Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine
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ClinicalTrials.gov Identifier: NCT01024686 |
Recruitment Status
:
Terminated
First Posted
: December 3, 2009
Last Update Posted
: May 30, 2013
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Sponsor:
Seattle Biomedical Research Institute
Information provided by (Responsible Party):
Seattle Biomedical Research Institute
Tracking Information | ||||
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First Submitted Date ICMJE | December 1, 2009 | |||
First Posted Date ICMJE | December 3, 2009 | |||
Last Update Posted Date | May 30, 2013 | |||
Study Start Date ICMJE | March 2010 | |||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01024686 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine | |||
Official Title ICMJE | Phase 1/2a Trial to Assess the Safety, Immunogenicity and Efficacy of Genetically-attenuated Plasmodium Falciparum Parasites p52-/p36- (GAP) Vaccine, Administered by Bite of Infected Anopheles Mosquito to Malaria-naïve Adults Living in the United States. | |||
Brief Summary | The purpose of this study is to assess safety and tolerability of escalating doses of a genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy malaria-naive adults. The study will also assess preliminary efficacy of p52-/p36- GAP vaccine following primary experimental challenge with P. falciparum sporozoites. Lastly, the study will assess immunogenicity of p52-/p36- GAP in malaria-naïve healthy adults and preliminary efficacy of p52-/p36- GAP vaccine following primary experimental re-challenge with P. falciparum sporozoites. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Malaria | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Spring M, Murphy J, Nielsen R, Dowler M, Bennett JW, Zarling S, Williams J, de la Vega P, Ware L, Komisar J, Polhemus M, Richie TL, Epstein J, Tamminga C, Chuang I, Richie N, O'Neil M, Heppner DG, Healer J, O'Neill M, Smithers H, Finney OC, Mikolajczak SA, Wang R, Cowman A, Ockenhouse C, Krzych U, Kappe SH. First-in-human evaluation of genetically attenuated Plasmodium falciparum sporozoites administered by bite of Anopheles mosquitoes to adult volunteers. Vaccine. 2013 Oct 9;31(43):4975-83. doi: 10.1016/j.vaccine.2013.08.007. Epub 2013 Sep 8. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
6 | |||
Original Estimated Enrollment ICMJE |
32 | |||
Actual Study Completion Date | June 2011 | |||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01024686 | |||
Other Study ID Numbers ICMJE | WR 1584 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Seattle Biomedical Research Institute | |||
Study Sponsor ICMJE | Seattle Biomedical Research Institute | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Seattle Biomedical Research Institute | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |