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

NCT01397227 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-09-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Angela Talley, MD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01397227 on ClinicalTrials.gov