Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device

Safety and Efficacy of Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination With the Novel Microneedle Delivery Device

Primary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1 vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the full-dose standard IM injection.

Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular (IM) vaccine.

Study Overview

• Status: Completed
• Conditions: Influenza Infection
• Intervention / Treatment: Biological: S-OIV H1N1 vaccine

Detailed Description

This is a prospective randomised, single-blinded trial in Queen Mary Hospital. We aim to recruit 200 subjects [with a minimum of 80 subjects per age group (21-65 with chronic diseases and age 65+)] who would be qualified for the Hospital Authority (HA)/ Centre for Health Protection (CHP) Mass Vaccination Program for S-OIV H1N1. These patients include all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness. Subjects will be randomly assigned to receive either the full-dose (1 dose) standard Panenza vaccine at day 0 (15ug non-adjuvanted monovalent influenza A(H1N1) 2009 vaccine) delivered intramuscularly using a conventional needle (IM group) or a low-dose (1 dose) intradermal injection of Panenza vaccine at day 0 (3ug non-adjuvanted monovalent influenza A(H1N1) 2009 vaccine) delivered with the MicronJet600 (ID group).

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Hong Kong, Guangdong, China
      • The University of Hong Kong, Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All participants qualified for the HA/ CHP Mass Vaccination Program for S-OIV H1N1 as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure.
• All patients give written informed consent.
• Subjects must be available to complete the study and comply with study procedures.
• Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria:

• Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers.
• Inability to comprehend and to follow all required study procedures.
• History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
• Have received an S-OIV H1N1 vaccination.
• Have a recent (starting May 2009) history (documented, confirmed or suspected) of a flu-like disease).
• Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients.
• Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
• Female of childbearing potential, not using any acceptable contraceptive methods for at least 2 months prior to study entry or that do not plan to use acceptable birth control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intramuscular; 15 mcg H1N1 vaccine delivered via intramuscular injection (control)	Biological: S-OIV H1N1 vaccine; Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional
Active Comparator: Intradermal; Intradermal: H1N1 vaccine delivered via intradermal injection: Experimental	Biological: S-OIV H1N1 vaccine; Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Seroconversion rate on day 21 as measured by S-OIV H1N1 specific neutralizing antibody (NT) and hemagglutination inhibition (HAI) in the intradermal (ID) and intramuscular (IM) groups	Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Seroconversion rate day 42	Day 21 and 42
Geometric mean titer increases in antibodies	Day 21 and 42
Specific neutralizing antibody (NT) titre	Day 21 and 42
Seroprotection rate	Day 21 and 42
Adverse events (30 minutes post vaccination period)	Day 21 and 42

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hospital Authority, Hong Kong
• Investigators: Principal Investigator: Ivan FN Hung, MD MRCP, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 13, 2010
• First Posted (Estimate): January 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Intradermal vaccination, H1N1, microneedle
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: HKU-2009-128