Plasmodium Falciparum InfectionPhase 1NCT02996695
Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults
A Phase 1 study testing Artesunate, Chloroquine and PfSPZ (NF54) Challenge in people with Plasmodium Falciparum Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Infection
- What is being tested?
- Artesunate, Chloroquine and PfSPZ (NF54) Challenge
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteMali
- Study dates
- 6 Apr 2017to 22 Jun 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A male or non-pregnant female aged 18-45 years inclusive at the time of screening.
- For women of childbearing potential, willingness not to become pregnant or breastfeed until one month after the last CQ dose*.
- Pre-menopausal female participants will be referred to the local family planning clinic, which offers several means of contraception that are approved and recommended by the Mali Ministry of Health. Contraception (male or female condoms, diaphragm or cervical cap with spermicide, intrauterine device, or hormone-based contraceptive) should be started 30 days before the first vaccination and continue until 30 days after last vaccination.
- Written informed consent obtained from the participant before screening.
- Available and willing to participate in follow-up for the duration of study.
- Residing in Bougoula Hameau region and environs.
- In general good health based on clinical and laboratory investigation.
Who cannot join
- Previous vaccination with an investigational malaria vaccine.
- Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days before the first study vaccination, or planned use up to 30 days after last vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months before the first vaccination*.
- This includes any dose level of oral steroids, but not inhaled steroids or topical steroids.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first study vaccination with the exception of tetanus toxoid.
- Confirmed or suspected immunosuppressive or immunodeficient condition.
Show all 29Show fewer
- Confirmed or suspected autoimmune disease.
- History of allergic reactions or anaphylaxis to chloroquine, 4-aminoquinolone derivatives, artesunate and artemisinin derivatives, vaccinations or to any vaccine component.
- History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care.
- History of allergy to any component of the PfSPZ Challenge product, including human serum albumin.
- Use or planned use of any drug with anti-malarial activity during the course of the study except for antimalarial medication administered by study clinicians.
- History of splenectomy.
- Confirmed pregnancy.
- Laboratory evidence of liver disease (ALT > upper limit of normal).
- Laboratory evidence of renal disease (serum or plasma creatinine > upper limit of normal).
- Laboratory evidence of hematologic disease (platelet count <114,000/mm^3 for males and <144,000/mm^3 for females, or hemoglobin <11.2 g/dL for males and <9.5 g/dL for females).
- Seropositive for hepatitis B surface antigen or hepatitis C virus (hepatitis C antibody).
- Seropositive for HIV.
- Sickle cell trait carriage or sickle cell disease.
- Administration of immunoglobulin and/or any blood products within the three months preceding the first study. vaccination or planned administration during the study period.
- Simultaneous participation in any other interventional clinical trial.
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, severe malnutrition, or any other clinical findings that may increase the risk of participating in the study*.
- As determined by the PI.
- Has evidence of increased cardiovascular disease risk (defined as > 10 percent, 5 year risk) as determined by the method of Gaziano*.
- Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking status, body mass index (BMI, kg/mm^2), reported diabetes status, and blood pressure.
- Abnormal screening ECG*.
- Pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial or ventricular contractions, right or left bundle branch block, advanced A-V heart block (secondary or tertiary), QT/QTc interval >450 ms.
- Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.
- Documented history of non-febrile seizures or atypical (complex) febrile seizures.
Trial locations and contacts
1 site in 1 country.
Mali1 site
University of Bamako - Epidemiology of Parasitic Diseases - Malaria Research and Training Center
Sikasso
About this study
Official title: Safety, Tolerability, Immunogenicity and Protective Efficacy Against Naturally-Transmitted Malaria of Infectious, Cryopreserved Plasmodium Falciparum Sporozoites (PfSPZ Challenge) Administered by Direct Venous Inoculation Under Chloroquine Chemoprophylaxis (PfSPZ-CVac), in Malian Adults: A Randomized, Double Blind, Placebo-Controlled Trial
Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides sterile protection against naturally-occurring malaria in malaria-experienced adults. The study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive, residing in Bougoula Hameau and surrounding villages, Mali. The primary objective of this study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac)
Read the detailed description
This is a single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides sterile protection against naturally-occurring malaria in malaria-experienced adults. Participants will receive three immunizing PfSPZ Challenge injections via direct venous inoculation (DVI) four weeks apart under chloroquine chemoprophylaxis. The PfSPZ Challenge dose will be 204,800 PfSPZ. This is based on results of studies in Europe and in Africa. In Tübingen, Germany, 100% of malaria-naïve adults who received three doses of 51,200 PfSPZ every four weeks under chloroquine chemoprophylaxis were protected against homologous controlled human malaria infection (CHMI). At the same time, studies of PfSPZ Vaccine in malaria-experienced adults in Mali and in Tanzania demonstrate that higher doses of PfSPZ are required to demonstrate immunogenicity and high grade protection in malaria-experienced adults that is comparable to that achieved in malaria-naïve adults studied in the USA. For this reason, the dose selected for this study is four-fold higher than the dose used for Tübingen, Germany. Controls will receive 0.9% sodium chloride (NaCl) as placebo. All participants will receive a standard chemoprophylactic regimen of chloroquine (CQ) for 10 weeks. Chloroquine will be given as a loading dose (600mg chloroquine base) two days before the first administration of PfSPZ Challenge, followed by weekly doses of chloroquine (300mg chloroquine base weekly). Participants will also be treated with a 7-day regimen of artesunate (200 mg per day) after the last PfSPZ Challenge dose of 204,800 sporozoites for malaria parasite clearance, one week after the last CQ dose is given. A total of 62 participants will be randomized in a 1:1 ratio to one of two groups and will be inoculated with PfSPZ Challenge or 0.9% NaCl by DVI so that a total of 62 adults will participate in the study. Participants will be recruited from the MRTC's Bougoula-Hameau site. All volunteers recruited will be healthy adults aged between 18 and 45 years. Safety and infectivity data will be collected. Volunteers, clinical and laboratory investigators will be blinded to group allocation. Participants will be followed every four weeks after the last vaccination as outpatients for active malaria diagnosis and treatment. Passive follow-up will be accomplished by continuous availability of study staff onsite to diagnose and treat malaria and other medical issues that arise. The primary objective of this study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac). The secondary objectives are: 1. to assess the protective efficacy of PfSPZ-CVac against naturally transmitted P. falciparum malaria infection as diagnosed by thick blood smear microscopy, 2. To assess protective efficacy of PfSPZ-CVac against naturally transmitted P. falciparum malaria infection as diagnosed by qPCR, 3. to assess the expanded efficacy of PfSPZ-CVac compared to placebo, and 4. to examine the immune response to P. falciparum malaria infection.
- Conditions
- Plasmodium Falciparum Infection
- Being tested
- Artesunate, Chloroquine, PfSPZ (NF54) Challenge, Placebo
- Keywords
- Chloroquine Chemoprophylaxis, Efficacy, Immunogenicity, Malaria, Placebo, Plasmodium falciparum Sporozoites, Safety, Tolerability
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesunateDrug
Artesunate is a succinic ester of artemether.
ChloroquineDrug
4-aminoquinolone, antimalarial agent for oral administration
PfSPZ (NF54) ChallengeBiological
Cryopreserved Plasmodium falciparum (Pf) fully infectious sporozoites (SPZ) that have been developed to be used to infect volunteers in controlled human malaria infection (CHMI) to assess the efficacy of antimalarial drugs and vaccines. The PfSPZ (NF54) Challenge contains a laboratory malaria strain isolated from a Dutch traveler to Africa.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 204,800 PfSPZ of PfSPZ Challenge | Experimental | 204,800 PfSPZ of PfSPZ Challenge every 4 weeks x 3 doses by DVI, n=31 Receives: Drug: Artesunate; Drug: Chloroquine; Biological: PfSPZ (NF54) Challenge |
| NaCl placebo | Placebo comparator | NaCl placebo every 4 weeks x 3 doses by DVI, n=31 Receives: Drug: Artesunate; Drug: Chloroquine; Biological: PfSPZ (NF54) Challenge; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of serious adverse events (SAEs)
Measured: 45 days
The number of solicited local and systemic adverse events (AE)
Measured: Day 12 after vaccination
The number of unsolicited AEs related to study product
Measured: Day 12 after vaccination
The severity of solicited local and systemic adverse events (AE)
Measured: Day 12 after vaccination
The severity of unsolicited AEs related to study product
Measured: Day 12 after vaccination
Secondary outcomes (6)
Antibody titers against P. falciparum circumsporozoite protein (CSP) and other P. falciparum proteins at serology time points
Measured: Days 3, 15, 31, 43,59, 71-77,87,245,and 413
Markers of cell-mediated immunity as assessed by cells producing interferon gamma and/or IL-2
Measured: Days 3, 15, 31, 43,59, 71-77,87,245,and 413
Time to P. falciparum parasitemia, detected by qPCR
Measured: within six months after the last vaccination
Time to P. falciparum parasitemia, detected by qPCR
Measured: within twelve months after the last vaccination
Time to P. falciparum parasitemia, detected by thick blood film microscopy
Measured: within twelve months after the last vaccination
Time to P. falciparum parasitemia, detected by thick blood smear microscopy
Measured: Within six months after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start6 Apr 2017
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
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 InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996695
- Sponsor's protocol ID
- 15-0052
- Other IDs
- HHSN272201300022I
- Status last verified
- 19 Jul 2017
- First submitted
- 15 Dec 2016
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Coulibaly D, Kone AK, Traore K, Niangaly A, Kouriba B, Arama C, Zeguime A, Dolo A, Lyke KE, Plowe CV, Abebe Y, Potter GE, Kennedy JK, Galbiati SM, Nomicos E, Deye GA, Richie TL, James ER, Kc N, Sim BKL, Hoffman SL, Doumbo OK, Thera MA, Laurens MB; DMID 15-0052 PfSPZ-CVac Study Team. PfSPZ-CVac malaria vaccine demonstrates safety among malaria-experienced adults: A randomized, controlled phase 1 trial. EClinicalMedicine. 2022 Jul 30;52:101579. doi: 10.1016/j.eclinm.2022.101579. eCollection 2022 Oct.
