Back to resultsImmunization of Human Volunteers With P. Vivax Irradiated Sporozoites (SPZ-Irrad)
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
Colombia
Study Type
Interventional
Intervention
Immunization with P. vivax irradiated sporozoites
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring GCP Good Clinical Practice, IFAT Indirect Immunofluorescence antibody test, MFA Membrane Feeding Assay, N Number (typically refers to subjects), RBC Red Blood Cells, SOP Standard Operating Procedure, TBS Thick blood smear, P. Vivax, irradiated sporozoite vaccination.
Eligibility Criteria
Inclusion Criteria:
• Healthy 18 to 45 years old man or non-pregnant women.
- To have the capacity to sign an informed consent in a free and voluntary way.
- Have an acceptable understanding of the clinical trial through the approval of a questionnaire regarding the information given in the consent process.
- Obligatory use of adequate contra-conceptive method from beginning of recruitment and screening time up to three months after last immunization
- Do not have chronic or acute diseases. These conditions will be determined by clinical history, physical exam and laboratory tests.
- To accept not traveling to malaria endemic areas during the clinical trial should
- To have telephone at home or mobile phone that permit permanent contact for follow up
- He (she) manifest that is willing to participated during both steps of the clinical trial.
Exclusion Criteria:
- Volunteers with less than 18 old year or more than 45 old years.
- Pregnant and suckling women will be excluded. Pregnancy will be determined both by interview, and by serum B-subunit chorionic gonadotrophin testing.
- History of moderate or severe insect, or food allergies.
- G-6PD deficiency or any Hb genetic defect (for example; sickle cell disease)
- Previous malaria infection demonstrated by think smear, PCR or specific antimalarial antibodies.
- If the subject has previously participated in a malarial vaccine trial.
- Clinical record of allergies to drug or insect bites.
- Symptoms, signs or data from laboratory test that suggests to the physician any systemic disorder like renal, hepatic, cardiovascular, pulmonary, psychiatric disorders or other illnesses that could interfere with results of clinical trial or could compromise the health of the volunteer.
- To have antibodies against hepatitis C, VIH, or hepatitis B superficial antigen and/or hepatitis B core antibodies.
- To have any abnormality in the parameters assessed by blood laboratory tests. Base-line values will be established before initiation of the clinical trial.
- Presence or history of an auto-immune disease such as; Asthma, lupus, rheumatoid arthritis, Graves's disease, Hashimoto tyroiditis, and others.
- History of surgical removal of the spleen (splenectomy).
- Volunteer with medical treatment known to alter the immune system before 3 months to recruitment, such as; cortico-steroids, chemotherapeutic agents, fludarabine, cyclosporine, tacrolimus, mycophenolate mofetil, rapamycine, ATG, alemtuzumab.
- Alcoholism or drug abuse that may interfere with social relationship of individual.
Sites / Locations
- Malaria Vaccine of Develepmente Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Fy(+)
Fy(+) control
Fy(-)
Arm Description
14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites
Seven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites.
Six Fy(-) volunteers will be exposed to infective mosquito bites.
Outcomes
Primary Outcome Measures
Three groups are considered to be intervened. Experimental, Control and Fy(-) groups. Comparison will be done between E and C groups for protective efficacy. For immune response tests E vs Fy(-),E vs Fy(-), and Fy(-) vs C, pairs will be compared.
Secondary Outcome Measures
The number of subjects reporting any AEs, the occurrence of specifics AEs, and discontinuation due to AEs will be tabulated. Frequency of AEs will be cross-tabulated by group for each immunization session
Full Information
NCT ID
NCT01082341
First Posted
March 5, 2010
Last Updated
March 21, 2018
Sponsor
Malaria Vaccine and Drug Development Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Asoclinic Inmunología Ltda.
1. Study Identification
Unique Protocol Identification Number
NCT01082341
Brief Title
Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
Acronym
SPZ-Irrad
Official Title
Phase 1 and Phase 2a Clinical Trial:Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malaria Vaccine and Drug Development Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Asoclinic Inmunología Ltda.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.
Detailed Description
Title: Phase 1 and Phase 2a Clinical Trial: Immunization of human volunteers with P. vivax irr-spz. (Short name: Irrad-SPZ) Population 27 healthy adult volunteers, males and non-pregnant females, between 18-45 years of age, who fulfill inclusion/exclusion criteria (described below) as determined by clinical history and serological tests. Approximately 20 parasitized blood-donor volunteers will be required to infected Anopheles mosquitoes which will be used to immunize volunteers with a total of 1000-1500 infected mosquitoes, during 8-10 months. Afterwards challenge to prove protection.
Number of Sites: 2 Study Duration: 2 years. Subject Duration : Step1: 1-2 hours to blood donors; Step 2 and 3: 2 years to immunized volunteers Objectives Primary
• To assess the safety and protective efficacy of P. vivax irradiated sporozoite vaccination.
