Response to Influenza Vaccine During Pregnancy (FLU-PG)

• ClinicalTrials.gov Identifier: NCT03888989
• Recruitment Status: Recruiting
• First Posted: March 25, 2019
• Last Update Posted: April 18, 2023
• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH); National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Philip Grant, Stanford University

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Quadrivalent inactivated influenza vaccine (IIV)	Phase 1

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Response to Influenza Vaccine During Pregnancy
• Actual Study Start Date: September 30, 2019
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Study Phase; Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV)	Biological: Quadrivalent inactivated influenza vaccine (IIV); Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection

Outcome Measures

Primary Outcome Measures :

1. Plasma HAI titer at Day 7 (year 1) [ Time Frame: Day 7 (year 1) ]
   HAI titer measures immune response to influenza vaccination
2. Number of Participants With Related Adverse Events (year 1) [ Time Frame: Day 28 (Year 1) ]
   AEs to IIV
3. Number of Participants With Related Adverse Events (Year 2) [ Time Frame: Day 28 (Year 2) ]
   AEs to IIV
4. Plasma HAI titer at Day 7 (Year 2) [ Time Frame: Day 7 (Year 2) ]
   HAI titer measures immune response to influenza vaccination

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant Females
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Philip Grant; 6507239443; pmgrant@stanford.edu

Locations

United States, California

Stanford University School of Medicine; Recruiting

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

National Institutes of Health (NIH)

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Philip M Grant; Assistant Professor of Medicine (Infectious Diseases)

More Information

• Responsible Party: Philip Grant, Assistant Professor of Medicine (Infectious Diseases), Stanford University
• ClinicalTrials.gov Identifier: NCT03888989
• Other Study ID Numbers: 50163; 5U19AI057229-15 ( U.S. NIH Grant/Contract )
• First Posted: March 25, 2019
• Last Update Posted: April 18, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Philip Grant, Stanford University:

Influenza; Pregnancy; Quadrivalent inactivated influenza vaccine (IIV).

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases