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A Study of the Safety and Effectiveness of Two New Malaria Vaccines

NCT01003314 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-03-28

No results posted yet for this study

Summary

This study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response), to provide protection against malaria infection. This protection has been demonstrated in nonhuman studies. Although these vaccines have not been given to humans before, similar vaccines using the same viruses with different malaria genes have been given to humans before. In these studies, the vaccines have been shown to be safe. They have also provided evidence from laboratory tests of immunogenicity. In this study the investigators main aim is to ensure these new vaccines given alone and in combination are safe. The investigators will increase the dose of the first vaccine (AdCh63 MSP1) given to volunteers if the initial dose is safe. The investigators also wish to ensure that challenging a small number of volunteers who have received both vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge) is safe. Sporozoite challenge has been widely used in humans to test the effectiveness of malaria vaccines and is considered a well established, reliable, predictable and safe system.In the study the investigators will also look for evidence of immunogenicity of these new vaccines, and whether there is any delay to developing malaria following sporozoite challenge. The study will be conducted at the University of Oxfords Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take place at the insectary at Imperial College, (Infection and Immunity Section)in London.

Conditions

Interventions

BIOLOGICAL

AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine

Group 1A: single dose of AdCh63-MSP1 vaccine 5 x 10\^9 vp administered IM. Group 1B: single dose of AdCh63-MSP1 vaccine 5 x 10\^9 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10\^8 vp administered IM 8 weeks later

BIOLOGICAL

AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge

Group 2A: single dose of AdCh63-MSP1 vaccine 5 x 10\^10 vp administered IM. Group 2B: single dose of AdCh63-MSP1 vaccine 5 x 10\^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10\^8 vp administered IM 8 weeks later. Group 2C: single dose of AdCh63-MSP1 vaccine 5 x 10\^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10\^8 vp administered IM 8 weeks later and subsequent sporozoite malaria challenge 12-28 days post second vaccination

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill, D.Phil, FRCP · Univeristy of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01003314 on ClinicalTrials.gov