Actively Recruiting

Phase 2
Age: 21Years - 59Years
All Genders
Healthy Volunteers
ID07527247

Using AS01 Adjuvant to Improve Immune Response in Adults Aged 21 to 59 Through Trained Immunity

Led by Singapore General Hospital · Updated on 2026-05-18

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Singapore General Hospital

Lead Sponsor

A

A*STAR Infectious Diseases Labs

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how the immune system weakens with age, making older adults more prone to infections and less responsive to vaccines. This trial focuses on AS01, an ingredient used in vaccines like the shingles vaccine, which may act like a fitness trainer for the immune system. The study aims to see if AS01 alone can boost and train the immune system in healthy adults aged 21 to 59, how long this effect lasts, and whether it helps fight other infections better. Participants receive a single intramuscular dose of either AS01 or a placebo on the first day. Then, they are randomly assigned to get a live-attenuated yellow fever vaccine (YF17D) either one month or three months later. There are four groups in total: AS01 plus yellow fever vaccine at 1 month, AS01 plus yellow fever vaccine at 3 months, placebo plus yellow fever vaccine at 1 month, and placebo plus yellow fever vaccine at 3 months. This design helps researchers study immune responses over approximately 2 to 4 months. Throughout the study, participants will have blood samples taken at multiple timepoints to measure immune changes, including gene and epigenetic markers, and immune responses to the yellow fever vaccine. Researchers will analyze how well the immune system controls the viral challenge and monitor safety, including common injection site reactions and systemic symptoms. The total participation time depends on the assigned group and lasts up to about 3 months.

CONDITIONS

Brief Title

Improving Vaccine Protection for Adults

Who Can Participate

Age: 21Years - 59Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 to 59 years at screening
  • Body mass index between 18.5 and 27.5 kg/m2 according to Asian population guidelines
  • Stable health status with satisfactory medical assessment
  • Willing and able to provide informed consent
  • Agree to comply with study visits and procedures
  • Accessible vein for blood sampling
  • Females must be of non-childbearing potential due to surgical sterilisation or menopause with at least 12 months of amenorrhoea
Not Eligible

You will not qualify if you...

  • Prior vaccination against yellow fever or dengue
  • Previous receipt of AS01-adjuvanted vaccines
  • Planned vaccination with AS01-adjuvanted or yellow fever vaccines outside the study during the trial period
  • Unwell within 7 days before screening
  • History of yellow fever or dengue infection
  • Dengue seropositivity at screening
  • Smoking within the last year
  • Planned travel to yellow fever endemic areas during the study
  • Known allergy to AS01, YF17D vaccine, or their components
  • Diabetes with HBA1c > 6.5
  • Medical conditions making intramuscular injection unsafe
  • Immunodeficiency, cancer treatment within 3 years, transplant history, or other immunocompromising conditions
  • Recent use of anti-inflammatory drugs, metformin, corticosteroids, or biologics within specified timeframes
  • Conditions complicating study participation or completion
  • Substance abuse history
  • Significant anemia (Hb < 10 g/dL)
  • Recent blood donation exceeding 450 ml
  • Participation in other investigational studies within 4 months
  • Recent or planned receipt of licensed vaccines or blood products within specified timeframes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 months

Participants receive a single intramuscular dose of AS01 adjuvant or placebo on Day 0. Then participants receive the licensed live-attenuated yellow fever vaccine (YF17D) either at 1 month (Day 30) or 3 months (Day 90) after AS01/placebo, based on randomization.

Visits on Days 0, 7, 14, 28, 30 or 90, and 37 or 97

Follow-up

Duration - Up to 4 months depending on group assignment

Participants undergo serial blood sampling to measure immune response, durability, and response to the viral challenge. Monitoring includes visits up to 3 months after the yellow fever vaccine.

Additional visits on Days 56, 84, and 120 depending on assignment

Trial Site Locations

Total: 1 location

1

Singapore General Hospital

Singapore, Singapore, 169608

Actively Recruiting

Loading map...

Research Team

C

Candice Y.Y. Chan, MBChB, MRCP

C

Christina Titin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

Similar Trials

A Novel Accessible and Widespread Healthcare Service Model B...

Parkinson Disease

Actively Recruiting

5 locations

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmaco...

Healthy Adult

Actively Recruiting

1 location

An Open-label, Randomized, Single-dose, Two-Cohort, Two-Peri...

Healthy Adult

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Live vaccine infection burden elicits adaptive humoral and cellular immunity required to prevent Zika virus infection.

Clement Yau, Esther Shuyi Gan, Swee Sen Kwek...

https://pubmed.ncbi.nlm.nih.gov/33045466

Early induction of functional SARS-CoV-2-specific T cells associates with rapid viral clearance and mild disease in COVID-19 patients.

Anthony T Tan, Martin Linster, Chee Wah Tan...

https://pubmed.ncbi.nlm.nih.gov/33516277

BCG Skin Infection Triggers IL-1R-MyD88-Dependent Migration of EpCAMlow CD11bhigh Skin Dendritic cells to Draining Lymph Node During CD4+ T-Cell Priming.

Vishnu Priya Bollampalli, Lívia Harumi Yamashiro, Xiaogang Feng...

https://pubmed.ncbi.nlm.nih.gov/26440518

Metabolic perturbations and cellular stress underpin susceptibility to symptomatic live-attenuated yellow fever infection.

Kuan Rong Chan, Esther Shuyi Gan, Candice Yuen Yue Chan...

https://pubmed.ncbi.nlm.nih.gov/31308506