scholarly journals An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine “Sputnik Light” for prevention of coronavirus infection in healthy adults

2021 ◽  
Vol 11 ◽  
pp. 100241
Author(s):  
Amir I. Tukhvatulin ◽  
Inna V. Dolzhikova ◽  
Dmitry V. Shcheblyakov ◽  
Olga V. Zubkova ◽  
Alina S. Dzharullaeva ◽  
...  
2021 ◽  
Author(s):  
Amir I. Tukhvatulin ◽  
Inna V. Dolzhikova ◽  
Dmitry V. Shcheblyakov ◽  
Olga V. Zubkova ◽  
Alina S. Dzharullaeva ◽  
...  

Author(s):  
Elizabeth B Brickley ◽  
Ruth I Connor ◽  
Wendy Wieland-Alter ◽  
Joshua A Weiner ◽  
Margaret E Ackerman ◽  
...  

Abstract In a blinded phase 1 trial (EudraCT 2017-0000908-21; NCT03430349) in Belgium, healthy adults (18 to 50 years) previously immunized exclusively with inactivated polio vaccine were administered a single dose of one of two novel type 2 oral polio vaccines (nOPV2-c1: S2/cre5/S15domV/rec1/hifi3 (N=15); nOPV2-c2: S2/S15domV/CpG40 (N=15)) and isolated for 28 days in a purpose-built containment facility. Using stool samples collected near days 0, 7, 14, and 28, we evaluated intestinal neutralization and IgA responses to the novel OPV2s and found that nOPV2-c1 and nOPV2-c2 induced detectable poliovirus type 2-specific intestinal neutralizing responses in 40.0% and 46.7% of participants respectively.


2016 ◽  
Vol 61 (3) ◽  
Author(s):  
M. Pamela Griffin ◽  
Anis A. Khan ◽  
Mark T. Esser ◽  
Kathryn Jensen ◽  
Therese Takas ◽  
...  

ABSTRACT Prevention of respiratory syncytial virus (RSV) illness in infants is a major public health priority, but there is no approved vaccine. Palivizumab is a monoclonal antibody that provides RSV prophylaxis but requires 5 monthly injections and is approved only for infants who experience the greatest morbidity and mortality from RSV. Thus, there remains a significant unmet medical need for prevention of RSV disease in healthy infants. MEDI8897 is a recombinant human RSV monoclonal antibody with a modified Fc region that extends its half-life and is being developed as RSV prophylaxis for all infants. In this phase 1, first-in-human, placebo-controlled study, 136 healthy adults were randomized to receive a single dose of MEDI8897 (n = 102) or placebo (n = 34) in 1 of 5 cohorts (300, 1,000, or 3,000 mg intravenously or 100 or 300 mg intramuscularly [i.m.]) and were monitored for 360 days. The mean half-life of MEDI8897 was 85 to 117 days across dose groups, and bioavailability after 300-mg i.m. dose administration was 77%. Time to maximum concentration following i.m. dosing was 5 to 9 days. Antidrug antibody (ADA) responses were detected in a similar proportion of placebo (15.2%) and MEDI8897 (13.7%) recipients. The safety profile of MEDI8897 was similar to that of the placebo. These results support clinical studies of the i.m. administration of a single dose of MEDI8897 in the target population of infants to provide protection for the duration of the RSV season. (This study has been registered at ClinicalTrials.gov under identifier NCT02114268.)


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