MalariaPhase 1NCT01546389
Sanaria™ PfSPZ Challenge Vaccine
A Phase 1 study testing Sanaria™ PfSPZ Vaccine and Chloroquine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will randomize 30 healthy adult participants to one of three cohorts comprised of six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID route. The goal will be to determine the optimal dose required to achieve 100% infectivity (ID100) of adult volunteers with P. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Sanaria™ PfSPZ Vaccine and Chloroquine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2013
- 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
- Male or nonpregnant female between the ages of 18 and 45 years, inclusive.
- Women who are not surgically sterile (no history of bilateral tubal ligation, bilateral salpingo-oophorectomy, or hysterectomy), post-menopausal (1 year without menses) or determined otherwise by medical evaluation to be sterile must agree to practice adequate contraception (such as double barrier methods (condoms plus foam or spermicide, diaphragm plus foam or spermicide), licensed intrauterine devices (IUDs), intravaginal or intra/transdermal or oral hormonal methods initiated at least 1 month prior to inoculation or challenge, documented surgical sterilization via tubal ligation the essure procedure or hysterectomy, abstinence or a vasectomized partner). The contraceptive method should remain unchanged throughout the entire study period (56 days). Serologic pregnancy tests will be conducted upon screening. Urine testing will be done on the day of malaria challenge, on the day of the first positive malaria smear and at the conclusion of active surveillance (Day 56).
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history, screening 12-lead ECG and a physical examination.
- Has normal laboratory values (Urinalysis (assessing blood, and protein presence as greater than trace by dipstick), hemoglobin, WBC, platelet count, AST, ALT, bilirubin, glucose, and creatinine) prior to challenge study. Any abnormal screening value for any screening test listed in Table 8 will exclude the participant from the study with the exception of elevated fasting glucose and hematuria >1+ detected during menses for females. Elevated fasting glucose may need to be repeated due to recent carbohydrate consumption and is therefore not a true fasting glucose. Subsequent repeat fasting glucose testing that is in the normal range will be acceptable for participation. For females who are menstruating, urinalysis frequently tests positive for blood and is not an indicator of poor health status or increased risk. This can be repeated if clinically warranted.
- Able to understand and comply with planned study procedures including an inpatient stay from Day 8-18 after malaria challenge.
- Provides informed consent prior to any study procedures, correctly answers > 70% on the post consent quiz and is available for all study visits.
- Willing to avoid non-study related blood donation for 3 years
Who cannot join
- While not a formal exclusion criterion, the deltoid area of both arms will be assessed for marks, burns and other skin damage. If, in the Investigator's opinion, assessment of local reactions could be impaired, the subject may be excluded under criterion 23.
- Has any known history of malaria infection, is a long-term resident (> 5 years) of a malaria-endemic area, was born and resided in a malaria-endemic area, or has traveled to a malaria-endemic area within the previous 6 months.
- Has a positive urine pregnancy test prior to malaria challenge (if female of childbearing potential), is lactating, or has the intention to become pregnant within 2 months after enrollment in this study.
- Use of any antibiotic (that has known or potential antimalarial properties) or antimalarial drug beginning 28 days prior to the screening and extending to Day 56 of study surveillance.
- Has evidence of increased cardiovascular disease risk (defined as > 10%, 5 year risk) as determined by the method of Gaziano. Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking staus (current vs. past or never), BMI (kg/mm2), reported diabetes status (yes/no), current treatment for raised blood pressure (yes/no).
- Is immunosuppressed (e.g., poorly-controlled diabetes mellitus, cirrhosis, renal insufficiency, active malignancy, connective tissue disease, organ transplant) as a result of an underlying illness or treatment.
Show all 24Show fewer
- An abnormal ECG, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block.
- Has an active neoplastic disease (excluding nonmelanotic skin cancer) or neoplastic disease within the past 5 years or any history of hematologic malignancy.
- Is using or intends to continue using oral or parenteral steroids, high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (an exception includes asthma for which any oral or inhaled steroid intake will mean exclusion from study enrollment).
