InfluenzaKIRVNCT03743688
Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults
An observational study of Influenza and Influenza, Human, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the body's immune response at different time points to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune system responds to the influenza vaccine, the investigators can design more effective vaccines against influenza. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza, Human, Vaccine Reaction
- What is being tested?
- Influenza Vaccine Recipients
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 26 Jul 2019
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Ten (10) individuals 18-45 years of age, 5 males and 5 non-pregnant females, who are in good health by history and meet all eligibility criteria, will be enrolled at one site participating in this study. The target population will reflect the community at large at the participating site.
Who may be able to join
- Provide written informed consent prior to initiation of any study procedures.
- Are able to understand and comply with planned study procedures and be available for all study visits.
- Are males or non-pregnant females, 18-45 years of age, inclusive.
- Are in overall good health. (As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses that could affect the assessment of the immunogenicity of influenza vaccine.)
- Women of childbearing potential (not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful metal coil placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal.) must use an acceptable contraception method (includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill")) from 30 days before vaccination until 30 days after vaccination.
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to vaccination.
Who cannot join
- Have an acute illness (an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol) as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to vaccination.
- Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation.
- Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
- Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to vaccination.
- Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
- Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
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- Have known hypersensitivity or allergy to components of cell-cultured influenza vaccine.
- Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
- Have a history of Guillain-Barre Syndrome.
- Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to vaccination.
- Received a licensed live vaccine within 30 days prior to vaccination, or plan to receive a licensed live vaccine within 30 days before or after vaccination.
- Received or plan to receive a licensed, inactivated vaccine within 14 days before or after vaccination.
- Received the 2018-2019 inactivated seasonal influenza vaccine prior to the study.
- Received immunoglobulin or other blood products (with exception of Rho D Ig) within 90 days prior to vaccination.
- Received an experimental agent within 30 days prior to vaccination or expect to receive an experimental agent during the study.
- Are participating or plan to participate in another clinical study with an interventional agent that will be received during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to evaluate the body's immune response at different time points to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune system responds to the influenza vaccine, the investigators can design more effective vaccines against influenza.
Read the detailed description
This is an observational study of seasonal, cell-cultured inactivated influenza vaccine (cc-IIV4) in healthy males and non-pregnant females aged 18 to 45 years old, inclusive. This clinical study is designed to comprehensively evaluate the characteristics and kinetics of the immune response to influenza vaccine.
By developing a comprehensive understanding of the mechanisms by which the immune system responds to influenza vaccine, including innate immune system responses, the effect of early influenza exposures, and (eventually) the effect of potent adjuvants, the investigators will be better equipped to design more highly effective vaccines to conquer seasonal influenza and prevent influenza pandemics.
Data from this pilot observational study will guide the design of global studies addressing age-specific responses, the impact of sex and geography, and the role of adjuvants on influenza immunity.
- Conditions
- Influenza, Influenza, Human, Vaccine Reaction, Influenza A, Influenza Type B, Influenza A H1N1
- Being tested
- Influenza Vaccine Recipients
- Keywords
- Influenza Vaccine, Influenza
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Vaccine RecipientsBiological
Also called Flucelvax (ccIIV4)
0.5 mL intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine Recipients (ccIIV-4) | All participants will receive one dose of FDA-approved inactivated influenza vaccine (Flucelvax Quadrivalent) via intramuscular injection (0.5 mL) as part of their standard of care. Receives: Biological: Influenza Vaccine Recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion (Hemagglutination (HAI) Assay)
Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40 or a pre- vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) 28 days after vaccination.
Measured: 28 days after vaccination
Seroconverstion (Microneutralization (MN) Assay)
Percentage of subjects achieving seroconversion (defined as either a pre-vaccination MN titer <1:10 and a post-vaccination MN titer ≥1:40 or a pre-vaccination MN titer ≥1:10 and a minimum four-fold rise in post-vaccination MN titer) 28 days after vaccination.
