- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02996695
Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Sikasso, Mali
- University of Bamako - Epidemiology of Parasitic Diseases - Malaria Research and Training Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 204,800 PfSPZ of PfSPZ Challenge
204,800 PfSPZ of PfSPZ Challenge every 4 weeks x 3 doses by DVI, n=31
|
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.
Artesunate is a succinic ester of artemether.
4-aminoquinolone, antimalarial agent for oral administration
|
Placebo Comparator: NaCl placebo
NaCl placebo every 4 weeks x 3 doses by DVI, n=31
|
Placebo
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.
Artesunate is a succinic ester of artemether.
4-aminoquinolone, antimalarial agent for oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of serious adverse events (SAEs)
Time Frame: 45 days
|
45 days
|
The number of solicited local and systemic adverse events (AE)
Time Frame: Day 12 after vaccination
|
Day 12 after vaccination
|
The number of unsolicited AEs related to study product
Time Frame: Day 12 after vaccination
|
Day 12 after vaccination
|
The severity of solicited local and systemic adverse events (AE)
Time Frame: Day 12 after vaccination
|
Day 12 after vaccination
|
The severity of unsolicited AEs related to study product
Time Frame: Day 12 after vaccination
|
Day 12 after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
within six months after the last vaccination
|
Time to P. falciparum parasitemia, detected by qPCR
Time Frame: within twelve months after the last vaccination
|
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
|
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
|
Within six months after the last vaccination
|
Collaborators and Investigators
Publications and helpful links
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
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Chloroquine
- Artesunate
Other Study ID Numbers
- 15-0052
- 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...CompletedPlasmodium Falciparum InfectionUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedPlasmodium Falciparum InfectionUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
University of OxfordCompletedPlasmodium Falciparum InfectionMyanmar
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States