MalariaPhase 1/2SPZ-IrradNCT01082341
Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
A Phase 1/2 study testing Immunization with P. vivax irradiated sporozoites in people with Malaria, run by Malaria Vaccine and Drug Development Center at 1 site in Colombia.
Trial summary
It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites. 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?
- Immunization with P. vivax irradiated sporozoites
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2012to Sep 2017
- Phase
- Phase 1/2
- 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
- • 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Malaria Vaccine of Develepmente Center
Cali, Valle del Cauca Department
About this study
Official title: Phase 1 and Phase 2a Clinical Trial:Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.
Read the 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
- Conditions
- Malaria
- Being tested
- Immunization with P. vivax irradiated sporozoites
- 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.
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunization with P. vivax irradiated sporozoitesBiological
Also called P. vivax irradiated sporozoites vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| Fy(+) | Experimental | 14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites Receives: Biological: Immunization with P. vivax irradiated sporozoites |
| Fy(+) control | Active comparator | Seven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites. Receives: Biological: Immunization with P. vivax irradiated sporozoites |
| Fy(-) | Active comparator | Six Fy(-) volunteers will be exposed to infective mosquito bites. Receives: Biological: Immunization with P. vivax irradiated sporozoites |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (114)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaria Vaccine and Drug Development Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Asoclinic Inmunología Ltda.
- Responsible party
- Principal investigator, Socrates Herrera Valencia, Malaria Vaccine and Drug Development Center
- Investigators
- Socrates Herrera, MD, Principal investigator, Malaria Vaccine Develepment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082341
- Sponsor's protocol ID
- MVDC-2008-005
- Other IDs
- SPZ IRR HUMAN, 5R01HL086488-02
- Acronym
- SPZ-Irrad
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2010
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang R, Arevalo-Herrera M, Gardner MJ, Bonelo A, Carlton JM, Gomez A, Vera O, Soto L, Vergara J, Bidwell SL, Domingo A, Fraser CM, Herrera S. Immune responses to Plasmodium vivax pre-erythrocytic stage antigens in naturally exposed Duffy-negative humans: a potential model for identification of liver-stage antigens. Eur J Immunol. 2005 Jun;35(6):1859-68. doi: 10.1002/eji.200425807.
PubMed 15864779Coban C, Ishii KJ, Horii T, Akira S. Manipulation of host innate immune responses by the malaria parasite. Trends Microbiol. 2007 Jun;15(6):271-8. doi: 10.1016/j.tim.2007.04.003. Epub 2007 Apr 26.
PubMed 17466521Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, Sacci J, de la Vega P, Dowler M, Paul C, Gordon DM, Stoute JA, Church LW, Sedegah M, Heppner DG, Ballou WR, Richie TL. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002 Apr 15;185(8):1155-64. doi: 10.1086/339409. Epub 2002 Apr 1.
PubMed 11930326Richie TL, Saul A. Progress and challenges for malaria vaccines. Nature. 2002 Feb 7;415(6872):694-701. doi: 10.1038/415694a.
PubMed 11832958Doolan DL, Hoffman SL, Southwood S, Wentworth PA, Sidney J, Chesnut RW, Keogh E, Appella E, Nutman TB, Lal AA, Gordon DM, Oloo A, Sette A. Degenerate cytotoxic T cell epitopes from P. falciparum restricted by multiple HLA-A and HLA-B supertype alleles. Immunity. 1997 Jul;7(1):97-112. doi: 10.1016/s1074-7613(00)80513-0.
PubMed 9252123Mellouk S, Lunel F, Sedegah M, Beaudoin RL, Druilhe P. Protection against malaria induced by irradiated sporozoites. Lancet. 1990 Mar 24;335(8691):721. doi: 10.1016/0140-6736(90)90832-p. No abstract available.
PubMed 1969073Nussenzweig R, Vanderberg J, Most H. Protective immunity produced by the injection of x-irradiated sporozoites of Plasmodium berghei. IV. Dose response, specificity and humoral immunity. Mil Med. 1969 Sep;134(10):1176-82. No abstract available.
