PMID- 31769402
OWN - NLM
STAT- MEDLINE
DCOM- 20200421
LR  - 20210110
IS  - 1476-1645 (Electronic)
IS  - 0002-9637 (Print)
IS  - 0002-9637 (Linking)
VI  - 102
IP  - 1
DP  - 2020 Jan
TI  - Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children 
      and Adolescents Aged 6-17 Years.
PG  - 48-57
LID - 10.4269/ajtmh.19-0241 [doi]
AB  - The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, 
      redeveloped as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) 
      response and protects against cholera-induced diarrhea in adult volunteer 
      challenge trials but has not been studied in children in developed countries. We 
      performed a phase 4, placebo-controlled, double-blind, multicenter study to 
      assess the safety, immunogenicity, and tolerability of a single, oral dose of 
      PXVX0200 in children and adolescents aged 6-17 years in the United States and 
      bridged immunogenicity to adults aged 18-45 years from a separate lot consistency 
      study. Volunteers were randomized to receive a single dose of 1 x 10(9) colony 
      forming units (CFU) of PXVX0200 or placebo. Immunogenicity endpoints included SVA 
      levels on days 1, 11, and 29 in volunteers aged 6-17 years and also on days 91 
      and 181 in volunteers aged 12-17 years. Safety was assessed by comparing 
      solicited signs and symptoms on days 1-8, unsolicited adverse events (AEs) 
      through day 29, and serious AEs through day 181. A total of 374 participants were 
      enrolled, comprising 321 vaccine and 53 placebo recipients. The SVA 
      seroconversion rates 10 days after immunization were 98.6% and 2.1% in vaccine 
      and placebo recipients, respectively, and the vaccine seroconversion rate was 
      non-inferior to the 93.5% rate seen in adults aged 18-45 years. Most 
      reactogenicity was mild to moderate, and there were no vaccine-related serious 
      AEs. The complete dose was consumed in 95.3% and 98.1% of vaccine and placebo 
      recipients, respectively. PXVX0200 appears safe, immunogenic, and well tolerated 
      in children and adolescents aged 6-17 years.
FAU - McCarty, James M
AU  - McCarty JM
AD  - Stanford University School of Medicine, Stanford, California.
FAU - Gierman, Emma C
AU  - Gierman EC
AD  - PaxVax, Inc., Redwood City, California.
FAU - Bedell, Lisa
AU  - Bedell L
AD  - PaxVax, Inc., Redwood City, California.
FAU - Lock, Michael D
AU  - Lock MD
AD  - PaxVax, Inc., Redwood City, California.
FAU - Bennett, Sean
AU  - Bennett S
AD  - PaxVax, Inc., Redwood City, California.
LA  - eng
SI  - ClinicalTrials.gov/NCT03220737
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am J Trop Med Hyg
JT  - The American journal of tropical medicine and hygiene
JID - 0370507
RN  - 0 (Cholera Vaccines)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Child
MH  - Cholera/*prevention & control
MH  - Cholera Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Male
MH  - United States
PMC - PMC6947768
COIS- Disclosure: All authors attest that they meet the AJTMH criteria for authorship.
EDAT- 2019/11/27 06:00
MHDA- 2020/04/22 06:00
PMCR- 2019/11/25
CRDT- 2019/11/27 06:00
PHST- 2019/11/27 06:00 [pubmed]
PHST- 2020/04/22 06:00 [medline]
PHST- 2019/11/27 06:00 [entrez]
PHST- 2019/11/25 00:00 [pmc-release]
AID - tpmd190241 [pii]
AID - 10.4269/ajtmh.19-0241 [doi]
PST - ppublish
SO  - Am J Trop Med Hyg. 2020 Jan;102(1):48-57. doi: 10.4269/ajtmh.19-0241.