Methods

In collaboration with the medical director and staff of the immunization division of the Louisville Metro Department of Public Health and Wellness, we developed a basic script for teaching self-administration of intranasal LAIV to a group of lay persons. This description included the goals of the project and the potential adverse effects and contraindications with use of the vaccine. Following this, a nurse demonstrated the administration of LAIV using a placebo version of the vaccine.

We used a 3-tiered approach to evaluate the self-vaccination process. This process began with a mock clinic in September 2008 with 25 graduate students from the University of Louisville School of Public Health and Information Sciences. Staff of the health department set out vaccine and supplies on 3 rows of tables for the participating students to use. One nurse then talked the students through the process of self-immunization as a group. Immediately after the mock clinic event, the students provided feedback regarding problems or concerns that they had with the experience in a group question-and-answer session.

On October 15, 2008, we invited community first responders and Louisville Metro Government employees to participate in a pilot study. We advertised this event by direct contact with first responder groups, such as police and fire departments, and mass e-mail notices to local government employees. The event was advertised as providing strictly LAIV via a self-immunization process. We worked with our health department emergency preparedness division to devise an appropriate flow strategy for this event (Figure 1).

Figure 1 Self-Immunization Clinic Flow.

1. Entrance; 2. Sign-in table, where clients read or hear basic information about vaccine and eligibility for receiving LAIV from a screener and are given paperwork to fill out; 3. Tables for completing paperwork; 4. Immunization tables, where clients listen to a brief oral presentation from the nurse educator, observe a demonstration and follow along with a step by step demonstration that clients complete until they have self-vaccinated, and fill out post-survey; 5. Nurse educator speaking site; 6. Exit

A subsequent event was held on November 23, 2008, which was open to the general public. Again, this event provided solely self-administered LAIV vaccine, which was provided free of charge. This open event was advertised using local media including television, radio, and newspapers, which noted that only LAIV was being offered. The physical setup and patient flow pattern was essentially the same as for the October event. In both events, persons who were unable to self-vaccinate would be offered LAIV given by a health care provider.

Participants were initially greeted at the door and told the appropriate ages for receiving the LAIV. They were then given forms to complete before participating in the study. These forms included descriptions of the limitations and LAIV contraindications for participants in this study. Persons had to be healthy and 18 to 49 years of age. Participants received a brief consent form, which indicated their understanding of the information that, while the vaccine to be received was a standard FDA-approved formulation, the method of delivery was not FDA approved. Participants were then directed to a separate space with tables and chairs for seating up to 30 people, where the health department medical director reviewed for each group of participants the purpose of the study and the indications and contraindications to receiving the vaccine. A nurse then led the participants through self-administration of vaccine as a group, in a process that took approximately 2 minutes. When participants finished performing the self-immunization, they were asked to fill in a brief postimmunization survey.

The University of Louisville Institutional Review Board reviewed and approved this study.