Completed

TIP4Re-exposure of Previously Immunized and Challenged Human Volunteers to a Heterologous Strain of P. Falciparum Sporozoites

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What is being tested

Heterologous challenge

+ Malarone treatment

+ Heterologous challenge

BiologicalDrug
Who is being recruted

Vector Borne Diseases+4

+ Mosquito-Borne Diseases

+ Infections

From 18 to 35 Years
+40 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorRadboud University Medical Center
Last updated: February 13, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

In a previous study (NL33904.091.10) the investigators challenged 24 volunteers after Chloroquine Prophylaxis Sporozoites (CPS) immunization with 45, 30 or 15 infected mosquito-bites respectively. The availability of this immunized cohort opens the unique opportunity to determine protection to a heterologous challenge for both of the protected and unprotected volunteers as the previous challenge infection might have served as immunological boost to the unprotected volunteers. In the current observational, proof of principle study, the investigators aim to investigate the protection on an individual basis of these previously immunized and challenged volunteers against a heterologous P. falciparum challenge.

NCT01660854
Principal SponsorRadboud University Medical Center
Last updated: February 13, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesMosquito-Borne DiseasesInfectionsParasitic DiseasesProtozoan InfectionsMalariaMalaria, Falciparum

Criteria

14 inclusion criteria required to participate
Age >= 18 and <= 35 years healthy volunteers (males or females)
Agreement to inform the general practitioner and to sign a request to release medical information concerning contra-indications for participation in the study
Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period
Agreement to stay in a hotel room close to the trial centre during a part of the study (Day 5 after challenge till treatment is finished)
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26 exclusion criteria prevent from participating
A history of convulsions
A history of sickle cell anaemia, sickle cell trait, thalassaemia (or trait), G6PD deficiency
A history of treatment for psychiatric disease
An estimated, ten year risk of fatal cardiovascular disease of >= 5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Biological: Heterologous challenge with 5 infected mosquito bites (NF135) after previous CPS immunization and challenge. Drug: Malarone treatment When thick smear positive, of at day 21 after challenge, all volunteers will be treated with malarone. Other Name: atovaquone/proguanil

Group II

Active Comparator
Biological: Plasmodium falciparum mosquito challenge by the bites of 5 Plasmodium falciparum infected mosquitoes (NF135). Drug: Malarone treatment When thick smear positive, of at day 21 after challenge, all volunteers will be treated with malarone. Other Name: atovaquone/proguanil

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Leiden University Medical Centre

Leiden, NetherlandsOpen Leiden University Medical Centre in Google Maps
CompletedOne Study Center