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Improving Vaccine Protection for Adults

NCT07527247 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Immune System Responses and Trained Immunity After AS01 Administration
  • Healthy Adult

Interventions

BIOLOGICAL

AS01 adjuvant (0.5 mL intramuscular)

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

BIOLOGICAL

YF17D (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).

OTHER

Placebo (NaCl 09%, 0.5mL)

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

Sponsors & Collaborators

  • A*STAR Infectious Diseases Labs

    collaborator INDUSTRY

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Candice Y.Y. Chan, MBChB, MRCP · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-06
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07527247 on ClinicalTrials.gov