Clinical trial NCT01049490: Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device
Official title: Safety and Efficacy of Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination With the Novel Microneedle Delivery Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Infection
Keywords: Intradermal vaccination, H1N1, microneedle
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2010-01-14
Enrollment: 262
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Day 21
Secondary outcomes:
measure: Seroconversion rate day 42
timeFrame: Day 21 and 42
measure: Geometric mean titer increases in antibodies
timeFrame: Day 21 and 42
measure: Specific neutralizing antibody (NT) titre
timeFrame: Day 21 and 42
measure: Seroprotection rate
timeFrame: Day 21 and 42
measure: Adverse events (30 minutes post vaccination period)
timeFrame: Day 21 and 42
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong, Queen Mary Hospital
state: Guangdong
Study officials:
affiliation: The University of Hong Kong
name: Ivan FN Hung, MD MRCP
role: PRINCIPAL_INVESTIGATOR
References: