Experimental Human Malaria Infection by PfSPZ

NCT01086917 | Completed Phase 1 DMC

• 1 other identifier: TIP2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a single center, varied dose, open label study. A maximum of eighteen volunteers will be exposed to live NF54 P. falciparum sporozoites (PfSPZ Challenge) by intradermal injection. Volunteers will be divided into three groups of 6 volunteers, each group spaced 25 days apart (21 days after the last challenge of the last volunteer from the previous dose group).

Conditions

Malaria

Keywords

Malaria Challenge; Plasmodium falciparum; Controlled human malaria infection; PfSPZ Challenge

Outcome Measures

Primary Outcomes (1)

• Number of volunteers with Plasmodium falciparum Infection

  To achieve a 100% infection rate of human volunteers by intradermal injection of aseptic, purified, cryopreserved Pf sporozoites (PfSPZ Challenge)as measured by 100% thick smear positivity (thick blood smears) of all volunteers from one group

  Upto 7 months

Secondary Outcomes (1)

• Kinetics of infection

  Upto 7 months

Study Arms (3)

Group 1

EXPERIMENTAL

to receive a dose of 2,500 PfSPZ Challenge

Biological: PfSPZ Challenge

Group 2

EXPERIMENTAL

to receive a dose of 10,000 PfSPZ Challenge

Biological: PfSPZ Challenge

Group 3

EXPERIMENTAL

to receive a dose of 25,000 PfSPZ Challenge

Biological: PfSPZ Challenge

Interventions

PfSPZ Challenge BIOLOGICAL

each volunteer to receive a single dose

Also known as: aseptic, purified, cryopreserved Plasmodium falciparum sporozoites

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 19 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 and \< 35 years healthy volunteers (males or females)
• Good health based on history and clinical examination
• Negative pregnancy test
• Use of adequate contraception for females
• All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study
• Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study
• Willingness to undergo a Pf sporozoite challenge
• For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till 3 days after treatment)
• Reachable (24/7) by mobile phone during the whole study period
• Living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till 3 days after treatment)
• Available to attend all study visits
• Agreement to refrain from blood donation to Sanquin or for other purposes, during the study period until day 140.
• Willingness to undergo HIV, hepatitis B and hepatitis C tests
• Negative urine toxicology screening test at screening visit and day before challenge
• Willingness to take a curative regimen of Malarone®

You may not qualify if:

• History of malaria
• Plans to travel to malaria endemic areas during the 140 day study period
• Plans to travel outside of the Netherlands during day 0-28 of the study
• Previous participation in any malaria vaccine study and/or positive serology for Pf
• Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
• History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
• History of arrhythmias or prolonged QT-interval
• Positive family history in 1st and 2nd degree relatives for cardiac disease \< 50 years old
• An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
• Clinically significant abnormalities in electrocardiogram (ECG) at screening
• Body Mass Index (BMI) below 18 or above 30 kg/m2
• Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
• Positive HIV, HBV or HCV tests
• Participation in any other clinical study within 30 days prior to the onset of the study
• Enrollment in any other clinical study during the study period

Sponsors & Collaborators

• Sanaria Inc.: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (2)

• Roestenberg M, Bijker EM, Sim BKL, Billingsley PF, James ER, Bastiaens GJH, Teirlinck AC, Scholzen A, Teelen K, Arens T, van der Ven AJAM, Gunasekera A, Chakravarty S, Velmurugan S, Hermsen CC, Sauerwein RW, Hoffman SL. Controlled human malaria infections by intradermal injection of cryopreserved Plasmodium falciparum sporozoites. Am J Trop Med Hyg. 2013 Jan;88(1):5-13. doi: 10.4269/ajtmh.2012.12-0613. Epub 2012 Nov 13.

  PMID: 23149582 RESULT

• Teirlinck AC, Roestenberg M, Bijker EM, Hoffman SL, Sauerwein RW, Scholzen A. Plasmodium falciparum Infection of Human Volunteers Activates Monocytes and CD16+ Dendritic Cells and Induces Upregulation of CD16 and CD1c Expression. Infect Immun. 2015 Sep;83(9):3732-9. doi: 10.1128/IAI.00473-15. Epub 2015 Jul 13.

  PMID: 26169270 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Robert Sauerwein, Md PhD

  UMC St Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

NL (1)