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

NCT01024686 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-10-28

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Michele Spring, M.D. · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024686 on ClinicalTrials.gov