InfluenzaPhase 1NCT02438423

Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

A Phase 1 study testing Inactivated influenza vaccine in people with Influenza, run by Mark Prausnitz at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Inactivated influenza vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Jun 2015to 23 Mar 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject provides written informed consent prior to any study procedures being performed.
Subject is male or non-pregnant female between the ages of 18 and 49, inclusive, on the day of signing informed consent.
Subject is in good health as determined by vital signs, medical history and targeted physical examination
Women of childbearing potential must agree to practice abstinence from sexual intercourse with men or use acceptable contraception, initiated at least 30 days prior to the study vaccination throughout D180 in order to avoid pregnancy.
Women of childbearing potential must have a negative urine pregnancy test prior to administration of the study product.
Subject is able to understand and comply with required study procedures.

Who cannot join

Subject has received a 2014-2015 seasonal influenza vaccine.
Subject with documented influenza infection during the 2014-2015 influenza season.
Subject has touched or handled a microneedle patch prior to study enrollment (excluding dermaroller-like devices).
Subject has a known allergy to eggs, egg or chicken protein or other components of the study product
Subject has a history of severe reactions following previous immunization with licensed influenza virus vaccines.
Subject has an acute illness with fever (temperature >100.4 °F) within 72 hours prior to vaccination.

Show all 27Show fewer

Subject has a known chronic medical problem
Subject has known immunosuppression due to underlying illness or treatment
Subject has a scar, tattoo, rash or other dermatologic condition in the area of the vaccination site which will interfere with the assessment of injection site reactogenicity.
Subject has a history of keloid formation.
Subject has used long-term* high-dose oral or parenteral glucocorticoids, or high-dose inhaled steroids*.
Long term is defined as taken for 2 weeks or more in total at any time during the past 2 months.
High dose defined as prednisone ≥ 20 mg total daily dose, or equivalent dose of other glucocorticoids.
High dose defined as > 800 mcg/day of beclomethasone dipropionate or equivalent.
If short term corticosteroids are given, then the subject should not receive study vaccination or have blood collected for immunogenicity studies within 1 week of steroid administration
Subject has a history of Guillain-Barre Syndrome.
Subject is pregnant, post-partum (<12 months after delivery), or breast feeding or plans to breastfeed during the study.
Alcohol or drug abuse and psychiatric conditions that, in the opinion of the investigator, would preclude compliance with the trial or interpretation of safety or endpoint data.
Subject has any condition that, in the opinion of the investigator, may put the subject at increased risk of harm, may cause the subject to be unable to meet the requirements or might otherwise interfere with evaluations required by the study.
Subject has received any experimental products within 30 days before study entry or plan to receive experimental products at any time during the study.
Subject has received a live vaccine within 28 days prior to study entry or plans to receive a live vaccine prior to Day 28 of the study.
Subject has received an inactivated vaccine within 14 days prior to study entry or plans to receive an inactivated vaccine prior to Day 28 of the study.
Subject has received immunoglobulin or blood products in the past 90 days or planned receipt at any time during the study.
Subject BMI >35 kg/m2.
Subject has a systolic blood pressure >160 or < 80 mmHg or diastolic blood pressure >100 or < 60 mmHg.
Subject has a resting pulse rate < 50 bpm or >100 bpm.
Subject donated blood 56 days before screening OR will donate blood on or before day 28 of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Hope Clinic
Decatur, Georgia, 30030

Other trials in United States

About this study

Official title: A Phase I Study of the Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.

This is a single center, partially blinded, randomized phase I study in which healthy adult subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an inactivated influenza vaccine delivered by microneedle patch.

Read the detailed description

Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.

Population: healthy adults, 18-49 years inclusive

Number of Sites: One

Study Duration: 12 months

Subject Duration: 6 months

Objectives:

Primary:

To evaluate the safety and reactogenicity following receipt of inactivated influenza vaccine delivered by microneedle patch (either by staff or self-administered).

Secondary:

To evaluate the HAI titers following receipt of inactivated influenza vaccine delivered either by microneedle patch or by hypodermic needle (both vaccines administered by study staff).

To evaluate unsolicited adverse events following receipt of IIV delivered by microneedle patch (administered by study staff or self-administered).

