Response to Influenza Vaccine During Pregnancy

NCT03888989 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 501635U19AI057229-15
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Plasma HAI Titer at Day 7 (Year 1)

  HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.

  Day 7 (after year 1 vaccine administration)

• Number of Participants With Related Adverse Events (Year 1)

  AEs related to IIV

  Baseline to Day 28 post year 1 vaccine administration

• Number of Participants With Related Adverse Events (Year 2)

  AEs to IIV

  Baseline to Day 28 post year 2 vaccine administration

• Plasma HAI Titer at Day 7 (Year 2)

  HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.

  Day 7 (Year 2)

Study Arms (1)

Study Phase

OTHER

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

Biological: Quadrivalent inactivated influenza vaccine (IIV)

Interventions

Quadrivalent inactivated influenza vaccine (IIV) BIOLOGICAL

Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection

Study Phase

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

The Covid-19 pandemic led to early termination and a very small numbers of subjects recruited and analyzed.

Results Point of Contact

• Title: Philip Grant
• Organization: Stanford University

pmgrant@stanford.edu

650-521-3540

Study Officials

• Philip M Grant

  Assistant Professor of Medicine (Infectious Diseases)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 25, 2019
• Study Start: September 30, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)