PubMed 35928033
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Immunogenicity and Protective Efficacy Against Naturally-Transmitted Malaria of Infectious, Cryopreserved Plasmodium Falciparum Sporozoites (PfSPZ Challenge) Administered by Direct Venous Inoculation Under Chloroquine Chemoprophylaxis (PfSPZ-CVac), in Malian Adults: A Randomized, Double Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02996695
- Acronym / sponsor ID
- 15-0052
- Conditions
- Plasmodium Falciparum Infection
- Keywords
- Chloroquine Chemoprophylaxis, Efficacy, Immunogenicity, Malaria, Placebo, Plasmodium falciparum Sporozoites, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 19 Dec 2016 (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.
Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides sterile protection against naturally-occurring malaria in malaria-experienced adults. The study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive, residing in Bougoula Hameau and surrounding villages, Mali. The primary objective of this study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac)
Detailed description
This is a single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides sterile protection against naturally-occurring malaria in malaria-experienced adults. Participants will receive three immunizing PfSPZ Challenge injections via direct venous inoculation (DVI) four weeks apart under chloroquine chemoprophylaxis. The PfSPZ Challenge dose will be 204,800 PfSPZ. This is based on results of studies in Europe and in Africa. In Tübingen, Germany, 100% of malaria-naïve adults who received three doses of 51,200 PfSPZ every four weeks under chloroquine chemoprophylaxis were protected against homologous controlled human malaria infection (CHMI). At the same time, studies of PfSPZ Vaccine in malaria-experienced adults in Mali and in Tanzania demonstrate that higher doses of PfSPZ are required to demonstrate immunogenicity and high grade protection in malaria-experienced adults that is comparable to that achieved in malaria-naïve adults studied in the USA. For this reason, the dose selected for this study is four-fold higher than the dose used for Tübingen, Germany. Controls will receive 0.9% sodium chloride (NaCl) as placebo. All participants will receive a standard chemoprophylactic regimen of chloroquine (CQ) for 10 weeks. Chloroquine will be given as a loading dose (600mg chloroquine base) two days before the first administration of PfSPZ Challenge, followed by weekly doses of chloroquine (300mg chloroquine base weekly). Participants will also be treated with a 7-day regimen of artesunate (200 mg per day) after the last PfSPZ Challenge dose of 204,800 sporozoites for malaria parasite clearance, one week after the last CQ dose is given. A total of 62 participants will be randomized in a 1:1 ratio to one of two groups and will be inoculated with PfSPZ Challenge or 0.9% NaCl by DVI so that a total of 62 adults will participate in the study. Participants will be recruited from the MRTC's Bougoula-Hameau site. All volunteers recruited will be healthy adults aged between 18 and 45 years. Safety and infectivity data will be collected. Volunteers, clinical and laboratory investigators will be blinded to group allocation. Participants will be followed every four weeks after the last vaccination as outpatients for active malaria diagnosis and treatment. Passive follow-up will be accomplished by continuous availability of study staff onsite to diagnose and treat malaria and other medical issues that arise. The primary objective of this study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac). The secondary objectives are: 1. to assess the protective efficacy of PfSPZ-CVac against naturally transmitted P. falciparum malaria infection as diagnosed by thick blood smear microscopy, 2. To assess protective efficacy of PfSPZ-CVac against naturally transmitted P. falciparum malaria infection as diagnosed by qPCR, 3. to assess the expanded efficacy of PfSPZ-CVac compared to placebo, and 4. to examine the immune response to P. falciparum malaria infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 204,800 PfSPZ of PfSPZ Challenge | Experimental | Drug: Artesunate, Drug: Chloroquine, Biological: PfSPZ (NF54) Challenge204,800 PfSPZ of PfSPZ Challenge every 4 weeks x 3 doses by DVI, n=31 |
| NaCl placebo | Placebo comparator | Drug: Artesunate, Drug: Chloroquine, Biological: PfSPZ (NF54) Challenge, Other: PlaceboNaCl placebo every 4 weeks x 3 doses by DVI, n=31 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A male or non-pregnant female aged 18-45 years inclusive at the time of screening.
