- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03196245
NK Cell Mediated Influenza Immunity During Pregnancy (Flu vaccine)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We will enroll a cohort of 94 healthy pregnant women from the Lucille Packard Children's Hospital Obstetrics Clinic from 2012-2017.
Women will be enrolled during their 2nd and 3rd trimesters, a time of high risk of complications from influenza infection. All subjects will provide blood samples at day 0, then be immunized with TIV as part of their regular medical care, and will return for additional blood samples on approximately days 7 and 28.
In accordance with minimal risk guidelines in pregnant women, a total of 50 cc of blood will be drawn across all three visits (20 cc, 20 cc, and 10 cc respectively).
An additional blood draw of 20 cc will be performed approximately 6 weeks postpartum to coincide with the standard postpartum obstetrical follow up.
This is a purely observational study. There is no treatment or randomization. Influenza vaccination is the standard of care during pregnancy and will not be influenced by our study design. All subjects will receive standard prenatal care, and will have access to maternal fetal medicine experts.
Volunteers for the flu like illness arm will be those who present to the Stanford Hospital and Clinics with active flu-like symptoms. If the volunteer is interested in participating in the study, Dr. Blish's staff will complete the consent process and continue with study procedures. For hospitalized inpatients, the initial visit will be conducted onsite in the hospital room. For patients seen at the outpatient clinics, the initial visit will be conducted at the outpatient clinic or at the Clinical Translational Research Unit (CTRU) using respiratory infection precaution procedures.
Volunteers are encouraged to complete a second study visit. However, if returning for the Visit 2 is a reason why a volunteer is unwilling to participate in the study, the volunteer may complete only the first study visit and the follow-up phone call in order to enroll. Volunteers will be encouraged to receive influenza vaccination (if they have not already done so) through their primary care physician after the acute illness has subsided.
Study Visit 1 (Day 0) Enrollment/Baseline
- Potential participants will be provided with a verbal description of the study (purpose and study schedule and procedures). They then will be asked if they have any questions and allowed to read/sign the consent form. The consent form will be signed prior to the performance of any study procedures.
- Review study eligibility criteria and collect an abbreviated medical history and current concomitant medication use.
- Obtain vital signs (oral temperature, blood pressure, pulse, and respiratory rate), height and weight. Whenever possible, information will be obtained from existing clinic or hospital records.
- Record information about history of present illness.
- Collect blood volume sample in 3 10 ml green top tubes (maximum volume not to exceed 30 mL).
- Collect two nasopharyngeal flocked swab specimens(one specimen for the research laboratory and one specimen for the clinical virology laboratory diagnosis if not already collected by the hospital or the clinic staff).
- Provide Memory Aid for volunteer to record course of illness, ILI resolution date and serious adverse events occurring during the study period.
Visit 1A (phone call follow-up 7-10 days after Visit 1)
- Study personnel will contact the volunteer to remind participant to record any changes and course of their flu-like illness on the Memory Aid provided.
- Subsequent study visit will be scheduled.
Visit 2 (Day 28 ± 7 after Visit 1), PREFERRED, BUT OPTIONAL
- Review of medications and Memory Aid or new-onset medical conditions, influenza-like illness and SAEs.
- Obtain vital signs (oral temperature, blood pressure, pulse, and respiratory rate), and weight
- Collect blood sample (maximum volume not to exceed 20 mL): in two 10 ml green top tubes
- Collect two nasopharyngeal flocked swab specimens (both swabs to be sent to research laboratory).
Early Termination Visit:
If a volunteer is terminated from the study early, every effort should be made to perform the following procedures:
- Review current health status and note any changes since the last visit. Solicit information regarding SAEs and record all concomitant medications. Any ongoing related SAEs will be followed to resolution or until a stable chronic condition has been established. Volunteers will be encouraged to permit continued follow-up of SAEs if necessary
- Obtain remaining blood samples, if possible.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women (18-42 years of age)
- Pregnant women planning to receive the TIV seasonal influenza vaccine or Pregnant women presenting with influenza like illness
Exclusion Criteria:
- Oral immunosuppressive agents (inhaled steroids OK)
- Serious chronic illness including autoimmune disease or chronic viral infections (eg, systemic lupus erythematosis,HIV, hepatitis B or C)
- Malignancy or blood dyscrasia
- Type I or II diabetes or morbid obesity (pre-pregnancy BMI>40)(gestational diabetes ok)
- Presence of fetal cardiac abnormalities
- Receipt of blood or blood products within the last year
- Prior receipt of current seasonal influenza vaccine for influenza vaccine arm
- History of egg allergy for influenza vaccine arm
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant women
Pregnant women undergoing influenza vaccination or acutely infected with influenza
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There is no intervention.
This is a purely observational study.
We enrolled pregnant women as they received a vaccine as part of their regular medical care; we did not administer the vaccine.
We also enrolled pregnant women acutely infected with influenza.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NK cell function
Time Frame: 2 years
|
We are assessing the NK cell repertoire and anti-influenza NK cell function
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2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Le Gars M, Seiler C, Kay AW, Bayless NL, Starosvetsky E, Moore L, Shen-Orr SS, Aziz N, Khatri P, Dekker CL, Swan GE, Davis MM, Holmes S, Blish CA. Pregnancy-Induced Alterations in NK Cell Phenotype and Function. Front Immunol. 2019 Oct 23;10:2469. doi: 10.3389/fimmu.2019.02469. eCollection 2019.
- Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.
- Kay AW, Blish CA. Immunogenicity and Clinical Efficacy of Influenza Vaccination in Pregnancy. Front Immunol. 2015 Jun 4;6:289. doi: 10.3389/fimmu.2015.00289. eCollection 2015.
- Kay AW, Bayless NL, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Blish CA. Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine. J Infect Dis. 2015 Sep 15;212(6):861-70. doi: 10.1093/infdis/jiv138. Epub 2015 Mar 4.
- Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-25182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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