Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT01397227
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model
Sponsor:
Crucell Holland BV
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: