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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT00408668
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults aged 18 to 50 years
* Written informed consent
* Resident in or near Oxford for the duration of the vaccination study
* For women only, willingness to practice continuous effective contraception during the study and (if participating) during the subsequent challenge study.
* Agreement to refrain from blood donation during the course of the study
* Willingness to undergo an HIV test
Exclusion Criteria:
* Any deviation from the protocol defined normal range in biochemistry or haematology blood tests or in urine analysis
* Prior receipt of an investigational malaria vaccine
* Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
* Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination.
* History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge
* Any history of malaria
* Travel to a malaria endemic area within the previous 6 months
* Planned travel to malarious areas during the study period
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
* History of haemoglobinopathies
* History of diabetes mellitus
* Chronic or active neurological disease
* History of \> 2 hospitalisations for invasive bacterial infections
* Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
* Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for hepatitis C virus (antibodies to HCV)
* Hepatomegaly, right upper quadrant abdominal pain or tenderness
* Evidence of serious psychiatric condition
* Any on-going chronic illness requiring hospital specialist supervision
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* Pregnant or lactating woman
* Any woman who is willing or intends to become pregnant during the study
* Any history of anaphylaxis in reaction to vaccination
* Principal Investigator assessment of lack of willingness to participate and comply with all requirements of the protocol
* History or clinical evidence of intravenous drug abuse
* Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00408668
Study Brief:
Protocol Section:
NCT00408668