The effect of dose on the safety and immunogenicity of the VSV Ebola candidate vaccine: a randomised double-blind, placebo-controlled phase 1/2 trial

• Published in: The Lancet infectious diseases Vol. 15; no. 10; pp. 1156 - 1166
• Main Authors: Huttner, Angela, MD, Dayer, Julie-Anne, MD, Yerly, Sabine, MSc, Combescure, Christophe, PhD, Auderset, Floriane, PhD, Desmeules, Jules, Prof, Eickmann, Markus, PhD, Finckh, Axel, Prof, Goncalves, Ana Rita, PhD, Hooper, Jay W, PhD, Kaya, Gürkan, MD, Krähling, Verena, PhD, Kwilas, Steve, PhD, Lemaître, Barbara, MSc, Matthey, Alain, MD, Silvera, Peter, PhD, Becker, Stephan, Prof, Fast, Patricia E, MD, Moorthy, Vasee, MD, Kieny, Marie Paule, PhD, Kaiser, Laurent, Prof, Siegrist, Claire-Anne, Prof
• Format: Journal Article
• Language: English
• Published: United States Elsevier Ltd 01.10.2015; Elsevier Limited
• Subjects: Adenoviruses; Adolescent; Adult; Aged; Ankle; Antibodies, Viral - blood; Antigens, Viral - genetics; Arthritis; Arthritis - chemically induced; Arthritis - epidemiology; Arthritis - pathology; Consortia; Dermatitis; Dermatitis - epidemiology; Dermatitis - pathology; Disease; Double-Blind Method; Drug Carriers; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Ebola Vaccines - administration & dosage; Ebola Vaccines - adverse effects; Ebola Vaccines - immunology; Ebola virus; Ebolavirus - genetics; Epidemics; Female; Fingers & toes; Hemorrhagic Fever, Ebola - prevention & control; Humans; Immunogenicity; Infectious Disease; Infectious diseases; Injection; Male; Middle Aged; Pain; Placebos - administration & dosage; Public health; Safety; Skin; Switzerland; Vaccination - adverse effects; Vaccination - methods; Vaccines; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Vasculitis - chemically induced; Vasculitis - epidemiology; Vasculitis - pathology; Vesiculovirus - genetics; Wrist; Young Adult; Switzerland; Gabon; Germany

Summary Background Safe and effective vaccines against Ebola could prevent or control outbreaks. The safe use of replication-competent vaccines requires a careful dose-selection process. We report the first safety and immunogenicity results in volunteers receiving 3 × 105 plaque-forming units (pfu)...