Plasmodium Falciparum MalariaPhase 1NCT02237586
Effect of Plasmodium Falciparum Exposure and Sickle Cell Trait on Infection Rates and Kinetics After IV Administration of PfSPZ Challenge
A Phase 1 study testing PfSPZ Challenge in people with Plasmodium Falciparum Malaria and Malaria, run by Sanaria Inc. at 1 site in Gabon.
Trial summary
The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) administration in three groups with different malaria immunity-status: 1. Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA) 2. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria, Malaria
- What is being tested?
- PfSPZ Challenge
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGabon
- Study dates
- Jul 2014to Feb 2015
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged 18 to 30 years
- Able and willing (in the investigator's opinion) to comply with all study requirements
- Women only: must agree to practice continuous effective contraception for the duration of the study (a method which results in a low failure rate; i.e. less than 1% per year)
- Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local blood banking eligibility criteria
- Written informed consent to undergo CHMI
- Reachable (24/7) by mobile phone during the whole study period
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- Willingness to take two curative anti-malarial regimens
- Agreement to stay overnight for observation during the period of intensive follow-up post-challenge if required
- Answer all questions on the informed consent quiz correctly
- A body mass index < 35
- A haemoglobin concentration ≥10 g/dl for women and ≥12 g/dl for men
- Additional inclusion criteria for IA and IS group only:
- History of long term residence (>10 years) in area known to have significant transmission of P. falciparum -
Who cannot join
- Use of anti-malarials within 30 days of study enrolment
- Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin)
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- Prior receipt of an investigational malaria vaccine
- Immunization with more than 1 other vaccines within the past month.
- HIV infection
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- Hemoglobin SS
- Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- Use of immunoglobulins or blood products within 3 months prior to enrolment
- Pregnancy, lactation or intention to become pregnant during the study
- A history of allergic disease or reactions likely to be exacerbated by malaria
- Contraindications to the use of the first-line anti-malarial medications: artemether/lumefantrine or atovaquone/proguanil.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition that may affect participation in the study
- History of epileptic seizures
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g (men) or 40 g (women) per day
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Falling in moderate risk or higher categories for fatal or non-fatal cardiovascular event within 5 years (>10%) determined by non-invasive criteria for cardiac risk
- Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial contractions, right of left bundle branch block, advanced A-V heart block (secondary or tertiary)
- A QT/QTc interval > 450 ms
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination
- Any other significant disease, disorder or finding which, in the opinion of the Investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Additional exclusion criteria for NI group only:
- History of P. falciparum malaria
- History of long term residence (>5 years) in area known to have significant transmission of P. falciparum
- Presence of sickle cell trait
- Known thalassemia or thalassemia trait
- Exclusion Criterion on Day of Challenge or Day before Challenge
- Acute disease, defined as moderate or severe illness with or without fever
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) administration in three groups with different malaria immunity-status:
- Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA)
- Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS)
- Adults without previous malaria episodes without sickle cell trait (HbAA)
Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear positivity after challenge will be assessed. If in any of the groups with a history of lifelong malaria exposure, 50% or less of individuals become thick blood smear positive during the 28 days post injection of PfSPZ Challenge, the dose will be increased 4-fold to 12,800 PfSPZ in this group.
Read the detailed description
LACHMI-001 is a partially-blinded, human pilot trial to study immunity against P. falciparum malaria in a controlled infection setting. The main objective is to characterise the role of sickle cell trait and naturally acquired immunity in development of malaria, defined by positive smear for P. falciparum and signs or symptoms associated with malaria. Three groups of volunteers will receive radical cure treatment and subsequently PfSPZ Challenge by IV administration. The groups are:
- Adults with naturally acquired immunity and HbAA (Group IA, n=10-20)
- Adults with naturally acquired immunity and HbAS (Group IS, n=10-20)
- Adults without previous exposure to malaria and HbAA (Group NI, n=5)
The initial challenge dose of 3,200 PfSPZ administered once intravenously leads to consistent infection in naïve adults (15/15 in prior studies) and thus should infect all volunteers in Group 3. However, volunteers with naturally acquired immunity or sickle cell trait might require a higher dose. Thus if 50% or less of volunteers become parasitemic in Groups IA or IS, 10 additional volunteers will be enrolled and challenged with 12,800 PfSPZ. All volunteers will be healthy adults aged 18 to 30 years. Safety and infectivity data will be collected for each of the regimens and dose-levels. Effective treatment is initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria.
