Vaccination; InfectionPhase 2HVaNaNCT05977127
Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly
A Phase 2 study testing Comirnaty in people with Vaccination; Infection and COVID-19, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Respiratory tract infections, e.g. caused by SARS-CoV-2, disproportionately affect elderly. Vaccination has shown to be the most cost-effective approach to prevent infections. However, older adults often fail to induce a potent immune response to vaccines, as was also seen recently for COVID-19 mRNA vaccines. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Infection, COVID-19
- What is being tested?
- Comirnaty
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Sep 2023to 21 Mar 2024
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or female aged ≥75 years at the moment of immunization.
- Healthy, determined by medical history and clinical judgement of the investigator. Participants with a pre-existing illness that is stable, defined as disease not requiring significant change in therapy or hospitalisation during the 6 weeks before enrolment and not expected to require any intervention during the study, can be included.
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- Willing to postpone their regular COVID-19 vaccination upon invitation by the Municipal Health Service or general practitioner until at least four months after receiving the intervention.
- Completed a primary series of COVID-19 vaccination.
- Capable and willing to give personal signed informed consent.
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- Adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Fully conversant in the Dutch language.
- Agrees his/her general practitioner is informed about participation in the study.
- Agrees to provide access to information regarding their vaccination background.
- Agrees that the study physician and his/her delegates have access to their medical file at Radboudumc.
Who cannot join
- Medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.
- No decision-making capacity.
- History of severe adverse reaction to a vaccine or to any component of the study intervention.
- Thrombose with thrombocytopenia syndrome after vaccination with a COVID-19 vaccine.
- Dermatological conditions that might interfere with the ID vaccination.
- Receipt of COVID-19 vaccination within 3 months before receiving the study intervention.
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- Known or suspected immunodeficiency, as determined by medical history or medication use (inhalation corticosteroids are allowed).
- History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
- Participation in other studies involving other study interventions within 28 days prior and during 28 days after receiving the study intervention.
- Receipt of any other non-study vaccine within 28 days prior and after receiving the study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Respiratory tract infections, e.g. caused by SARS-CoV-2, disproportionately affect elderly. Vaccination has shown to be the most cost-effective approach to prevent infections. However, older adults often fail to induce a potent immune response to vaccines, as was also seen recently for COVID-19 mRNA vaccines. This is likely due to immune dysfunction as a consequence of aging. To potentiate a stronger immune response, vaccine administration into the papillary dermis (intradermal, ID) has been proposed as an alternative strategy to intramuscular (IM) administration.
Vaccination through the ID route has shown to be safe and equally or more effective than IM vaccination with a wide variety of vaccines. Recently, ID administration has been tested with two COVID-19 mRNA vaccines (Spikevax, Moderna and Comirnaty, Pfizer/BioNTech) in reduced (fractional) doses of the standard IM dose.
Read more
To ease ID administration and thereby facilitate the implementation of this route, silicon-based microneedles have been developed. These needles have shown to allow ID administration of the Spikevax vaccine with equal safety and immunogenicity profiles as the traditional Mantoux approach in young adults.
In the present study, we will investigate the immunogenicity of a 20 mcg dose of the COVID-19 mRNA Comirnaty vaccine through ID administration with silicon microneedles in elderly people (75 years and older), and compare this to immunogenicity of IM administration of a 20 mcg dose and a 30 mcg (standard IM) dose.
- Conditions
- Vaccination; Infection, COVID-19
- Being tested
- Comirnaty
- Keywords
- Intradermal, COVID-19 mRNA vaccine, Elderly, Immune response
- 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.
ComirnatyBiological
Administration of Comirnaty vaccine
| Study group | Role | What they receive |
|---|---|---|
| Intradermal vaccination with 20 mcg mRNA vaccine | Experimental | Participants will receive a single dose of 20 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intradermal route using microneedles. Receives: Biological: Comirnaty |
| Intramuscular vaccination with 30 mcg mRNA vaccine | Active comparator | Participants will receive a single dose of 30 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intramuscular route. Receives: Biological: Comirnaty |
| Intramuscular vaccination with 20 mcg mRNA vaccine | Active comparator | Participants will receive a single dose of 20 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intramuscular route. Receives: Biological: Comirnaty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of SARS-CoV-2-Spike protein specific IgG antibodies in serum for the different intervention groups
Measured: at 28 days after vaccination
Secondary outcomes (2)
Titers of SARS-CoV-2 specific neutralising antibodies in serum of the different intervention groups
Measured: at 28 days after vaccination
The percentage of participants with local and systemic adverse events
- Solicited adverse events (AEs): local reactions, reaction of regional lymph nodes, and systemic reactions up to 14 days following vaccination
- Unsolicited AEs up to 28 days following vaccination
- Serious AEs (SAEs) up to 28 days following vaccination
- Use of antipyretics and analgesics up to 14 days following vaccination
Measured: up to 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start26 Sep 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Why it stopped: Recruitment rate dropped because of national COVID-19 vaccination campaign taking place parallel to this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- More trials run by Radboud 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, proof-of-concept intervention study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans de Graaf, Principal investigator, Stichting Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977127
- Sponsor's protocol ID
- 2023-503800-99-00
- Other IDs
- 2023
- Acronym
- HVaNa
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly
- ClinicalTrials.gov ID
- NCT05977127
- Acronym / sponsor ID
- HVaNa / 2023-503800-99-00
- Conditions
- Vaccination; Infection, COVID-19
- Keywords
- Intradermal, COVID-19 mRNA vaccine, Elderly, Immune response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment rate dropped because of national COVID-19 vaccination campaign taking place parallel to this study.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 4 Aug 2023 (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.
