Food HypersensitivityNCT02213341
Impact of Vaccination on Th2 Immunity in Infancy
An observational study of Food Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to assess the responses in the immune system of infants after they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators will do this by studying the immune cells and allergy responses in the blood prior to and after receipt of the third DTaP vaccine. Read more about this study
- Who is it for?
- Ages 5 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Hypersensitivity
- What is being tested?
- Skin prick allergen test and Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 14 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants who are scheduled to receive their ~6 month (third dose of primary series) vaccines including the DTaP vaccine as part of routine care.
Who may be able to join
- Written informed consent from parent/guardian
- General good health without other known need for blood draws that would conflict with the study volume requirements
- Aged 5 months - 7 months, any race/ethnicity, any gender
- Subjects must not have yet received their third DTaP vaccination, which typically is given at 6 months of age. Subjects must have previously received two doses of the DTaP vaccination, at ages 2 months and 4 months
- Willingness to return for follow-up testing as defined in the protocol and consent if screening tests indicate eligibility
- Group 1 participants must have all of the following:
Show all 17Show fewer
- A negative skin prick test to egg, milk, and peanut
- A negative IgE to egg, milk, and peanut
- Group 2 participants must have all of the following:
- A positive family history of allergic disease
- Atopic Dermatitis not requiring prescription medication
- A positive IgE to milk, egg, and/or peanut
- If Group 1 enrollment is completed first, participants must have all of the following to be enrolled in Group 2:
- A family history of atopy
- Atopic dermatitis not requiring prescription medication
- If Group 2 enrollment is completed first, participants must have all of the following to be enrolled in Group 1:
- -No personal or family history of atopic disease
Who cannot join
- History of anemia requiring any treatment
- Previous allergic reaction to any food, defined as itching, rash, hives, swelling, vomiting, diarrhea, sneezing, rhinorrhea, wheezing, breathing difficulty, or passing out immediately after food ingestion.
- Evidence of non-IgE-mediated reaction to milk or soy (i.e. milk/soy protein intolerance) or evidence of food protein induced enterocolitis syndrome (FPIES)
- Severe atopic dermatitis (liberally defined as requiring prescription medication)
- Unable to obtain serum sample for determination of egg, milk and peanut IgE levels
- Use of short-acting anti-histamines (diphenhydramine, etc.) more than one time within 3 days of skin testing or on the day of skin testing
- Any history of intravenous or oral steroid medication
- Known underlying immune defect/deficiency or bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this study is to assess the responses in the immune system of infants after they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators will do this by studying the immune cells and allergy responses in the blood prior to and after receipt of the third DTaP vaccine.
Read the detailed description
This is a single-site study of infants who are scheduled to receive their third series (~6 month) vaccinations, as routine care, to investigate whether the diphtheria, tetanus, and pertussis (DTaP) vaccination has an effect on specific immunoglobulin E (IgE) levels to milk, egg, or peanut. Infants will be assigned to one of two groups depending on the infant's sensitization to milk, egg, and peanut.
- Conditions
- Food Hypersensitivity
- Being tested
- Skin prick allergen test, Blood draw
- Keywords
- Milk Allergy, Egg Allergy, Peanut Allergy, Infant Vaccination
- Medical subject headings
- Food Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick allergen testProcedure or surgery
To test for hypersensitivity to milk, egg, or peanut
Blood drawProcedure or surgery
Also called venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Positive blood test to milk, egg, and/or peanut | Family history to atopy Receives: Procedure: Skin prick allergen test; Procedure: Blood draw | |
| Negative blood test to allergy | A negative skin prick test to egg, milk, and peanut and a negative Immunoglobulin E (IgE) to egg, milk, and peanut. Receives: Procedure: Skin prick allergen test; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen-specific IgE
Magnitude of increase of allergen-specific IgE. For each child, the maximum allergen-specific IgE change to milk, egg, or peanut will be considered as the primary endpoint.
