Optimisation of Controlled Human Malaria Infection Using Sporozoites Administered by Needle and Syringe
|ClinicalTrials.gov Identifier: NCT01465048|
Recruitment Status : Completed
First Posted : November 4, 2011
Results First Posted : May 28, 2013
Last Update Posted : June 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malaria Plasmodium Falciparum||Biological: Plasmodium falciparum sporozoites 2sites Biological: Plasmodium falciparum sporozoites 1 site Biological: Plasmodium falciparum sporozoites 1site||Not Applicable|
Studies involving CHMI are a powerful tool for investigating malaria vaccine and prophylactic drug efficacy.CHMI has now become established as a key tool to assess the efficacy of novel malaria vaccines and drugs. As CHMI trials are carried out in a controlled environment, they allow unprecedented detailed evaluation of parasite growth and immunological responses, providing essential information for vaccine and drug development.
Out of three currently available methods of performing experimental human malaria infections (blood stage infection, mosquito bites and sporozoite infection), experimental injection directly by needle and syringe using aseptic, purified, cryopreserved sporozoites is, in principle, the most accurate and practical way of dosing sporozoites for challenge studies. Recently, Sanaria Inc have been able to overcome the technical issues associated with the production of aseptic, purified, cryopreserved Plasmodium falciparum sporozoites. As a result, an Investigational New Drug application (IND) was submitted to the U.S. Food and Drug Administration in February 2009, and a Phase 1 clinical trial with experimental challenge of volunteers was initiated in April 2009. Another trial sponsored by Sanaria to find the dose of aseptic, purified, cryopreserved sporozoites that should be used for experimental human malaria infections is currently ongoing with collaboration with the Radboud University Nijmegen Medical Center, The Netherlands.
This trial will be the first time aseptic, purified, cryopreserved P. falciparum sporozoites have been administered intramuscularly to humans.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Optimise Controlled Human Malaria Infections Using Plasmodium Falciparum Sporozoites Administered by Needle and Syringe|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2013|
Experimental: Plasmodium falciparum sporozoites 2sites
2,500 sporozoites intradermally
Biological: Plasmodium falciparum sporozoites 2sites
Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intradermal injection sites
Experimental: Plasmodium falciparum sporozoites 1 site
2,500 sporozoites intramuscularly
Biological: Plasmodium falciparum sporozoites 1 site
Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intramuscular injection sites
Experimental: Plasmodium falciparum sporozoites 1site
25,000 sporozoites intramuscularly
Biological: Plasmodium falciparum sporozoites 1site
Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 25,000 sporozoites, 50ulx2, 2 intramuscular injection sites
- Number of Participants Infected [ Time Frame: 21 days post administration of PfSPZ Challenge ]To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.
- Frequency, Incidence and Nature of Adverse Events and Serious Adverse Events Arising. [ Time Frame: Participants will be followed for the duration of the study, an expected average of 3 months ]To assess the safety of PfSPZ Challenge administered in various regimens by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements, including lab reports and adverse events.
- Dynamics of Plasmodium Falciparum Parasite Growth Following PfSPZ Challenge Administered in Various Regimens [ Time Frame: 21 days post administration of PfSPZ Challenge ]To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465048
|Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital|
|Oxford, United Kingdom, OX3 7LJ|
|Principal Investigator:||Adrian VS Hill, DPhil FRCP||University of Oxford|