Safety and Immunogenicity of Malaria Vaccines AdCh63 AMA1, MVA AMA1 and AMA1-C1/Alhydrogel®+/- CPG 7909
A Phase Ia Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination With the Candidate Malaria Vaccines; AdCh63 AMA1, MVA AMA1 & AMA1-C1/Alhydrogel® +/- CPG 7909
1 other identifier
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 14, 2013
March 1, 2013
1.8 years
May 9, 2011
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of vaccination
To assess the safety of vaccination of healthy adults with AdCh63 AMA1, MVA AMA1 \& AMA1-C1/Alhydrogel® +/- CPG 7909 administered in various schedules using actively and passively collected data on adverse events
Expected average of 12 months
Secondary Outcomes (1)
Immunogenicity of vaccination
Expected average of 12 months
Study Arms (5)
Group 1
EXPERIMENTALAdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909
Group 2
EXPERIMENTALAdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909
Group 3
EXPERIMENTALAdCh63 AMA1 + AMA1-C1/Alhydrogel®
Group 4
EXPERIMENTALAdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909
Group 5
EXPERIMENTALAdCh63 AMA1 + MVA AMA1
Interventions
5x10\^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections
5x10\^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel® (80ug, 800ug respectively) Day 56. IM injections
5x10\^10 vp AdCh63 AMA1 Day 0, 1.25x10\^8 pfu MVA AMA1 Day 112. IM injections
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
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- Women only: Must practice continuous effective contraception for the duration of the study.
- Men only: Must use barrier contraception from day of any vaccination with CPG 7909, for 3 months.
- Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study.
- Written informed consent
You may not qualify if:
- History of clinical P. falciparum malaria
- Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure.
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period.
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- Pregnancy, lactation or intention to become pregnant during the study
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine e.g. egg products, Kathon.
- History of clinically significant contact dermatitis.
- History of a known allergy to nickel (volunteers may be enrolled in group 5 if they have an allergy to nickel)
- Any history of anaphylaxis post vaccination.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of serious psychiatric condition that may affect participation in the study.
- Any other serious chronic illness requiring hospital specialist supervision.
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington
Oxford, OX3 7LJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian VS Hill, D.Phil, FRCP
The Jenner Institute, University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 11, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 14, 2013
Record last verified: 2013-03