Isobel M Blake; Philippe Barboza; Daniel Bausch; Richard J Brennan; Peter Clement; Pasqualina Coffey; Anne Cori; Christl A Donnelly; Ilaria Dorigatti; Patrick Drury; Kara Durski; Christopher Dye; Tim Eckmanns; Neil M Ferguson; Christophe Fraser; Erika Garcia; Tini Garske; Alex Gasasira; Céline Gurry; Esther Hamblion; Wes Hinsley; Robert Holden; David Holmes; Stéphane Hugonnet; Giovanna Jaramillo Gutierrez; Thibaut Jombart; Edward Kelley; Ravi Santhana; Nuha Mahmoud; Harriet L Mills; Yasmine Mohamed; Emmanuel Musa; Dhamari Naidoo; Gemma Nedjati-Gilani; Emily Newton; Ian Norton; Pierre Nouvellet; Devin Perkins; Mark Perkins; Steven Riley; Dirk Schumacher; Anita Shah; Minh Tang; Olivia Varsaneux; Maria D Van Kerkhove Journal: N Engl J Med Date: 2016-08-11 Impact factor: 91.245
Authors: Olamide D Jarrett; Jane F Seward; Augustin E Fombah; Robert Lindblad; Mohamed I Jalloh; Jill El-Khorazaty; Peter Dawson; Deron Burton; Jane Zucker; Wendy Carr; Mohamed M Bah; Gibrilla F Deen; Peter M George; Faustine James; Durodami R Lisk; Dudley Pratt; James B W Russell; Jibao D Sandy; Patrick Turay; Mary J Hamel; Stephanie J Schrag; Robert E Walker; Mohamed Samai; Susan T Goldstein Journal: J Infect Dis Date: 2018-05-18 Impact factor: 5.226
Authors: Muhammad-Abbas Conteh; Susan T Goldstein; Haja R Wurie; Jane Gidudu; Durodami Radcliffe Lisk; Rosalind J Carter; Jane F Seward; Lee M Hampton; David Wang; Lauren E Andersen; Melissa Arvay; Stephanie J Schrag; Peter Dawson; Augustin E Fombah; Carey R Petrie; Daniel R Feikin; James B W Russell; Robert Lindblad; S A S Kargbo; Mohamed Samai; Barbara E Mahon Journal: J Infect Dis Date: 2018-05-18 Impact factor: 5.226
Authors: Mohamed Samai; Jane F Seward; Susan T Goldstein; Barbara E Mahon; Durodami Radcliffe Lisk; Marc-Alain Widdowson; Mohamed I Jalloh; Stephanie J Schrag; Ayesha Idriss; Rosalind J Carter; Peter Dawson; S A S Kargbo; Bailah Leigh; Mohamed Bawoh; Jennifer Legardy-Williams; Gibrilla Deen; Wendy Carr; Amy Callis; Robert Lindblad; James B W Russell; Carey R Petrie; Augustin E Fombah; Brima Kargbo; Wendi McDonald; Olamide D Jarrett; Robert E Walker; Paul Gargiullo; Donald Bash-Taqi; Laura Gibson; Abu Bakarr Fofanah; Anne Schuchat Journal: J Infect Dis Date: 2018-05-18 Impact factor: 5.226
Authors: Barbara E Mahon; Jakub Simon; Marc-Alain Widdowson; Mohamed Samai; Eric Rogier; Jennifer Legardy-Williams; Kenneth Liu; Jarad Schiffer; James Lange; Carolynn DeByle; Robert Pinner; Anne Schuchat; Laurence Slutsker; Susan Goldstein Journal: J Infect Dis Date: 2021-12-01 Impact factor: 5.226