Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455169
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2007-03-30
Brief Title:
Influenza Vaccine in Premature Infants
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Influenza Vaccine Immunogenicity in Extremely Premature Infants
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Influenza is increasingly recognized as causing severe respiratory illness in children High-risk infants like former premature infants and particularly those with lung disease have influenza hospitalization rates about five times higher than healthy children Influenza vaccine does not protect young children against influenza as well as it does healthy adults A small study that measured antibodies proteins that protect against infection to influenza suggested that premature infants get even less protection from influenza vaccine than full-term infants More information about influenza vaccine in premature infants is needed The overall goals of this project are to collect information about the how well the influenza vaccine induces antibody production and to develop the collaborative network of centers necessary for a larger trial of influenza vaccine in premature infants
Objective and Hypotheses The objective of this study is to measure the amount of protective antibody produced by influenza vaccine in premature less than 30 weeks about 7 months gestation at birth extremely-low-birth-weight 1000 grams 2¼ pounds or less at birth infants Influenza vaccine needs to be given yearly We will assess premature infants during their first series of influenza vaccines We hypothesize that the levels of antibody will be lower in premature infants receiving their first series of influenza vaccine than in full-term infants
Design We will measure the immune response in premature and full term infants During the 2007-2008 influenza season a total of 92 subjects divided among 2 groups premature infants 6-17 months old receiving their first influenza vaccine series and full-term infants 6-17 months old receiving their first influenza vaccine series will be recruited at a consortium of five centers the University of Rochester the University of Texas Southwestern Medical Center Wake Forest University the University of Miami and the State University of New York at Buffalo receive 2 doses of influenza vaccine and have antibody and immune cell responses to each vaccine component measured 4-6 weeks after the second dose of vaccine
Potential Impact If this study and future investigations suggested ways to improve premature infants influenza vaccine responses they could lead to changes in recommendations for the number or timing of vaccine doses or of the type of vaccine used in this high-risk group
Objective and Hypotheses The objective of this study is to measure the amount of protective antibody produced by influenza vaccine in premature less than 30 weeks about 7 months gestation at birth extremely-low-birth-weight 1000 grams 2¼ pounds or less at birth infants Influenza vaccine needs to be given yearly We will assess premature infants during their first series of influenza vaccines We hypothesize that the levels of antibody will be lower in premature infants receiving their first series of influenza vaccine than in full-term infants
Design We will measure the immune response in premature and full term infants During the 2007-2008 influenza season a total of 92 subjects divided among 2 groups premature infants 6-17 months old receiving their first influenza vaccine series and full-term infants 6-17 months old receiving their first influenza vaccine series will be recruited at a consortium of five centers the University of Rochester the University of Texas Southwestern Medical Center Wake Forest University the University of Miami and the State University of New York at Buffalo receive 2 doses of influenza vaccine and have antibody and immune cell responses to each vaccine component measured 4-6 weeks after the second dose of vaccine
Potential Impact If this study and future investigations suggested ways to improve premature infants influenza vaccine responses they could lead to changes in recommendations for the number or timing of vaccine doses or of the type of vaccine used in this high-risk group
Detailed Description:
Background Influenza infection causes an estimated 1 million deaths worldwide yearly Severe influenza respiratory disease is increasingly recognized in children Influenza hospitalization rates in high-risk infants such as premature infants are increased some five-fold over rates in other children Influenza vaccine immunogenicity is generally modest even in healthy children and influenza vaccines have been incompletely studied in premature infants Further investigation is required to optimize vaccine responses in premature infants The overall goals of this project are to generate estimates of effect size and variance of influenza vaccine immunogenicity for use in planning a larger multi-center trial and to develop the collaborative network of centers necessary for such a trial
Objective and Hypotheses The primary objective of this study is to measure influenza vaccine immunogenicity in extremely-low-birth-weight ELBW 1001 grams at birth premature 30 weeks gestation infants receiving trivalent inactivated split-virion influenza vaccine TIV We hypothesize that the geometric mean titer GMT of antibody to each of the three vaccine components will be lower in ELBW infants receiving their first series of TIV than in full-term FT 37 weeks gestation normal-birth-weight 2500 grams infants
