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Response to Influenza Vaccine During Pregnancy (FLU-PG)

Primary Purpose

Influenza

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quadrivalent inactivated influenza vaccine (IIV)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza focused on measuring Influenza, Pregnancy, Quadrivalent inactivated influenza vaccine (IIV).

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-49-year-old pregnant woman
  2. Willing and able to complete the informed consent process
  3. Availability for follow-up for the planned duration of the study with the expected delivery date more than 28 days after vaccination
  4. Acceptable medical history by review of inclusion/exclusion criteria

Exclusion Criteria:

  1. Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
  2. Life-threatening reactions to previous influenza vaccinations
  3. Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, or arginine.
  4. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  5. History of immunodeficiency (including HIV infection)
  6. Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
  7. Chronic Hepatitis B or C.
  8. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
  9. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
  10. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
  11. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  12. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
  13. Receipt of blood or blood products within the past 6 months or planned used during the study.
  14. A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  15. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (~ 28 days after study vaccination)
  16. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 days after study enrollment)
  17. Need for allergy immunization (that cannot be postponed) until after the last study visit.
  18. History of Guillain-Barre# syndrome
  19. Use of investigational agents within 30 days prior to enrollment or planned use during the study.
  20. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit.
  21. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

Sites / Locations

  • Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Phase

Arm Description

Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV)

Outcomes

Primary Outcome Measures

Plasma HAI titer at Day 7 (year 1)
HAI titer measures immune response to influenza vaccination
Number of Participants With Related Adverse Events (year 1)
AEs to IIV
Number of Participants With Related Adverse Events (Year 2)
AEs to IIV
Plasma HAI titer at Day 7 (Year 2)
HAI titer measures immune response to influenza vaccination

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
April 17, 2023
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03888989
Brief Title
Response to Influenza Vaccine During Pregnancy
Acronym
FLU-PG
Official Title
Response to Influenza Vaccine During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to vaccination in pregnancy.
Detailed Description
This is a Phase I mechanistic study of licensed influenza vaccines with up to 50 pregnant female volunteers, 18-49 years of age. Investigator intends to collect blood from pregnant women and then from the same women a year later when they are not pregnant after routine seasonal influenza vaccination. By studying the blood of immunized pregnant women and in these same women after pregnancy, the investigator will gain a better understanding of the immune response to vaccination in pregnancy and after pregnancy. Each volunteer will participate for approximately 4 weeks including enrollment, vaccination, and completion of sample collection in 2 consecutive flu seasons. The Study has a total of 6 visits over 2 Flu seasons. Study procedures: Year One: First Visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained Year Two: First Visit: Study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Pregnancy, Quadrivalent inactivated influenza vaccine (IIV).

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Phase
Arm Type
Other
Arm Description
Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV)
Intervention Type
Biological
Intervention Name(s)
Quadrivalent inactivated influenza vaccine (IIV)
Intervention Description
Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
Primary Outcome Measure Information:
Title
Plasma HAI titer at Day 7 (year 1)
Description
HAI titer measures immune response to influenza vaccination
Time Frame
Day 7 (year 1)
Title
Number of Participants With Related Adverse Events (year 1)
Description
AEs to IIV
Time Frame
Day 28 (Year 1)
Title
Number of Participants With Related Adverse Events (Year 2)
Description
AEs to IIV
Time Frame
Day 28 (Year 2)
Title
Plasma HAI titer at Day 7 (Year 2)
Description
HAI titer measures immune response to influenza vaccination
Time Frame
Day 7 (Year 2)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant Females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-49-year-old pregnant woman Willing and able to complete the informed consent process Availability for follow-up for the planned duration of the study with the expected delivery date more than 28 days after vaccination Acceptable medical history by review of inclusion/exclusion criteria Exclusion Criteria: Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination Life-threatening reactions to previous influenza vaccinations Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, or arginine. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination History of immunodeficiency (including HIV infection) Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease Chronic Hepatitis B or C. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia). Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol. Receipt of blood or blood products within the past 6 months or planned used during the study. A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (~ 28 days after study vaccination) Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 days after study enrollment) Need for allergy immunization (that cannot be postponed) until after the last study visit. History of Guillain-Barre# syndrome Use of investigational agents within 30 days prior to enrollment or planned use during the study. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Grant
Phone
6507239443
Email
pmgrant@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip M Grant
Organizational Affiliation
Assistant Professor of Medicine (Infectious Diseases)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Response to Influenza Vaccine During Pregnancy

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