NCT01949909

Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib

Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A With Alhydrogel® Or GLA-SE As Adjuvant: A Staggered, Antigen And Adjuvant Dose-Finding, Randomized, Multi-Centre Phase Ia/Ib Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	CH-Alum50	intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg)
BIOLOGICAL	CH-GLA2.5/50	intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)
BIOLOGICAL	TZ Ver	intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections
BIOLOGICAL	TZ Alum 50	intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg)
BIOLOGICAL	TZ GLA 2.5/10	intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg)
BIOLOGICAL	TZ GLA5/50	intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg)
BIOLOGICAL	TZ GLA2.5/50	intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-09-25
• Last updated: 2018-07-18

Locations

2 sites across 2 countries: Switzerland, Tanzania