To evaluate new-onset chronic illnesses (NOCI) following receipt of IIV delivered by microneedle patch (administered by study staff or self-administered).

Exploratory:

To evaluate microneutralizing antibody titers following receipt of inactivated influenza vaccine delivered either by microneedle patch or by hypodermic needle (both vaccines administered by study staff).

To evaluate HAI +/- microneutralization and ELISA titers following receipt of inactivated influenza vaccine delivered by microneedle patch (administered by study staff or self- administered) and compare to inactivated influenza vaccine delivered by hypodermic needle (administered by study staff).

To evaluate HAI +/- microneutralization and ELISA titers following receipt of inactivated influenza vaccine delivered by microneedle patch (administered by study staff) and compare to inactivated Influenza vaccine delivered by microneedle patch (self-administered).

To evaluate T follicular helper cells following receipt of inactivated influenza vaccine delivered by microneedle patch (administered by study staff or self-administered) and compare to inactivated influenza vaccine delivered by hypodermic needle (administered by study staff).

To evaluate innate immunity signatures by microarrays following receipt of inactivated influenza vaccine delivered by microneedle patch (administered by study staff or self-administered) and compare to inactivated influenza vaccine delivered by hypodermic needle (administered by study staff).

To evaluate B memory cells, CD4 and CD8 central memory and effector T cells, intracellular cytokine staining (ICS) for interferon-gamma and interleukin-4, cross reactive T cells following receipt of inactivated influenza vaccine delivered by microneedle patch (administered by study staff or self- administered) and compare to inactivated influenza vaccine delivered by hypodermic needle (administered by study staff).

To evaluate the acceptability of inactivated Influenza vaccine delivered by microneedle patch (administered by study staff or self-administered) and compare to inactivated influenza vaccine delivered by hypodermic needle (administered by study staff).

Schematic of Study Design:

A total of 100 subjects (25 subjects in each group) will be randomized to one of four groups as in the schematic of the study design below.

Group A: Inactivated influenza vaccine delivered by microneedle patch administered by study staff Group B: Inactivated influenza vaccine delivered by intramuscular injection administered by study staff Group C: Inactivated influenza vaccine delivered by microneedle patch administered by subject Group D: Placebo delivered by microneedle patch and administered by study staff

Each subject will have 6 clinic visits: D0, D2 (+1 day), D8 (+2 days), D28 (+/- 2 days), D56 (+/- 5 days), and D180( +/- 14 days).

Blood draws will be obtained at 6 clinic visits to evaluate for immunogenicity (D0, D2 (+1 day) D8 (+ 2 days) - D28 (+/- 2 days), D56 (+/- 5 days), and D180 (+/- 14 days)) and at four clinic visits for safety (D0, D2 (+1 day), D8 (+2 days), and D28 (+/- 2 days)).

Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after, and serious adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study product administration.

Immunogenicity testing will include performing hemagglutination inhibition (HAI) +/- microneutralizing antibody assays as well as other adaptive immune assays on D0 prior to study product administration and at D8 (+2 days) , D28 (+/- 2 days), D56 (+/-5 days), and D180 (+/-14 days)) .

Conditions: Influenza
Being tested: Inactivated influenza vaccine, Placebo
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inactivated influenza vaccineBiological
Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
PlaceboOther

Study groups in NCT02438423
Study group	Role	What they receive
IIV delivered by MN patch by study staff	Experimental	Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff Receives: Biological: Inactivated influenza vaccine
IIV delivered IM by study staff	Active comparator	Inactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff Receives: Biological: Inactivated influenza vaccine
IIV delivered by MN patch by subject	Experimental	Inactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject Receives: Biological: Inactivated influenza vaccine
Placebo MN patch by study staff	Placebo comparator	Placebo delivered by microneedle patch administered by study staff Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after, and serious adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study product administration. Local and systemic reactions were graded using an Injection Site Reaction table listing local reactions (e.g., swelling, erythema, etc.) and grade levels from 0 to 4 for each local reaction, a General Adverse Reaction table listing systemic reactions (e.g., fatigue, myalgia, etc.) and grade levels from 0 to 4 for each systemic reaction, and a Clinical Adverse Event Grading Scale (grades 1-4) for safety labs. In all tables, the higher the grade, the worse the adverse event.
Measured: From Day 0 through Day 8
Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.
Measured: From Day 0 until Day 180
Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.
Measured: From Day 0 until Day 28