Specific Aim To measure the humoral and cellular immunogenicity of influenza vaccine in extremely-low-birth-weight ELBW greater than or equal to 1000 grams at birth premature infants receiving trivalent inactivated split-virion influenza vaccine TIV for their first influenza vaccine series in 2007-8
Design This prospective cohort immunogenicity study will estimate the GMT to influenza in ELBW infants with a comparison group of FT infants Using the established vaccine study infrastructure at a consortium of five centers the University of Rochester the University of Texas Southwestern Medical Center Wake Forest University the University of Miami and the State University of New York at Buffalo we will recruit 46 un-immunized for influenza ELBW infants 6-17 months old and 46 un-immunized FT infants 6-17 months old Infants will receive the recommended 2 doses of TIV 4 weeks apart with blood drawing at the first vaccine dose and 4-6 weeks after the second Antibody to each vaccine component will be measured by hemagglutination inhibition The frequency of hemagglutinin-specific T cell interleukin IL-2 IL-4 and interferon gamma IFNγ responses will be measured by ELISPOT assay The primary outcome will be influenza GMT A sample size of 46 subjects per group provides 80 power using a two-sided alpha 005 to detect a 15-fold difference in GMT between groups assuming a standard deviation SD spanning 05 to 20 times the value of each GMT In addition the five-center consortium will monitor the quality of the collaboration strengthen its capabilities through the design and implementation of a secure web-based information system and expand its efforts by seeking additional outside funding to implement a companion protocol assessing live attenuated influenza vaccine in premature infants
Potential Impact This study is designed to assess the immunogenicity of the current generation of influenza vaccines in premature infants This and future trials assessing novel immunization strategies such as an additional vaccine dose or vaccines for instance the live attenuated influenza virus vaccine in premature infants could eventually lead to the tailoring of specific vaccine strategies for this high-risk group In addition this proposal would bring to maturity a multi-center collaborative mechanism for vaccine trials in premature infants
Objective and Hypotheses The primary objective of this study is to measure influenza vaccine immunogenicity in extremely-low-birth-weight ELBW 1001 grams at birth premature 30 weeks gestation infants receiving trivalent inactivated split-virion influenza vaccine TIV We hypothesize that the geometric mean titer GMT of antibody to each of the three vaccine components will be lower in ELBW infants receiving their first series of TIV than in full-term FT 37 weeks gestation normal-birth-weight 2500 grams infants
Specific Aim To measure the humoral and cellular immunogenicity of influenza vaccine in extremely-low-birth-weight ELBW greater than or equal to 1000 grams at birth premature infants receiving trivalent inactivated split-virion influenza vaccine TIV for their first influenza vaccine series in 2007-8
Design This prospective cohort immunogenicity study will estimate the GMT to influenza in ELBW infants with a comparison group of FT infants Using the established vaccine study infrastructure at a consortium of five centers the University of Rochester the University of Texas Southwestern Medical Center Wake Forest University the University of Miami and the State University of New York at Buffalo we will recruit 46 un-immunized for influenza ELBW infants 6-17 months old and 46 un-immunized FT infants 6-17 months old Infants will receive the recommended 2 doses of TIV 4 weeks apart with blood drawing at the first vaccine dose and 4-6 weeks after the second Antibody to each vaccine component will be measured by hemagglutination inhibition The frequency of hemagglutinin-specific T cell interleukin IL-2 IL-4 and interferon gamma IFNγ responses will be measured by ELISPOT assay The primary outcome will be influenza GMT A sample size of 46 subjects per group provides 80 power using a two-sided alpha 005 to detect a 15-fold difference in GMT between groups assuming a standard deviation SD spanning 05 to 20 times the value of each GMT In addition the five-center consortium will monitor the quality of the collaboration strengthen its capabilities through the design and implementation of a secure web-based information system and expand its efforts by seeking additional outside funding to implement a companion protocol assessing live attenuated influenza vaccine in premature infants
Potential Impact This study is designed to assess the immunogenicity of the current generation of influenza vaccines in premature infants This and future trials assessing novel immunization strategies such as an additional vaccine dose or vaccines for instance the live attenuated influenza virus vaccine in premature infants could eventually lead to the tailoring of specific vaccine strategies for this high-risk group In addition this proposal would bring to maturity a multi-center collaborative mechanism for vaccine trials in premature infants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None