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Host Genetic Susceptibility to Avian Influenza A/H5N1

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ClinicalTrials.gov Identifier: NCT01074736
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : November 4, 2010
Sponsor:
Collaborators:
University of Oxford
Wellcome Trust
Information provided by:
South East Asia Infectious Disease Clinical Research Network

Tracking Information
First Submitted Date February 23, 2010
First Posted Date February 24, 2010
Last Update Posted Date November 4, 2010
Study Start Date July 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Host Genetic Susceptibility to Avian Influenza A/H5N1
Official Title Host Genetic Susceptibility to Avian Influenza A/H5N1 in Vietnam, Thailand, Indonesia and Singapore
Brief Summary

The identification and characterization of susceptibility loci for H5N1 infection in humans could have profound implications. The detection of host genetic factors may shed light on key pathogenic interactions between H5N1 and human cells, assisting in identifying the viral characteristics determining pandemic potential. In addition, the identification and verification of susceptibility loci would be followed by functional studies which might point the way to new therapeutic and preventive options.

The objective of this study is to investigate if host genetic factors are associated with susceptibility to influenza H5N1 illness

Detailed Description

This is primarily an hypothesis screening exercise and while guesses based on biological plausibility are possible, a comprehensive analysis of genetic susceptibility can only be achieved by a whole genome approach. Therefore we will test for genetic linkage and association using a large number of Single Nucleotide Polymorphisms (SNPs) spanning the whole genome.

Principal Investigators have access to information on all surviving and deceased laboratory confirmed H5N1 cases. These cases will form the study base. The epidemiologist will attempt to make telephone contact with either the recovered patient or,if the patient died, the closest relative of the deceased patient. The proposed study will be explained and permission will be sought for the epidemiologist and a study nurse to visit the household to explain the study in greater detail, to offer an opportunity for questions and, if the subject agrees, to obtain informed consent for participation. If the epidemiologist has difficulty in making contact with the case or their family the local public authorities will be asked to assist in making contact. Eligible family members of H5N1 cases will be identified by face-to-face interviews with the surviving confirmed cases or close family members of deceased cases.

Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • whole blood in tubes containing EDTA
  • mouth wash.
  • buffy coat; cell pellet from centrifuged blood, nucleic acid extracted for diagnostic purposes, serum, throat, nose or endotracheal swabs
Sampling Method Non-Probability Sample
Study Population
  • symptomatic cases with laboratory confirmed H5N1 infection will be eligible for inclusion.
  • Priority for recruitment will be given to cases from multi-case families in order tomaximize the probability of including cases with a genetic etiology.
Condition Influenza A Virus/H5N1 Subtype
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February¬†23,¬†2010)
500
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The individual had a clinically compatible illness (defined as respiratory symptoms and an abnormal chest x-ray or encephalitis), AND
  • Influenza A/H5 RNA identified in a clinical sample by reverse transcription-polymerase chain reaction [RT-PCR], OR
  • Influenza A/H5 cultured from a clinical sample, OR
  • High titres (1:80 or higher) of anti-H5 antibodies by microneutralization in convalescent samples of patients who had a compatible illness but no or negative RT-PCR, AND
  • The patient survived or if they died an archived biological specimen is available for potential DNA extraction, AND
  • Valid, written consent is obtained.
  • The biological parents and biological siblings of all the cases and any other family members linking two cases, AND
  • Valid, written consent is obtained.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT01074736
Other Study ID Numbers SEA 007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Peter Horby, NCC Oxford University Clinical Research Unit - The Hospital for Tropical Diseases, Vietnam
Study Sponsor South East Asia Infectious Disease Clinical Research Network
Collaborators
  • University of Oxford
  • Wellcome Trust
Investigators
Principal Investigator: Tawee Chotpitayasunond, Professor Queen Sirikit National Institute of Child Health, Bangkok, Thailand
Principal Investigator: Herawati Sudoyo, Dr. Eijkman Institute for Molecular Biology
Principal Investigator: Tran Hien Nguyen, Professor National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
Principal Investigator: Martin Hibberd, Dr. Genome Institute of Singapore, Singapore
PRS Account South East Asia Infectious Disease Clinical Research Network
Verification Date November 2010