Secondary
To determine the immune responses and duration elicited by the P. vivax challenge in human Fy(+) volunteers previously immunized with irr-spz, as compared with non-immunized human volunteers.
To determine the immune responses and duration elicited by irr-spz immunization scheme in human Fy(+) volunteers; comparing it with the same immunization scheme with non irr-spz in Fy(-) participants, and also with controls exposed to the same mosquito bite scheme as that of immunization but using mosquitoes without parasite infection.
To study new antigens potentially useful to induce pre-erythrocytic protection against P. vivax malaria infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
GCP Good Clinical Practice, IFAT Indirect Immunofluorescence antibody test, MFA Membrane Feeding Assay, N Number (typically refers to subjects), RBC Red Blood Cells, SOP Standard Operating Procedure, TBS Thick blood smear, P. Vivax, irradiated sporozoite vaccination.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fy(+)
Arm Type
Experimental
Arm Description
14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites
Arm Title
Fy(+) control
Arm Type
Active Comparator
Arm Description
Seven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites.
Arm Title
Fy(-)
Arm Type
Active Comparator
Arm Description
Six Fy(-) volunteers will be exposed to infective mosquito bites.
Intervention Type
Biological
Intervention Name(s)
Immunization with P. vivax irradiated sporozoites
Other Intervention Name(s)
P. vivax irradiated sporozoites vaccine
Intervention Description
Anopheles albimanus mosquitoes will be infected by artificial membrane feeding using blood from P. vivax infected donors. Once mosquitoes are positive will be irradiated at 15000 cGy and kept in boxes until use.
14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites. Seven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites. Six Fy(-) volunteers will be exposed to infective mosquito bites. For the challenge both the immunized and control groups will be exposed to 3 ± 1 infective mosquito bites. Volunteers will be closely monitored post infection and will be treated with antimalarials.
Primary Outcome Measure Information:
Title
Three groups are considered to be intervened. Experimental, Control and Fy(-) groups. Comparison will be done between E and C groups for protective efficacy. For immune response tests E vs Fy(-),E vs Fy(-), and Fy(-) vs C, pairs will be compared.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The number of subjects reporting any AEs, the occurrence of specifics AEs, and discontinuation due to AEs will be tabulated. Frequency of AEs will be cross-tabulated by group for each immunization session
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Healthy 18 to 45 years old man or non-pregnant women.
To have the capacity to sign an informed consent in a free and voluntary way.
Have an acceptable understanding of the clinical trial through the approval of a questionnaire regarding the information given in the consent process.
Obligatory use of adequate contra-conceptive method from beginning of recruitment and screening time up to three months after last immunization
Do not have chronic or acute diseases. These conditions will be determined by clinical history, physical exam and laboratory tests.
To accept not traveling to malaria endemic areas during the clinical trial should
To have telephone at home or mobile phone that permit permanent contact for follow up
He (she) manifest that is willing to participated during both steps of the clinical trial.
Exclusion Criteria:
Volunteers with less than 18 old year or more than 45 old years.
Pregnant and suckling women will be excluded. Pregnancy will be determined both by interview, and by serum B-subunit chorionic gonadotrophin testing.
History of moderate or severe insect, or food allergies.
G-6PD deficiency or any Hb genetic defect (for example; sickle cell disease)
Previous malaria infection demonstrated by think smear, PCR or specific antimalarial antibodies.
If the subject has previously participated in a malarial vaccine trial.
Clinical record of allergies to drug or insect bites.
Symptoms, signs or data from laboratory test that suggests to the physician any systemic disorder like renal, hepatic, cardiovascular, pulmonary, psychiatric disorders or other illnesses that could interfere with results of clinical trial or could compromise the health of the volunteer.
To have antibodies against hepatitis C, VIH, or hepatitis B superficial antigen and/or hepatitis B core antibodies.
To have any abnormality in the parameters assessed by blood laboratory tests. Base-line values will be established before initiation of the clinical trial.
Presence or history of an auto-immune disease such as; Asthma, lupus, rheumatoid arthritis, Graves's disease, Hashimoto tyroiditis, and others.
History of surgical removal of the spleen (splenectomy).
Volunteer with medical treatment known to alter the immune system before 3 months to recruitment, such as; cortico-steroids, chemotherapeutic agents, fludarabine, cyclosporine, tacrolimus, mycophenolate mofetil, rapamycine, ATG, alemtuzumab.
Alcoholism or drug abuse that may interfere with social relationship of individual.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Socrates Herrera, MD
Organizational Affiliation
Malaria Vaccine Develepment Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaria Vaccine of Develepmente Center
City
Cali
State/Province
Valle
Country
Colombia
12. IPD Sharing Statement
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Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
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