Influenza Clinical Trial
Official title:
Influenza Vaccine Immunogenicity in Extremely Premature Infants
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.
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 = 0.05, to detect a 1.5-fold difference in
GMT between groups, assuming a standard deviation (SD) spanning 0.5 to 2.0 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.
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Observational Model: Cohort, Time Perspective: Prospective
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