PMID- 34161579
OWN - NLM
STAT- MEDLINE
DCOM- 20220223
LR  - 20220223
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Linking)
VI  - 225
IP  - 1
DP  - 2022 Jan 5
TI  - Safety and Tolerability of Mosquito Bite-Induced Controlled Human Infection with 
      Plasmodium vivax in Malaria-Naive Study Participants-Clinical Profile and Utility 
      of Molecular Diagnostic Methods.
PG  - 146-156
LID - 10.1093/infdis/jiab332 [doi]
AB  - BACKGROUND: Plasmodium vivax controlled human malaria infection (PvCHMI) is an 
      important tool for evaluation of drugs, vaccines, and pathologies associated with 
      this parasite. However, there are few data on safety due to limited numbers of 
      PvCHMIs performed. METHODS: We report clinical and laboratory data, including 
      hematological and biochemical profiles and adverse events (AEs), following 
      mosquito bite-induced PvCHMI in malaria-naive study participants. Malaria 
      diagnosis and treatment initiation was based on microscopic analysis of 
      Giemsa-stained slides. Exploratory molecular assays were used to detect parasites 
      using real-time polymerase chain reaction (PCR). RESULTS: AEs were mild to 
      moderate and no study-related severe AEs were observed in any study participants. 
      The majority of symptoms were transient, resolving within 48 hours. Molecular 
      diagnostic methods detected parasitemia in 100% of study participants before 
      malaria diagnosis using microscopy. Of reported AEs, microscopy detected 
      67%-100%, quantitative PCR 79%-100%, and quantitative real-time 
      reverse-transcription PCR 96%-100% of study participants prior to appearance of 
      symptoms. Almost all symptoms appeared after initiation of treatment, likely as 
      known consequence of drug treatment. CONCLUSIONS: PvCHMI is safe with the 
      majority of infections being detected prior to appearance of clinical symptoms, 
      which can be further alleviated by using sensitive molecular methods for clinical 
      diagnosis. Clinical Trials Registration. NCT01157897.
CI  - Published by Oxford University Press for the Infectious Diseases Society of 
      America 2021.
FAU - Kamau, Edwin
AU  - Kamau E
AD  - Malaria Biologics Branch, Walter Reed Army Institute of Research, Silver Spring, 
      Maryland, USA.
FAU - Bennett, Jason W
AU  - Bennett JW
AD  - Malaria Biologics Branch, Walter Reed Army Institute of Research, Silver Spring, 
      Maryland, USA.
FAU - Yadava, Anjali
AU  - Yadava A
AD  - Malaria Biologics Branch, Walter Reed Army Institute of Research, Silver Spring, 
      Maryland, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01157897
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (DNA, Protozoan)
SB  - IM
MH  - Adult
MH  - DNA, Protozoan/blood/*isolation & purification
MH  - Female
MH  - Humans
MH  - *Insect Bites and Stings
MH  - Malaria/blood/*diagnosis
MH  - Malaria, Vivax/*diagnosis
MH  - Male
MH  - Middle Aged
MH  - Pathology, Molecular
MH  - Plasmodium vivax/*genetics/isolation & purification
MH  - Real-Time Polymerase Chain Reaction/*methods
MH  - Young Adult
OTO - NOTNLM
OT  - Plasmodium vivax
OT  - PvCHMI
OT  - controlled human malaria infection (CHMI)
OT  - malaria
OT  - malaria naive
OT  - malaria symptoms
EDAT- 2021/06/24 06:00
MHDA- 2022/02/24 06:00
CRDT- 2021/06/23 17:27
PHST- 2021/04/19 00:00 [received]
PHST- 2021/06/22 00:00 [accepted]
PHST- 2021/06/24 06:00 [pubmed]
PHST- 2022/02/24 06:00 [medline]
PHST- 2021/06/23 17:27 [entrez]
AID - 6308400 [pii]
AID - 10.1093/infdis/jiab332 [doi]
PST - ppublish
SO  - J Infect Dis. 2022 Jan 5;225(1):146-156. doi: 10.1093/infdis/jiab332.