- Has a known history of human immunodeficiency virus, hepatitis B surface antigen positivity, or Hepatitis C infection.
- Has a history of alcohol or drug abuse in the last 5 years.
- Has a history of receiving blood products within the 3 months prior to enrollment in this study.
- Has a history of psoriasis or porphyria, which may be exacerbated after treatment with chloroquine.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render malaria challenge unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known liver disease, renal disease, neurological disorders, visual field defects, cardiac disorders, pulmonary disorders, auditory damage, diabetes mellitus, and transplant recipients).
- Has a history of anaphylactic response to mosquito bites or known allergy to chloroquine, 4-aminoquinoline derivatives, atovaquone/proguanil, (Malarone®), ibuprofen, or acetaminophen that may be used to treat volunteers developing malaria after P. falciparum challenge.
- Is using or intends to continue using a medication known to cause drug reactions with chloroquine or Malarone®, such as cimetidine, metoclopramide, antacids or kaolin (antacids and kaolin can be administered at least 4 hours from intake of chloroquine).
- History of retinal or visual field changes, auditory damage, or seizures.
- History of splenectomy
- Has known sickle cell trait or laboratory evidence of sickle cell trait.
- Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 24 hours prior to CHMI.
- Plans to undergo surgery (elective or otherwise) between enrollment and 4 weeks (28 days) post-challenge
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 2-month post-challenge period.
- Has a diagnosis of schizophrenia, bi-polar disease or other major psychiatric condition that makes study compliance difficult (e.g. subjects with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide)
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
About this study
Official title: A Phase I, Randomized Malaria Challenge Study of Intradermally-Administered Infectious (Replication-intact), Cryopreserved Plasmodium Falciparum Sporozoites (PfSPZ Challenge) in Malaria-Naïve Adults
This study will randomize 30 healthy adult participants to one of three cohorts comprised of six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID route. The goal will be to determine the optimal dose required to achieve 100% infectivity (ID100) of adult volunteers with P. falciparum malaria.
Read the detailed description
Study Phase and Design Phase I with experimental malaria challenge. The study will enroll 30 healthy adult participants randomized to one of three cohorts comprised of six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID route. The goal will be to determine the optimal dose required to achieve 100% infectivity (ID100) of adult volunteers. The parameters of 1) dose (number of sporozoites) 2) number of injections and 3) aliquot volume will be studied; adding to previous data collected at the University of Nijmegen. The following single time point inoculation regimens (a-f) will be assessed: Cohort 1: Medium dose, medium aliquot volume: a. 10,000 PfSPZ ID in 2 divided doses of 50 microliter aliquot volume b. 10,000 PfSPZ ID in 8 divided doses of 50 microliter aliquot volume Cohort 2: Medium dose, low aliquot volume: c. 10,000 PfSPZ ID in 2 divided doses of 10 microliter aliquot volume d. 10,000 PfSPZ ID in 8 divided doses of 10 ml aliquot volume Cohort 3: High dose, low aliquot volume: e. 50,000 PfSPZ ID in 2 divided doses of 10 ml aliquot volume f. 50,000 PfSPZ ID in 8 divided doses of 10 ml aliquot volume. Safety, tolerability and efficacy of the inoculation regimens will be evaluated. All 30 volunteers will be evaluated as part of an inpatient stay (Days 8-18 post-injection) to diagnose and treat Pf malaria infection with chloroquine. Following review, and with the assistance of an independent SMC, 2 regimens will be chosen for further testing in DMID 11-0042. The following criteria strategy will be employed in the order listed: 1. Regimen necessary to achieve ID100 of adult volunteers; 2. Regimen eliciting Pf patency and parasite density (as detected by qRT-PCR) that most closely approximates patency rates experienced after mosquito challenge; 3. Regimen requiring the least number of injections; 4. Regimen utilizing the fewest number of PfSPZ; 5. Volume of administration considered to be the easiest to administer by the clinicians. Chloroquine sub-study: Eighteen of thirty participants (3 volunteers from each of the six groups comprised of 5-subjects/group) will be assigned to participate in a CQ and possibly desethylchloroquine blood and urine study designed to assess the drug kinetics of CQ over the course of four weeks after standard CQ dose administration.
