MalariaPhase 1NCT01728701
Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis
A Phase 1 study testing PfSPZ Challenge and Normal Saline (NS) in people with Malaria and Plasmodium Falciparum, run by Sanaria Inc. at 1 site in Netherlands.
Trial summary
The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Plasmodium Falciparum
- What is being tested?
- PfSPZ Challenge and Normal Saline (NS)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (males or females) of ≥ 18 and ≤ 35 years of age
- Good health based on history and clinical examination (physical examination and laboratory screening)
- Negative pregnancy test
- Use of adequate contraception for females
- Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
- Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study
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- Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites
- For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished)
- Reachable (24/7) by mobile phone during the whole study period
- For volunteers living in Nijmegen: 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 centre during a part of the study (day 5 after challenge until treatment is finished)
- Available to attend all study visits
- Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period
- Willingness to undergo HIV, hepatitis B and hepatitis C tests
- Negative urine toxicology screening test at screening visit and the day before challenge
- Willingness to take a prophylactic regime of chloroquine and a curative regimen of Malarone®
- Willingness to undergo ophthalmologic examination after passing all other inclusion criteria
Who cannot join
- History of malaria
- Plans to travel to malaria endemic areas during the study period
- Plans to travel outside of the Netherlands during the challenge period
- 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)
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- History of arrhythmias or prolonged QT-interval
- Positive family history of 1st and/or 2nd degree relatives who experienced cardiac events when < 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 haematology blood tests
- Positive HIV, HBV or HCV tests
- Participation in any other clinical study within 30 days prior to the onset of the study
- Enrolment in any other clinical study during the study period
- For women: pregnancy or lactation
- Volunteers unable to give written informed consent
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- History of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- A history of psychiatric disease
- A history of convulsions
- Known hypersensitivity to Malarone® or chloroquine
- The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period
- Contraindications to Malarone® or chloroquine including treatment taken by the volunteer that interferes with Malarone® or chloroquine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
- Co-workers or trainees of the departments of Medical Microbiology or Internal Medicine of the RUNMC
- Known history of sickle cell anaemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency. If there is any suspicion of G6PD deficiency (based on medical history during screening or ethnic background -Mediterranean, African, or Asian), we will assess G6PD status of that particular subject before inclusion.
- Abnormalities during ophthalmologic examination
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).
Read the detailed description
The study is a single centre, double blind, randomized controlled clinical trial. Volunteers, investigators and laboratory personnel will be blinded.
A maximum of 30 volunteers will be randomly divided into four groups. All volunteers will receive standard weekly chloroquine chemoprophylaxis for a period of 14 weeks (98 days). During this period, groups 1 and 3 will receive six ID injections of PfSPZ Challenge, containing a total of 75,000 PfSPZ of the Pf NF54 strain, on days 8, 36 and 64 (immunizations 1, 2 and 3). The control groups 2 and 4 will receive ID injections with normal saline (NS) on the same days.
Thirty-three days after the last dose of chloroquine, volunteers in groups 1 and 2 will have controlled human malaria infection (CHMI) by the bites of five mosquitoes infected with PfSPZ of the Pf NF54 strain. If ≥75% of volunteers in group 1 are protected against this homologous Pf CHMI, volunteers in groups 3 and 4 will have CHMI by the bites of five mosquitoes infected with the heterologous Pf NF135.C10 strain 75 days after the last dose of chloroquine.
If <75% of volunteers in group 1 are protected against the homologous Pf CHMI, volunteers in groups 3 and 4 will receive an additional immunization (immunization 4), which will consist of six ID injections on the same day of 75,000 PfSPZ Challenge and NS respectively, at day 162. In this fourth immunization period chloroquine will be administered for another 6 weeks starting at day 154. Finally, 33 days after the last dose of chloroquine, volunteers in groups 3 and 4 will have homologous Pf CHMI by the bites of five PfSPZ-infected mosquitoes.
After CHMI all volunteers will be treated with a curative regimen of Malarone® (each tablet containing 250 mg atovaquone and 100 mg proguanil), either at the time of detection of blood stage parasitemia or 21 days after exposure to PfSPZ-infected mosquitoes. Volunteers will be checked for parasites by thick smear at least twice after treatment.
If one of the volunteers is not fit to participate in the study on day -1, an alternate volunteer who passed screening will replace him or her. For this purpose 3 additional volunteers will be screened for possible back up.
- Conditions
- Malaria, Plasmodium Falciparum
- Being tested
- PfSPZ Challenge, Normal Saline (NS)
- Keywords
- Malaria, Plasmodium falciparum, PfSPZ Challenge, Chemoprophylaxis, PfSPZ-CVac
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfSPZ ChallengeBiological
PfSPZ Challenge is a suspension of aseptic, purified, cryopreserved PfSPZ that are thawed and formulated in diluent on the day of administration.
