Expert answer:Final Report

Solved by verified expert:Follow instruction file and read 4 articles (Milk and egg allergy) that I will give them to you below and write paper report in 5 pages with double space and size 12. Guidelines for Discussion and Final Written PaperYou will be expected to identify, evaluate, interpret and utilize the information you obtain through research to critically discuss problems related to those issues. You will be graded on your ability to address complex issues related to food toxicology and our environment using analytical, reasoning and critical thinking skills to develop sound and effective arguments in support of your opinions, and to effectively communicate your ideas through both oral and written communication.Evaluation of Final Written Report (50 pts)9 pts objectives, point of view or arguments clearly presented?4 pts Research design/methods described?4 pts Was the evidence, arguments, and findings reported without bias?9 pts Was a critical evaluation made of the studies, including methods and interpretation of data? Were strengths and limitations noted?9 pts Was a conclusion clearly stated? Did it draw from the findings?4 pts Was a discussion made of the significance of the findings?7 pts Was the paper written clearly, with few grammatical errors, and in an organized manner?4 pts Was the paper submitted in a professional manner (i.e. with name, date, title, following instructions, and handed in on time)?The paper should:include a specific, clearly stated objective statement in the Introduction. For example, the objective of this presentation / paper is to — “evaluate current evidence regarding the scientific safety of genetically modified organism” or “examine current research on the relationship between polychlorinated biphenols contamination and reproductive failure in women”;report all findings in the past tense, and your summary in the present tense;not use first or second person or value-based statements (i.e. I believe, I think, etc). Use objective descriptive statements (e.g. “the data suggest”, “the studies provide strong evidence“, or “the data support the conclusion”);be properly referenced – make sure your citations in the text are in the reference list and vise versa.
final_report_instructions_spring18.pdf

20180316025608safety_of_live_attenuated_influenza_vaccine_in_atopic_children_with_egg_allergy.pdf

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NuFS 115: Final Written Report (Due date: 5/10/2018)
(1) Submit a hard copy in class, and (2) submit a copy on Canvas
• What to cover: group presentation content (some subtopics)

Format —- A scientific review in APA citation format

Number of references to be included in this writing: at least 4 references (the two
references you have for assignment #2 + a few more references from your group members)

OK to use your own assignment #2 (shorten your assignment#2) as the foundation of your
final written report (but don’t use the assignment#2 of your group members!)

Cover page + 4-5-page writing (1000-1200 words) + reference page
– Cover page: descriptive title; your name
– Introduction includes
– Brief background information about the chemical(s) of interest; the health effect
you researched; the significance of this topic.
– Don’t forget to include in-text citations (if needed).
– Don’t forget to state the purpose of this final report.
– Subtopic 1 (Give a subtitle)
– What is the question (or controversy)?
– What are your findings? Summarize the study (or studies). Do the results of the
study (studies) answer the question? Is there any limitation of the study (studies)?
(Remember in-text citations)
– Subtopic 2 (Give a subtitle)
– What is the question (or controversy)?
– What are your findings? Summarize the study (or studies). Do the results of the
study (studies) answer the question? Is there any limitation of the study (studies)?
(Remember in-text citations)
– Subtopic 3….. (add more subtopics if needed)
– Conclusion
– The overall conclusion of the report. What do we learn after reviewing the above
studies? You may also include recommendations /regulations, future research
directions of this topic, etc. (If regulations come from government websites, include
the websites into your reference list and make in-text citations).
– Reference page
– List all references (For each reference, list authors, year, article title, journal title,
volume number, page number).
Not familiar with APA format? Go to : https://owl.english.purdue.edu/owl/resource/560/01/
Safety of live attenuated influenza vaccine in atopic children
with egg allergy
Paul J. Turner, FRACP, PhD,a,b,c Jo Southern, PhD,b Nick J. Andrews, PhD,b Elizabeth Miller, FRCPath,b
and Michel Erlewyn-Lajeunesse, DM,d on behalf of the SNIFFLE Study Investigators*
London and Southampton,
United Kingdom, and Sydney, Australia
Background: Live attenuated influenza vaccine (LAIV) is an
intranasal vaccine recently incorporated into the United
Kingdom immunization schedule. However, it contains egg
protein and, in the absence of safety data, is contraindicated in
patients with egg allergy. Furthermore, North American
guidelines recommend against its use in asthmatic children.
