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Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device

Primary Purpose

Influenza Infection

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

S-OIV H1N1 vaccine

About this trial

This is an interventional prevention trial for Influenza Infection focused on measuring Intradermal vaccination, H1N1, microneedle

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

The University of Hong Kong, Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intramuscular

Intradermal

Arm Description

15 mcg H1N1 vaccine delivered via intramuscular injection (control)

Intradermal: H1N1 vaccine delivered via intradermal injection: Experimental

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Seroconversion rate day 42

Geometric mean titer increases in antibodies

Specific neutralizing antibody (NT) titre

Seroprotection rate

Adverse events (30 minutes post vaccination period)

Full Information

NCT ID

NCT01049490

First Posted

January 12, 2010

Last Updated

December 13, 2013

Sponsor

The University of Hong Kong

Collaborators

Hospital Authority, Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01049490

Brief Title

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

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Hong Kong

Collaborators

Hospital Authority, Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Infection

Keywords

Intradermal vaccination, H1N1, microneedle

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intramuscular

Arm Type

Active Comparator

Arm Description

15 mcg H1N1 vaccine delivered via intramuscular injection (control)

Arm Title

Intradermal

Arm Type

Active Comparator

Arm Description

Intradermal: H1N1 vaccine delivered via intradermal injection: Experimental

Intervention Type

Biological

Intervention Name(s)

S-OIV H1N1 vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Day 21

Secondary Outcome Measure Information:

Title

Seroconversion rate day 42

Time Frame

Day 21 and 42

Title

Geometric mean titer increases in antibodies

Time Frame

Day 21 and 42

Title

Specific neutralizing antibody (NT) titre

Time Frame

Day 21 and 42

Title

Seroprotection rate

Time Frame

Day 21 and 42

Title

Adverse events (30 minutes post vaccination period)

Time Frame

Day 21 and 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivan FN Hung, MD MRCP

Organizational Affiliation

The University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Hong Kong, Queen Mary Hospital

City

Hong Kong

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

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Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device

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