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Safety and Immunogenicity of Malaria Vaccines AdCh63 AMA1, MVA AMA1 and AMA1-C1/Alhydrogel®+/- CPG 7909

NCT01351948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-03-14

No results posted yet for this study

Summary

This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine candidates administered alone and with adjuvants in various schedules. These vaccines consist of inactivated viruses which have been modified, so they cannot reproduce in humans, and also to include genetic material for malaria protein AMA1 which is expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to this malaria protein and thus provide protection against malaria infection. Adjuvants are a crucial component of modern vaccine regimens, increasing the immunogenicity and potency of protein vaccines. In this study we will assess whether virus vectored vaccines combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909 adjuvant (emulsion containing TLR agonist) can induce stronger and more durable immune response.

Conditions

Interventions

BIOLOGICAL

AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909

5x10\^10 vp AdCh63 AMA1 Day 0, 1.25x10\^8 pfu MVA AMA1 Day 56, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections

BIOLOGICAL

AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909

5x10\^10 vp AdCh63 AMA1 Day 0,AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 56. IM injections

BIOLOGICAL

AdCh63 AMA1 + AMA1-C1/Alhydrogel®

5x10\^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel® (80ug, 800ug respectively) Day 56. IM injections

BIOLOGICAL

AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909

5x10\^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections

BIOLOGICAL

AdCh63 AMA1 + MVA AMA1

5x10\^10 vp AdCh63 AMA1 Day 0, 1.25x10\^8 pfu MVA AMA1 Day 112. IM injections

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill, D.Phil, FRCP · The Jenner Institute, University 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
2011-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01351948 on ClinicalTrials.gov