Immune Response Following Seasonal Influenza Vaccination

NCT03163342 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ALT-FLZ-401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.

Conditions

Influenza

Keywords

Seasonal

Outcome Measures

Primary Outcomes (1)

• HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain

  To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.

  Day 29 after vaccine

Secondary Outcomes (3)

• Antibody Response to Divergent Influenza Strains

  Day 29 after vaccine

• Cellular Immune Response

  Day 8 after vaccine

• Mucosal Influenza Antibody Response

  Day 29 after vaccine

Study Arms (1)

Open label

OTHER

Licensed seasonal influenza vaccine, intramuscular

Biological: Licensed seasonal influenza vaccine

Interventions

Licensed seasonal influenza vaccine BIOLOGICAL

20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine

Open label

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women 18 to 50 years of age, inclusive
• Good general health status, as determined by the Investigator
• Adequate venous access for repeated phlebotomies
• Screening laboratory results within institutional normal range or Grade 1 elevation if the Investigator documents clinical insignificance. Bilirubin may be Grade 2 if associated with no1mal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant (e.g. vigorous exercise or Gilbert's syndrome)
• Negative drug and alcohol screen at Screening and pre-dose on Day I
• For women of child bearing potential, negative pregnancy test
• Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex,monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the Fluzone Intramuscular Quadrivalent vaccine dose.

You may not qualify if:

• Pregnant, possibly pregnant, or lactating women
• Body mass index\> 35.0 kg/m2
• Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening
• Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
• Daily symptoms
• Daily use of short acting beta 2 agonists
• Use of inhaled steroids or theophylline
• Use of pulse systemic steroids
• Emergency care or hospitalization related to asthma or other chronic lung disease
• Systemic steroids for asthma exacerbation
• History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
• History of coronary artery disease, arrhythmia, or congestive heart failure
• Clinically significant ECG abnormality
• Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg) at Screening or pre-dose on Day I
• History of anaphylaxis or angioedema

Sponsors & Collaborators

• Altimmune, Inc.: lead
• Optimal Health Research: collaborator

Study Sites (1)

Optimal Health Research

Rockville, Maryland, 20850, 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: Stephanie Holland, Clinical Project Manager
• Organization: Altimmune

Sholland@altimmune.com

240

Study Officials

• Stephan Bart, MD

  Optimal Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 23, 2017
• Study Start: May 8, 2017
• Primary Completion: November 21, 2017
• Study Completion: June 15, 2018
• Last Updated: April 26, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)