Normal Saline (NS)Biological
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Grp 1: 75,000 PfSPZ Challenge, 3 immunizations | Experimental | Grp 1 (10 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 weeks(98 days). In this time, Grp 1 gets 6 ID injections of PfSPZ Challenge (total 75,000 PfSPZ NF54 strain), on days 8, 36 \& 64 (immunizations 1, 2 \& 3). 33 days after last dose of CQ, Grp 1 will have CHMI by bites of 5 mosquitoes infected with Pf NF54 strain. Receives: Biological: PfSPZ Challenge |
| Grp 2: Normal Saline (NS) | Placebo comparator | Grp 2 (5 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 weeks(98 days). In this time, Grp 2 gets ID injections of normal saline, on days 8, 36 \& 64 (immunizations 1, 2 \& 3). 33 days after last dose of CQ, Grp 2 will have CHMI by bites of 5 mosquitoes infected with Pf NF54 strain. Receives: Biological: Normal Saline (NS) |
| Grp 3: 75,000 PfSPZ Challenge, 3/4 immunizations | Experimental | Grp 3 (10 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 weeks(98 days). In this time, Grp 3 gets 6 ID injections of PfSPZ Challenge (total 75,000 PfSPZ NF54 strain), on days 8, 36 \& 64 (immunizations 1, 2 \& 3). Grp 3 outcome is dependent on results of Grp 1. If ≥75% of Grp 1 are protected against homologous Pf CHMI, Grp 3 will have CHMI by bites of 5 mosquitoes infected with heterologous Pf NF135.C10 strain 75 days after last dose of CQ. If <75% of Grp 1 are protected against homologous Pf CHMI, Grp 3 will receive 1 additional immunization (immunization 4), consisting of 6 ID injections on the same day of 75,000 PfSPZ Challenge, at day 162. In this 4th immunization period CQ will be administered for another 6 weeks starting at day 154. Finally, 33 days after last dose of CQ, Grp 3 will have homologous Pf CHMI by bites of 5 PfSPZ-infected mosquitoes. Receives: Biological: PfSPZ Challenge |
| Grp 4: Normal Saline (NS) | Placebo comparator | Grp 4 (5 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 wks(98 days). In this time, Grp 4 gets ID injections of NS, on days 8, 36 \& 64 (immunizations 1, 2 \& 3). Grp 4 outcome is dependent on results of Grp 1. If ≥75% of Grp 1 are protected against homologous Pf CHMI, Grp 4 will have CHMI by bites of 5 mosquitoes infected with heterologous Pf NF135.C10 strain 75 days after last dose of CQ. If <75% of Grp 1 are protected against homologous Pf CHMI, Grp 4 will receive 1 additional immunization (immunization 4), consisting of ID injections of NS, at day 162. In this 4th immunization period CQ will be administered for another 6 weeks starting at day 154. Finally, 33 days after last dose of CQ, Grp 4 will have homologous Pf CHMI by bites of 5 PfSPZ-infected mosquitoes. Receives: Biological: Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and magnitude of adverse events in study groups
Signs and symptoms will be recorded at all visits, and whenever a trial volunteer reports signs or symptoms to the trial physician between visits. The following signs and symptoms will be solicited: Fever, Headache, Malaise, Fatigue, Dizziness, Myalgia, Arthralgia, Nausea, Vomiting, Chills, Diarrhoea, Abdominal pain (Verhage 2005), Chest pain, Palpitations and Shortness of breath.
Measured: All study visits+as reported by volunteer upto 53 weeks
Secondary outcomes (3)
Presence of parasitemia after Pf CHMI as assessed by microscopy
Thick smear samples will be taken from a 3 ml EDTA vacutainer tube. Thick smears will be performed on all visits following immunizations and Pf CHMI until treatment is finished.
Thick smears will be performed according to a standard operating procedure, which is based on an internationally harmonized protocol for thick smears in CHMIs (Moorthy et al., WHO). In short, 15μl of whole blood will be distributed on standardized 3-well slides, providing an equal slide thickness for all smears. Slides are dried and stained with Giemsa. Per slide, 200 fields will be read, which correlates to 0.5 µl of blood. Slides are considered positive if they contain 2 or more parasites per 200 fields. Thick smears evaluation will take place at the RUNMC.
Measured: Thick smears will be performed on all visits following immunizations and Pf CHMI until treatment is finished upto 53 weeks
Time to parasitemia after Pf CHMI as assessed by microscopy
Thick smear samples will be taken from a 3 ml EDTA vacutainer tube. Thick smears will be performed on all visits following immunizations and Pf CHMI until treatment is finished.