Objective: We sought to assess the safety of LAIV in children
with egg allergy.
Methods: We performed a prospective, multicenter, open-label,
phase IV intervention study involving 11 secondary/tertiary
centers in the United Kingdom. Children with egg allergy
(defined as a convincing clinical reaction to egg within the past
12 months and/or >95% likelihood of clinical egg allergy as per
published criteria) were recruited. LAIV was administered
under medical supervision, with observation for 1 hour and
telephone follow-up 72 hours later.
From athe Section of Paediatrics (Allergy & Immunology) and MRC & Asthma UK
Centre in Allergic Mechanisms of Asthma, Imperial College London; bthe Immunisation, Hepatitis and Blood Safety Department, Public Health England, London;
c
the Division of Paediatrics and Child Health, University of Sydney; and dthe Department of Paediatric Allergy & Immunology, University Hospital Southampton NHS
Foundation Trust, Southampton.
*The SNIFFLE Study Investigators are Christine Doyle, George Du Toit, Michel
Erlewyn-Lajeunesse, Roisin Fitzsimons, Paul T. Heath, Stephen M. Hughes, Louise
Michealis, J€
urgen Schwarz, Matthew D. Snape, Gary Stiefel, Huw M. Thomas, and
Paul J. Turner.
This report is independent research commissioned and funded by the Department of
Health Policy Research Programme (National Vaccine Evaluation Consortium, 039/
0031). The views expressed in this publication are those of the authors and not necessarily those of the Department of Health. The study received additional local support
through the NIHR Clinical Research Networks, with additional funding for a Scottish
site from Health Protection Scotland. P.J.T. and M.E.-L had financial support from the
Department of Health for the submitted work. P.J.T. is a recipient of a Clinician Scientist award from the UK Medical Research Council (grant MR/K010468/1) and is
supported by the National Institute for Health Research (NIHR) Imperial Biomedical
Research Centre and the MRC–Asthma UK Centre in Allergic Mechanisms of
Asthma.
Disclosure of potential conflict of interest: P. J. Turner has received research support from
the United Kingdom Department of Health, the UK Medical Research Council, and the
National Institute for Health Research. M. Erlewyn-Lajeuness has received support for
attendance at scientific meetings from Allergy Therapeutics, ALK-Abello, MEDA
Pharmaceuticals, and Thermo Fisher. The rest of the authors declare that they have
no relevant conflicts of interest.
ClinicalTrials.gov registration NCT01859039, European Clinical Trials database registration 2013-002031-26.
Received for publication November 25, 2014; revised December 19, 2014; accepted for
publication December 23, 2014.
Available online February 13, 2015.
Corresponding author: Paul J. Turner, FRACP, PhD, Section of Paediatrics (Allergy &
Immunology), Imperial College London, Norfolk Place, London, W2 United
Kingdom. E-mail: p.turner@imperial.ac.uk.
0091-6749
Ó 2015 The Authors. Published by Elsevier Inc. on behalf of the American Academy
of Allergy, Asthma & Immunology. This is an open access article under the CC BY
license (http://creativecommons.org/licenses/by/4.0/).
http://dx.doi.org/10.1016/j.jaci.2014.12.1925
376
Results: Four hundred thirty-three doses were administered to
282 children with egg allergy (median, 4.9 years; range, 2-17
years); 115 (41%) had experienced prior anaphylaxis to egg.
A physician’s diagnosis of asthma/recurrent wheezing was noted
in 67%, and 51% were receiving regular preventer therapy.
There were no systemic allergic reactions (upper 95% CI for
population, 1.3%). Eight children experienced mild self-limiting
symptoms, which might have been due an IgE-mediated allergic
reaction. Twenty-six (9.4%; 95% CI for population, 6.2% to
13.4%) children experienced lower respiratory tract symptoms
within 72 hours, including 13 with parent-reported wheeze.
None of these episodes required medical intervention beyond
routine treatment.
