Vaccination; InfectionPhase 2MILESTONENCT05315362
Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery of mRNA COVID-19 Vaccine
A Phase 2 study testing solid microneedle skin patch, mRNA-1273 and standard needle in people with Vaccination; Infection and COVID-19, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
COVID-19 vaccines are limited in supply, especially in low- and middle-income countries, leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access (COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries, probably 80% of the vaccine needs of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Infection, COVID-19
- What is being tested?
- solid microneedle skin patch, mRNA-1273 and standard needle
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2022to 1 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Previously vaccinated with Comirnaty (Pfizer) and/or previously contracted COVID-19 at least 3 months before inclusion
- Healthy participants who are determined by medical history and clinical judgment of the investigator to be eligible for inclusion in the study. Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 6 weeks before enrolment, can be included.
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Participants are willing to postpone their regular COVID-19 revaccination upon invitation by the municipal health center or general practitioner until four weeks after receiving the intervention (after the last sampling of D29).
- Capable of giving personal signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Who cannot join
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
- Receipt of medications intended to prevent COVID-19.
- Previous microbiological diagnosis of COVID-19.
- Previous COVID-19 vaccination other than Comirnaty (Pfizer)
- Individuals at high risk for severe COVID-19 (e.g. BMI > 40, diabetes, heart- end/or lung disease), who are planned to receive COVID vaccine within the next two months.
Show all 17Show fewer
- Immunosuppressed individuals with known or suspected immunodeficiency, as determined by history.
- Individuals with an active autoimmune disease requiring therapeutic intervention.
- Receipt of systemic or topical corticosteroids.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Planned pregnancy within four weeks after injection.
- Positive serological test for SARS-CoV-2 anti-N IgM and/or IgG antibodies at screening visit.
- SARS-CoV-2 PCR-positive mid-turbinate/throat swab at the screening before receipt of the vaccine dose.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- Receipt of any other non-study vaccine within 28 days, before receipt of the study dose.
- Anticipated receipt of any other non-study vaccine within 28 days, after the study dose administration.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333ZA
Anna H Roukens, MD, PhD, +31715262613, a.h.e.roukens@lumc.nl
Leo G Visser, MD, PhD, +31715262613, l.g.visser@lumc.nl
About this study
Official title: Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery by Solid Micro Needle Skin Patch of mRNA SARS-CoV-2 Vaccine as a Revaccination Strategy in Healthy Volunteers
COVID-19 vaccines are limited in supply, especially in low- and middle-income countries, leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access (COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries, probably 80% of the vaccine needs of participating countries will not be met soon.
In addition, there is an increasing demand for revaccination of the population globally, because of waning immunity which will further limit vaccine supplies. Exploring dose-sparing techniques, could therefore provide the solution to immunise more people with the same vaccine stockpile.
Read more
The intramuscular injection (IM) is the standard inoculation route of vaccines. However, the skin (dermis) is much richer in antigen presenting dendritic cells than muscle. As a consequence, a fractional vaccine dose introduced directly into the dermis (intradermal administration, ID) might be as effective as the intramuscular administration of the full standard dose to achieve a protective immune response. This principle has recently been demonstrated for the ID dermal delivery of one-fifth fractional dose mRNA-1273 (Spikevax, Moderna) vaccine.
However, needle-based immunisation has several limitations. Fear of needles makes immunisation a stressful event. In addition, needle stick injuries, as well as unsafe injection practices carry serious health risks. Therefore, the development of needle-free delivery has been identified as an important goal in global health care. The WHO reported that microneedle vaccine delivery is top priority and requires additional research to explore the benefits in more detail. A big advantage of intradermal delivery via a solid needle patch is not only the absence of needles and pain since no nerves are at the proximity where the needles are presented, but also the local delivery close to immune cells as with the above mentioned intradermal injection enables a much lower dose as compared to IM dosing. And since with the patch a larger skin surface is involved as compared to intradermal injection, even lower doses are possibly still immunogenic.
In this study, we will investigate the immunogenicity and safety in healthy volunteers of the needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer) vaccine and/or after having contracted COVID-19.
Read the detailed description
Objectives Primary objective
- to describe immunogenicity and safety in healthy volunteers of the needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer) vaccine and/or after have contracted COVID-19.
Secondary objectives
- to describe the kinetics of the SARS-CoV-2 anti-Spike1 (S1) and Region Binding Domain (RBD) IgG binding antibodies elicited by needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine in healthy volunteers after a single fractional dose of 20µg mRNA-1273 LNP vaccine
- to describe the kinetics of the SARS-CoV-2 neutralising antibodies elicited by needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine in healthy volunteers after a single fractional dose of 20µg mRNA-1273 LNP vaccine
Exploratory objectives:
- to describe the kinetics of memory B-cell and plasma cell responses elicited by needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)
- to describe the interferon-gamma release in whole blood in response to SARS-CoV 2 peptides after needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of a single fractional doses of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)
Study design:
This is a Phase 2a, open-label, randomised-controlled, proof-of-concept vaccine study
Study population:
Healthy volunteers aged 18 - 40 years who have been vaccinated with Comirnaty (Pfizer) vaccine at least 3 months before
Intervention group:
Participants will receive 20 µg of mRNA-1273 vaccine through the needle-free intradermal route using a micro-needle delivery system.
