PMID- 29470934
OWN - NLM
STAT- MEDLINE
DCOM- 20190128
LR  - 20190128
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 14
IP  - 6
DP  - 2018 Jun 3
TI  - Bivalent oral cholera vaccine in participants aged 1 year and older in the 
      Dominican Republic: A phase III, single-arm, safety and immunogenicity trial.
PG  - 1403-1411
LID - 10.1080/21645515.2018.1430540 [doi]
AB  - The Dominican Republic, historically non-endemic for cholera, is experiencing an 
      ongoing cholera epidemic. We assessed the safety and immunogenicity of two doses 
      of the killed bivalent (O1 and O139) whole-cell oral cholera vaccine (OCV) on day 
      (D)0 and D14 in healthy participants aged >/=1 year. Immediate unsolicited systemic 
      adverse events (AEs) were monitored up to 30 minutes and solicited systemic 
      reactions, up to 7 days after each vaccination. Unsolicited AEs were recorded up 
      to D14 (post-dose 1) and 30 days post-dose 2. A vibriocidal antibody assay with 
      microtiter technique was used to measure serum antibodies to V. cholerae strains 
      (O1 El Tor Inaba, O1 El Tor Ogawa, O139) on D0, D14 and D28. Geometric mean 
      titers (GMTs) and seroconversion (>/=4-fold increase from D0) rates were 
      calculated. We recruited 336 participants; 112 in three age groups (1-4, 5-14 and 
      >/=15 years). No safety concerns were observed. GMTs increased from baseline for 
      all serotypes, with marked increases for O1 Inaba and Ogawa post-dose 1. 
      Post-dose 2 GMTs tended to be equal or slightly lower, with ranges: O1 Inaba, 283 
      (95% confidence interval 191-419) to 612 (426-880); O1 Ogawa, 346 (223-536) to 
      754 (553-1028); and O139, 20.3 (13.5-30.6) to 43.8 (30.1-63.7). Seroconversion 
      rates post-dose 2 for O1 Inaba and Ogawa were high (>/=87%) for all age groups. OCV 
      demonstrated an acceptable safety profile and robust immunogenicity in these 
      participants, in-line with previous observations in epidemic and endemic 
      settings.This study is registered on www.clinicaltrials.gov (NCT02434822).
FAU - Cordero De Los Santos, Lina
AU  - Cordero De Los Santos L
AD  - a CAIMED Dominicana S.A.S., Investigacion en Salud , Santo Domingo , Dominican 
      Republic.
FAU - Feris-Iglesias, Jesus
AU  - Feris-Iglesias J
AD  - b Hospital Infantil Dr. Robert Reid Cabral, Centro de los Heroes, Departamento de 
      Enfermedades Infecciosas , Santo Domingo , Dominican Republic.
FAU - Aloysia D'Cor, Naveena
AU  - Aloysia D'Cor N
AD  - c Clinical R&D, Shantha Biotechnics Private Limited (A Sanofi Company) , 
      Basheerbagh, Hyderabad , Telangana , India.
FAU - Midde, Venkata Jayanth
AU  - Midde VJ
AD  - c Clinical R&D, Shantha Biotechnics Private Limited (A Sanofi Company) , 
      Basheerbagh, Hyderabad , Telangana , India.
FAU - Patnaik, Badri Narayan
AU  - Patnaik BN
AD  - c Clinical R&D, Shantha Biotechnics Private Limited (A Sanofi Company) , 
      Basheerbagh, Hyderabad , Telangana , India.
FAU - Thollot, Yael
AU  - Thollot Y
AD  - d Medical Department , Sanofi Pasteur , Lyon , France.
FAU - Rasuli, Anvar
AU  - Rasuli A
AD  - d Medical Department , Sanofi Pasteur , Lyon , France.
FAU - Desauziers, Eric
AU  - Desauziers E
AD  - d Medical Department , Sanofi Pasteur , Lyon , France.
LA  - eng
SI  - ClinicalTrials.gov/NCT02434822
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180222
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Cholera Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Bacterial/*blood
MH  - Child
MH  - Child, Preschool
MH  - Cholera/*prevention & control
MH  - Cholera Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Dominican Republic
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Infant
MH  - Male
MH  - Serogroup
MH  - Vaccines, Inactivated/administration & dosage/adverse effects/immunology
MH  - Vibrio cholerae/immunology
MH  - Young Adult
PMC - PMC6037475
OTO - NOTNLM
OT  - Dominican Republic
OT  - OCV
OT  - Shanchol
OT  - bivalent oral cholera vaccine
OT  - cholera
OT  - immunogenicity
OT  - safety
EDAT- 2018/02/23 06:00
MHDA- 2019/01/29 06:00
PMCR- 2018/02/22
CRDT- 2018/02/23 06:00
PHST- 2018/02/23 06:00 [pubmed]
PHST- 2019/01/29 06:00 [medline]
PHST- 2018/02/23 06:00 [entrez]
PHST- 2018/02/22 00:00 [pmc-release]
AID - 1430540 [pii]
AID - 10.1080/21645515.2018.1430540 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2018 Jun 3;14(6):1403-1411. doi: 
      10.1080/21645515.2018.1430540. Epub 2018 Feb 22.