Laboratory staff reading blood films and processing samples will be blinded to group allocation. Volunteers and clinical investigators will be blinded to group allocation among the IA and IS groups.
- Conditions
- Plasmodium Falciparum Malaria, Malaria
- Being tested
- PfSPZ Challenge
- Keywords
- Plasmodium falciparum malaria, Malaria, PfSPZ Challenge, Controlled Human Malaria Infection (CHMI), Sickle Cell Trait, Sporozoites
- Medical subject headings
- Malaria, Falciparum, Malaria, Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfSPZ ChallengeBiological
live, aseptic, cryopreserved P. falciparum sporozoites
| Study group | Role | What they receive |
|---|---|---|
| Group IA | Experimental | Adults with naturally acquired immunity and HbAA (Group IA, n=10)
As any parasitemia other than PfSPZ will interfere with results, volunteers will undergo a treatment course against P. falciparum with a five-day course of 12-hourly 5 mg/kg clindamycin (corresponds to a 300 mg tablet of clindamycin base administered twice daily). This will be completed no less than three days prior to CHMI. The initial challenge dose of 3,200 PfSPZ Challenge will be administered once intravenously. If 50% or less of volunteers become parasitemic in Groups IA or IS, 10 additional volunteers will be enrolled and challenged with 12,800 PfSPZ. Effective treatment will be initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria. Receives: Biological: PfSPZ Challenge |
| Group IS | Experimental | Adults with naturally acquired immunity and HbAS (Group IS, n=10)
As any parasitemia other than PfSPZ will interfere with results, volunteers will undergo a treatment course against P. falciparum with a five-day course of 12-hourly 5 mg/kg clindamycin (corresponds to a 300 mg tablet of clindamycin base administered twice daily). This will be completed no less than three days prior to CHMI. The initial challenge dose of 3,200 PfSPZ Challenge will be administered once intravenously. If 50% or less of volunteers become parasitemic in Groups IA or IS, 10 additional volunteers will be enrolled and challenged with 12,800 PfSPZ. Effective treatment will be initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria. Receives: Biological: PfSPZ Challenge |
| Group NI | Experimental | Adults without previous exposure to malaria and HbAA (Group NI, n=5)
As any parasitemia other than PfSPZ will interfere with results, volunteers will undergo a treatment course against P. falciparum with a five-day course of 12-hourly 5 mg/kg clindamycin (corresponds to a 300 mg tablet of clindamycin base administered twice daily). This will be completed no less than three days prior to CHMI. The initial challenge dose of 3,200 PfSPZ Challenge administered once intravenously should lead to consistent infection in naïve adults (15/15 in prior studies) and thus should infect all volunteers in Group NI. Effective treatment will be initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria. Receives: Biological: PfSPZ Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days from inoculation to start of malaria episode
The time from parasite inoculation to first detection of malaria will be assessed by thick blood film microscopy and a clinical questionnaire. Malaria is defined as both parasitemia and clinical symptoms suggestive of malaria.
Measured: From day of injection until day 28
Frequency, incidence and nature of adverse events
The safety of PfSPZ Challenge administered IV and the resultant P. falciparum infection will be assessed by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements.
Measured: From day of injection until day 28
Secondary outcomes (1)
Dynamics of P. falciparum parasite growth
The dynamics of P. falciparum parasite growth following administration of PfSPZ Challenge is assessed by analyzing parasite multiplication rates using highly sensitive qPCR for P. falciparum DNA. Measurements will be used to model parasite kinetics and to estimate the number of infected liver cells.
