Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly (HVaNa)
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ClinicalTrials.gov Identifier: NCT05977127 |
Recruitment Status :
Terminated
(Recruitment rate dropped because of national COVID-19 vaccination campaign taking place parallel to this study.)
First Posted : August 4, 2023
Last Update Posted : March 28, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
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Vaccination; Infection COVID-19 | Biological: Comirnaty | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | open-label, randomised, proof-of-concept intervention study |
Masking: | None (Open Label) |
Masking Description: | Only laboratory personnel is masked. Because of the different administration routes it is not possible to mask the participants or investigators |
Primary Purpose: | Prevention |
Official Title: | Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly |
Actual Study Start Date : | September 26, 2023 |
Actual Primary Completion Date : | March 21, 2024 |
Actual Study Completion Date : | March 21, 2024 |
Arm | Intervention/treatment |
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Experimental: Intradermal vaccination with 20 mcg mRNA vaccine
Participants will receive a single dose of 20 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intradermal route using microneedles.
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Biological: Comirnaty
Administration of Comirnaty vaccine |
Active Comparator: Intramuscular vaccination with 30 mcg mRNA vaccine
Participants will receive a single dose of 30 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intramuscular route.
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Biological: Comirnaty
Administration of Comirnaty vaccine |
Active Comparator: Intramuscular vaccination with 20 mcg mRNA vaccine
Participants will receive a single dose of 20 mcg COVID-19 mRNA vaccine (Comirnaty; Pfizer/BioNTech) through the intramuscular route.
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Biological: Comirnaty
Administration of Comirnaty vaccine |
- Concentrations of SARS-CoV-2-Spike protein specific IgG antibodies in serum for the different intervention groups [ Time Frame: at 28 days after vaccination ]
- 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 ]
- 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
- Concentrations of SARS-CoV-2-Spike protein specific antibodies in serum and mucosal samples for the different intervention groups at various timepoints [ Time Frame: Day 0, day 28 and month 4 after vaccination ]
- Titers of SARS-CoV-2 specific neutralising antibodies in serum and mucosal samples of the different intervention groups at various timepoints [ Time Frame: Day 0, day 28 and month 4 after vaccination ]
- Changes in expression level of host genes [ Time Frame: day 0 and day 1 after vaccination ]
- Cellular responses in blood and mucosal samples at various timepoints [ Time Frame: Day 0, Day 28, month 4 after vaccination ]e.g. expressed as percentages of immune cell subsets or concentration of cytokines
- Functional and phenotypic characterization of T cells at various timepoints after vaccination [ Time Frame: Day 0, Day 28, month 4 after vaccination ]e.g. expressed as percentages of immune cell subsets or concentration of cytokines
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Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977127
Netherlands | |
Radboudumc | |
Nijmegen, Netherlands |
Principal Investigator: | Hans de Graaf | Stichting Radboud University Medical Center |
Responsible Party: | Radboud University Medical Center |
ClinicalTrials.gov Identifier: | NCT05977127 |
Other Study ID Numbers: |
2023-503800-99-00 |
First Posted: | August 4, 2023 Key Record Dates |
Last Update Posted: | March 28, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Intradermal COVID-19 mRNA vaccine Elderly Immune response |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |