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A study comparing the immune response to a booster dose of the RBD-mRNA COVID-19 vaccine (DS-5670) with the immune response to a booster dose of the full-length Spike protein mRNA vaccine

Comparative Evaluation of the Immunological Response to the Booster Dose of the RBD-mRNA COVID-19 Vaccine (DS-5670)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031240457
Enrollment
120
Registered
2024-11-05
Start date
2024-11-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of COVID-19

Interventions

Inoculate once intramuscularly (usually in the deltoid muscle of the upper arm) at the prescribed dose as per the prescribing information.

Sponsors

Koga Michiko
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1, Individuals aged 18 or older who are in good health, have previously received a COVID-19 vaccine, and can provide documentation of their vaccination history at the time of consent. 2, For those with a history of COVID-19 infection, the infection date must be identifiable, and at least one month must have passed since the last COVID-19 infection. 3, At least six months must have passed since the last COVID-19 vaccination. 4, Individuals who are able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1, Individuals presenting with an evident fever at the vaccination. 2, Individuals suffering from a severe acute illness. 3, Individuals who have experienced febrile upper respiratory tract infections within one month before vaccination. 4, Individuals with a history of severe hypersensitivity to any vaccine component. 5, Individuals in any other condition deemed unsuitable for vaccination. 6, Any other individuals whom the principal investigator considers ineligible for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
SARS-CoV-2 Neutralizing Antibody Titer (Omicron Variant JN-1) Before and One Month After Vaccination

Secondary

MeasureTime frame
Other SARS-CoV-2 Neutralizing Antibody Titers and Additional Immune Responses (T Cells, B Cells)

Contacts

Public ContactKono Minako

IMSUT Hospital, The Institute of Medical Science, The Univers ity of Tokyo

dctsm@ims.u-tokyo.ac.jp+81-3-5449-5462

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026