Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers

14-0071

This was an open label, single arm, Phase IV study of longitudinal immunologic responses to influenza vaccine in healthy adult participants, with the aim of enrolling up to 70 participants. This study enrolled males and non-pregnant females, 18-49 years old, inclusive. The participants were screened at enrollment with a history and physical exam and laboratory testing to ensure they were healthy enough to participate. Total enrollment was 60 participants. Qualifying participants were vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. The study enrolled a total 60 participants. The primary objective of the study was to characterize HA-specific plasmablasts and memory B cells after influenza vaccination. Note: Due to the Coronavirus Disease 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Five participants had their Day 180 visits halted due to the COVID-19 pandemic.

2015-04-01

2019-12-06

2020-12-31

Terminated

Early phase I

60

Inclusion Criteria: * Male or female subjects between 18 and 49 years of age, inclusive. * Subjects capable of providing written informed consent prior to initiation of any study procedures. Subjects able to understand and comply with planned study procedures and be available for all study visits. * Screening labs within normal limits per the local laboratory normal ranges or considered to be not clinically significant by the investigator. Normal laboratory ranges are as listed below: * Hematology: * Hemoglobin: Male- 12.9-16.1 gm/dL, Female- 11.4-14.4 gm/dL * White blood cells (WBC): Male- 4.2-9.2 upper limit (uL), Female- 4-10 upper limit (uL) * Platelet count: 150-400 upper limit (uL) * Chemistries: * Kidney function: Glomerular filtration rate (GFR) \> / = 60 mL/min/1.73 m\^2; * Liver enzymes: Albumin \> / = 3.5 g/dL; alanine aminotransferase (ALT) \<66 U/L; aspartate aminotransferase (AST) \<62 U/L * Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season. * Female subjects of child bearing potential must have a negative urine pregnancy test at the screening visit, enrollment visit and all subsequent study visits longer than 14 days since the last pregnancy test. Exclusion Criteria: * Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). This information will be obtained verbally from the patient. * If female, active pregnancy or breast-feeding or plans to become pregnant during study participation. * Chronic medical conditions that cause immunodeficiency or that require medications which could alter immune function such as immunosuppressants and immunoenhancers. * Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation. This includes any chronic medical disease or condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study * Have an acute illness, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. * Persons taking anticoagulants, long-term aspirin therapy, or long-term systemic steroids (greater than 3 months in the past 12 months and any within 30 days). * Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine; * Have a known latex allergy; * Have a history of severe reactions following previous immunization with licensed influenza virus vaccines. * Have a history of Guillain-Barre syndrome. * Subjects who had or are suspected to have had an influenza infection in the current influenza season. * Subjects who, at screening, have abnormal vital signs and/or physical exam, including a temperature \> / = 38.0 C, Systolic blood pressure \< / = 90 or \> / = 160 mmHg, pulse \< / = 60 or \> 110 beats per minute, new rash, signs of infection. * Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-10-25