Conclusions: In contrast to current recommendations, LAIV
appears to be safe for use in children with egg allergy.
Furthermore, the vaccine appears to be well tolerated
in children with a diagnosis of asthma or recurrent wheeze. (J
Allergy Clin Immunol 2015;136:376-81.)
Key words: Egg allergy, live attenuated influenza vaccine, asthma,
recurrent wheezing, safety
Egg allergy is one of the most common food allergies in
childhood, with an estimated prevalence of at least 2% in
preschool children.1 Influenza vaccines generally contain egg
protein (including ovalbumin) because the vaccine virus is
cultured in hen’s eggs; only vaccines with an ovalbumin concentration of less than 2 mg/mL are currently approved by the United
Kingdom (UK) national regulator. In theory, patients with egg allergy might be at increased risk of an allergic reaction to influenza
vaccines. In recent years, inactivated influenza vaccines (IIVs)
with very low or no ovalbumin content have become available.
Observational studies have confirmed the safety of the parenteral
IIV in children with egg allergy, including those with a history of
previous anaphylaxis to egg,2,3 and have led to a relaxation of
contraindications relating to egg allergy in some guidelines.4-6
A trivalent live attenuated influenza vaccine (LAIV) administered through the intranasal route has been available in the United
States for several years and received approval for use in Europe in
2010. The vaccine has high efficacy against influenza in children
aged 2 to 17 years,7,8 with a similar safety profile to IIV in children
without egg allergy.9-14 LAIV is also grown in hen’s eggs and contains egg proteins. Until recently, there were no published data on
the safety of LAIV in children with egg allergy, and thus its use in
this population has been contraindicated.
Authorities in North America recommend annual influenza
vaccination in children from 2 to 8 years of age, preferably with
LAIV.6 LAIV is not licensed for use in children less than 2 years
of age because of an increased incidence of wheezing in this age
group after immunization.10,15 This effect has not been seen in
TURNER ET AL 377
J ALLERGY CLIN IMMUNOL
VOLUME 136, NUMBER 2
Abbreviations used
BTS: British Thoracic Society
IIV: Inactivated influenza vaccine
IQR: Interquartile range
LAIV: Live attenuated influenza vaccine
SIGN: Scottish Intercollegiate Guidelines Network
UK: United Kingdom
older children,11,15,16 even in those with pre-existing asthma and
wheeze,9 a finding confirmed in postmarketing surveillance
data.12,13 Nonetheless, current guidance from the US Centers
for Disease Control and Prevention recommends against using
LAIV in children less than 5 years of age with asthma or an
episode of wheezing in the previous year.6
In 2013, the UK introduced annual influenza immunization
using LAIV into the National Immunization Schedule for
children.17 Given that the rate of egg allergy in this age group is
estimated to be 2.5%, we estimate (on the basis of UK 2013 population data) that there are 60,000 children in this age group for
whom LAIV is contraindicated because of a diagnosis of egg
allergy. Therefore egg allergy is a significant barrier to successful
implementation of the immunization program, resulting in a
requirement to vaccinate children with egg allergy with IIV
administered by means of injection (typically in the hospital environment), something which is less acceptable to families and
would incur significantly higher health costs. As a result, we
sought to assess the safety of LAIV in children with egg allergy
to provide data to inform an evidence-based consideration of a
change to current guidelines.
METHODS
We conducted a phase IV open-label study of LAIV in children with egg
allergy during the UK influenza season (September 2013 to January 2014)
across 12 hospital-based allergy centers in the UK. Study participants were
recruited locally from allergy clinics. Eligible participants were aged 2 to 17
years with (1) IgE-mediated food allergy to egg, which was defined as a
positive food challenge result to egg within the last 12 months under medical
supervision; (2) a previous convincing clinical reaction to egg within the past
12 months with evidence of current sensitization on the basis of a positive skin
prick test response or serum-specific IgE level to egg white; or (3) evidence of
current sensitization consistent with a greater than 95% likelihood of clinical
egg allergy, as per published criteria.18 Patients with a history of prior anaphylaxis to egg or a history of severe but stable asthma were not excluded.