Secondary outcomes (3)

Geometric Mean Titer (GMT) of HAI Antibody Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
Measured: At Day 28
Percentage of Subjects Achieving Seroprotection (Defined as a HAI Antibody Titer of 1:40 or Greater) Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
Measured: At Day 28
Percentage of Subjects Achieving Seroconversion Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
Seroconversion is defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer.
Measured: At Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201523 Mar 2016

First posted8 May 2015 (estimated)
Study startJun 2015
Primary completion23 Mar 2016
Study completion23 Mar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02438423
Sponsor's protocol ID: 2015 TIV-MNP
Status last verified: Apr 2019
First submitted: 6 May 2015
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rouphael NG, Paine M, Mosley R, Henry S, McAllister DV, Kalluri H, Pewin W, Frew PM, Yu T, Thornburg NJ, Kabbani S, Lai L, Vassilieva EV, Skountzou I, Compans RW, Mulligan MJ, Prausnitz MR; TIV-MNP 2015 Study Group. The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial. Lancet. 2017 Aug 12;390(10095):649-658. doi: 10.1016/S0140-6736(17)30575-5. Epub 2017 Jun 27.
PubMed 28666680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of the Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle
ClinicalTrials.gov ID: NCT02438423
Acronym / sponsor ID: 2015 TIV-MNP
Conditions: Influenza
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Mark PrausnitzUniversity, hospital or other
Collaborators: Emory University
Study start: Jun 2015
Primary completion: 23 Mar 2016 (actual)
Study completion: 23 Mar 2016 (actual)
First posted: 8 May 2015 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.

Detailed description

Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.

Population: healthy adults, 18-49 years inclusive

Number of Sites: One

Study Duration: 12 months

Subject Duration: 6 months

Objectives:

Primary:

To evaluate the safety and reactogenicity following receipt of inactivated influenza vaccine delivered by microneedle patch (either by staff or self-administered).

Secondary:

To evaluate the HAI titers following receipt of inactivated influenza vaccine delivered either by microneedle patch or by hypodermic needle (both vaccines administered by study staff).

To evaluate unsolicited adverse events following receipt of IIV delivered by microneedle patch (administered by study staff or self-administered).

To evaluate new-onset chronic illnesses (NOCI) following receipt of IIV delivered by microneedle patch (administered by study staff or self-administered).

Exploratory:

Schematic of Study Design:

A total of 100 subjects (25 subjects in each group) will be randomized to one of four groups as in the schematic of the study design below.

Each subject will have 6 clinic visits: D0, D2 (+1 day), D8 (+2 days), D28 (+/- 2 days), D56 (+/- 5 days), and D180( +/- 14 days).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
IIV delivered by MN patch by study staff	Experimental	Biological: Inactivated influenza vaccineInactivated influenza vaccine (IIV) delivered by microneedle (MN) patch administered by study staff
IIV delivered IM by study staff	Active comparator	Biological: Inactivated influenza vaccineInactivated influenza vaccine (IIV) delivered by intramuscular (IM) injection administered by study staff
IIV delivered by MN patch by subject	Experimental	Biological: Inactivated influenza vaccineInactivated influenza vaccine (IIV) delivered by microneedle (MN) patch self-administered by subject
Placebo MN patch by study staff	Placebo comparator	Other: PlaceboPlacebo delivered by microneedle patch administered by study staff

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Subject provides written informed consent prior to any study procedures being performed.
Subject is male or non-pregnant female between the ages of 18 and 49, inclusive, on the day of signing informed consent.
Subject is in good health as determined by vital signs, medical history and targeted physical examination
Women of childbearing potential must agree to practice abstinence from sexual intercourse with men or use acceptable contraception, initiated at least 30 days prior to the study vaccination throughout D180 in order to avoid pregnancy.
Women of childbearing potential must have a negative urine pregnancy test prior to administration of the study product.

