- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02780154
PfSPZ Challenge in Non-immune Adults in Baltimore, USA
A Phase 1 Trial to Evaluate the Safety and Infectivity of Direct Venous Inoculation of Aseptic, Purified, Cryopreserved Plasmodium Falciparum (7G8 and NF54) Sporozoites in Non-immune Adults in Baltimore, USA
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201-1509
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Healthy adults between the ages of 18 and 45 years, inclusive 2. Able and willing to participate for the duration of the study 3. Able and willing to provide written (not proxy) informed consent 4. Provides informed consent and correctly answers greater than or equal to 70% on the post consent quiz before any study procedures, and is available for all study visits -Note: Two attempts permitted 5. Females of childbearing potential must agree to practice highly effective contraception -Note: Contraception must be practiced from 30 days before the time of enrollment until at least 30 days following inoculation (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 30 days before 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 required period 6. Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature); medical history; normal laboratory ranges listed in Appendix C; and a physical examination -Note: hemoglobin, white blood cell count, platelet count, glucose (random), serum alanine aminotransferase (ALT), serum creatinine, urine protein and urine blood 7. Agree not to travel to a malaria endemic region during study days 1-29 8. Willing to avoid non-study related blood donation from screening until 3 years (45) following P. falciparum challenge 9. Able to understand and comply with planned study procedures including daily outpatient follow-up visits beginning 5 days after inoculation
Exclusion Criteria:
1. Any history of malaria infection, or travel to a malaria endemic region within 3 months before planned date of CHMI 2. History of long-term residence (>5 years) in an area known to have significant transmission of P. falciparum 3. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg) 4. Positive sickle cell screening test or known hemoglobinopathy 5. Current or recent (within the last four weeks) treatment with parenteral or oral corticosteroids (intranasal or inhaled steroids are acceptable), or other immunosuppressive agents, or chemotherapy 6. Screening laboratory values outside protocol-specified acceptable normal ranges as noted in Appendix C, except hematuria>1+ detected during menses for females. Note: For females who are menstruating, urinalysis frequently tests positive for blood and is not an indicator of poor health status or increased risk; other exceptions include ALT and creatinine below the lower limit of the reference range 7. Known hypersensitivity to components of PfSPZ Challenge, atovaquone-proguanil or artemether-lumefantrine 8. History of acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, nervous system, or other metabolic or autoimmune/inflammatory conditions 9. History of anaphylaxis or severe hypersensitivity reaction 10. Receipt of an investigational product on study days -31 to -1 or planned receipt of an investigational product on study days 1-57. 11. Any condition that, in the opinion of the investigator, would affect a participant's ability to understand or comply with the study protocol or would jeopardize a participant's safety or rights 12. Use or planned use of any drug with anti-malarial activity 30 days before or after CHMI Note: Medications with antimalarial activity include trimethoprim-sulfamethoxazole, azithromycin, erythromycin, tetracycline, doxycycline, minocycline, clindamycin, ciprofloxacin, levofloxacin, norfloxacin and rifampin 13. Planned surgery 30 days before or after CHMI 14. History of drug or alcohol abuse within the last five years 15. Receipt of blood or blood products in the previous six months or donation of a unit of blood within two months before screening 16. History of schizophrenia, bipolar disorder or other psychiatric condition that makes study compliance difficult Note: Subjects with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide. 17. History of diabetes mellitus with the exception of pregnancy-induced diabetes that has resolved 18. Has evidence of increased cardiovascular disease risk (defined as > 10%, 5 year risk) as determined by the method of Gaziano (46) Note: Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking status, body mass index (BMI, kg/mm2), reported diabetes status, and blood pressure. 19. Abnormal screening ECG Note: Pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial or ventricular contractions, right of left bundle branch block, advanced A-V heart block (secondary or tertiary), QT/QTc interval >450 ms 20. Body mass index (BMI) >40 21. Known hypersensitivity to atovaquone-proguanil or artemether-lumefantrine 22. Anticipated medication use during the 28-day post-challenge period known to interact with atovaquone-proguanil or artemether-lumefantrine Note: Such as rifampin, carbamazepine, phenytoin, St. John's wort, cimetidine, metoclopramide, antacids, and kaolin 23. Personal beliefs that prevent receipt of human serum albumin 24. Immunization with more than three other vaccines within the past month and through study day 57 after CHMI 25. Previous vaccination with a candidate malaria vaccine or participation in a CHMI study 26. History of splenectomy 27. Pregnant or lactating females
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1600 7G8 PfSPZ
N= 7-9 participants will receive 1600 7G8 PfSPZ DVI in a volume of 500mcL
|
PfSPZ (7G8) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
|
EXPERIMENTAL: 3200 7G8 PfSPZ
N= 9 participants will receive 3200 7G8 PfSPZ DVI in a volume of 500mcL
|
PfSPZ (7G8) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
|
EXPERIMENTAL: 3200 NF54 PfSPZ
N= 5-6 participants will receive 3200 NF54 PfSPZ DVI in a volume of 500mcL
|
PfSPZ (NF54) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
|
EXPERIMENTAL: 4800 7G8 PfSPZ
N= 2-3 participants will receive 4800 7G8 PfSPZ DVI in a volume of 500mcL
|
PfSPZ (7G8) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
|
EXPERIMENTAL: 800 7G8 PfSPZ
N= 7-9 participants will receive 800 7G8 PfSPZ DVI in a volume of 500mcL
|
PfSPZ (7G8) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number and severity of local and systemic solicited and unsolicited reactogenicity symptoms related to PfSPZ Challenge for 7 days following DVI administration
Time Frame: Days 1-7
|
Days 1-7
|
The number of serious adverse events recorded from study
Time Frame: Days 1-57
|
Days 1-57
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent infectivity of each PfSPZ dose regimen
Time Frame: Days 1-57
|
Days 1-57
|
Time to P. falciparum asexual parasitemia following experimental malaria challenge
Time Frame: Days 1-57
|
Days 1-57
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0040
- HHSN272201300022I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plasmodium Falciparum Infection
-
SanofiMedicines for Malaria VentureCompletedPlasmodium Falciparum InfectionBenin, Burkina Faso, Gabon, Kenya, Uganda
-
SanofiMedicines for Malaria VentureTerminatedPlasmodium Falciparum InfectionBenin, Burkina Faso, Gabon, Kenya, Mozambique, Uganda, Vietnam
-
Papua New Guinea Institute of Medical ResearchSwiss Tropical & Public Health Institute; Walter and Eliza Hall Institute of... and other collaboratorsCompletedPlasmodium Falciparum Infection | Plasmodium Vivax Infection | Plasmodium Vivax Clinical Episode | Plasmodium Falciparum Clinical EpisodePapua New Guinea
-
Radboud University Medical CenterErasmus Medical Center; The PATH Malaria Vaccine Initiative (MVI); Havenzieke...CompletedPlasmodium Falciparum | Malaria,Falciparum | Plasmodium Berghei | Controlled Human Malaria Infection (CHMI)Netherlands
-
Menzies School of Health ResearchWorld Health Organization; Eijkman Institute for Molecular BiologyCompletedPlasmodium Falciparum Infection | Plasmodium Vivax InfectionIndonesia
-
National Institute of Allergy and Infectious Diseases...Completed
-
University of OxfordCompletedPlasmodium Falciparum InfectionMyanmar
-
SanofiTerminatedPlasmodium Falciparum InfectionBenin, Burkina Faso, Cameroon, Gabon, Kenya, Tanzania
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); University of Washington; Vaccine Research... and other collaboratorsActive, not recruiting
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on PfSPZ (7G8) Challenge
-
Sanaria Inc.German Federal Ministry of Education and Research; German Center for Infection... and other collaboratorsCompleted
-
Sanaria Inc.Fred Hutchinson Cancer CenterCompleted
-
Sanaria Inc.University of Maryland, BaltimoreTerminatedMalaria | Malaria,FalciparumUnited States
-
Sanaria Inc.Barcelona Centre for International Health ResearchCompleted
-
Sanaria Inc.University of Maryland; Walter Reed Army Institute of Research (WRAIR); Naval... and other collaboratorsCompleted
-
London School of Hygiene and Tropical MedicineRadboud University Medical Center; Sanaria Inc.Completed
-
Sanaria Inc.Swiss Tropical & Public Health Institute; Ifakara Health Institute; Government... and other collaboratorsCompleted
-
Sanaria Inc.Swiss Tropical & Public Health Institute; Ifakara Health Institute; Medical Care... and other collaboratorsCompleted
-
Sanaria Inc.Swiss Tropical & Public Health Institute; Ifakara Health Research and Development...Completed
-
Sanaria Inc.Swiss Tropical & Public Health Institute; Ifakara Health Institute; Government... and other collaboratorsCompleted