PMID- 26011728
OWN - NLM
STAT- MEDLINE
DCOM- 20160223
LR  - 20181113
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 10
IP  - 5
DP  - 2015
TI  - Accuracy of Clinical Diagnosis of Dengue Episodes in the RV144 HIV Vaccine 
      Efficacy Trial in Thailand.
PG  - e0127998
LID - 10.1371/journal.pone.0127998 [doi]
LID - e0127998
AB  - RV144 was a community-based HIV vaccine efficacy trial conducted in 
      HIV-uninfected adults in Thailand, where dengue virus continues to cause a large 
      number of infections every year. We attempted to document the accuracy of 
      clinically diagnosed dengue episodes reported as serious adverse events (SAEs) 
      and adverse events (AEs) and examine whether dengue serology would support the 
      clinical diagnosis. Subjects without a clinical dengue diagnosis but with an 
      infection or idiopathic fever were selected as a control population. Dengue 
      serology was performed by hemagglutination inhibition on plasma samples. A total 
      of 124 clinical dengue episodes were reported (103 SAEs and 21 AEs). Overall 
      82.6% of the clinically diagnosed dengue episodes were supported by a positive 
      dengue serology: 71.4% of the AEs and 85.0% of the SAEs. Of the 100 subjects with 
      both clinical dengue and positive serology, all presented with fever, 83% with 
      leucopenia, 54% with thrombocytopenia, and 27% with hemorrhagic symptoms. All 
      episodes resolved spontaneously without sequellae. Only two of 15 subjects with a 
      negative serology presented with fever. The sensitivity and specificity of 
      clinical dengue diagnosis were 90.9% and 74.4%, respectively, when compared to 
      the control population, and with a positive predictive value of 82.6% and 
      negative predictive value of 84.7% when compared to dengue serology. Clinical 
      diagnosis of dengue is an accurate method of dengue diagnosis in adults in 
      Thailand. Large-scale clinical trials offer the opportunity to systematically 
      study infectious diseases such as dengue and other infections that may occur 
      during the trial.
FAU - Pitisuttithum, Punnee
AU  - Pitisuttithum P
AD  - Vaccine Trial Center, Faculty of Tropical Medicine, Mahidol University, Bangkok, 
      Thailand.
FAU - Rerks-Ngarm, Supachai
AU  - Rerks-Ngarm S
AD  - Department of Diseases Control, Ministry of Public Health, Nonthaburi, Thailand.
FAU - Stablein, Donald
AU  - Stablein D
AD  - EMMES Corporation, Rockville, Maryland, United States of America.
FAU - Dawson, Peter
AU  - Dawson P
AD  - EMMES Corporation, Rockville, Maryland, United States of America.
FAU - Nitayaphan, Sorachai
AU  - Nitayaphan S
AD  - Royal Thai Army Component, Armed Forces Research Institute of Medical Sciences 
      (AFRIMS), Bangkok, Thailand.
FAU - Kaewkungwal, Jaranit
AU  - Kaewkungwal J
AD  - Center of Excellence for Biomedical and Public Health Informatics, Faculty of 
      Tropical Medicine, Mahidol University, Bangkok, Thailand.
FAU - Michael, Nelson L
AU  - Michael NL
AD  - US Military HIV Research Program (MHRP), Bethesda, Maryland, United States of 
      America.
FAU - Kim, Jerome H
AU  - Kim JH
AD  - US Military HIV Research Program (MHRP), Bethesda, Maryland, United States of 
      America.
FAU - Robb, Merlin L
AU  - Robb ML
AD  - US Military HIV Research Program (MHRP), Bethesda, Maryland, United States of 
      America; The Henry M. Jackson Foundation for the Advancement of Military 
      Medicine, Bethesda, Maryland, United States of America.
FAU - O'Connell, Robert J
AU  - O'Connell RJ
AD  - US Military HIV Research Program (MHRP), Bethesda, Maryland, United States of 
      America; Department of Retrovirology, US Component-Armed Forces Research 
      Institute of Medical Sciences (AFRIMS), Bangkok, Thailand.
FAU - Yoon, In-Kyu
AU  - Yoon IK
AD  - Department of Virology, Armed Forces Research Institute of Medical Sciences 
      (AFRIMS), Bangkok, Thailand.
FAU - Fernandez, Stefan
AU  - Fernandez S
AD  - Department of Virology, Armed Forces Research Institute of Medical Sciences 
      (AFRIMS), Bangkok, Thailand.
FAU - Excler, Jean-Louis
AU  - Excler JL
AD  - US Military HIV Research Program (MHRP), Bethesda, Maryland, United States of 
      America; The Henry M. Jackson Foundation for the Advancement of Military 
      Medicine, Bethesda, Maryland, United States of America.
LA  - eng
GR  - Y1-AI-2642-12/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20150526
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (AIDS Vaccines)
SB  - IM
MH  - *AIDS Vaccines
MH  - Adult
MH  - Dengue/*diagnosis/etiology
MH  - Female
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Male
MH  - Sensitivity and Specificity
MH  - Thailand
MH  - Young Adult
PMC - PMC4444125
COIS- Competing Interests: Co-authors Donald Stablein and Peter Dawson are employed by 
      The EMMES Corporation. The EMMES Corporation is an independent contract research 
      organization providing statistical support for USMHRP activities through a 
      contract with the Henry Jackson Foundation. The EMMES Corporation has no related 
      patents, products in development or marketed products to declare. The EMMES 
      Corporation will adhere to all the PLOS ONE policies on sharing data and 
      materials, as detailed online in the guidelines for authors.
EDAT- 2015/05/27 06:00
MHDA- 2016/02/26 06:00
PMCR- 2015/05/26
CRDT- 2015/05/27 06:00
PHST- 2015/02/19 00:00 [received]
PHST- 2015/04/21 00:00 [accepted]
PHST- 2015/05/27 06:00 [entrez]
PHST- 2015/05/27 06:00 [pubmed]
PHST- 2016/02/26 06:00 [medline]
PHST- 2015/05/26 00:00 [pmc-release]
AID - PONE-D-15-06956 [pii]
AID - 10.1371/journal.pone.0127998 [doi]
PST - epublish
SO  - PLoS One. 2015 May 26;10(5):e0127998. doi: 10.1371/journal.pone.0127998. 
      eCollection 2015.