NCT01397227

A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model

A Phase I/IIa, Double-blind, Randomized, Placebo-controlled, Dose-escalation Clinical Study Evaluating Safety, Tolerability and Immunogenicity of Two Dose Levels of Recombinant Adenoviral Serotype Ad35 and Serotype Ad26 Vectors Expressing the Malaria Plasmodium Falciparum Circumsporozoite Antigen Administered as Heterologous Prime-boost Regimen, and Assessing Protective Efficacy of the Higher Dose in a Malaria Challenge Model in Unblinded Conditions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of two dose levels (1x10\^10 and 5x10\^10 virus particles (vp)) of the adenovirus serotype (Ad) Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the protective efficacy of the higher dose level in an experimental malaria challenge. The study will be in 3 phases: 1. a dose escalation / vaccination phase in which both dose levels will be tested 2. a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01 5x10\^10 vp dose level, together with six infectivity control subjects, will be exposed to experimental challenge with Plasmodium falciparum 3. a long term follow up phase in which all subjects who received active vaccine from both dose levels and/or malaria challenge will be included

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp)	Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).
BIOLOGICAL	Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp)	Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).
BIOLOGICAL	Placebo	Each placebo subject receives in total three injections of placebo: Day 0, Day 28, and either Day 55 or 59

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-07-19
• Last updated: 2012-09-07

Locations

1 site across 1 country: United States