The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets

NCT03898986 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 502005U19AI057229-15
• Study Type: interventional
• Target: 18
• 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 the live attenuated influenza vaccine (LAIV) vs. the Inactivated Influenza Vaccine (IIV) in identical and fraternal twins.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• HAI Titers

  Evaluate HAI titers in 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 28

Study Arms (2)

MZ twins (IIV or LAIV4)

EXPERIMENTAL

Up to 20 healthy monozygotic (MZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Biological: Live attenuated influenza vaccine (LAIV4); Biological: Inactivated Influenza Vaccine (IIV4)

DZ twins (IIV or LAIV4)

EXPERIMENTAL

Up to 20 healthy dizygotic (DZ) individual twin volunteers, 2-20 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 7 and Day 28 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Biological: Live attenuated influenza vaccine (LAIV4); Biological: Inactivated Influenza Vaccine (IIV4)

Interventions

Live attenuated influenza vaccine (LAIV4) BIOLOGICAL

LAIV4 vaccine dosage is 0.2 mL. The vaccine will be administered as an intranasal spray. Each sprayer contains a single dose of FluMist® Quadrivalent; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose-divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril.

Also known as: FluMist® Quadrivalent

DZ twins (IIV or LAIV4); MZ twins (IIV or LAIV4)

Inactivated Influenza Vaccine (IIV4) BIOLOGICAL

IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection.

Also known as: Fluzone® Quadrivalent vaccine

DZ twins (IIV or LAIV4); MZ twins (IIV or LAIV4)

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• year old male and female patients
• Willing and able to complete the informed consent process
• Availability for follow-up for the planned duration of the study

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
• Asthma (contraindication for receipt of LAIV4)
• Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG.
• 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
• Hospitalization in the past year for congestive heart failure or emphysema.
• 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.
• Participants in close contact with anyone who has a severely weakened immune system
• 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.

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Philip Grant, MD
• Organization: Stanford University

pmgrant@stanford.edu

6507239001

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: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 2, 2019
• Study Start: October 8, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)