NCT01024686

Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine

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.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	p52-/p36- GAP Vaccine	Administered by five bites from GAP-infected Anopheles mosquito
BIOLOGICAL	p52-p36- GAP Vaccine	Administered by 200 bites from GAP-infected Anopeles mosquito
BIOLOGICAL	p52-/p36- GAP Vaccine	Five doses separated by 4-weeks, each administered by 200 bites from GAP-infected Anopheles mosquito

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-12-03
• Last updated: 2019-10-28
• Results posted: 2019-10-28

Locations

1 site across 1 country: United States