- Conditions
- Malaria
- Being tested
- Sanaria™ PfSPZ Vaccine, Chloroquine
- Keywords
- Malaria, vaccine, PfSPZ, challenge
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanaria™ PfSPZ VaccineBiological
30 subjects in 3 cohorts, 6 groups in different doses of PfSPZ vaccine via the intradermal route. Cohort 1 Medium Dose, Medium Aliquot: Group a: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 50 microliter (mcL) dose), Group b: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 50 mcL dose). Cohort 2: Medium dose, Low Aliquot: Group c: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 10 mcL dose), Group d: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 10 mcL dose), Cohort 3: High Dose, Low Aliquot; Group e: 50,000 PfSPZ in 2 divided doses (e.g., 25,000 PfSPZ per 10 mcL dose), Group f: 50,000 PfSPZ in 8 divided doses (e.g., 6,250 PfSPZ per 10 mcL dose)
ChloroquineDrug
Rescue therapy after challenge: 1500 mg chloroquine base orally, over 48 hours (600 mg at time 0 followed by 300 mg oral base at hours 6, 24 and 48)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 3, Group E | Experimental | Cohort 3 (High Dose, Low Aliquot), Group e: 50,000 PfSPZ in 2 divided doses (e.g., 25,000 PfSPZ per 10 mcL dose); 5 subjects Receives: Biological: Sanaria™ PfSPZ Vaccine; Drug: Chloroquine |
| Cohort 1, Group A | Experimental | Cohort 1 (Medium Dose, Medium Aliquot), Group a: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 50 microliter (mcL) dose); 5 subjects. Receives: Biological: Sanaria™ PfSPZ Vaccine; Drug: Chloroquine |
| Cohort 1, Group B | Experimental | Cohort 1 (Medium Dose, Medium Aliquot), Group b: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 50 mcL dose); 5 subjects Receives: Biological: Sanaria™ PfSPZ Vaccine; Drug: Chloroquine |
| Cohort 3, Group F | Experimental | Cohort 3 (High Dose, Low Aliquot), Group f: 50,000 PfSPZ in 8 divided doses (e.g., 6,250 PfSPZ per 10 mcL dose); 5 subjects Receives: Biological: Sanaria™ PfSPZ Vaccine; Drug: Chloroquine |
| Cohort 2, Group D | Experimental | Cohort 2 (Medium Dose, Low Aliquot), Group d: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 10 mcL dose); 5 subjects Receives: Biological: Sanaria™ PfSPZ Vaccine; Drug: Chloroquine |
| Cohort 2, Group C | Experimental | Cohort 2 (Medium Dose, Low Aliquot), Group c: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 10 mcL dose); 5 subjects Receives: Biological: Sanaria™ PfSPZ Vaccine; Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a positive malaria smear after the malaria challenge during a 56-day surveillance period and stratified by group.
Measured: Days 0, 5-18, 20, 22, 24, 26, 28, 35, 42, and 56 .
The number of serious adverse events throughout the duration of the study.
Measured: Day 0 to1 year.
The number and severity of solicited systemic symptoms for 14 days following ID administration of PfSPZ.
Measured: Within 14 days after PfSPZ administration.
The number and severity of injection site reactions within 14 days following ID administration of PfSPZ.
Measured: Within 14 days after PfSPZ administration.
The number and severity of unsolicited adverse events after the malaria challenge during a 56-day surveillance period (day of challenge and 55 subsequent days) but not related to malaria event symptoms.
Measured: Days 0-56.
Secondary outcomes (3)
T cell responses, effector/central memory populations, and intracellular cytokine secretion (ICS) against the malaria antigens by Multiparameter Flow Cytometry
Measured: Days 0, 5, 14 and 28
Occurrence of a positive real-time quantitative polymerase chain reaction (PCR) after the malaria challenge during a 56-day surveillance period.
Measured: Days 0, 5-18, 20, 22, 24, 26, 28, 35, 42, and 56.