Key exclusion criteria (27 listed)

Subject has received a 2014-2015 seasonal influenza vaccine.
Subject with documented influenza infection during the 2014-2015 influenza season.
Subject has touched or handled a microneedle patch prior to study enrollment (excluding dermaroller-like devices).
Subject has a known allergy to eggs, egg or chicken protein or other components of the study product
Subject has a history of severe reactions following previous immunization with licensed influenza virus vaccines.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inactivated influenza vaccineSeasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season	Biological	IIV delivered IM by study staff, IIV delivered by MN patch by study staff, IIV delivered by MN patch by subject
Placebo	Other	Placebo MN patch by study staff

Primary outcome

Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.
Time frame: From Day 0 through Day 8
Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after, and serious adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study product administration. Local and systemic reactions were graded using an Injection Site Reaction table listing local reactions (e.g., swelling, erythema, etc.) and grade levels from 0 to 4 for each local reaction, a General Adverse Reaction table listing systemic reactions (e.g., fatigue, myalgia, etc.) and grade levels from 0 to 4 for each systemic reaction, and a Clinical Adverse Event Grading Scale (grades 1-4) for safety labs. In all tables, the higher the grade, the worse the adverse event.
Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.
Time frame: From Day 0 until Day 180
Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.
Time frame: From Day 0 until Day 28

3 secondary outcomes

Geometric Mean Titer (GMT) of HAI Antibody Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
Time frame: At Day 28
Percentage of Subjects Achieving Seroprotection (Defined as a HAI Antibody Titer of 1:40 or Greater) Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
Time frame: At Day 28
Percentage of Subjects Achieving Seroconversion Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).
Time frame: At Day 28

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IIV Delivered by MN Patch by Study Staff	25	25
IIV Delivered IM by Study Staff	25	25
IIV Delivered by MN Patch by Subject	25	25
Placebo MN Patch by Study Staff	25	25

Primary outcome: Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.

Time frame: From Day 0 through Day 8. Number. Unit: Reactions

Measure	IIV Delivered by MN Patch by Study Staff n = 25	IIV Delivered IM by Study Staff n = 25	IIV Delivered by MN Patch by Subject n = 25	Placebo MN Patch by Study Staff n = 25
Reactions D1-D7 (pruritus)	20	4	21	4
Reactions D1-D7 (Pain)	5	11	5	2
Reactions D1-D7 (Redness/Erythema)	10	0	10	0
Reactions D1-D7 (Tenderness)	17	15	16	4
Reactions D1-D7 (Nausea)	2	4	2	1
Reactions D1-D7 (Fatigue)	13	10	4	5
Reactions D1-D7 (Headache)	5	7	7	2
Reactions D1-D7 (Swelling/Induration)	4	1	2	0

Primary outcome: Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.

Time frame: From Day 0 until Day 180. Number. Unit: Serious adverse events

Measure	IIV Delivered by MN Patch by Study Staff n = 25	IIV Delivered IM by Study Staff n = 25	IIV Delivered by MN Patch by Subject n = 25	Placebo MN Patch by Study Staff n = 25
Value	0	0	0	0

Primary outcome: Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.

Time frame: From Day 0 until Day 28. Number. Unit: Grade 3 adverse events

Measure	IIV Delivered by MN Patch by Study Staff n = 25	IIV Delivered IM by Study Staff n = 25	IIV Delivered by MN Patch by Subject n = 25	Placebo MN Patch by Study Staff n = 25
Value	0	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IIV Delivered by MN Patch by Study Staff	0 of 25 (0%)	23 of 25 (92%)	0 of 25
IIV Delivered IM by Study Staff	0 of 25 (0%)	20 of 25 (80%)	0 of 25
IIV Delivered by MN Patch by Subject	1 of 25 (4%)	23 of 25 (92%)	0 of 25
Placebo MN Patch by Study Staff	0 of 25 (0%)	12 of 25 (48%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28666680Rouphael NG, Paine M, Mosley R, Henry S, McAllister DV, Kalluri H, Pewin W, Frew PM, Yu T, Thornburg NJ, Kabbani S, Lai L, Vassilieva EV, Skountzou I, Compans RW, Mulligan MJ, Prausnitz MR; TIV-MNP 2015 Study Group. The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial. Lancet. 2017 Aug 12;390(10095):649-658. doi: 10.1016/S0140-6736(17)30575-5. Epub 2017 Jun 27.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nadine Rouphael, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Inactivated influenza vaccine in people with Influenza, run by Mark Prausnitz at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration. (time frame: From Day 0 through Day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438423, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.