Measured: From day 6 after injection until approximately day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Falciparum 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche Médicale de Lambaréné, Institute of Tropical Medicine, University of Tuebingen
- Responsible party
- Sponsor
- Investigators
- Bertrand Lell, MD, Principal investigator, Centre de Recherche Médicale de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237586
- Sponsor's protocol ID
- LACHMI-001
- Status last verified
- Apr 2015
- First submitted
- 27 Aug 2014
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Requena P, Gomez-Perez GP, McCall MBB, Barrios D, Aguilar R, Fernandez-Morata J, Vidal M, Campo JJ, Sanchez C, Yazdabankhsh M, Sim BKL, Hoffman SL, Kremsner P, Lell B, Mordmuller B, Dobano C, Moncunill G. Effect of controlled human Plasmodium falciparum infection on B cell subsets in individuals with different levels of malaria immunity. Med Microbiol Immunol. 2025 Sep 27;214(1):47. doi: 10.1007/s00430-025-00847-x.
PubMed 41014333
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plasmodium Falciparum Exposure and Sickle Cell Trait on Infection Rates and Kinetics After IV Administration of PfSPZ Challenge
- ClinicalTrials.gov ID
- NCT02237586
- Acronym / sponsor ID
- LACHMI-001
- Conditions
- Plasmodium Falciparum Malaria, Malaria
- Keywords
- Plasmodium falciparum malaria, Malaria, PfSPZ Challenge, Controlled Human Malaria Infection (CHMI), Sickle Cell Trait, Sporozoites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sanaria Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche Médicale de Lambaréné, Institute of Tropical Medicine, University of Tuebingen
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Sep 2014 (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 study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) administration in three groups with different malaria immunity-status:
- Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA)
- Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS)
- Adults without previous malaria episodes without sickle cell trait (HbAA)
Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear positivity after challenge will be assessed. If in any of the groups with a history of lifelong malaria exposure, 50% or less of individuals become thick blood smear positive during the 28 days post injection of PfSPZ Challenge, the dose will be increased 4-fold to 12,800 PfSPZ in this group.
Detailed description
LACHMI-001 is a partially-blinded, human pilot trial to study immunity against P. falciparum malaria in a controlled infection setting. The main objective is to characterise the role of sickle cell trait and naturally acquired immunity in development of malaria, defined by positive smear for P. falciparum and signs or symptoms associated with malaria. Three groups of volunteers will receive radical cure treatment and subsequently PfSPZ Challenge by IV administration. The groups are:
- Adults with naturally acquired immunity and HbAA (Group IA, n=10-20)
- Adults with naturally acquired immunity and HbAS (Group IS, n=10-20)
- Adults without previous exposure to malaria and HbAA (Group NI, n=5)
The initial challenge dose of 3,200 PfSPZ administered once intravenously leads to consistent infection in naïve adults (15/15 in prior studies) and thus should infect all volunteers in Group 3. However, volunteers with naturally acquired immunity or sickle cell trait might require a higher dose. Thus if 50% or less of volunteers become parasitemic in Groups IA or IS, 10 additional volunteers will be enrolled and challenged with 12,800 PfSPZ. All volunteers will be healthy adults aged 18 to 30 years. Safety and infectivity data will be collected for each of the regimens and dose-levels. Effective treatment is initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria.
