Clinical trial NCT01933048: Self-Administered Nasal Influenza Feasibility Study
Official title: Self-Administered Nasal Influenza Vaccine: Immunogenicity and Feasibility of Group Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: influenza
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 1077
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group self-administration of LAIV.

Detailed description: This Phase IV, open-label, prospective clinical trial assesses SA-LAIV, testing whether the immunogenicity of SA-LAIV is non-inferior to that of HCWA-LAIV, as well as evaluating the feasibility of utilizing group administration for SA-LAIV. Subjects will be enrolled into one of two major treatment arms: HCWA-LAIV (Estimated N = 550) and SA-LAIV (Estimated N = 550). Enrollment into each major treatment arm will be stratified by study site. Enrollment in the HCWA-LAIV and SA-LAIV treatment arms may occur concurrently at each site. Subjects enrolling in the study will be randomized to HCWA or SA, and within the SA arm to either individual self-administration, or group administration. Specifically, following self-administration of LAIV to 190 individual subjects, 180 subjects will be vaccinated in 36 groups of 5 and 180 subjects will be vaccinated in 18 groups of 10. All vaccinations in the SA-LAIV arm will be given under the direction and supervision of a research staff member who is trained to administer LAIV vaccines. Following immunization all subjects will return for one visit at approximately 28 (± 7) days for follow-up.

Eligibility criteria: Inclusion Criteria:

* Healthy males or healthy, non-pregnant females
* 18-49 years of age
* Department of Defense beneficiary including active duty members
* Able to speak and understand English, and provide written informed consent

Exclusion Criteria:

* Known hypersensitivity to eggs, egg-proteins, gentamicin, gelatin, or arginine or life-threatening reactions to previous influenza vaccination
* Prior receipt of the 2012-2013 seasonal influenza vaccine for 2012-2013 season or prior receipt of the 2013-2014 seasonal influenza vaccine for 2013-2014 season
* Known clinical diagnosis of reactive airway disease, wheezing, or asthma (excluding exercise-induced asthma)
* Reported febrile upper respiratory illness (oral or tympanic temperature greater than 100°F or a subjective fever) at the time of or within the 24 hours prior to immunization
* Known to be pregnant, possibly pregnant or breast-feeding
* Known diagnosis of human immunodeficiency virus (HIV) infection, chronic active hepatitis B infection, or chronic hepatitis C infection
* History of Guillain-Barre Syndrome
* Household member known to be immunocompromised (either a known disease or disorder such as HIV, or other acquired or congenital immunodeficiency disorder, or taking systemic steroids (any dose) or high daily dose inhaled steroids, tumor necrosis factor-alpha inhibitors, or monoclonal antibodies used to treat autoimmune disease)
* Receipt of medications with activity against influenza A and/or B (ex: Tamiflu®, Relenza®, amantadine, or rimantadine) within 48 hours prior to vaccine administration
* Use of any oral or intravenous systemic steroids (any dose) or any daily dose inhaled steroids
* At the time of enrollment, any person who is trained to administer intranasal vaccines or who has been involved in any recurring role associated with the administration of intranasal vaccines to others in the clinic or military treatment facility (MTF)
* Prior participation in this research study
* Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions may include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); poorly controlled diabetes mellitus or patients with diabetes mellitus on insulin (subjects with well-controlled diabetes mellitus on oral agents may enroll as long there has been no dosage increase within the past 6 months); cardiac insufficiency, if heart failure is present; an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
* If the individual received a live virus vaccine (e.g., Varicella, Measles-Mumps-Rubella, Yellow Fever, Smallpox) in the past 4 weeks, they should wait 28 days before receiving LAIV. There is no reason to defer vaccination if the individual was vaccinated with an inactivated vaccine or if they have recently received blood or other antibody-containing blood products.

Primary outcomes:
measure: Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
timeFrame: 28+/- 7 days post-vaccination
Secondary outcomes:
measure: Difference and Proportion in Seroresponse of Subjects
timeFrame: 28+/- 7 days post-vaccination
measure: Difference and Proportion in Seroconversion of Subjects
timeFrame: 28+/- 7 days post-vaccination
Other outcomes:
measure: Feasibility of Self-administration Prior to Vaccine Administration
timeFrame: 28+/- 7 days post-vaccination
measure: Feasibility of Self-administration Following Vaccine Administration
timeFrame: 28+/- 7 days post-vaccination
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Fort Sam Houston
country: United States
facility: San Antonio Military Health System
state: Texas
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Timothy Burgess, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Burgess TH, Murray CK, Bavaro MF, Landrum ML, O'Bryan TA, Rosas JG, Cammarata SM, Martin NJ, Ewing D, Raviprakash K, Mor D, Zell ER, Wilkins KJ, Millar EV. Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine. 2015 Jul 31;33(32):3894-9. doi: 10.1016/j.vaccine.2015.06.061. Epub 2015 Jun 25.