Control group:
Participants will receive 20 µg of mRNA-1273 vaccine through the intramuscular route
Main study parameters/endpoints:
- Solicited local reactions and systemic events self-reported by diary on a daily basis over a 2-week period, telephone interview on D4, as well as by on site visits on D15 and D29
- Adverse events (AEs) until two weeks after administration
- Serious AEs (SAEs) until six months after administration
- Seroconversion for anti-spike IgG antibodies (D29)
- Geometric mean concentrations (GMC) for anti-spike IgG antibodies (D1, D29)
- Conditions
- Vaccination; Infection, COVID-19
- Being tested
- solid microneedle skin patch, mRNA-1273, standard needle
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solid microneedle skin patchDevice
intradermal vaccination with a skin patch
mRNA-1273Biological
administration of mRNA-1273 vaccine
standard needleDevice
intramuscular vaccination with a standard needle
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - intradermal vaccination with patch | Experimental | Participants will receive 20 µg of mRNA-1273 vaccine through the intradermal route using a solid micro needle delivery system Receives: Device: solid microneedle skin patch; Biological: mRNA-1273 |
| Control group - intramuscular vaccination with standard needle | Active comparator | Participants will receive 20 µg of mRNA-1273 vaccine through the intramuscular route Receives: Biological: mRNA-1273; Device: standard needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2-spike protein-specific binding IgG antibody levels
SARS-CoV-2-spike protein-specific binding IgG antibody levels
Measured: 3 months
adverse events
local and systemic reactions after intradermal vaccination with a solid microneedle patch
Measured: 1 month
Secondary outcomes (3)
SARS CoV 2 neutralizing antibody levels
SARS CoV 2 neutralizing antibody levels
Measured: 3 months
Number of Spike-protein specific proliferating B-cells, plasma cells and B-memory cells
Number of Spike-protein specific proliferating B-cells, plasma cells and B-memory cells
Measured: 6 months
INF-gamma concentration and other cytokine responses after over-night incubation
INF-gamma concentration and other cytokine responses after over-night incubation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, randomised-controlled, proof-of-concept vaccine study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aheroukens, Leiden University Medical Center
- Investigators
- Anna H Roukens, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315362
- Sponsor's protocol ID
- NL80101.058.22
- Acronym
- MILESTONE
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prins MLM, Prins C, de Vries JJC, Visser LG, Roukens AHE. Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers. Virus Res. 2023 Sep;334:199175. doi: 10.1016/j.virusres.2023.199175. Epub 2023 Jul 21.
PubMed 37473964
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery by Solid Micro Needle Skin Patch of mRNA SARS-CoV-2 Vaccine as a Revaccination Strategy in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05315362
- Acronym / sponsor ID
- MILESTONE / NL80101.058.22
- Conditions
- Vaccination; Infection, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COVID-19 vaccines are limited in supply, especially in low- and middle-income countries, leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access (COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries, probably 80% of the vaccine needs of participating countries will not be met soon.
In addition, there is an increasing demand for revaccination of the population globally, because of waning immunity which will further limit vaccine supplies. Exploring dose-sparing techniques, could therefore provide the solution to immunise more people with the same vaccine stockpile.
The intramuscular injection (IM) is the standard inoculation route of vaccines. However, the skin (dermis) is much richer in antigen presenting dendritic cells than muscle. As a consequence, a fractional vaccine dose introduced directly into the dermis (intradermal administration, ID) might be as effective as the intramuscular administration of the full standard dose to achieve a protective immune response. This principle has recently been demonstrated for the ID dermal delivery of one-fifth fractional dose mRNA-1273 (Spikevax, Moderna) vaccine.
However, needle-based immunisation has several limitations. Fear of needles makes immunisation a stressful event. In addition, needle stick injuries, as well as unsafe injection practices carry serious health risks. Therefore, the development of needle-free delivery has been identified as an important goal in global health care. The WHO reported that microneedle vaccine delivery is top priority and requires additional research to explore the benefits in more detail. A big advantage of intradermal delivery via a solid needle patch is not only the absence of needles and pain since no nerves are at the proximity where the needles are presented, but also the local delivery close to immune cells as with the above mentioned intradermal injection enables a much lower dose as compared to IM dosing. And since with the patch a larger skin surface is involved as compared to intradermal injection, even lower doses are possibly still immunogenic.
In this study, we will investigate the immunogenicity and safety in healthy volunteers of the needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer) vaccine and/or after having contracted COVID-19.
