Pharma-Pen (Formerly Innoject) Auto-injectory TIV
| Status: | Withdrawn |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/25/2019 |
| End Date: | October 2006 |
Demonstration of Safety, Effectiveness, and Ease-of-Use of an Advanced Self-Delivery System (Pharma-Pen™) for IM and SC Administration of Vaccines by Untrained Users - Phase I
The purpose of this study is to evaluate the safety, effectiveness, and tolerability, of the
Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by
untrained users to self-administer Influenza vaccines as compared to standard IM injections
administered by a licensed healthcare professional (e.g. a nurse). Participants will be 120
healthy men and women aged 18 - 50 years who have not received influenza vaccine for at least
four years and who have no experience in giving intramuscular or subcutaneous injections.
Subjects will be randomly placed in one of three treatment types. They will receive one
injection of commercially available Influenza vaccine and will be evaluated over the course
of six months.
Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by
untrained users to self-administer Influenza vaccines as compared to standard IM injections
administered by a licensed healthcare professional (e.g. a nurse). Participants will be 120
healthy men and women aged 18 - 50 years who have not received influenza vaccine for at least
four years and who have no experience in giving intramuscular or subcutaneous injections.
Subjects will be randomly placed in one of three treatment types. They will receive one
injection of commercially available Influenza vaccine and will be evaluated over the course
of six months.
Pharma-Pen, Inc. (hereinafter "Pharma-Pen") and Virginia Commonwealth University ("VCU") have
partnered to demonstrate the safety, effectiveness and tolerability of two versions of the
Pharma-Pen(TM) auto-injector for IM injection (Treatment 1) or SC injection (Treatment 2) by
untrained users compared to standard IM injection (Treatment 3) by a licensed healthcare
professional (e.g. nurse). Commercially available Influenza vaccine will be used as a model
to demonstrate the ease-of-use and effectiveness of the delivery system. The proposed study
will compare safety and immunogenicity of three treatments in healthy volunteers: 1)
Self-administered flu vaccine given IM by auto-injector in the thigh; 2) Self-administered
flu vaccine given subcutaneously by auto-injector in the thigh; 3) Standard IM vaccine
administered in the deltoid muscle by a licensed clinician. Primary objectives of this
program are to demonstrate that the Pharma-Pen(TM) system can be safely and successfully used
by untrained adults to self-inject with vaccines and to show that the resulting
immunogenicity is comparable to vaccinations administered by trained medical personnel using
conventional syringe/needle technology. There will be secondary information that accrues from
the study. The outcomes of the IM route can be compared to the outcomes of the SC route, and
the outcomes of the IM route in the deltoid muscle can be compared to the outcomes in the
lateral thigh muscle. This safety/proof-of-concept study will be a randomized, single-dose,
open-label, parallel, three treatment trial in 120 healthy subjects (male & female, ages 18
to 50 years) who have not received an influenza vaccine for at least four years, meet all
inclusion/exclusion criteria, and sign an informed consent form. The individuals should be
non-medical individuals with no experience in giving IM or SC injections. Each subject will
be randomly assigned to one of three treatments. The study is divided into two successive
parts (1A and 1B). Part 1A will be conducted in the first 12 subjects who will be randomized
to only Treatment 1 (3 males, 3 females) and Treatment 2 (3 males, 3 females). The purpose of
part 1A is to obtain initial safety information on the IM and SC auto-injectors
(Pharma-Pen[TM]) in a few carefully observed subjects (10% of total) to assure that the
devices are functioning as designed and do not produce significant injury to the injection
site. Part 1A will be conducted under the direct supervision of the Medical Investigator
(MI). The results of part 1A will be forwarded to the appointed Safety Monitoring Committee
(SMC). If serious device deficiencies are detected early in part 1A, the study may be
terminated prior to all 12 subjects completing this initial phase. Part 1B will be initiated
only after approval of the MI and SMC, based upon the data from the 12 subjects in part 1A.
Part 1B will involve the remaining 108 subjects. All injections will be performed under
licensed clinician supervision.
partnered to demonstrate the safety, effectiveness and tolerability of two versions of the
Pharma-Pen(TM) auto-injector for IM injection (Treatment 1) or SC injection (Treatment 2) by
untrained users compared to standard IM injection (Treatment 3) by a licensed healthcare
professional (e.g. nurse). Commercially available Influenza vaccine will be used as a model
to demonstrate the ease-of-use and effectiveness of the delivery system. The proposed study
will compare safety and immunogenicity of three treatments in healthy volunteers: 1)
Self-administered flu vaccine given IM by auto-injector in the thigh; 2) Self-administered
flu vaccine given subcutaneously by auto-injector in the thigh; 3) Standard IM vaccine
administered in the deltoid muscle by a licensed clinician. Primary objectives of this
program are to demonstrate that the Pharma-Pen(TM) system can be safely and successfully used
by untrained adults to self-inject with vaccines and to show that the resulting
immunogenicity is comparable to vaccinations administered by trained medical personnel using
conventional syringe/needle technology. There will be secondary information that accrues from
the study. The outcomes of the IM route can be compared to the outcomes of the SC route, and
the outcomes of the IM route in the deltoid muscle can be compared to the outcomes in the
lateral thigh muscle. This safety/proof-of-concept study will be a randomized, single-dose,
open-label, parallel, three treatment trial in 120 healthy subjects (male & female, ages 18
to 50 years) who have not received an influenza vaccine for at least four years, meet all
inclusion/exclusion criteria, and sign an informed consent form. The individuals should be
non-medical individuals with no experience in giving IM or SC injections. Each subject will
be randomly assigned to one of three treatments. The study is divided into two successive
parts (1A and 1B). Part 1A will be conducted in the first 12 subjects who will be randomized
to only Treatment 1 (3 males, 3 females) and Treatment 2 (3 males, 3 females). The purpose of
part 1A is to obtain initial safety information on the IM and SC auto-injectors
(Pharma-Pen[TM]) in a few carefully observed subjects (10% of total) to assure that the
devices are functioning as designed and do not produce significant injury to the injection
site. Part 1A will be conducted under the direct supervision of the Medical Investigator
(MI). The results of part 1A will be forwarded to the appointed Safety Monitoring Committee
(SMC). If serious device deficiencies are detected early in part 1A, the study may be
terminated prior to all 12 subjects completing this initial phase. Part 1B will be initiated
only after approval of the MI and SMC, based upon the data from the 12 subjects in part 1A.
Part 1B will involve the remaining 108 subjects. All injections will be performed under
licensed clinician supervision.
Inclusion Criteria:
1. All Subjects will be men or women between the ages of 18 and 50 years.
2. Able and willing to provide Informed Consent.
3. No previous experience of self-administered IM or SC injections.
4. In good health (no chronic diseases or medications apart from vitamins and
contraceptives) as assessed by the study clinician.
Exclusion Criteria:
1. Have received influenza vaccine or had the flu in the past 4 years.
2. Have a known hypersensitivity to eggs, thimerosal or any other vaccines.
3. Subjects receiving immunosuppressive therapy within 6 weeks of enrollment.
4. Subjects who have a documented immunosuppressive syndrome.
5. Persons who have had a serious allergic reaction or other problems after exposure to
influenza vaccine.
6. Persons with acute respiratory infections or other active infections or illnesses
including active neurological disorders.
7. Adults with chronic metabolic diseases (including diabetes mellitus), renal
dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression
caused by medications or by human immunodeficiency virus [HIV]).
8. Adults who have chronic disorders of the pulmonary or cardiovascular systems,
including asthma.
9. Persons with a history of Guillain-Barré syndrome (GBS).
10. Women that are pregnant or expect to become pregnant within the next 6 weeks.
11. Persons with history of thrombocytopenia or bleeding disorders.
12. Persons who have received a blood or plasma transfusion of immunoglobulin during the
past 12 months.
13. Current drug abuse or alcoholism as reported by Subject.
14. History of alcohol or drug abuse in the last 5 years.
15. Have taken any immunosuppressive medications for the duration of the study.
16. Current participation in any other clinical trial or planned participation in any
clinical trial in the 6 months follow-up period.
17. Subjects that state they are unable or unwilling to return to the clinic for the
scheduled one month follow-up.
We found this trial at
1
site
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
Click here to add this to my saved trials
