Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT05876195
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study and is able to comply with the study protocol.
* Male or female between 18 and 45 years of age inclusive, at the time of signing the informed consent.
* Healthy as determined by a physician, based on a detailed medical history and a complete physical examination including vital signs and laboratory measurements.
* Body weight \>= 50 kg and body mass index (BMI) within the range 18 to 30 kilogram/meter squared (inclusive).
* Female participants of child bearing potential: Females of child bearing potential are eligible to enter if they are not pregnant (negative pregnancy test on the day of both screening and vaccination) and willing to use effective methods of contraception to prevent pregnancy from the time of first dose to 60 days afterwards.
* Male participants with female partners of child-bearing potential: must agree to use effective methods of contraception from the time of the first dose of challenge agent to 60 days afterwards.
* At least 2 previous doses of a registered SARS-CoV2 vaccination, at least 60 days previously
* Sufficient English language ability to enable appropriate informed consent procedures to be conducted in English
Exclusion Criteria:
* Antibiotics or antiviral therapy after a serious illness within 30 days of study entry.
* SARS CoV2 (COVID-19) infection within the previous 30 days, diagnosed using PCR test or lateral flow device
* Any use of immunosuppressant or immunomodulatory agents (systemic or topical) in 3 months prior to study entry.
* Chronic medical conditions with potential effect on immune responses including diabetes, significant history of atopy, or any condition that, in the opinion of the investigator, would interfere with the study
* Presence of tattoos, naevi or other skin abnormalities such as keloids (or history of keloids) that may, in the opinion of the investigator, interfere with study assessments.
* Fitzpatrick skin type V and VI (due to potential interference with assessment of DTH response)
* Pregnancy or breastfeeding
* Allergy to KLH, aluminium hydroxide, Montanide ISA-51, related vaccine adjuvants, or components of the study challenge agents
* Allergy to shellfish
* Residency in or significant previous travel to areas endemic for schistosomiasis (due to potential cross-reactive immune responses to KLH)
* Previous exposure to Keyhole Limpet Haemocyanin, e.g. in the context of a previous study
* Participants participating, within 7 days of screening, in recreational sun-bathing, or use of sun-bed, on the area of the skin from wrist to shoulder inclusive.
* Phobia of needles or minor surgical procedures.
* Current smoker or using nicotine replacement therapy
* Participants receiving any vaccinations within 2 months prior to screening visit, or will require vaccination prior to the end of study follow-up.
* Any other significant disease, disorder, or finding, which, in the opinion of the investigator, may either put the participant at risk, affect their ability to participate in the study or impair interpretation of the study data
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05876195
Study Brief:
Protocol Section:
NCT05876195