- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01434381
Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)
Open Label Phase 1 Study in Malaria Naive Adults of the Safety and Immunogenicity of Pfs25-EPA/Alhydrogel, a Transmission Blocking Vaccine Against Plasmodium Falciparum
Background:
- The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people from getting sick with malaria. Researchers want to test the safety of and response to this vaccine.
Objectives:
- To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel.
Eligibility:
- Healthy volunteers between 18 and 50 years of age.
Design:
- Participants will be screened with a medical history, physical exam, and blood tests.
- They will be assigned to a study group to have either two or three doses of the vaccine. Participants will have checkups after each dose of vaccine,
- The additional doses will be given 2 months or 2 and 4 months after the first vaccine.
- Participants will have regular blood tests to check the level of the response to the vaccine.
- They will be followed for up to 1 year after the last vaccine to have any additional tests as needed.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
All of the following criteria must be fulfilled for a volunteer to participate in this trial:
- Age between 18 and 50 years.
- Good general health as a result of review of medical history and/or clinical testing at the time of screening.
- Available for the duration of the trial.
- Willingness to participate in the study as evidenced by signing the informed consent document.
- If female: subject is willing to use reliable contraception methods for the period of at least 1month (2 months for oral contraceptive pills) prior to first vaccination to 3 months after last vaccination. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; transdermal patch; intrauterine device; abstinence; and post-menopause.
EXCLUSION CRITERIA:
A volunteer will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- Pregnancy as determined by a positive urine or serum human choriogonadotropin (Beta-hCG) test at any point during the study (if female).
- Currently is lactating and breast-feeding (if female).
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
- Neutropenia as defined by an absolute neutrophil count < 1500/mm(3).
- Alanine transaminase (ALT) level above the laboratory-defined upper limit of normal.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
- History of receiving any investigational product within the past 30 days.
- Receipt of antimalarial prophylaxis during the past 12 months, or planned travel to a destination which would require malaria prophylaxis during the period of participation.
- Prior malaria infection by history.
- Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
Severe asthma. This will be defined as:
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years, or that requires the use of oral or parenteral corticosteroids.
- Clinically significant reactive airway disease that does not respond to bronchodilators.
- Positive ELISA and confirmatory Western blot tests for HIV-1.
- Positive ELISA and confirmatory tests for hepatitis C virus (HCV).
- Positive hepatitis B surface antigen (HBsAg) by ELISA.
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
- Known immunodeficiency syndrome.
- Use of chronic (greater than or equal to 14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone > 10 mg/ day) or immunosuppressive drugs within 30 days of starting this study.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- Previous receipt of an investigational malaria vaccine.
- Refusal to allow storage of samples for future research.
- Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pfs25-EPA/Alhydrogel
Dose-escalation of Pfs25-EPA/Alhydrogel. Participants will receive 1 of 3 doses of Pfs25-EPA/Alhydrogel- 8 micro g, 16 micro g, or 47 micro g.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of local and systemic adverse events
Time Frame: All adverse events will be recorded though Day 28 after each vaccination. The frequency of systemic and local AEs will be summarized.
|
Subjects will be monitored for 30 minutes following each immunization.
Subjects will return to the clinic on Days 3,7,14 and 28 following each vaccination for clinical assessments, and periodically thereafter until completion
|
All adverse events will be recorded though Day 28 after each vaccination. The frequency of systemic and local AEs will be summarized.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the antibody response to the Pfs25 protein vaccines as measured by ELISA and transmission blocking assays, and the effect on antibody responses of a third dose at four months
Time Frame: ELISA testing will occur on vaccination days, 2 weeks after each vaccination, and periodically until study completion
|
ELISA testing will occur on vaccination days, 2 weeks after each vaccination, and periodically until study completion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick Duffy, MD, National Institute of Allergy and Infectious Diseases (NIAID)
Publications and helpful links
General Publications
- Birkett AJ. PATH Malaria Vaccine Initiative (MVI): perspectives on the status of malaria vaccine development. Hum Vaccin. 2010 Jan;6(1):139-45. doi: 10.4161/hv.6.1.10462. Epub 2010 Jan 29. No abstract available.
- Cheru L, Wu Y, Diouf A, Moretz SE, Muratova OV, Song G, Fay MP, Miller LH, Long CA, Miura K. The IC(50) of anti-Pfs25 antibody in membrane-feeding assay varies among species. Vaccine. 2010 Jun 17;28(27):4423-9. doi: 10.1016/j.vaccine.2010.04.036. Epub 2010 Apr 29.
- Coler RN, Baldwin SL, Shaverdian N, Bertholet S, Reed SJ, Raman VS, Lu X, DeVos J, Hancock K, Katz JM, Vedvick TS, Duthie MS, Clegg CH, Van Hoeven N, Reed SG. A synthetic adjuvant to enhance and expand immune responses to influenza vaccines. PLoS One. 2010 Oct 27;5(10):e13677. doi: 10.1371/journal.pone.0013677.
Study record dates
Study Major Dates
Study Start
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-I-N237 (Other Identifier: NIH)
- CIR 276 (Other Identifier: Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health)
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 Malaria
-
University of California, San FranciscoCenters for Disease Control and Prevention; University of Massachusetts, Amherst and other collaboratorsRecruitingPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaLao People's Democratic Republic
-
Medicines for Malaria VentureAsociacion Civil Selva AmazonicaCompletedPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaPeru
-
Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis Ababa... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaEthiopia, Bangladesh, Indonesia
-
University of OxfordWellcome Trust; Ministry of public Health AfghanistanCompletedVivax Malaria | Uncomplicated Falciparum MalariaAfghanistan
-
Gadjah Mada UniversityMenzies School of Health Research; Eijkman Institute for Molecular Biology; Timika...Completed
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
London School of Hygiene and Tropical MedicineWorld Health Organization; United Nations High Commissioner for Refugees; HealthNet... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaPakistan
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
University of IbadanShin Poong Pharm Co Ltd 161 yoksam-ro, Gangnam-Gu Seoul 135-925, Korea; Institute...CompletedPlasmodium Falciparum Malaria | Uncomplicated Malaria | Malaria FeverNigeria
-
Research Institute for Tropical Medicine, PhilippinesWorld Health OrganizationCompletedTES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014 (TES)Malaria | Vivax Malaria | Falciparum Malaria | Malaria Recrudescence
Clinical Trials on Pfs25-EPA/Alhydrogel
-
National Institute of Allergy and Infectious Diseases...Malaria Research and Training Center, Bamako, MaliCompleted
-
National Institute of Allergy and Infectious Diseases...Rodolphe Merieux Laboratory@@@Bamako, MaliCompleted
-
Eunice Kennedy Shriver National Institute of Child...WithdrawnMalaria | Plasmodium Falciparum Malaria | Malaria Vaccines
-
University of OxfordCompleted
-
University of OxfordIfakara Health InstituteRecruiting
-
Fraunhofer, Center for Molecular BiotechnologyCompleted
-
University of OxfordTerminatedMalaria,FalciparumUnited Kingdom
-
Baylor College of MedicineGeorge Washington University; Children's National Research InstituteCompletedHookworm Infection | Hookworm DiseaseUnited States
-
SCF PharmaCompleted
-
National Science Council, TaiwanCompletedMajor Depressive DisorderTaiwan