Measured: baseline and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startJan 2015
- Primary completion14 Jun 2016
- Study completion14 Jun 2016
Why it stopped: Lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Consortium of Food Allergy Research
- Responsible party
- Sponsor
- Investigators
- Hugh A. Sampson, MD, Principal investigator, Icahn School of Medicine at Mt. SinaiScott Sicherer, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213341
- Sponsor's protocol ID
- DAIT CoFAR9
- Status last verified
- Jul 2019
- First submitted
- 7 Aug 2014
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vaccination on Th2 Immunity in Infancy
- ClinicalTrials.gov ID
- NCT02213341
- Acronym / sponsor ID
- DAIT CoFAR9
- Conditions
- Food Hypersensitivity
- Keywords
- Milk Allergy, Egg Allergy, Peanut Allergy, Infant Vaccination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Consortium of Food Allergy Research
- Study start
- Jan 2015 (actual)
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 14 Jun 2016 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the responses in the immune system of infants after they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators will do this by studying the immune cells and allergy responses in the blood prior to and after receipt of the third DTaP vaccine.
Detailed description
This is a single-site study of infants who are scheduled to receive their third series (~6 month) vaccinations, as routine care, to investigate whether the diphtheria, tetanus, and pertussis (DTaP) vaccination has an effect on specific immunoglobulin E (IgE) levels to milk, egg, or peanut. Infants will be assigned to one of two groups depending on the infant's sensitization to milk, egg, and peanut.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive blood test to milk, egg, and/or peanut | – | Procedure: Skin prick allergen test, Procedure: Blood drawFamily history to atopy |
| Negative blood test to allergy | – | Procedure: Skin prick allergen test, Procedure: Blood drawA negative skin prick test to egg, milk, and peanut and a negative Immunoglobulin E (IgE) to egg, milk, and peanut. |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants who are scheduled to receive their ~6 month (third dose of primary series) vaccines including the DTaP vaccine as part of routine care.
Key inclusion criteria (17 listed)
- Written informed consent from parent/guardian
- General good health without other known need for blood draws that would conflict with the study volume requirements
- Aged 5 months - 7 months, any race/ethnicity, any gender
- Subjects must not have yet received their third DTaP vaccination, which typically is given at 6 months of age. Subjects must have previously received two doses of the DTaP vaccination, at ages 2 months and 4 months
- Willingness to return for follow-up testing as defined in the protocol and consent if screening tests indicate eligibility
Key exclusion criteria (8 listed)
- History of anemia requiring any treatment
- Previous allergic reaction to any food, defined as itching, rash, hives, swelling, vomiting, diarrhea, sneezing, rhinorrhea, wheezing, breathing difficulty, or passing out immediately after food ingestion.
- Evidence of non-IgE-mediated reaction to milk or soy (i.e. milk/soy protein intolerance) or evidence of food protein induced enterocolitis syndrome (FPIES)
- Severe atopic dermatitis (liberally defined as requiring prescription medication)
- Unable to obtain serum sample for determination of egg, milk and peanut IgE levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin prick allergen testTo test for hypersensitivity to milk, egg, or peanut | Procedure or surgery | Negative blood test to allergy, Positive blood test to milk, egg, and/or peanut |
| Blood drawAlso: venipuncture | Procedure or surgery | Negative blood test to allergy, Positive blood test to milk, egg, and/or peanut |
Primary outcome
Allergen-specific IgE
Time frame: baseline and day 28
Magnitude of increase of allergen-specific IgE. For each child, the maximum allergen-specific IgE change to milk, egg, or peanut will be considered as the primary endpoint.
Results and safety
The study was stopped early (reason given: Lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Consortium of Food Allergy Research (CoFAR)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh A. Sampson, MD principal investigator
Icahn School of Medicine at Mt. Sinai
Scott Sicherer, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergen-specific IgE (time frame: baseline and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.