Antibody titers to the pre-erythrocytic stage antigens, and by indirect fluorescent antibody test for antibodies to P. falciparum sporozoites, late liver stage parasites, asexual and sexual erythrocytic stages.
Measured: Days 0, 5, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
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 MalariaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546389
- Sponsor's protocol ID
- 11-0027
- Other IDs
- N01AI80057C
- Status last verified
- Sep 2013
- First submitted
- 29 Dec 2011
- Last updated
- 13 Sep 2013
- Results posted
- No
Publications
Lyke KE, Laurens MB, Strauss K, Adams M, Billingsley PF, James E, Manoj A, Chakravarty S, Plowe CV, Li ML, Ruben A, Edelman R, Green M, Dube TJ, Sim BKL, Hoffman SL. Optimizing Intradermal Administration of Cryopreserved Plasmodium falciparum Sporozoites in Controlled Human Malaria Infection. Am J Trop Med Hyg. 2015 Dec;93(6):1274-1284. doi: 10.4269/ajtmh.15-0341. Epub 2015 Sep 28.
PubMed 26416102
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized Malaria Challenge Study of Intradermally-Administered Infectious (Replication-intact), Cryopreserved Plasmodium Falciparum Sporozoites (PfSPZ Challenge) in Malaria-Naïve Adults
- ClinicalTrials.gov ID
- NCT01546389
- Acronym / sponsor ID
- 11-0027
- Conditions
- Malaria
- Keywords
- Malaria, vaccine, PfSPZ, challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Mar 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.
This study will randomize 30 healthy adult participants to one of three cohorts comprised of six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID route. The goal will be to determine the optimal dose required to achieve 100% infectivity (ID100) of adult volunteers with P. falciparum malaria.
Detailed description
Study Phase and Design Phase I with experimental malaria challenge. The study will enroll 30 healthy adult participants randomized to one of three cohorts comprised of six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID route. The goal will be to determine the optimal dose required to achieve 100% infectivity (ID100) of adult volunteers. The parameters of 1) dose (number of sporozoites) 2) number of injections and 3) aliquot volume will be studied; adding to previous data collected at the University of Nijmegen. The following single time point inoculation regimens (a-f) will be assessed: Cohort 1: Medium dose, medium aliquot volume: a. 10,000 PfSPZ ID in 2 divided doses of 50 microliter aliquot volume b. 10,000 PfSPZ ID in 8 divided doses of 50 microliter aliquot volume Cohort 2: Medium dose, low aliquot volume: c. 10,000 PfSPZ ID in 2 divided doses of 10 microliter aliquot volume d. 10,000 PfSPZ ID in 8 divided doses of 10 ml aliquot volume Cohort 3: High dose, low aliquot volume: e. 50,000 PfSPZ ID in 2 divided doses of 10 ml aliquot volume f. 50,000 PfSPZ ID in 8 divided doses of 10 ml aliquot volume. Safety, tolerability and efficacy of the inoculation regimens will be evaluated. All 30 volunteers will be evaluated as part of an inpatient stay (Days 8-18 post-injection) to diagnose and treat Pf malaria infection with chloroquine. Following review, and with the assistance of an independent SMC, 2 regimens will be chosen for further testing in DMID 11-0042. The following criteria strategy will be employed in the order listed: 1. Regimen necessary to achieve ID100 of adult volunteers; 2. Regimen eliciting Pf patency and parasite density (as detected by qRT-PCR) that most closely approximates patency rates experienced after mosquito challenge; 3. Regimen requiring the least number of injections; 4. Regimen utilizing the fewest number of PfSPZ; 5. Volume of administration considered to be the easiest to administer by the clinicians. Chloroquine sub-study: Eighteen of thirty participants (3 volunteers from each of the six groups comprised of 5-subjects/group) will be assigned to participate in a CQ and possibly desethylchloroquine blood and urine study designed to assess the drug kinetics of CQ over the course of four weeks after standard CQ dose administration.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 3, Group E | Experimental | Biological: Sanaria™ PfSPZ Vaccine, Drug: ChloroquineCohort 3 (High Dose, Low Aliquot), Group e: 50,000 PfSPZ in 2 divided doses (e.g., 25,000 PfSPZ per 10 mcL dose); 5 subjects |