Detailed description
Objectives Primary objective
- to describe immunogenicity and safety in healthy volunteers of the needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer) vaccine and/or after have contracted COVID-19.
Secondary objectives
- to describe the kinetics of the SARS-CoV-2 anti-Spike1 (S1) and Region Binding Domain (RBD) IgG binding antibodies elicited by needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine in healthy volunteers after a single fractional dose of 20µg mRNA-1273 LNP vaccine
- to describe the kinetics of the SARS-CoV-2 neutralising antibodies elicited by needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine in healthy volunteers after a single fractional dose of 20µg mRNA-1273 LNP vaccine
Exploratory objectives:
- to describe the kinetics of memory B-cell and plasma cell responses elicited by needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)
- to describe the interferon-gamma release in whole blood in response to SARS-CoV 2 peptides after needle-free intradermal or intramuscular delivery of mRNA-1273 vaccine of a single fractional doses of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna)
Study design:
This is a Phase 2a, open-label, randomised-controlled, proof-of-concept vaccine study
Study population:
Healthy volunteers aged 18 - 40 years who have been vaccinated with Comirnaty (Pfizer) vaccine at least 3 months before
Intervention group:
Participants will receive 20 µg of mRNA-1273 vaccine through the needle-free intradermal route using a micro-needle delivery system.
Control group:
Participants will receive 20 µg of mRNA-1273 vaccine through the intramuscular route
Main study parameters/endpoints:
- Solicited local reactions and systemic events self-reported by diary on a daily basis over a 2-week period, telephone interview on D4, as well as by on site visits on D15 and D29
- Adverse events (AEs) until two weeks after administration
- Serious AEs (SAEs) until six months after administration
- Seroconversion for anti-spike IgG antibodies (D29)
- Geometric mean concentrations (GMC) for anti-spike IgG antibodies (D1, D29)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, randomised-controlled, proof-of-concept vaccine study
| Arm | Type | Receives |
|---|---|---|
| Intervention group - intradermal vaccination with patch | Experimental | Device: solid microneedle skin patch, Biological: mRNA-1273Participants will receive 20 µg of mRNA-1273 vaccine through the intradermal route using a solid micro needle delivery system |
| Control group - intramuscular vaccination with standard needle | Active comparator | Biological: mRNA-1273, Device: standard needleParticipants will receive 20 µg of mRNA-1273 vaccine through the intramuscular route |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Previously vaccinated with Comirnaty (Pfizer) and/or previously contracted COVID-19 at least 3 months before inclusion
- Healthy participants who are determined by medical history and clinical judgment of the investigator to be eligible for inclusion in the study. Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 6 weeks before enrolment, can be included.
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Participants are willing to postpone their regular COVID-19 revaccination upon invitation by the municipal health center or general practitioner until four weeks after receiving the intervention (after the last sampling of D29).
- Capable of giving personal signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Key exclusion criteria (17 listed)
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
- Receipt of medications intended to prevent COVID-19.
- Previous microbiological diagnosis of COVID-19.
- Previous COVID-19 vaccination other than Comirnaty (Pfizer)
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 |
|---|---|---|
| solid microneedle skin patchintradermal vaccination with a skin patch | Device | Intervention group - intradermal vaccination with patch |
| mRNA-1273administration of mRNA-1273 vaccine | Biological | Control group - intramuscular vaccination with standard needle, Intervention group - intradermal vaccination with patch |
| standard needleintramuscular vaccination with a standard needle | Device | Control group - intramuscular vaccination with standard needle |
Primary outcome
SARS-CoV-2-spike protein-specific binding IgG antibody levels
Time frame: 3 months
SARS-CoV-2-spike protein-specific binding IgG antibody levels
adverse events
Time frame: 1 month
local and systemic reactions after intradermal vaccination with a solid microneedle patch
3 secondary outcomes
SARS CoV 2 neutralizing antibody levels
Time frame: 3 months
Number of Spike-protein specific proliferating B-cells, plasma cells and B-memory cells
Time frame: 6 months
INF-gamma concentration and other cytokine responses after over-night incubation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 37473964Prins MLM, Prins C, de Vries JJC, Visser LG, Roukens AHE. Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers. Virus Res. 2023 Sep;334:199175. doi: 10.1016/j.virusres.2023.199175. Epub 2023 Jul 21.
- Individual participant dataSharing planned: No
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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.
Anna H Roukens, MD PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing solid microneedle skin patch, mRNA-1273 and standard needle in people with Vaccination; Infection and COVID-19, run by Leiden University Medical Center at 1 site in Netherlands.
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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. 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 Netherlands. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna H Roukens, MD PhD (+31715262613, a.h.e.roukens@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2-spike protein-specific binding IgG antibody levels (time frame: 3 months). The study lists 2 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 NCT05315362, 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 22 Apr 2022.