Antibody Titer Analysis After H1N1 Vaccination in Pediatric Haemato-oncology Patients - Full Text View

Purpose

The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza infection than general population, and they are strongly recommended to receive novel H1N1 vaccination. However, there is no previous data to answer how the efficacy and effectiveness of novel H1N1 vaccination is in patients of pediatric haemato-oncology. This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients. Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI). A HAI titer with a 4-fold rise or greater is defined as seroconversion. Study subjects with seroconversion are regarded as responsiveness to the vaccination. Meanwhile, if the patient presents influenza-like symptoms, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis. After the study, we will be able to know whether or not current novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric haemato-oncology patients.

Condition	Intervention
Serology Analysis Novel H1N1 Influenza Vaccination Pediatric Haemato-oncology Patients	Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Antibody Titer Analysis Afer Monovalent Vaccination in Pediatric Haemato-oncology Patients

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients. Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI). [ Time Frame: Dec, 2009 - Feb, 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

If the patient presents influenza-like symptoms during the six month follow up period, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis. [ Time Frame: Dec, 2009 - Jun, 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Serum for serology of H1N1 antibody Nasopharyngeal or oropharyngeal swab for Novel H1N1 PCR

Estimated Enrollment:	50
Study Start Date:	December 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Serology after Novel H1N1 vaccination This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients.	Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated Serology study before and after Influenza A (2009) monovalent vaccine, inactivated Other Name: Influenza Virus Vaccine, AdimFlu-S (A/H1N1)

Detailed Description:

The emergence of novel H1N1 influenza in 2009 has a great impact to the societies in Taiwan and worldwide. The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza infection than general population, and they are strongly recommended to receive novel H1N1 vaccination. However, there is no previous data to answer how the efficacy and effectiveness of novel H1N1 vaccination is in patients of pediatric haemato-oncology. This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients. Thus two blood samples will be drawn. The first sample will be collected before the vaccination and the second one will be collected three weeks after the vaccination (If the patient is younger than 9 years old, the third sample will be collected three weeks after the booster vaccination). Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI). A HAI titer with a 4-fold rise or greater is defined as seroconversion. Study subjects with seroconversion are regarded as responsiveness to the vaccination. We will analyze seroconversion rate as well. Meanwhile, if the patient presents influenza-like symptoms, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis. After the study, we will be able to know whether or not current novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric haemato-oncology patients.

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients.

Criteria

Inclusion Criteria:

Boys or girls aged ≧ 6 months old to 18 years old on the day of first vaccination;
Subject and/or parents(s)/legal guardian(s) was willing to comply with planned study procedures and be available for all study visits;
Subject was ever treated at pediatric haemato-oncology ward
Subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.

Exclusion Criteria:

History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication (AdimFlu-S (A/H1N1));
Personal or family history of Guillain-Barré Syndrome;
An acute febrile illness within the last 72 hours prior to vaccination;
Subject with bleeding disorder or has any coagulation disorder that needs receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection;
Subjects with influenza-like illness as defined by the presence of fever (temperature ≧38.5℃ ) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
Female subjects who are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
Underlying condition in the investigator's opinion may be inappropriate for vaccination;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046227

Contacts

Contact: Luan-Yin Chang, MD

886-23123456 ext 75128

ly7077@tpts6.seed.net.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan
Contact: Luan-Yin Chang, MD 886-2-23123456 ext 71528 ly7077@tpts6.seed.net.tw

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Luan-Yin Chang, MD

National Taiwan University Hospital, Taipei, Taiwan

More Information

No publications provided

Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT01046227 History of Changes
Other Study ID Numbers:	200912031R
Study First Received:	January 8, 2010
Last Updated:	January 8, 2010
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Serology
Monovalent inactivated H1N1 vaccine
Pediatric haemato-oncology patients

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013