| Cohort 1, Group A | Experimental | Biological: Sanaria™ PfSPZ Vaccine, Drug: ChloroquineCohort 1 (Medium Dose, Medium Aliquot), Group a: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 50 microliter (mcL) dose); 5 subjects. |
| Cohort 1, Group B | Experimental | Biological: Sanaria™ PfSPZ Vaccine, Drug: ChloroquineCohort 1 (Medium Dose, Medium Aliquot), Group b: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 50 mcL dose); 5 subjects |
| Cohort 3, Group F | Experimental | Biological: Sanaria™ PfSPZ Vaccine, Drug: ChloroquineCohort 3 (High Dose, Low Aliquot), Group f: 50,000 PfSPZ in 8 divided doses (e.g., 6,250 PfSPZ per 10 mcL dose); 5 subjects |
| Cohort 2, Group D | Experimental | Biological: Sanaria™ PfSPZ Vaccine, Drug: ChloroquineCohort 2 (Medium Dose, Low Aliquot), Group d: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 10 mcL dose); 5 subjects |
| Cohort 2, Group C | Experimental | Biological: Sanaria™ PfSPZ Vaccine, Drug: ChloroquineCohort 2 (Medium Dose, Low Aliquot), Group c: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 10 mcL dose); 5 subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or nonpregnant female between the ages of 18 and 45 years, inclusive.
- Women who are not surgically sterile (no history of bilateral tubal ligation, bilateral salpingo-oophorectomy, or hysterectomy), post-menopausal (1 year without menses) or determined otherwise by medical evaluation to be sterile must agree to practice adequate contraception (such as double barrier methods (condoms plus foam or spermicide, diaphragm plus foam or spermicide), licensed intrauterine devices (IUDs), intravaginal or intra/transdermal or oral hormonal methods initiated at least 1 month prior to inoculation or challenge, documented surgical sterilization via tubal ligation the essure procedure or hysterectomy, abstinence or a vasectomized partner). The contraceptive method should remain unchanged throughout the entire study period (56 days). Serologic pregnancy tests will be conducted upon screening. Urine testing will be done on the day of malaria challenge, on the day of the first positive malaria smear and at the conclusion of active surveillance (Day 56).
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history, screening 12-lead ECG and a physical examination.
- Has normal laboratory values (Urinalysis (assessing blood, and protein presence as greater than trace by dipstick), hemoglobin, WBC, platelet count, AST, ALT, bilirubin, glucose, and creatinine) prior to challenge study. Any abnormal screening value for any screening test listed in Table 8 will exclude the participant from the study with the exception of elevated fasting glucose and hematuria >1+ detected during menses for females. Elevated fasting glucose may need to be repeated due to recent carbohydrate consumption and is therefore not a true fasting glucose. Subsequent repeat fasting glucose testing that is in the normal range will be acceptable for participation. For females who are menstruating, urinalysis frequently tests positive for blood and is not an indicator of poor health status or increased risk. This can be repeated if clinically warranted.
- Able to understand and comply with planned study procedures including an inpatient stay from Day 8-18 after malaria challenge.
Key exclusion criteria (24 listed)
- While not a formal exclusion criterion, the deltoid area of both arms will be assessed for marks, burns and other skin damage. If, in the Investigator's opinion, assessment of local reactions could be impaired, the subject may be excluded under criterion 23.
- Has any known history of malaria infection, is a long-term resident (> 5 years) of a malaria-endemic area, was born and resided in a malaria-endemic area, or has traveled to a malaria-endemic area within the previous 6 months.
- Has a positive urine pregnancy test prior to malaria challenge (if female of childbearing potential), is lactating, or has the intention to become pregnant within 2 months after enrollment in this study.
- Use of any antibiotic (that has known or potential antimalarial properties) or antimalarial drug beginning 28 days prior to the screening and extending to Day 56 of study surveillance.
