InfluenzaNCT00170508
Young Adult Influenza Vaccine Immunogenicity Substudy
A study testing Fluzone® in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza antigens. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone®
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2005
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period (28 days).
- In good health, as determined by medical history and a targeted physical examination, if necessary.
- Able to understand and comply with planned study procedures.
- Able to provide informed consent and be available for all study visits.
Who cannot join
- Has a known allergy to eggs or other components of the vaccine.
- Has a positive urine pregnancy test at screening or prior to vaccination (if female), is lactating, or has the intention to become pregnant within 3 months of enrollment in this study.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
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- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.4 degrees F, within one week of vaccination.
- Received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expects to receive an experimental vaccine, medication, or blood product during the 4 week study period.
- Has any condition that would place the volunteer at an unacceptable risk of injury or any condition that in the opinion of the investigator may compromise the safety of the volunteer or integrity of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore
Baltimore, Maryland, 21201
About this study
Official title: In Depth Immunologic Studies in Healthy Young Adults Who Receive The Standard Dose Fluzone® (15mcgHA/Virus Strain) Trivalent Inactivated Influenza Virus Vaccine
This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza antigens.
Read the detailed description
The goals of this study are to provide in depth humoral and cellular immune responses to the standard-dose trivalent SV influenza virus vaccine containing 15 pg HA of each virus strain in healthy young adults. Serum samples will be submitted for the following analysis: measurement of serum anti-HA (hemagglutinin) IgG and IgA antibodies by ELISA, IgG antibody subclasses, IgG and IgA Avidity, Virus neutralizing functional assay, HAI antibody titer. Peripheral blood mononuclear cells (PBMC) isolated from these subjects will be evaluated for the following: "central" (TCM) and "effector" (TEM) memory T cell responses, including their proliferative responses and cytokine production profiles by flow cytometry, IFN-7 production by ELISPOT, following specific antigenic stimulation. Serum samples will be submitted for the following analysis: measurement ex vivo of the frequency of circulating influenza-specificT cells by using commercially available MHC/tetramers and/or MHC/pentamers and flow cytometry, role of regulatory T cells in the modulation of influenza responses in young adults. Fifteen healthy young adult subjects, age 18-40 years, inclusive, will be recruited from the general population to be enrolled in this study. No randomization or masking procedures will be used. All eligible subjects will be administered one intramuscular (IM) injection of the same FDA approved standard-dose (15 mcg HA per strain) trivalent inactivated influenza vaccine, 2004-2005 season, and key humoral and cell-mediated immunity (CMI) responses will be compared to those of elderly subjects enrolled under DMID 05-0028. On both Day 0 (pre-vaccination) and day 28 (post-vaccination), an 100 ml volume of whole blood will be obtained for a complete blood count (CBC) with differential and to isolate and cryopreserve serum and PBMCs. This study will evaluate key humoral and cell-mediated immunity (CMI) responses in healthy young adults to establish a baseline immune response which will be used to evaluate changes associated with immunosenescence. This study is linked to DMID protocol 05-0028.
- Conditions
- Influenza
- Being tested
- Fluzone®
- Keywords
- Influenza, sub-study
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone®Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170508
- Sponsor's protocol ID
- 05-0055
- Other IDs
- Influenza CVD 12000
- Status last verified
- Jul 2011
- First submitted
- 9 Sep 2005
- Last updated
- 23 Aug 2013
- Results posted
- No
Publications
Chen WH, Cross AS, Edelman R, Sztein MB, Blackwelder WC, Pasetti MF. Antibody and Th1-type cell-mediated immune responses in elderly and young adults immunized with the standard or a high dose influenza vaccine. Vaccine. 2011 Apr 5;29(16):2865-73. doi: 10.1016/j.vaccine.2011.02.017. Epub 2011 Feb 23.
PubMed 21352939
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Depth Immunologic Studies in Healthy Young Adults Who Receive The Standard Dose Fluzone® (15mcgHA/Virus Strain) Trivalent Inactivated Influenza Virus Vaccine
- ClinicalTrials.gov ID
- NCT00170508
- Acronym / sponsor ID
- 05-0055
- Conditions
- Influenza
- Keywords
- Influenza, sub-study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 15 Sep 2005 (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.
This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza antigens.
Detailed description
The goals of this study are to provide in depth humoral and cellular immune responses to the standard-dose trivalent SV influenza virus vaccine containing 15 pg HA of each virus strain in healthy young adults. Serum samples will be submitted for the following analysis: measurement of serum anti-HA (hemagglutinin) IgG and IgA antibodies by ELISA, IgG antibody subclasses, IgG and IgA Avidity, Virus neutralizing functional assay, HAI antibody titer. Peripheral blood mononuclear cells (PBMC) isolated from these subjects will be evaluated for the following: "central" (TCM) and "effector" (TEM) memory T cell responses, including their proliferative responses and cytokine production profiles by flow cytometry, IFN-7 production by ELISPOT, following specific antigenic stimulation. Serum samples will be submitted for the following analysis: measurement ex vivo of the frequency of circulating influenza-specificT cells by using commercially available MHC/tetramers and/or MHC/pentamers and flow cytometry, role of regulatory T cells in the modulation of influenza responses in young adults. Fifteen healthy young adult subjects, age 18-40 years, inclusive, will be recruited from the general population to be enrolled in this study. No randomization or masking procedures will be used. All eligible subjects will be administered one intramuscular (IM) injection of the same FDA approved standard-dose (15 mcg HA per strain) trivalent inactivated influenza vaccine, 2004-2005 season, and key humoral and cell-mediated immunity (CMI) responses will be compared to those of elderly subjects enrolled under DMID 05-0028. On both Day 0 (pre-vaccination) and day 28 (post-vaccination), an 100 ml volume of whole blood will be obtained for a complete blood count (CBC) with differential and to isolate and cryopreserve serum and PBMCs. This study will evaluate key humoral and cell-mediated immunity (CMI) responses in healthy young adults to establish a baseline immune response which will be used to evaluate changes associated with immunosenescence. This study is linked to DMID protocol 05-0028.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period (28 days).
- In good health, as determined by medical history and a targeted physical examination, if necessary.
- Able to understand and comply with planned study procedures.
- Able to provide informed consent and be available for all study visits.
Key exclusion criteria (12 listed)
- Has a known allergy to eggs or other components of the vaccine.
- Has a positive urine pregnancy test at screening or prior to vaccination (if female), is lactating, or has the intention to become pregnant within 3 months of enrollment in this study.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
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 |
|---|---|---|
| Fluzone® | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Derived from this study: PubMed 21352939Chen WH, Cross AS, Edelman R, Sztein MB, Blackwelder WC, Pasetti MF. Antibody and Th1-type cell-mediated immune responses in elderly and young adults immunized with the standard or a high dose influenza vaccine. Vaccine. 2011 Apr 5;29(16):2865-73. doi: 10.1016/j.vaccine.2011.02.017. Epub 2011 Feb 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluzone® in people with Influenza, 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 23 Aug 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00170508, which also lists 1 linked publication.
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 Aug 2013.