PubMed 4987036Seguin MC, Klotz FW, Schneider I, Weir JP, Goodbary M, Slayter M, Raney JJ, Aniagolu JU, Green SJ. Induction of nitric oxide synthase protects against malaria in mice exposed to irradiated Plasmodium berghei infected mosquitoes: involvement of interferon gamma and CD8+ T cells. J Exp Med. 1994 Jul 1;180(1):353-8. doi: 10.1084/jem.180.1.353.
PubMed 7516412Weiss WR. Host-parasite interactions and immunity to irradiated sporozoites. Immunol Lett. 1990 Aug;25(1-3):39-42. doi: 10.1016/0165-2478(90)90088-8.
PubMed 2283161Weiss WR, Sedegah M, Beaudoin RL, Miller LH, Good MF. CD8+ T cells (cytotoxic/suppressors) are required for protection in mice immunized with malaria sporozoites. Proc Natl Acad Sci U S A. 1988 Jan;85(2):573-6. doi: 10.1073/pnas.85.2.573.
PubMed 2963334Collins WE, Contacos PG. Immunization of monkeys against Plasmodium cynomolgi by X-irradiated sporozoites. Nat New Biol. 1972 Apr 12;236(67):176-7. doi: 10.1038/newbio236176a0. No abstract available.
PubMed 4624244Collins WE, Nussenzweig RS, Ballou WR, Ruebush TK 2nd, Nardin EH, Chulay JD, Majarian WR, Young JF, Wasserman GF, Bathurst I, et al. Immunization of Saimiri sciureus boliviensis with recombinant vaccines based on the circumsporozoite protein of Plasmodium vivax. Am J Trop Med Hyg. 1989 May;40(5):455-64. doi: 10.4269/ajtmh.1989.40.455.
PubMed 2658634Gwadz RW, Cochrane AH, Nussenzweig V, Nussenzweig RS. Preliminary studies on vaccination of rhesus monkeys with irradiated sporozoites of Plasmodium knowlesi and characterization of surface antigens of these parasites. Bull World Health Organ. 1979;57 Suppl 1(Suppl):165-73.
PubMed 120766Zavala F, Cochrane AH, Nardin EH, Nussenzweig RS, Nussenzweig V. Circumsporozoite proteins of malaria parasites contain a single immunodominant region with two or more identical epitopes. J Exp Med. 1983 Jun 1;157(6):1947-57. doi: 10.1084/jem.157.6.1947.
PubMed 6189951Egan JE, Hoffman SL, Haynes JD, Sadoff JC, Schneider I, Grau GE, Hollingdale MR, Ballou WR, Gordon DM. Humoral immune responses in volunteers immunized with irradiated Plasmodium falciparum sporozoites. Am J Trop Med Hyg. 1993 Aug;49(2):166-73. doi: 10.4269/ajtmh.1993.49.166.
PubMed 8357078
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 and Phase 2a Clinical Trial:Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
- ClinicalTrials.gov ID
- NCT01082341
- Acronym / sponsor ID
- SPZ-Irrad / MVDC-2008-005
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Malaria Vaccine and Drug Development CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Asoclinic Inmunología Ltda.
- Study start
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Mar 2010 (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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fy(+) | Experimental | Biological: Immunization with P. vivax irradiated sporozoites14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites |
| Fy(+) control | Active comparator | Biological: Immunization with P. vivax irradiated sporozoitesSeven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites. |
| Fy(-) | Active comparator | Biological: Immunization with P. vivax irradiated sporozoitesSix Fy(-) volunteers will be exposed to infective mosquito bites. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Healthy 18 to 45 years old man or non-pregnant women.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Immunization with P. vivax irradiated sporozoitesAlso: P. vivax irradiated sporozoites vaccineAnopheles 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. | Biological | Fy(+), Fy(+) control, Fy(-) |
Primary outcome
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
1 secondary outcome
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
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 23 Mar 2018.
- Background: PubMed 15864779Wang R, Arevalo-Herrera M, Gardner MJ, Bonelo A, Carlton JM, Gomez A, Vera O, Soto L, Vergara J, Bidwell SL, Domingo A, Fraser CM, Herrera S. Immune responses to Plasmodium vivax pre-erythrocytic stage antigens in naturally exposed Duffy-negative humans: a potential model for identification of liver-stage antigens. Eur J Immunol. 2005 Jun;35(6):1859-68. doi: 10.1002/eji.200425807.
