Safety Study of Seasonal Influenza Vaccine by Jet Injection

NCT00987350 | Completed Phase 4

• 2 other identifiers: HP-00042669LectraJet-TIV CVD 1000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research study involves testing of a device that can give injections (shots) without the use of a needle.

Conditions

Healthy Adults

Keywords

Jet Injector; Vaccine; Influenza

Outcome Measures

Primary Outcomes (1)

• Adverse event (AE) and serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessment)

  90 Days

Secondary Outcomes (3)

• Proportion of volunteers in each administration group achieving a greater than four-fold rise in hemagglutination inhibition (HI) titer from pre-vaccination to 28 days post-vaccination against each of the vaccine-associated strains

  Day 28

• Proportion of volunteers in each administration group achieving a HI titer >40 on day 28 post-vaccination against each of the vaccine-associated strains

  Day 28

• Geometric mean titer (GMT) of HI titers against each of the vaccine-associated strains in each group 28 days after receipt of the vaccine

  Day 28

Study Arms (2)

Trivalent influenza vaccine by needle and syringe

ACTIVE COMPARATOR

Thirty volunteers will receive 1 intramuscular (IM) dose of licensed trivalent inactivated 2009-10 seasonal influenza vaccine by the standard needle and syringe method

Device: TIV by jet injection; Biological: Seasonal Trivalent Influenza Vaccine

Trivalent influenza vaccine by jet injection

EXPERIMENTAL

Thirty volunteers will receive 1 intramuscular (IM) dose of licensed trivalent inactivated 2009-10 seasonal influenza vaccine by the experimental method of jet injection

Device: LectraJet; Biological: Seasonal Trivalent Influenza Vaccine

Interventions

LectraJet DEVICE

LectraJet is a new jet injector studied for the first time in humans. It is in the category known as disposable-syringe jet injectors that have the advantage of eliminating the risk of disease transmission between subjects. A new syringe and nozzle is used for each patient so that no splash back of blood can occur onto the jet apparatus itself.

Trivalent influenza vaccine by jet injection

TIV by jet injection DEVICE

Administration of seasonal trivalent influenza vaccine (TIV) by jet injection

Trivalent influenza vaccine by needle and syringe

Seasonal Trivalent Influenza Vaccine BIOLOGICAL

Licensed trivalent influenza vaccine provided by either jet injection or traditional needle and syringe.

Trivalent influenza vaccine by jet injection; Trivalent influenza vaccine by needle and syringe

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 and 49 years, inclusive
• In good health as evidenced by screening evaluation within the 30 days prior to immunization.
• Expressed interest and availability to fulfill the study requirements.
• Signed, informed consent.
• For women of child-bearing potential, agreement to avoid pregnancy for the 90 days following vaccination by use of effective birth control methods.
• Agreement to refrain from taking any experimental drug or vaccine from Day minus 30 to Day 90 (from screening until the volunteer completes the study).

You may not qualify if:

• A known allergy to a component of the vaccine, including egg, egg products, chicken proteins, formaldehyde, gentamicin sulfate, or sodium deoxycholate.
• A positive urine pregnancy test in the 24 hours prior to vaccination. (A negative urine pregnancy test is required within the 24 before vaccination for all women who have not had a hysterectomy or are not at least 1 year post-menopausal)
• A woman who is breastfeeding.
• Any current medical illness that might jeopardize the volunteer's safety or interfere with the interpretation of the study results. These include, but are not limited to the following: cancer; immunodeficiency; bleeding disorder.
• Any underlying medical condition for which influenza vaccination is recommended: chronic heart or lung conditions, including asthma; metabolic diseases; kidney disease; blood disorder (such as sickle cell anemia); weakened immune systems, including HIV/AIDS.
• Resident of nursing homes and long term care facility.
• Health care worker involved in direct patient care.
• Any current illness requiring daily medication, except for vitamins, contraceptives, topical medications, antihistamines, antacids and other reflux medications, smoking cessation medications, headache medications that do not have antipyretic activity, nasal allergy medications, ophthalmologic and otic medications, psychiatric medications for well-controlled conditions such as depression or anxiety, and thyroxine for stable, inactive hypothyroidism. Volunteers may not take daily oral, nasal, inhaled, or parenteral steroids or non-steroidal anti-inflammatory medications. Medications other than those mentioned above will require approval from the PI, the sponsor, and the medical monitor.
• Any use of antibiotics in the 7 days before enrollment.
• Vital signs that are abnormal and thought by the investigator to increase the risk to the volunteer. Mild elevations or depressions of blood pressure or heart rate may be allowed.
• Current alcohol or illicit drug dependence.
• History of receipt of an influenza vaccine in the 2008-2009 and/or 2009-2010 season
• History of Guillain-Barré Syndrome
• Failure to pass the written exam; a passing score is 70% or greater.
• Receipt of an experimental agent (e.g., a vaccine or medication) within the 30 days prior to enrollment or the expectation of receipt of an experimental agent while participating in this study.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• D'Antonio Consultants International, Inc.: collaborator

Study Sites (1)

University of Maryland College Park Health Center

College Park, Maryland, United States

Location

Related Publications (3)

• Parent du Chatelet I, Lang J, Schlumberger M, Vidor E, Soula G, Genet A, Standaert SM, Saliou P. Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule): comparison with standard syringe injection. Imule Investigators Group. Vaccine. 1997 Mar;15(4):449-58. doi: 10.1016/s0264-410x(96)00173-9.

  PMID: 9141217 BACKGROUND

• Fisch A, Cadilhac P, Vidor E, Prazuck T, Dublanchet A, Lafaix C. Immunogenicity and safety of a new inactivated hepatitis A vaccine: a clinical trial with comparison of administration route. Vaccine. 1996 Aug;14(12):1132-6. doi: 10.1016/0264-410x(96)00044-8.

  PMID: 8911009 BACKGROUND

• Williams J, Fox-Leyva L, Christensen C, Fisher D, Schlicting E, Snowball M, Negus S, Mayers J, Koller R, Stout R. Hepatitis A vaccine administration: comparison between jet-injector and needle injection. Vaccine. 2000 Mar 17;18(18):1939-43. doi: 10.1016/s0264-410x(99)00446-6.

  PMID: 10699344 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jakub K Simon, MD, MS

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Ped-Infectious Diseases and Tropical Medicine

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

US (1)