- For women of childbearing potential, willingness not to become pregnant or breastfeed until one month after the last CQ dose*.
- Pre-menopausal female participants will be referred to the local family planning clinic, which offers several means of contraception that are approved and recommended by the Mali Ministry of Health. Contraception (male or female condoms, diaphragm or cervical cap with spermicide, intrauterine device, or hormone-based contraceptive) should be started 30 days before the first vaccination and continue until 30 days after last vaccination.
- Written informed consent obtained from the participant before screening.
- Available and willing to participate in follow-up for the duration of study.
Key exclusion criteria (29 listed)
- Previous vaccination with an investigational malaria vaccine.
- Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days before the first study vaccination, or planned use up to 30 days after last vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months before the first vaccination*.
- This includes any dose level of oral steroids, but not inhaled steroids or topical steroids.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first study vaccination with the exception of tetanus toxoid.
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 |
|---|---|---|
| ArtesunateArtesunate is a succinic ester of artemether. | Drug | 204,800 PfSPZ of PfSPZ Challenge, NaCl placebo |
| Chloroquine4-aminoquinolone, antimalarial agent for oral administration | Drug | 204,800 PfSPZ of PfSPZ Challenge, NaCl placebo |
| PfSPZ (NF54) ChallengeCryopreserved Plasmodium falciparum (Pf) fully infectious sporozoites (SPZ) that have been developed to be used to infect volunteers in controlled human malaria infection (CHMI) to assess the efficacy of antimalarial drugs and vaccines. The PfSPZ (NF54) Challenge contains a laboratory malaria strain isolated from a Dutch traveler to Africa. | Biological | 204,800 PfSPZ of PfSPZ Challenge, NaCl placebo |
| PlaceboPlacebo | Other | NaCl placebo |
Primary outcome
The number of serious adverse events (SAEs)
Time frame: 45 days
The number of solicited local and systemic adverse events (AE)
Time frame: Day 12 after vaccination
The number of unsolicited AEs related to study product
Time frame: Day 12 after vaccination
The severity of solicited local and systemic adverse events (AE)
Time frame: Day 12 after vaccination
The severity of unsolicited AEs related to study product
Time frame: Day 12 after vaccination
6 secondary outcomes
Antibody titers against P. falciparum circumsporozoite protein (CSP) and other P. falciparum proteins at serology time points
Time frame: Days 3, 15, 31, 43,59, 71-77,87,245,and 413
Markers of cell-mediated immunity as assessed by cells producing interferon gamma and/or IL-2
Time frame: Days 3, 15, 31, 43,59, 71-77,87,245,and 413
Time to P. falciparum parasitemia, detected by qPCR
Time frame: within six months after the last vaccination
Time to P. falciparum parasitemia, detected by qPCR
Time frame: within twelve months after the last vaccination
Time to P. falciparum parasitemia, detected by thick blood film microscopy
Time frame: within twelve months after the last vaccination
Time to P. falciparum parasitemia, detected by thick blood smear microscopy
Time frame: Within six months after the last vaccination
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 2 Dec 2019.
- Derived from this study: PubMed 35928033Coulibaly D, Kone AK, Traore K, Niangaly A, Kouriba B, Arama C, Zeguime A, Dolo A, Lyke KE, Plowe CV, Abebe Y, Potter GE, Kennedy JK, Galbiati SM, Nomicos E, Deye GA, Richie TL, James ER, Kc N, Sim BKL, Hoffman SL, Doumbo OK, Thera MA, Laurens MB; DMID 15-0052 PfSPZ-CVac Study Team. PfSPZ-CVac malaria vaccine demonstrates safety among malaria-experienced adults: A randomized, controlled phase 1 trial. EClinicalMedicine. 2022 Jul 30;52:101579. doi: 10.1016/j.eclinm.2022.101579. eCollection 2022 Oct.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Artesunate, Chloroquine and PfSPZ (NF54) Challenge in people with Plasmodium Falciparum Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
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 7 inclusion and 29 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 2 Dec 2019. 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 Mali. 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?
The number of serious adverse events (SAEs) (time frame: 45 days). The study lists 5 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 NCT02996695, 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 2 Dec 2019.