Influenza Virus VaccineNCT01522248
Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study
A study testing Trivalent Inactivated Influenza vaccine in people with Influenza Virus Vaccine, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
Some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. The cause of some of these symptoms is likely to be an immune response to the vaccine. The investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Virus Vaccine
- What is being tested?
- Trivalent Inactivated Influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-50 years.
- Good general health as a result of review of medical history and medications.
- Willingness to participate in the study as evidenced by signing informed consent document.
- Available for the duration of the trial.
Who cannot join
- Known to be pregnant.
- Medical, behavioral, cognitive or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
- Severe allergy to eggs or any component of the influenza vaccine
- Previous receipt of the 2011-2012 season influenza vaccine
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
- History of receiving any investigational product within the past 30 days.
Show all 15Show fewer
- Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
- Known immunodeficiency syndrome.
- Use of chronic (≥14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone >10 mg/ day) or immunosuppressive drugs within 30 days of starting this study.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- Refusal to allow storage of samples for future research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for Immunization Research
Baltimore, Maryland, 21205
About this study
Official title: A Pilot Study to Examine the Early Cytokine Responses After Inactivated Influenza Vaccination in Adults 18-50.
Some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. The cause of some of these symptoms is likely to be an immune response to the vaccine. The investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. This pilot study will help us to determine at what time points we should look.
- Conditions
- Influenza Virus Vaccine
- Being tested
- Trivalent Inactivated Influenza vaccine
- Keywords
- influenza vaccine, cytokines, chemokines, symptoms
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent Inactivated Influenza vaccineBiological
0.5 ml IM once only
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination. Receives: Biological: Trivalent Inactivated Influenza vaccine |
| Cohort 2 | Active comparator | receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination. Receives: Biological: Trivalent Inactivated Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Measured: 0 hours, 16 hours, 24 hours, 14 days
Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Measured: 0 hours, 16 hours, 24 hours, 14 days
Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Measured: 0 hours, 16 hours, 24 hours, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza Virus VaccineStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kawsar Talaat, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522248
- Sponsor's protocol ID
- CIR 281
- Status last verified
- Mar 2019
- First submitted
- 27 Jan 2012
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Talaat KR, Halsey NA, Cox AB, Coles CL, Durbin AP, Ramakrishnan A, Bream JH. Rapid changes in serum cytokines and chemokines in response to inactivated influenza vaccination. Influenza Other Respir Viruses. 2018 Mar;12(2):202-210. doi: 10.1111/irv.12509. Epub 2018 Jan 4.
PubMed 28991404
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine the Early Cytokine Responses After Inactivated Influenza Vaccination in Adults 18-50.
- ClinicalTrials.gov ID
- NCT01522248
- Acronym / sponsor ID
- CIR 281
- Conditions
- Influenza Virus Vaccine
- Keywords
- influenza vaccine, cytokines, chemokines, symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Posted 15 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. The cause of some of these symptoms is likely to be an immune response to the vaccine. The investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. This pilot study will help us to determine at what time points we should look.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Biological: Trivalent Inactivated Influenza vaccinereceives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination. |
| Cohort 2 | Active comparator | Biological: Trivalent Inactivated Influenza vaccinereceives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-50 years.
- Good general health as a result of review of medical history and medications.
- Willingness to participate in the study as evidenced by signing informed consent document.
- Available for the duration of the trial.
Key exclusion criteria (15 listed)
- Known to be pregnant.
- Medical, behavioral, cognitive or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
- Severe allergy to eggs or any component of the influenza vaccine
- Previous receipt of the 2011-2012 season influenza vaccine
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
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 |
|---|---|---|
| Trivalent Inactivated Influenza vaccine0.5 ml IM once only | Biological | Cohort 1, Cohort 2 |
Primary outcome
Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
Time frame: 0 hours, 16 hours, 24 hours, 14 days
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
Time frame: 0 hours, 16 hours, 24 hours, 14 days
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
Time frame: 0 hours, 16 hours, 24 hours, 14 days
This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28991404Talaat KR, Halsey NA, Cox AB, Coles CL, Durbin AP, Ramakrishnan A, Bream JH. Rapid changes in serum cytokines and chemokines in response to inactivated influenza vaccination. Influenza Other Respir Viruses. 2018 Mar;12(2):202-210. doi: 10.1111/irv.12509. Epub 2018 Jan 4.
- Individual participant dataSharing planned: Undecided
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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.
Kawsar Talaat, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trivalent Inactivated Influenza vaccine in people with Influenza Virus Vaccine, run by Johns Hopkins Bloomberg School of Public Health 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 4 inclusion and 15 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 15 Mar 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?
Yes. Results are posted in the registry (first posted 15 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine (time frame: 0 hours, 16 hours, 24 hours, 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522248, 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 15 Mar 2019.