Improving Vaccine Protection for Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-59
SponsorSingapore General Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Subjects who have been unwell in the last 7 days prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
AS01 adjuvant (0.5 mL intramuscular)
Biological/VaccineThe 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.
YF17D (Stamaril, Sanofi-Pasteur)
Biological/VaccineStamaril, 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).
Placebo (NaCl 09%, 0.5mL)
Other interventionThe placebo will consist of 0.9% saline solution in equivalent volume.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: AS01 + YF17D at 1 MonthExperimental treatment 2 interventions
Group B: AS01 + YF17D at 3 MonthsExperimental treatment 2 interventions
Group C: Placebo + YF17D at 1 MonthPlacebo comparator 2 interventions
Group D: Placebo + YF17D at 3 MonthsPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Host Immune Response
Explorative evaluation of host immune response profile (cytokines, immune cell populations, gene expression, epigenetic modifications) induced by AS01 versus placebo, using panel of validated multi-omics assay tests, over a 3-month period.
Time frame
Days 0, 7, 14, 28, 56, 84 (3 months)Secondary outcomes
1
Viraemia Levels
Measure Yellow Fever viraemia levels via quantitative RT-PCR and calculate area under the curve (AUC) up to 7 days following yellow fever vaccine administration in AS01 versus placebo recipients.
Time frame
7 days following yellow fever vaccine administration2
B Cell Response
Assess B cell responses to yellow fever by measurement of neutralising antibodies titres using plaque reduction neutralization test (PRNT) with sera at day 30 compared with pre-vaccination day 0, following yellow fever vaccine administration in AS01 versus placebo recipients.
Time frame
30 days3
T Cell Response
Assess T cell responses to yellow fever vaccine using virus-specific IFNγ ELISPOT assay, with results expressed as spot-forming units (SFU) per 10\^6 PBMCs at day 14 and day 30 versus pre-vaccination at day 9 in AS01 versus placebo recipients.
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Singapore General Hospital
Lead sponsor
A*STAR Infectious Diseases Labs
Collaborator
Source ClinicalTrials.gov