scholarly journals Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18–45

Vaccine ◽  
2018 ◽  
Vol 36 (6) ◽  
pp. 833-840 ◽  
Author(s):  
James M. McCarty ◽  
Michael D. Lock ◽  
Kristin M. Hunt ◽  
Jakub K. Simon ◽  
Marc Gurwith
2013 ◽  
Vol 21 (1) ◽  
pp. 66-73 ◽  
Author(s):  
Wilbur H. Chen ◽  
Richard N. Greenberg ◽  
Marcela F. Pasetti ◽  
Sofie Livio ◽  
Michael Lock ◽  
...  

ABSTRACTCurrently, no cholera vaccine is available for persons traveling from the United States to areas of high cholera transmission and who for reasons of occupation or host factors are at increased risk for development of the disease. A single-dose oral cholera vaccine with a rapid onset of protection would be particularly useful for such travelers and might also be an adjunct control measure for cholera outbreaks. The attenuatedVibrio choleraeO1 vaccine strain CVD 103-HgR harbors a 94% deletion of the cholera toxin A subunit gene (ctxA) and has a mercury resistance gene inserted in the gene encoding hemolysin A. We undertook a phase I randomized placebo-controlled two-site trial to assess the safety and immunogenicity of a preliminary formulation of CVD 103-HgR prepared from new master and working cell banks. Healthy young adults were randomized (5:1 vaccinees to placebo recipients) to receive a single oral dose of ∼4.4 × 108CFU of vaccine or a placebo. Blood serum vibriocidal and cholera toxin-specific IgG antibodies were measured before and 10, 14, and 28 days following vaccination or placebo. Excretion of the vaccine strain in the stool was assessed during the first week postvaccination. A total of 66 subjects were enrolled, comprising 55 vaccinees and 11 placebo recipients. The vaccine was well tolerated. The overall vibriocidal and anti-cholera toxin seroconversion rates were 89% and 57%, respectively. CVD 103-HgR is undergoing renewed manufacture for licensure in the United States under the auspices of PaxVax. Our data mimic those from previous commercial formulations that elicited vibriocidal antibody seroconversion (a correlate of protection) in ∼90% of vaccinees. (This study has been registered at ClinicalTrials.gov under registration no. NCT01585181.)


1993 ◽  
Vol 168 (5) ◽  
pp. 1169-1176 ◽  
Author(s):  
C. H. Simanjuntak ◽  
P. O'Hanley ◽  
N. H. Punjabi ◽  
F. Noriega ◽  
G. Pazzaglia ◽  
...  

Author(s):  
James McCarty ◽  
Lisa Bedell ◽  
Paul-Andre de Lame ◽  
David Cassie ◽  
Michael Lock ◽  
...  

2017 ◽  
Vol 16 (3) ◽  
pp. 197-213 ◽  
Author(s):  
Myron M. Levine ◽  
Wilbur H. Chen ◽  
James B. Kaper ◽  
Michael Lock ◽  
Lisa Danzig ◽  
...  

2016 ◽  
Vol 375 (7) ◽  
pp. e12 ◽  
Author(s):  
Andrew S. Azman ◽  
Francisco J. Luquero

2017 ◽  
Vol 51 (7) ◽  
pp. 584-589 ◽  
Author(s):  
Adriana Cabrera ◽  
Jayne E. Lepage ◽  
Karyn M. Sullivan ◽  
Sheila M. Seed

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