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

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 59
Healthy Volunteers: t
View:

• Adults aged 21 to 59 years of age at time of screening.

• BMI 18.5 - 27.5 kg / m2 (BMI values for Asian population according to MOH guideline NIH Consensus Conference).

• Satisfactory baseline medical assessment as assessed by physical examination and a stable health status. For subjects with underlying comorbidities, the conditions must be deemed stable by the investigators, and they must not have any hospitalisation relating to these conditions in the last 6 months.

• Voluntarily participate, understand and sign an informed consent form approved by the Ethical Review Board.

• Subjects who are willing to comply with the requirements of the study protocol and scheduled visits. These requirements include completion of the subject diary, return for follow-up visits. Subjects should also be willing to make themselves available for the duration of the study, with access to a consistent means of contact.

• Accessible vein at the forearm for blood taking.

• Female subjects of non-childbearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Post-menopausal subjects must have had at least 12 months of natural (spontaneous) amenorrhoea.

Locations
Other Locations
Singapore
Singapore General Hospital
RECRUITING
Singapore
Contact Information
Primary
Candice Y.Y. Chan, MBChB, MRCP
candice.chan.y.y@singhealth.com.sg
+6563213479
Backup
Christina Titin
christina.titin@singhealth.com.sg
+6565762802
Time Frame
Start Date: 2025-11-06
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 40
Treatments
Experimental: AS01 + YF17D at 1 Month
Participants receive AS01 (0.5 mL IM on Day 0) and yellow fever vaccine YF17D on Day 30.
Experimental: AS01 + YF17D at 3 Months
Participants receive AS01 (0.5 mL IM on Day 0) and yellow fever vaccine YF17D on Day 90.
Placebo_comparator: Placebo + YF17D at 1 Month
Participants receive placebo (0.9% saline, 0.5 mL IM on Day 0) and yellow fever vaccine YF17D on Day 30.
Placebo_comparator: Placebo + YF17D at 3 Months
Participants receive placebo (0.9% saline, 0.5 mL IM on Day 0) and yellow fever vaccine YF17D on Day 90.
Sponsors
Leads: Singapore General Hospital

This content was sourced from clinicaltrials.gov

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