Malaria
Conditions
Interventions
P.falciparum sporozoites (Pf SPZ) Challenge
Sponsors
Univeristy of Oxford
Sanaria Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adults aged 18 to 40 years. Minimum of 4 completed years (Form 4) of secondary education. Able and willing (in the Investigator¿s opinion) to comply with all study requirements. Informed consent to undergo CHMI. Answer all questions on the informed consent questionnaire correctly. Willingness to take a course of curative anti-malaria medication. Agreement to stay in an in-patient unit during a part of the study (from day of administration of PfSPZ Challenge until completion of curative course of atovaquone/ proguanil hydrochloride given either at malaria diagnosis or day 21 post administration of PfSPZ Challenge). Use of effective method of contraception for duration of study (women only).
Exclusion criteria
Exclusion criteria: ¿ PCR positive for P. falciparum parasites at screening. ¿ Use of systemic antibiotics with known antimalarial activity within 30 days of administration of PfSPZ Challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin). ¿ Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period. ¿ Current participation in another clinical trial or recent participation within 12 weeks of enrolment. ¿ Prior receipt of an investigational malaria vaccine. ¿ Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). ¿ Use of immunoglobulins or blood products within 3 months prior to enrolment. ¿ Haemoglobinopathy (sickle-cell trait) deemed to interfere with study endpoints ¿ A history of allergic disease or reactions likely to be exacerbated by malaria infection. ¿ Contraindications to atovaquone/proguanil hydrochloride. ¿ History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). ¿ History of serious psychiatric condition that may affect participation in the study. ¿ Any other serious chronic illness requiring hospital specialist supervision. ¿ Women only; pregnancy, intention to become pregnant or breast-feeding during study. ¿ Suspected or known current alcohol abuse. ¿ Suspected or known injecting drug abuse. ¿ Seropositive for hepatitis B surface antigen (HBsAg). ¿ Seropositive for hepatitis C virus (antibodies to HCV) with PCR positive for Hepatitis C. ¿ Positive family history in 1st and 2nd degree relatives 37.5oC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The infectivity of PfSPZ Challenge in healthy Kenyan adults will be assessed using thick film microscopy and highly sensitive PCR for P. falciparum DNA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Volunteers' natural immunity to P. falciparum will be assessed by comparing parasite growth dynamics between volunteers with maximum and minimal prior exposure to malaria following CHMI. | — |
Countries
Kenya
Contacts
Public ContactElizabeth Juma
Investigator
Outcome results
None listed