Clinical trial NCT03888989: Response to Influenza Vaccine During Pregnancy
Official title: Response to Influenza Vaccine During Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
Pregnancy
Quadrivalent inactivated influenza vaccine (IIV).
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-03-25
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility 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.

Primary outcomes:
measure: Plasma HAI Titer at Day 7 (Year 1)
timeFrame: Day 7 (after year 1 vaccine administration)
measure: Number of Participants With Related Adverse Events (Year 1)
timeFrame: Baseline to Day 28 post year 1 vaccine administration
measure: Number of Participants With Related Adverse Events (Year 2)
timeFrame: Baseline to Day 28 post year 2 vaccine administration
measure: Plasma HAI Titer at Day 7 (Year 2)
timeFrame: Day 7 (Year 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Assistant Professor of Medicine (Infectious Diseases)
name: Philip M Grant
role: PRINCIPAL_INVESTIGATOR
References: