RecruitingPhase 2NCT07527247

Improving Vaccine Protection for Adults

Using AS01 Adjuvant to Improve Immune Response in Older Adults Through Trained Immunity


Sponsor

Singapore General Hospital

Enrollment

40 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

As people grow older, their immune system - the body's natural defence against diseases - becomes weaker, making them more vulnerable to infections and less responsive to vaccines. This was clearly seen during the COVID-19 pandemic, where older adults were more likely to develop severe illness. Researchers have made an interesting discovery about AS01, an ingredient already used in successful vaccines like the shingles vaccine. They found clues that AS01 might work like a general fitness trainer for the immune system, potentially making it stronger and better at fighting off various types of infections, not just specific ones. To confirm this possibility, we are conducting this research study with adults aged 21-59 to test whether AS01 by itself can boost and train the immune system, how long this boost lasts, and if it actually helps you fight off other infections more effectively.


Eligibility

Min Age: 21 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called AS01 adjuvant (0.5 mL intramuscular), Placebo (NaCl 09%, 0.5mL), and others for people with healthy adult and immune system responses and trained immunity after as01 administration. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years to 59 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAS01 adjuvant (0.5 mL intramuscular)

The AS01 suspension contains 50 mcg/micrograms of 3-O-desacyl-4'monophosphoryl lipid A (MPL) and 50 mcg/micrograms of Quillaja Saponaria Molina, fraction 21 (QS21), licensed by GSK, available as a separate vial from the licensed Shingrix vaccine.

BIOLOGICALYF17D (Stamaril, Sanofi-Pasteur)

Stamaril, the live-attenuated yellow fever vaccine, utilises the YF17D strain. Stamaril is supplied in the form of powder and solvent for suspension for injection in pre-filled syringe, Yellow fever vaccine (live).

OTHERPlacebo (NaCl 09%, 0.5mL)

The placebo will consist of 0.9% saline solution in equivalent volume.


Locations(1)

Singapore General Hospital

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT07527247


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