An interventional study of Plasmodium falciparum sporozoites 2sites and Plasmodium falciparum sporozoites 1 site in Malaria and Plasmodium Falciparum, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by University of Oxford · Not applicable and Interventional
This is an open label, human pilot study to optimise controlled human malaria infection (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be inoculated with PfSPZ Challenge. The route of administration and dose will vary in order to identify the optimal regimen that achieves the greatest infection rate in volunteers with Plasmodium falciparum. All volunteers recruited will be healthy adults aged between 18 and 45 years. Safety and infectivity data will be collected for each of the regimens.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 18 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
2,500 sporozoites intradermally
Biological: Plasmodium falciparum sporozoites 2sites
2,500 sporozoites intramuscularly
Biological: Plasmodium falciparum sporozoites 1 site
25,000 sporozoites intramuscularly
Biological: Plasmodium falciparum sporozoites 1site
Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intradermal injection sites
Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intramuscular injection sites
Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 25,000 sporozoites, 50ulx2, 2 intramuscular injection sites
Number of Participants Infected
To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.
Time frame: 21 days post administration of PfSPZ Challenge
Frequency, Incidence and Nature of Adverse Events and Serious Adverse Events Arising.
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.
Time frame: Participants will be followed for the duration of the study, an expected average of 3 months
Dynamics of Plasmodium Falciparum Parasite Growth Following PfSPZ Challenge Administered in Various Regimens
To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.
Time frame: 21 days post administration of PfSPZ Challenge
| Milestone | PfSPZ Challenge 2,500 ID | PfSPZ Challenge 2,500 IM | PfSPZ Challenge 25,000 IM |
|---|---|---|---|
| Started | 6 | 6 | 6 |
| Completed | 6 | 6 | 6 |
| Not completed | 0 | 0 | 0 |
To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.
| Participants | PfSPZ Challenge 2,500 ID | PfSPZ Challenge 2,500 IM | PfSPZ Challenge 25,000 IM |
|---|---|---|---|
| Number of Participants Infected | 5 | 3 | 6 |
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.
Results for this outcome have not been posted.
To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.
Results for this outcome have not been posted.
Collected over 07/11/11 to 13/02/12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PfSPZ Challenge 2,500 ID | — | 0/6 (0%) | 2/6 (33.3%) |
| PfSPZ Challenge 2,500 IM | — | 0/6 (0%) | 2/6 (33.3%) |
| PfSPZ Challenge 25,000 IM | — | 0/6 (0%) | 3/6 (50%) |
| Event | PfSPZ Challenge 2,500 ID | PfSPZ Challenge 2,500 IM | PfSPZ Challenge 25,000 IM |
|---|---|---|---|
| HeadacheGeneral disorders | 2/6 | 0/6 | 1/6 |
| PainGeneral disorders | 0/6 | 0/6 | 2/6 |
| FeverGeneral disorders | 0/6 | 1/6 | 0/6 |
| NauseaGeneral disorders | 0/6 | 1/6 | 0/6 |
| MalasieGeneral disorders | 0/6 | 0/6 | 1/6 |
| Gum BleedingGeneral disorders | 0/6 | 0/6 | 1/6 |
| Age, Categorical(Participants) | PfSPZ Challenge 2,500 ID | PfSPZ Challenge 2,500 IM | PfSPZ Challenge 25,000 IM | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 6 | 18 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | PfSPZ Challenge 2,500 ID | PfSPZ Challenge 2,500 IM | PfSPZ Challenge 25,000 IM | Total |
|---|---|---|---|---|
| Female | 3 | 3 | 2 | 8 |
| Male | 3 | 3 | 4 | 10 |
| Region of Enrollment(participants) | PfSPZ Challenge 2,500 ID | PfSPZ Challenge 2,500 IM | PfSPZ Challenge 25,000 IM | Total |
|---|---|---|---|---|
| United Kingdom | 6 | 6 | 6 | 18 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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