Laboratory staff reading blood films and processing samples will be blinded to group allocation. Volunteers and clinical investigators will be blinded to group allocation among the IA and IS groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group IA | Experimental | Biological: PfSPZ ChallengeAdults with naturally acquired immunity and HbAA (Group IA, n=10) As any parasitemia other than PfSPZ will interfere with results, volunteers will undergo a treatment course against P. falciparum with a five-day course of 12-hourly 5 mg/kg clindamycin (corresponds to a 300 mg tablet of clindamycin base administered twice daily). This will be completed no less than three days prior to CHMI. The initial challenge dose of 3,200 PfSPZ Challenge will be administered once intravenously. If 50% or less of volunteers become parasitemic in Groups IA or IS, 10 additional volunteers will be enrolled and challenged with 12,800 PfSPZ. Effective treatment will be initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria. |
| Group IS | Experimental | Biological: PfSPZ ChallengeAdults with naturally acquired immunity and HbAS (Group IS, n=10) As any parasitemia other than PfSPZ will interfere with results, volunteers will undergo a treatment course against P. falciparum with a five-day course of 12-hourly 5 mg/kg clindamycin (corresponds to a 300 mg tablet of clindamycin base administered twice daily). This will be completed no less than three days prior to CHMI. The initial challenge dose of 3,200 PfSPZ Challenge will be administered once intravenously. If 50% or less of volunteers become parasitemic in Groups IA or IS, 10 additional volunteers will be enrolled and challenged with 12,800 PfSPZ. Effective treatment will be initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria. |
| Group NI | Experimental | Biological: PfSPZ ChallengeAdults without previous exposure to malaria and HbAA (Group NI, n=5) As any parasitemia other than PfSPZ will interfere with results, volunteers will undergo a treatment course against P. falciparum with a five-day course of 12-hourly 5 mg/kg clindamycin (corresponds to a 300 mg tablet of clindamycin base administered twice daily). This will be completed no less than three days prior to CHMI. The initial challenge dose of 3,200 PfSPZ Challenge administered once intravenously should lead to consistent infection in naïve adults (15/15 in prior studies) and thus should infect all volunteers in Group NI. Effective treatment will be initiated immediately upon development of parasitemia together with the presence of symptoms associated with malaria. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy adult aged 18 to 30 years
- Able and willing (in the investigator's opinion) to comply with all study requirements
- Women only: must agree to practice continuous effective contraception for the duration of the study (a method which results in a low failure rate; i.e. less than 1% per year)
- Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local blood banking eligibility criteria
- Written informed consent to undergo CHMI
Key exclusion criteria (34 listed)
- Use of anti-malarials within 30 days of study enrolment
- Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin)
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- Prior receipt of an investigational malaria vaccine
- Immunization with more than 1 other vaccines within the past month.
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 Challengelive, aseptic, cryopreserved P. falciparum sporozoites | Biological | Group IA, Group IS, Group NI |
Primary outcome
Days from inoculation to start of malaria episode
Time frame: From day of injection until day 28
The time from parasite inoculation to first detection of malaria will be assessed by thick blood film microscopy and a clinical questionnaire. Malaria is defined as both parasitemia and clinical symptoms suggestive of malaria.
Frequency, incidence and nature of adverse events
Time frame: From day of injection until day 28
The safety of PfSPZ Challenge administered IV and the resultant P. falciparum infection will be assessed by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements.
1 secondary outcome
Dynamics of P. falciparum parasite growth
Time frame: From day 6 after injection until approximately day 28
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 23 Apr 2015.
- Derived from this study: PubMed 41014333Requena P, Gomez-Perez GP, McCall MBB, Barrios D, Aguilar R, Fernandez-Morata J, Vidal M, Campo JJ, Sanchez C, Yazdabankhsh M, Sim BKL, Hoffman SL, Kremsner P, Lell B, Mordmuller B, Dobano C, Moncunill G. Effect of controlled human Plasmodium falciparum infection on B cell subsets in individuals with different levels of malaria immunity. Med Microbiol Immunol. 2025 Sep 27;214(1):47. doi: 10.1007/s00430-025-00847-x.
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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.
Bertrand Lell, MD principal investigator
Centre de Recherche Médicale de Lambaréné
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 in people with Plasmodium Falciparum Malaria and Malaria, run by Sanaria Inc. at 1 site in Gabon.
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 13 inclusion and 34 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 23 Apr 2015. 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 Gabon. 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. 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?
Days from inoculation to start of malaria episode (time frame: From day of injection until day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237586, which also lists 1 linked publication.
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 23 Apr 2015.