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start4 Dec 2018
- Primary completion26 Jul 2019
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Human Vaccines Project
- Responsible party
- Principal investigator, Buddy Creech, Vanderbilt University Medical Center
- Investigators
- Buddy Creech, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743688
- Sponsor's protocol ID
- 181619
- Acronym
- KIRV
- Status last verified
- Aug 2019
- First submitted
- 31 Oct 2018
- Last updated
- 5 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT03743688
- Acronym / sponsor ID
- KIRV / 181619
- Conditions
- Influenza, Influenza, Human, Vaccine Reaction, Influenza A, Influenza Type B, Influenza A H1N1
- Keywords
- Influenza Vaccine, Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Human Vaccines Project
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- 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 evaluate the body's immune response at different time points to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune system responds to the influenza vaccine, the investigators can design more effective vaccines against influenza.
Detailed description
This is an observational study of seasonal, cell-cultured inactivated influenza vaccine (cc-IIV4) in healthy males and non-pregnant females aged 18 to 45 years old, inclusive. This clinical study is designed to comprehensively evaluate the characteristics and kinetics of the immune response to influenza vaccine.
By developing a comprehensive understanding of the mechanisms by which the immune system responds to influenza vaccine, including innate immune system responses, the effect of early influenza exposures, and (eventually) the effect of potent adjuvants, the investigators will be better equipped to design more highly effective vaccines to conquer seasonal influenza and prevent influenza pandemics.
Data from this pilot observational study will guide the design of global studies addressing age-specific responses, the impact of sex and geography, and the role of adjuvants on influenza immunity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine Recipients (ccIIV-4) | – | Biological: Influenza Vaccine RecipientsAll participants will receive one dose of FDA-approved inactivated influenza vaccine (Flucelvax Quadrivalent) via intramuscular injection (0.5 mL) as part of their standard of care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Ten (10) individuals 18-45 years of age, 5 males and 5 non-pregnant females, who are in good health by history and meet all eligibility criteria, will be enrolled at one site participating in this study. The target population will reflect the community at large at the participating site.
Key inclusion criteria (6 listed)
- Provide written informed consent prior to initiation of any study procedures.
- Are able to understand and comply with planned study procedures and be available for all study visits.
- Are males or non-pregnant females, 18-45 years of age, inclusive.
- Are in overall good health. (As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses that could affect the assessment of the immunogenicity of influenza vaccine.)
- Women of childbearing potential (not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful metal coil placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal.) must use an acceptable contraception method (includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill")) from 30 days before vaccination until 30 days after vaccination.
Key exclusion criteria (16 listed)
- Have an acute illness (an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol) as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to vaccination.
- Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation.
- Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
- Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to vaccination.
- Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
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 |
|---|---|---|
| Influenza Vaccine RecipientsAlso: Flucelvax (ccIIV4)0.5 mL intramuscular injection | Biological | Influenza Vaccine Recipients (ccIIV-4) |
Primary outcome
Seroconversion (Hemagglutination (HAI) Assay)
Time frame: 28 days after vaccination
Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40 or a pre- vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) 28 days after vaccination.
Seroconverstion (Microneutralization (MN) Assay)
Time frame: 28 days after vaccination
Percentage of subjects achieving seroconversion (defined as either a pre-vaccination MN titer <1:10 and a post-vaccination MN titer ≥1:40 or a pre-vaccination MN titer ≥1:10 and a minimum four-fold rise in post-vaccination MN titer) 28 days after vaccination.
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 5 Aug 2019.
- Individual participant dataSharing planned: No. There is no IPD sharing plan.
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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.
Buddy Creech, MD, MPH principal investigator
Vanderbilt University Medical Center
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 Influenza and Influenza, Human, run by Vanderbilt University Medical Center 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 6 inclusion and 16 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 5 Aug 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 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.
What does the primary outcome measure?
Seroconversion (Hemagglutination (HAI) Assay) (time frame: 28 days after vaccination). The study lists 2 primary outcomes in all. 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 5 Aug 2019.