A Phase I Clinical Trial Immunizing Healthy Adults With the NMRC-M3V-Ad-PfCA Vaccine to Generate Biologic Reagents
NCT ID: NCT01843491
Last Updated: 2015-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2013-06-30
2014-06-30
Brief Summary
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Detailed Description
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Subjects will be eligible for participation regardless of baseline adenovirus 5 serostatus. At least 6 subjects will be "malaria naïve", meaning that 1) they have not been the recipient of a malaria vaccine, 2) they have no history of malaria infection or travel to a malaria endemic region within 6 months of first leukapheresis procedure or 60mL blood draw, 3) they have no history of long-term residence (\>5 years) in an area known to have significant transmission of P. falciparum, and 4) they have a negative P. falciparum circumsporozoite (PfCSP) ELISpot assay at baseline. (From herein, for simplicity, we refer to PfCSP simply as CSP). The remaining subjects will have no restrictions regarding receipt of malaria vaccines, travel history or baseline CSP ELISpot results. Although it is more difficult to recruit "malaria-naïve" subjects, the inclusion of at least 6 such subjects should provide a more varied array of immune responses; this may be helpful for assay development.
Eligible subjects will receive a single administration of the Ad-PfCA malaria candidate vaccine at a dose of 2 x 1010 pu by intramuscular injection. Approximately 1 month pre-immunization, study subjects will either have a large number of PBMCs collected by means of leukapheresis, or a simple 60 mL blood draw, dependent upon initial pre-screening. Pre-immunization samples designated for the repository do not require large volume sampling of PBMCs. Rather, a 60 mL whole blood draw is sufficient for repository purposes. Thus, subjects will be separated into sub-groups, dependent upon initial pre-screening. Subjects whose samples are designated for the repository will undergo a simple, 60 mL blood draw in lieu of leukapheresis #1 (sub-group A). Samples assigned for assay development will be obtained from sub-group B.
Approximately 1 month post-immunization, study subjects in both sub-groups will have PBMCs collected by means of leukapheresis. Consultation with immunology experts after post-immunization screening will assist to identify those subjects whose samples do not meet assay development or repository needs. In an effort to eliminate unnecessary procedures for subjects, these individuals will not undergo a second leukapheresis, but will return for their safety visit on day 84.
Prior to each leukapheresis/60 mL blood draw, a sample will be tested by CSP-ELISpot and AMA1 ELISpot; the results will be used to categorize samples (see below). Follow up visits will occur 2, 7, 14, 21, and 84 days following immunization. Depending on guidance from the FDA, subjects will then be followed annually by phone, email, or mailings up to five years from the time of immunization per FDA recommendation.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Ad-PfCA
Single injection of Ad-PfCA containing 2 x 10\^10 pu total dose in 1 ml of Final Formulation Buffer by intramuscular injection
Ad-PfCA
Vaccine
Interventions
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Ad-PfCA
Vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Available and willing to participate for duration of study
* Able and willing to provide written informed consent
* Able to complete an Assessment of Understanding with a score of at least 75% correct
* In good general health with no clinically significant health problems as established by medical history, physical exam, and laboratory screening
* Men, and women of childbearing potential must agree to use effective means of birth control from time of enrollment through the duration of the active phase of the study (3 months following immunization)
* Women: Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) prior to dosing of study vaccine, and must agree to continue using such precautions for at least 3 months after immunization. Female subjects unable to bear children must have a note from a Primary Care Provider as proof of her documentation (e.g. tubal ligation or hysterectomy) or must be post-menopausal as appropriate by age with at least one year of amenorrhea.
* Men must agree to use of effective means of birth control. If a male subject has had a vasectomy this will be considered an adequate means of birth control.
* Agree to refrain from blood donation for one year after immunization
* Agree not to travel to a malaria endemic region during the active phase of the study
* Good peripheral venous access
Exclusion Criteria
* Positive HIV, HBsAg or HCV serology
* An abnormal EKG, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block.
* Weight less than 110 pounds
* Use of systemic immunosuppressant pharmacotherapy (inhaled and topical steroids are allowed) within 60 days of scheduled leukapheresis/60 mL blood draw or immunization
* Current significant medical condition (cardiovascular, pulmonary, hepatic, renal, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination (includes bleeding disorders)
* Plan for surgery between screening visit and second (final) leukapheresis
* Known allergy to any component of the vaccine formulation
* Participation in any study involving another investigational vaccine or drug within 30 days prior to the first scheduled leukapheresis/60 mL blood draw or plan to participate in another investigational vaccine/drug research study during participation in the active phase of this study
* Receipt of immunoglobulin and/or any blood products within 90 days of scheduled leukapheresis/60 mL blood draw or immunization
* Any other significant finding which, in the investigator's judgment, may substantially increase the risk associated with the subject's participation in the study or compromise the scientific objectives
* Risk factors for HIV exposure: unsafe sex and injectable drug use
18 Years
50 Years
ALL
Yes
Sponsors
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The PATH Malaria Vaccine Initiative (MVI)
OTHER
U.S. Army Medical Research and Development Command
FED
Responsible Party
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Principal Investigators
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Judith Epstein, MD
Role: PRINCIPAL_INVESTIGATOR
Naval Medical Research Center
Locations
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Naval Medical Research Center Clinical Trials Center
Bethesda, Maryland, United States
Countries
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References
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Tamminga C, Sedegah M, Regis D, Chuang I, Epstein JE, Spring M, Mendoza-Silveiras J, McGrath S, Maiolatesi S, Reyes S, Steinbeiss V, Fedders C, Smith K, House B, Ganeshan H, Lejano J, Abot E, Banania GJ, Sayo R, Farooq F, Belmonte M, Murphy J, Komisar J, Williams J, Shi M, Brambilla D, Manohar N, Richie NO, Wood C, Limbach K, Patterson NB, Bruder JT, Doolan DL, King CR, Diggs C, Soisson L, Carucci D, Levine G, Dutta S, Hollingdale MR, Ockenhouse CF, Richie TL. Adenovirus-5-vectored P. falciparum vaccine expressing CSP and AMA1. Part B: safety, immunogenicity and protective efficacy of the CSP component. PLoS One. 2011;6(10):e25868. doi: 10.1371/journal.pone.0025868. Epub 2011 Oct 7.
Sedegah M, Tamminga C, McGrath S, House B, Ganeshan H, Lejano J, Abot E, Banania GJ, Sayo R, Farooq F, Belmonte M, Manohar N, Richie NO, Wood C, Long CA, Regis D, Williams FT, Shi M, Chuang I, Spring M, Epstein JE, Mendoza-Silveiras J, Limbach K, Patterson NB, Bruder JT, Doolan DL, King CR, Soisson L, Diggs C, Carucci D, Dutta S, Hollingdale MR, Ockenhouse CF, Richie TL. Adenovirus 5-vectored P. falciparum vaccine expressing CSP and AMA1. Part A: safety and immunogenicity in seronegative adults. PLoS One. 2011;6(10):e24586. doi: 10.1371/journal.pone.0024586. Epub 2011 Oct 7.
Other Identifiers
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NMRC.2012.0006
Identifier Type: -
Identifier Source: org_study_id