Anaphylaxis was defined by using World Allergy Organization criteria.19
Asthma was classified according to current therapy at the time of immunization using the British Thoracic Society (BTS) and Scottish Intercollegiate
Guidelines Network (SIGN) guidelines.20 Skin prick testing was performed
in all participants before inclusion according to published guidelines to
confirm sensitization to egg (egg white extract; ALK-Abello, Hørsholm,
Denmark) and detect sensitization to potential aeroallergens. Testing and
vaccination were deferred if participants had received an antihistamine within
the previous 4 days. Participants were excluded if they had previously required
invasive ventilation for an anaphylactic reaction to egg, had severe unstable
asthma, or had a contraindication to LAIV, such as a prior allergic reaction
to a vaccine component (other than egg) or current salicylate therapy or had
experienced significant immunocompromise. Vaccination was deferred in participants with acute febrile illness or evidence of increased asthma symptoms
for at least 2 weeks after symptom resolution.
The study was approved by the West Midlands–Edgbaston Research Ethics
Committee (13/WM/0231), and the parent/guardian of each participant
provided written informed consent. Children older than 8 years were
encouraged to provide their own assent. The study sponsor was the University
Hospital Southampton NHS Foundation Trust (study no. RHM CHI0659).
This study was registered with ClinicalTrials.gov (NCT01859039) and the
European Union Clinical Trials Register (EudraCT 2013-002031-26).
Procedures
Participants had baseline parameters (blood pressure, heart rate, respiratory
rate, and oxygen saturation) measured before LAIVadministration, with clinical
respiratory and dermatologic assessment at the same time. LAIV (Fluenz
[marketed as Flumist in North America] produced for the 2013-2014 influenza
season; AstraZeneca, London, UK) was administered into the nasal airway
according to the approved summary of product characteristics (ie, 0.1 mL per
nostril) in either the allergy day case or clinical research unit at each hospital site.
Participants were observed for at least 1 hour for symptoms of local or systemic
allergic reactions, as defined by international consensus.21 Clinical observations
were recorded for 60 minutes after vaccine administration, along with symptom
scoring (total ocular and nasal symptom score).22 In one center a subset of patients underwent acoustic rhinometry, an objective assessment of nasal airway
patency before and 10 minutes after LAIV administration, as previously
described.23 Emergency contact details were provided for parents to seek advice
in the event of any concerns after vaccination. Parents were contacted by telephone after a minimum of 72 hours to detect any delayed adverse reaction.
Participants who had not received immunization with nonpandemic
influenza vaccine in previous years were offered a second dose of LAIV at
least 4 weeks later in line with the product recommendations.
Outcomes
The primary outcome was the incidence of allergic reaction as an adverse
event after immunization occurring within 2 hours of LAIV administration in
children with egg allergy. A systemic allergic reaction (anaphylaxis) was
defined according to the Brighton Collaboration case definition.24 Secondary
outcomes were as follows: incidence of delayed symptoms occurring up to 72
hours after LAIV administration; incidence of adverse events of nonallergic
cause after LAIV administration; and change in nasal airway patency in
children who underwent acoustic rhinometry as an additional assessment.
The causality of all adverse events was confirmed by an independent data
monitoring committee in conjunction with the local study team.
Statistical analyses
Analyses were planned prospectively and detailed in a statistical analysis
plan. The incidence of reactions to LAIV (both immediate and delayed) was
estimated with 2-sided exact 95% CIs. For subgroup analyses, incidences of
reactions were compared between different cohorts by using a 2-sided Fisher
exact test. Sample size was considered with respect to a historical comparison
and also based on the precision around an estimate of zero. If there were no
allergic reactions in a sample size of 300, then this would provide confidence
(based on the upper end of the 2-sided 95% CI) that the true rate of allergic
reaction to LAIV in children with egg allergy within the population is no more
than 1.2%. The analysis data set was as treated and with relevant safety data
measured.