- Has evidence of increased cardiovascular disease risk (defined as > 10%, 5 year risk) as determined by the method of Gaziano. Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking staus (current vs. past or never), BMI (kg/mm2), reported diabetes status (yes/no), current treatment for raised blood pressure (yes/no).
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 |
|---|---|---|
| Sanaria™ PfSPZ Vaccine30 subjects in 3 cohorts, 6 groups in different doses of PfSPZ vaccine via the intradermal route. Cohort 1 Medium Dose, Medium Aliquot: Group a: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 50 microliter (mcL) dose), Group b: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 50 mcL dose). Cohort 2: Medium dose, Low Aliquot: Group c: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 10 mcL dose), Group d: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 10 mcL dose), Cohort 3: High Dose, Low Aliquot; Group e: 50,000 PfSPZ in 2 divided doses (e.g., 25,000 PfSPZ per 10 mcL dose), Group f: 50,000 PfSPZ in 8 divided doses (e.g., 6,250 PfSPZ per 10 mcL dose) | Biological | Cohort 1, Group A, Cohort 1, Group B, Cohort 2, Group C, Cohort 2, Group D, Cohort 3, Group E, Cohort 3, Group F |
| ChloroquineRescue therapy after challenge: 1500 mg chloroquine base orally, over 48 hours (600 mg at time 0 followed by 300 mg oral base at hours 6, 24 and 48) | Drug | Cohort 1, Group A, Cohort 1, Group B, Cohort 2, Group C, Cohort 2, Group D, Cohort 3, Group E, Cohort 3, Group F |
Primary outcome
Occurrence of a positive malaria smear after the malaria challenge during a 56-day surveillance period and stratified by group.
Time frame: Days 0, 5-18, 20, 22, 24, 26, 28, 35, 42, and 56 .
The number of serious adverse events throughout the duration of the study.
Time frame: Day 0 to1 year.
The number and severity of solicited systemic symptoms for 14 days following ID administration of PfSPZ.
Time frame: Within 14 days after PfSPZ administration.
The number and severity of injection site reactions within 14 days following ID administration of PfSPZ.
Time frame: Within 14 days after PfSPZ administration.
The number and severity of unsolicited adverse events after the malaria challenge during a 56-day surveillance period (day of challenge and 55 subsequent days) but not related to malaria event symptoms.
Time frame: Days 0-56.
3 secondary outcomes
T cell responses, effector/central memory populations, and intracellular cytokine secretion (ICS) against the malaria antigens by Multiparameter Flow Cytometry
Time frame: Days 0, 5, 14 and 28
Occurrence of a positive real-time quantitative polymerase chain reaction (PCR) after the malaria challenge during a 56-day surveillance period.
Time frame: Days 0, 5-18, 20, 22, 24, 26, 28, 35, 42, and 56.
Antibody titers to the pre-erythrocytic stage antigens, and by indirect fluorescent antibody test for antibodies to P. falciparum sporozoites, late liver stage parasites, asexual and sexual erythrocytic stages.
Time frame: Days 0, 5, 14 and 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 13 Sep 2013.
- Derived from this study: PubMed 26416102Lyke KE, Laurens MB, Strauss K, Adams M, Billingsley PF, James E, Manoj A, Chakravarty S, Plowe CV, Li ML, Ruben A, Edelman R, Green M, Dube TJ, Sim BKL, Hoffman SL. Optimizing Intradermal Administration of Cryopreserved Plasmodium falciparum Sporozoites in Controlled Human Malaria Infection. Am J Trop Med Hyg. 2015 Dec;93(6):1274-1284. doi: 10.4269/ajtmh.15-0341. Epub 2015 Sep 28.
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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 Sanaria™ PfSPZ Vaccine and Chloroquine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 24 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 13 Sep 2013. 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 United States. 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?
Occurrence of a positive malaria smear after the malaria challenge during a 56-day surveillance period and stratified by group. (time frame: Days 0, 5-18, 20, 22, 24, 26, 28, 35, 42, and 56 .). 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 NCT01546389, 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 13 Sep 2013.