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A study comparing the immunological responses to a self-amplifying mRNA COVID-19 vaccine booster with those to a conventional mRNA vaccine booster in people with HIV.

Comparative Analysis of Immunological Responses to a Self-Amplifying mRNA COVID-19 Booster Vaccine in People with HIV

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031250429
Enrollment
70
Registered
2025-10-15
Start date
2025-11-19
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 COVID-19 vaccine, self

Interventions

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

Sponsors

Koga Michiko
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 years or older who are healthy at the time of obtaining informed consent. Adults aged 18 years or older with confirmed HIV infection at the time of obtaining informed consent. 2. Participants with a history of COVID-19 infection must have a confirmed date of infection, and at least one month must have elapsed since the most recent episode. 3. Participants who have previously received a COVID-19 vaccine, with at least six months having passed since their most recent vaccination. 4. Participants who are able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Individuals presenting with a clear fever at the time of vaccination ( generally defined as a body temperature over 37.5 degrees). 2. Individuals with a severe acute illness. 3. Individuals who developed febrile upper respiratory tract infection within one month prior to vaccination. 4. Individuals with a history of severe hypersensitivity to any component of the study vaccine. 5. Individuals deemed inappropriate for vaccination based on the precautions or contraindications stated in the package insert of the study vaccine. 6. Any other individuals judged by the principal investigator or subinvestigator to be unsuitable for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
SARS-CoV-2 Neutralizing Antibody (XEC,LP8.1)

Secondary

MeasureTime frame
Other Additional Immune Responses

Contacts

Public ContactFumitaka Nagamura

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