RESULTS
Two hundred eighty-two children with egg allergy were
enrolled in the study and received at least 1 dose of LAIV
between September 2013 and January 2014. The median age of
the cohort was 4.9 years (range, 2-17 years; interquartile range
[IQR], 3-8 years), and 185 (66%) were male. A total of 433 doses
of LAIV were administered to 282 children, 64 with prior
influenza vaccination and 218 vaccine-naive children, as
depicted in Fig 1. One hundred fifty-one children received a second dose of LAIV 4 weeks later. The reasons for only a single
dose of LAIV being administered in the remainder are shown in
378 TURNER ET AL
J ALLERGY CLIN IMMUNOL
AUGUST 2015
FIG 1. Patient flow diagram. *One child could not receive LAIV because a family member had commenced
immunosuppressant therapy for medical reasons. This child was given IIV instead.
Fig 1. Unfortunately, 53 children were unable to receive a second
dose because of unavailability of in-date vaccine; none of these
children were in a high-risk clinical category requiring 2 doses according to UK immunization guidelines.17
All children had evidence of current egg allergy at the time of
immunization. One hundred forty-five (51%) children experienced an allergic reaction to egg in the last 12 months with
evidence of sensitization at enrollment. Twenty-two (8%) had
undergone formal, in-hospital food challenges to egg within the
previous 12 months to substantiate their diagnosis. A total of 137
(49%) had not reacted to egg in the last 12 months but had
evidence of sensitization (ie, greater than the published criteria of
>95% positive predictive values for clinical egg allergy).20 Only
35 (12%) had never eaten egg and were given a diagnosis based
on results of predictive allergy testing alone. The median
skin prick test response to egg white was 7 mm (IQR, 5-9 mm;
range, 0-16 mm), and the median serum-specific IgE level was
12.1 kUA/L (IQR, 2.9-35.2 kUA/L; range, 0->100 kUA/L). The
cohort included 115 (41%) children with a history of prior
anaphylaxis to egg, of whom 68 (24%) had experienced
respiratory symptoms, cardiovascular symptoms, or both with
egg ingestion. Seventy-six (27%) were currently tolerating baked
egg (eg, in cakes) at the time of enrollment.
Physician-diagnosed asthma/recurrent wheeze
One hundred eighty-eight (67%) children had a physician’s
diagnosis of asthma or recurrent wheeze, of whom 145 (51% of
total cohort) were using daily preventer therapy (BTS/SIGN step
2 or greater). Sixty-nine (25%) were using high-dose inhaled
corticosteroids, multiple preventer therapy, or both. One
hundred fifty-seven (56%) had allergic rhinitis, 180 (64%) had
atopic eczema, and 138 (49%) were allergic to 3 or more food
groups.
TURNER ET AL 379
J ALLERGY CLIN IMMUNOL
VOLUME 136, NUMBER 2
TABLE I. Delayed adverse events reported by parents
Delayed symptoms
experienced after LAIV
Denominator (no. of
doses/children in study)
Upper respiratory
Upper respiratory (any)
Isolated symptoms only,
<24-h duration Isolated symptoms only, >24-h duration
Nasal symptoms with
ocular involvement
Lower respiratory
Lower respiratory (any)
Parent-reported wheeze
Constitutional
Any
Fever <24 h Fever >24 h
Other: lethargy, headache,
dizziness, myalgia
Dermatological
Flare in eczema
Nonspecific rash, no
response to
antihistamine
Abdominal symptoms
Vomiting, nausea,
abdominal pain
Loose stools
Ear-nose-throat
Mild epistaxis
Ocular
Itch, redness
Neurological
Any
Cardiovascular
Any
No. of No. of Rate in
doses children cohort
426
95% CI
for population
TABLE II. Rates of adverse events occurring within 72 hours
after LAIV administration in this study compared with published rates in the literature
Symptoms within 72 h
278
65
23
59
22
21.2% 16.6% to 26.5%
7.9% 5.0% to 11.7%
9
9
3.2%
1.5% to 6.1%
6
6
2.2%
0.8% to 4.6%
26
13
26
13
9.4%
4.7%
6.2% to 13.4%
2.5% to 7.9%
31
20
5
8
31
20
3
8
11.2%
7.2%
1.1%
2.9%
7.7% to 15.5%
4.4% to 10.9%
0.2% to 3.1%
1.3% to 5.6%
13
2

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