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New treatment option for Immune System Responses and Trained Immunity After AS01 Administration
Official title Improving Vaccine Protection for Adults
ClinicalTrials.gov ID: NCT07527247
What this study is testing
What is AS01 adjuvant (0.5 mL intramuscular)?
AS01 adjuvant (0.5 mL intramuscular) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for immune system responses and trained immunity after as01 administration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 59. Healthy volunteers may be eligible.
You may be able to join if
- 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 people with underlying comorbidities...
- Voluntarily participate, understand and sign an informed consent form approved by the Ethical Review Board.
- people who are willing to comply with the requirements of the study protocol and scheduled visits. These requirements include completion of the...
You likely can't join if
- Previous vaccination against yellow fever, dengue either with a registered product or from participation in a previous vaccine study.
- Previously received AS01-adjuvanted vaccines (e.g. Recombinant zoster vaccine, RTS,S/AS01, RSVPre-F3-AS01), either with a registered product or from...
- Planned administration of a AS01-adjuvanted vaccine or yellow fever vaccine other than the study vaccine during the study.
- people who have been unwell in the last 7 days prior to screening.
- History of documented yellow fever and / or dengue infection.
- Dengue seropositivity upon screening.
See the full eligibility criteria
- 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 people with underlying comorbidities, the conditions must be deemed stable by the investigators, and they must...
- Voluntarily participate, understand and sign an informed consent form approved by the Ethical Review Board.
- people 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. people should also be willing...
- Accessible vein at the forearm for blood taking.
- Female people of non-childbearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Post-menopausal people must have had at least 12 months of natural...
- Previous vaccination against yellow fever, dengue either with a registered product or from participation in a previous vaccine study.
- Previously received AS01-adjuvanted vaccines (e.g. Recombinant zoster vaccine, RTS,S/AS01, RSVPre-F3-AS01), either with a registered product or from participation in a previous vaccine study.
- Planned administration of a AS01-adjuvanted vaccine or yellow fever vaccine other than the study vaccine during the study.
- people who have been unwell in the last 7 days prior to screening.
- History of documented yellow fever and / or dengue infection.
- Dengue seropositivity upon screening.
- History of smoking within the last 1 year.
- Planned travel to yellow fever endemic countries during the study.
- Known allergy to AS01 and YF17D vaccine or their components (e.g. egg products).
- Diagnosis of diabetes HBA1c \> 6.5 according to American Diabetes Association criteria62.
- Any medical condition that in the judgment of the investigator will make intramuscular injection unsafe (e.g. thrombocytopenia with platelet count \< 50x10\^9/L, coagulopathy, anti-coagulant therapy).
- Risk factor for live-attenuated vaccines, including any confirmed or suspected primary or acquired immunodeficiency based on history and physical examination:
- History of thymus gland disease
- Haematologic neoplasms including leukaemia, lymphoma, myelodysplastic syndromes
- Diagnosed with cancer or treatment for cancer (except for localised basal cell carcinoma) within 3 years prior to screening
- Post-transplant: solid organ and haematopoietic stem cell transplant
- Immunocompromised due to primary or acquired (including HIV/AIDS) immunodeficiency
- Other significantly immunocompromising conditions
- Administration of anti-inflammatory drugs for the past 7 days (e.g. NSAIDs, Paracetamol, aspirin).
- Use of metformin for the last 1 month.
- Use of corticosteroids within the last 6 months prior to the first vaccine dose (defined as prednisolone \> 10 mg / day or equivalent for \> 2 weeks, or prednisolone \> 40mg / day or \> 1 week). Inhaled and topical...
- Received biologics (such as anti-TNF inhibitors, IL-1 inhibitors, co-stimulation blockers, B-cell depleting therapy) for the last 12 months.
- Any condition (e.g. extensive psoriasis, chronic pain syndrome, severe hearing loss, cognitive impairment, dialysis, autoimmune disorders) that in the opinion of the investigator, would complicate or compromise the...
- Evidence of substance abuse, or previous substance abuse.
- Clinically significant anaemia (Hb \< 10 g/dL).
- Blood donation exceeding \> 450 ml in the past 3 months.
- Participation in a study involving administration of an investigational or non-investigational compound within the past four months or planned participation during the duration of this study.
- Administration of any licensed vaccine within 30 days before the first study vaccine dose or planned to receive such products within 30 days after the study vaccination.
- Received immunoglobulin or any blood products within the 90 days preceding the first dose of study vaccine or planned to receive such products during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.