Respiratory tract infections, e.g. caused by SARS-CoV-2, disproportionately affect elderly. Vaccination has shown to be the most cost-effective approach to prevent infections. However, older adults often fail to induce a potent immune response to vaccines, as was also seen recently for COVID-19 mRNA vaccines. This is likely due to immune dysfunction as a consequence of aging. To potentiate a stronger immune response, vaccine administration into the papillary dermis (intradermal, ID) has been proposed as an alternative strategy to intramuscular (IM) administration.
Vaccination through the ID route has shown to be safe and equally or more effective than IM vaccination with a wide variety of vaccines. Recently, ID administration has been tested with two COVID-19 mRNA vaccines (Spikevax, Moderna and Comirnaty, Pfizer/BioNTech) in reduced (fractional) doses of the standard IM dose.
To ease ID administration and thereby facilitate the implementation of this route, silicon-based microneedles have been developed. These needles have shown to allow ID administration of the Spikevax vaccine with equal safety and immunogenicity profiles as the traditional Mantoux approach in young adults.
In the present study, we will investigate the immunogenicity of a 20 mcg dose of the COVID-19 mRNA Comirnaty vaccine through ID administration with silicon microneedles in elderly people (75 years and older), and compare this to immunogenicity of IM administration of a 20 mcg dose and a 30 mcg (standard IM) dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- open-label, randomised, proof-of-concept intervention study
| Arm | Type | Receives |
|---|---|---|
| Intradermal vaccination with 20 mcg mRNA vaccine | Experimental | Biological: ComirnatyParticipants will receive a single dose of 20 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intradermal route using microneedles. |
| Intramuscular vaccination with 30 mcg mRNA vaccine | Active comparator | Biological: ComirnatyParticipants will receive a single dose of 30 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intramuscular route. |
| Intramuscular vaccination with 20 mcg mRNA vaccine | Active comparator | Biological: ComirnatyParticipants will receive a single dose of 20 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intramuscular route. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Male or female aged ≥75 years at the moment of immunization.
- Healthy, determined by medical history and clinical judgement of the investigator. Participants with a pre-existing illness that is stable, defined as disease not requiring significant change in therapy or hospitalisation during the 6 weeks before enrolment and not expected to require any intervention during the study, can be included.
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- Willing to postpone their regular COVID-19 vaccination upon invitation by the Municipal Health Service or general practitioner until at least four months after receiving the intervention.
- Completed a primary series of COVID-19 vaccination.
Key exclusion criteria (11 listed)
- Medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.
- No decision-making capacity.
- History of severe adverse reaction to a vaccine or to any component of the study intervention.
- Thrombose with thrombocytopenia syndrome after vaccination with a COVID-19 vaccine.
- Dermatological conditions that might interfere with the ID vaccination.
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 |
|---|---|---|
| ComirnatyAdministration of Comirnaty vaccine | Biological | Intradermal vaccination with 20 mcg mRNA vaccine, Intramuscular vaccination with 20 mcg mRNA vaccine, Intramuscular vaccination with 30 mcg mRNA vaccine |
Primary outcome
Concentrations of SARS-CoV-2-Spike protein specific IgG antibodies in serum for the different intervention groups
Time frame: at 28 days after vaccination
2 secondary outcomes
Titers of SARS-CoV-2 specific neutralising antibodies in serum of the different intervention groups
Time frame: at 28 days after vaccination
The percentage of participants with local and systemic adverse events
Time frame: up to 28 days after vaccination
Results and safety
The study was stopped early (reason given: Recruitment rate dropped because of national COVID-19 vaccination campaign taking place parallel to this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hans de Graaf principal investigator
Stichting Radboud 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 Comirnaty in people with Vaccination; Infection and COVID-19, run by Radboud 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Mar 2024. 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?
The study was stopped early (reason given: Recruitment rate dropped because of national COVID-19 vaccination campaign taking place parallel to this study.). Results are not available in the source record.
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?
Concentrations of SARS-CoV-2-Spike protein specific IgG antibodies in serum for the different intervention groups (time frame: at 28 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2024.