Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device

Influenza Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049490
• Other study ID #: HKU-2009-128
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: December 13, 2013
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: December 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza Infection
• Influenza, Human

Intervention

Biological:
• S-OIV H1N1 vaccine
Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional

Locations

Country	Name	City	State
China	The University of Hong Kong, Queen Mary Hospital	Hong Kong	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Seroconversion rate day 42		Day 21 and 42	Yes
Secondary	Geometric mean titer increases in antibodies		Day 21 and 42	Yes
Secondary	Specific neutralizing antibody (NT) titre		Day 21 and 42	Yes
Secondary	Seroprotection rate		Day 21 and 42	Yes
Secondary	Adverse events (30 minutes post vaccination period)		Day 21 and 42	Yes