- Background: PubMed 17466521Coban C, Ishii KJ, Horii T, Akira S. Manipulation of host innate immune responses by the malaria parasite. Trends Microbiol. 2007 Jun;15(6):271-8. doi: 10.1016/j.tim.2007.04.003. Epub 2007 Apr 26.
- Background: PubMed 11930326Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, Sacci J, de la Vega P, Dowler M, Paul C, Gordon DM, Stoute JA, Church LW, Sedegah M, Heppner DG, Ballou WR, Richie TL. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002 Apr 15;185(8):1155-64. doi: 10.1086/339409. Epub 2002 Apr 1.
- Background: PubMed 11832958Richie TL, Saul A. Progress and challenges for malaria vaccines. Nature. 2002 Feb 7;415(6872):694-701. doi: 10.1038/415694a.
- Background: PubMed 9252123Doolan DL, Hoffman SL, Southwood S, Wentworth PA, Sidney J, Chesnut RW, Keogh E, Appella E, Nutman TB, Lal AA, Gordon DM, Oloo A, Sette A. Degenerate cytotoxic T cell epitopes from P. falciparum restricted by multiple HLA-A and HLA-B supertype alleles. Immunity. 1997 Jul;7(1):97-112. doi: 10.1016/s1074-7613(00)80513-0.
- Background: PubMed 1969073Mellouk S, Lunel F, Sedegah M, Beaudoin RL, Druilhe P. Protection against malaria induced by irradiated sporozoites. Lancet. 1990 Mar 24;335(8691):721. doi: 10.1016/0140-6736(90)90832-p. No abstract available.
- Background: PubMed 4987036Nussenzweig R, Vanderberg J, Most H. Protective immunity produced by the injection of x-irradiated sporozoites of Plasmodium berghei. IV. Dose response, specificity and humoral immunity. Mil Med. 1969 Sep;134(10):1176-82. No abstract available.
- Background: PubMed 7516412Seguin MC, Klotz FW, Schneider I, Weir JP, Goodbary M, Slayter M, Raney JJ, Aniagolu JU, Green SJ. Induction of nitric oxide synthase protects against malaria in mice exposed to irradiated Plasmodium berghei infected mosquitoes: involvement of interferon gamma and CD8+ T cells. J Exp Med. 1994 Jul 1;180(1):353-8. doi: 10.1084/jem.180.1.353.
- Background: PubMed 2283161Weiss WR. Host-parasite interactions and immunity to irradiated sporozoites. Immunol Lett. 1990 Aug;25(1-3):39-42. doi: 10.1016/0165-2478(90)90088-8.
- Background: PubMed 2963334Weiss WR, Sedegah M, Beaudoin RL, Miller LH, Good MF. CD8+ T cells (cytotoxic/suppressors) are required for protection in mice immunized with malaria sporozoites. Proc Natl Acad Sci U S A. 1988 Jan;85(2):573-6. doi: 10.1073/pnas.85.2.573.
- Background: PubMed 4624244Collins WE, Contacos PG. Immunization of monkeys against Plasmodium cynomolgi by X-irradiated sporozoites. Nat New Biol. 1972 Apr 12;236(67):176-7. doi: 10.1038/newbio236176a0. No abstract available.
- Background: PubMed 2658634Collins WE, Nussenzweig RS, Ballou WR, Ruebush TK 2nd, Nardin EH, Chulay JD, Majarian WR, Young JF, Wasserman GF, Bathurst I, et al. Immunization of Saimiri sciureus boliviensis with recombinant vaccines based on the circumsporozoite protein of Plasmodium vivax. Am J Trop Med Hyg. 1989 May;40(5):455-64. doi: 10.4269/ajtmh.1989.40.455.
- www.inmuno.orgLink provided by the sponsor.
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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.
Socrates Herrera, MD principal investigator
Malaria Vaccine Develepment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immunization with P. vivax irradiated sporozoites in people with Malaria, run by Malaria Vaccine and Drug Development Center at 1 site in Colombia.
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 8 inclusion and 14 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 23 Mar 2018. 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 Colombia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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). 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 NCT01082341, which also lists 114 linked publications.
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 23 Mar 2018.