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

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

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)

Sponsors & Collaborators

• European Vaccine Initiative

  collaborator OTHER

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Centre Hospitalier Universitaire Vaudois

  lead OTHER

Principal Investigators

• François Spertini, MD · Centre Hospitalier Universitaire Vaudois (CHUV)

• Salim Abdulla, MD · Bagamoyo Research and Training Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• Switzerland
• Tanzania

Study Locations