Thick smears will be performed according to a standard operating procedure, which is based on an internationally harmonized protocol for thick smears in CHMIs (Moorthy et al., WHO). In short, 15μl of whole blood will be distributed on standardized 3-well slides, providing an equal slide thickness for all smears. Slides are dried and stained with Giemsa. Per slide, 200 fields will be read, which correlates to 0.5 µl of blood. Slides are considered positive if they contain 2 or more parasites per 200 fields. Thick smears evaluation will take place at the RUNMC.
Measured: Thick smears will be performed on all visits following immunizations and Pf CHMI until treatment is finished upto 53 weeks
Kinetics of parasitemia as assessed by qPCR
Samples for qPCR will be collected from the same 3 ml EDTA vacutainer tubes as the thick smear sample. qPCR will be performed according to standard procedure described in Hermsen et al. Mol, Biochem. Parasitol. 2001; 118: 247-251. In short, qPCR will be performed on the multicopy 18S ribosomal RNA gene. All samples are spiked with murine white blood cells and a murine albumin gene PCR is used to determine efficacy of DNA isolation.
Samples for quantitative measurement of parasitemia will be prepared and stored at RUNMC. Measurement by qPCR will be performed retrospectively.
Measured: Samples collected on all visits following immunizations and Pf CHMI until treatment is finished upto 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Robert Sauerwein, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728701
- Sponsor's protocol ID
- TIP5
- Other IDs
- 2012-000322-21
- Status last verified
- May 2014
- First submitted
- 6 Nov 2012
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis
- ClinicalTrials.gov ID
- NCT01728701
- Acronym / sponsor ID
- TIP5
- Conditions
- Malaria, Plasmodium Falciparum
- Keywords
- Malaria, Plasmodium falciparum, PfSPZ Challenge, Chemoprophylaxis, PfSPZ-CVac
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).
Detailed description
The study is a single centre, double blind, randomized controlled clinical trial. Volunteers, investigators and laboratory personnel will be blinded.
A maximum of 30 volunteers will be randomly divided into four groups. All volunteers will receive standard weekly chloroquine chemoprophylaxis for a period of 14 weeks (98 days). During this period, groups 1 and 3 will receive six ID injections of PfSPZ Challenge, containing a total of 75,000 PfSPZ of the Pf NF54 strain, on days 8, 36 and 64 (immunizations 1, 2 and 3). The control groups 2 and 4 will receive ID injections with normal saline (NS) on the same days.
Thirty-three days after the last dose of chloroquine, volunteers in groups 1 and 2 will have controlled human malaria infection (CHMI) by the bites of five mosquitoes infected with PfSPZ of the Pf NF54 strain. If ≥75% of volunteers in group 1 are protected against this homologous Pf CHMI, volunteers in groups 3 and 4 will have CHMI by the bites of five mosquitoes infected with the heterologous Pf NF135.C10 strain 75 days after the last dose of chloroquine.
If <75% of volunteers in group 1 are protected against the homologous Pf CHMI, volunteers in groups 3 and 4 will receive an additional immunization (immunization 4), which will consist of six ID injections on the same day of 75,000 PfSPZ Challenge and NS respectively, at day 162. In this fourth immunization period chloroquine will be administered for another 6 weeks starting at day 154. Finally, 33 days after the last dose of chloroquine, volunteers in groups 3 and 4 will have homologous Pf CHMI by the bites of five PfSPZ-infected mosquitoes.
After CHMI all volunteers will be treated with a curative regimen of Malarone® (each tablet containing 250 mg atovaquone and 100 mg proguanil), either at the time of detection of blood stage parasitemia or 21 days after exposure to PfSPZ-infected mosquitoes. Volunteers will be checked for parasites by thick smear at least twice after treatment.
If one of the volunteers is not fit to participate in the study on day -1, an alternate volunteer who passed screening will replace him or her. For this purpose 3 additional volunteers will be screened for possible back up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Grp 1: 75,000 PfSPZ Challenge, 3 immunizations | Experimental | Biological: PfSPZ ChallengeGrp 1 (10 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 weeks(98 days). In this time, Grp 1 gets 6 ID injections of PfSPZ Challenge (total 75,000 PfSPZ NF54 strain), on days 8, 36 \& 64 (immunizations 1, 2 \& 3). 33 days after last dose of CQ, Grp 1 will have CHMI by bites of 5 mosquitoes infected with Pf NF54 strain. |
| Grp 2: Normal Saline (NS) | Placebo comparator | Biological: Normal Saline (NS)Grp 2 (5 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 weeks(98 days). In this time, Grp 2 gets ID injections of normal saline, on days 8, 36 \& 64 (immunizations 1, 2 \& 3). 33 days after last dose of CQ, Grp 2 will have CHMI by bites of 5 mosquitoes infected with Pf NF54 strain. |
| Grp 3: 75,000 PfSPZ Challenge, 3/4 immunizations | Experimental | Biological: PfSPZ ChallengeGrp 3 (10 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 weeks(98 days). In this time, Grp 3 gets 6 ID injections of PfSPZ Challenge (total 75,000 PfSPZ NF54 strain), on days 8, 36 \& 64 (immunizations 1, 2 \& 3). Grp 3 outcome is dependent on results of Grp 1. If ≥75% of Grp 1 are protected against homologous Pf CHMI, Grp 3 will have CHMI by bites of 5 mosquitoes infected with heterologous Pf NF135.C10 strain 75 days after last dose of CQ. If <75% of Grp 1 are protected against homologous Pf CHMI, Grp 3 will receive 1 additional immunization (immunization 4), consisting of 6 ID injections on the same day of 75,000 PfSPZ Challenge, at day 162. In this 4th immunization period CQ will be administered for another 6 weeks starting at day 154. Finally, 33 days after last dose of CQ, Grp 3 will have homologous Pf CHMI by bites of 5 PfSPZ-infected mosquitoes. |
| Grp 4: Normal Saline (NS) | Placebo comparator | Biological: Normal Saline (NS)Grp 4 (5 volunteers) receive std weekly chloroquine (CQ) chemoprophylaxis for 14 wks(98 days). In this time, Grp 4 gets ID injections of NS, on days 8, 36 \& 64 (immunizations 1, 2 \& 3). Grp 4 outcome is dependent on results of Grp 1. If ≥75% of Grp 1 are protected against homologous Pf CHMI, Grp 4 will have CHMI by bites of 5 mosquitoes infected with heterologous Pf NF135.C10 strain 75 days after last dose of CQ. If <75% of Grp 1 are protected against homologous Pf CHMI, Grp 4 will receive 1 additional immunization (immunization 4), consisting of ID injections of NS, at day 162. In this 4th immunization period CQ will be administered for another 6 weeks starting at day 154. Finally, 33 days after last dose of CQ, Grp 4 will have homologous Pf CHMI by bites of 5 PfSPZ-infected mosquitoes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy volunteers (males or females) of ≥ 18 and ≤ 35 years of age
- Good health based on history and clinical examination (physical examination and laboratory screening)
- Negative pregnancy test
- Use of adequate contraception for females
- Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
Key exclusion criteria (28 listed)
- History of malaria
- Plans to travel to malaria endemic areas during the study period
- Plans to travel outside of the Netherlands during the challenge period
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PfSPZ ChallengePfSPZ Challenge is a suspension of aseptic, purified, cryopreserved PfSPZ that are thawed and formulated in diluent on the day of administration. | Biological | Grp 1: 75,000 PfSPZ Challenge, 3 immunizations, Grp 3: 75,000 PfSPZ Challenge, 3/4 immunizations |
| Normal Saline (NS)Normal saline | Biological | Grp 2: Normal Saline (NS), Grp 4: Normal Saline (NS) |
Primary outcome
Frequency and magnitude of adverse events in study groups
Time frame: All study visits+as reported by volunteer upto 53 weeks
Signs and symptoms will be recorded at all visits, and whenever a trial volunteer reports signs or symptoms to the trial physician between visits. The following signs and symptoms will be solicited: Fever, Headache, Malaise, Fatigue, Dizziness, Myalgia, Arthralgia, Nausea, Vomiting, Chills, Diarrhoea, Abdominal pain (Verhage 2005), Chest pain, Palpitations and Shortness of breath.
3 secondary outcomes
Presence of parasitemia after Pf CHMI as assessed by microscopy
Time frame: Thick smears will be performed on all visits following immunizations and Pf CHMI until treatment is finished upto 53 weeks
Time to parasitemia after Pf CHMI as assessed by microscopy
Time frame: Thick smears will be performed on all visits following immunizations and Pf CHMI until treatment is finished upto 53 weeks
Kinetics of parasitemia as assessed by qPCR
Time frame: Samples collected on all visits following immunizations and Pf CHMI until treatment is finished upto 53 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Sauerwein, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PfSPZ Challenge and Normal Saline (NS) in people with Malaria and Plasmodium Falciparum, run by Sanaria Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and magnitude of adverse events in study groups (time frame: All study visits+as reported by volunteer upto 53 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.