Malaria Challenge Study

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201211000433272
• Date of registration: 10/10/2012
• Primary sponsor: Univeristy of Oxford
• Public title: Malaria Challenge Study
• Scientific title: A pilot study to optimise controlled human malaria infections in humans with varying degrees of prior exposure to malaria using P. falciparum sporozoites administered by needle and syringe
• Date of first enrolment: 2013-05-06
• Target sample size: 28
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201211000433272
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Elizabeth Juma
• Affiliation: Investigator

• Name: Susanne Sheehy
• Affiliation: Investigator

Key inclusion & exclusion 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: ? 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 ` 50 years old for cardiac disease.
? Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
? Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Exclusion Criterion on Day of Challenge
? Acute disease, defined as moderate or severe illness with or without fever (temperature b37.5oC.

Age minimum: 18 Year
Age maximum: 40 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

OxTREC Reference 161-12

SSC 2313

Source(s) of Monetary Support

EDCTP

Secondary Sponsor(s)

Sanaria Inc