A Challenge Study to Assess the Protective Efficacy of Two Malaria Vaccine Candidates
VAC045
A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of Two Prime-Boost Malaria Vaccine Candidates: ChAd63 and MVA Encoding ME-TRAP and the Same Viral Vectors Encoding CS
1 other identifier
interventional
30
1 country
3
Brief Summary
This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS \& MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP). The hope is that these vaccines will induce immune responses in vaccinees that are able to prevent malaria. This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP. The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2012
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 16, 2015
February 1, 2015
7 months
May 16, 2012
February 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effectiveness of ChAd63-MVA CS and ChAd63-MVA ME-TRAP at preventing malaria infection
Comparison of the number of individuals who develop malaria infection between vaccinees and unvaccinated control volunteers.
Up to 30 days post challenge
Secondary Outcomes (1)
The safety and immunogenicity of ChAd63-MVA CS and ChAd63-MVA ME-TRAP
up to 7 months post first vaccination
Study Arms (3)
Group 1: ChAd63-MVA CS
ACTIVE COMPARATOR1 dose of ChAd63 CS 5 x 10\^10 vp intramuscularly and 1 dose MVA CS 2 x 10\^8 pfu intramuscularly 8 weeks later.
Group 2: ChAd63-MVA ME-TRAP
ACTIVE COMPARATOR1 dose of ChAd63 ME-TRAP 5 x 10\^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10\^8 pfu intramuscularly 8 weeks later.
Group 3: Unvaccinated Infectivity Controls
ACTIVE COMPARATORInterventions
1 dose of ChAd63 CS 5 x 10\^10 vp intramuscularly and 1 dose MVA CS 2 x 10\^8 pfu intramuscularly 8 weeks later.
1 dose of ChAd63 ME-TRAP 5 x 10\^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10\^8 pfu intramuscularly 8 weeks later.
Approximately 3 weeks post MVA dosing
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18 to 45 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.
- Agreement to refrain from blood donation during the course of the study and for at least 3 years after the end of their involvement in the study.
- Written informed consent to participate in the trial.
- Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.
- Willingness to take a curative anti-malaria regimen following CHMI.
- For volunteers not living in Oxford: agreement to stay in a hotel room close to the trial centre during a part of the study (from at least day 6.5 post mosquito bite until anti-malarial treatment is completed).
- Answer all questions on the informed consent quiz correctly.
You may not qualify if:
- History of clinical malaria (any species).
- Travel to a malaria endemic region during the study period or within the preceding six months with significant risk of malaria exposure.
- Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt 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.
- 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).
- Use of immunoglobulins or blood products within 3 months prior to enrolment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products, Kathon) or malaria infection.
- Any history of anaphylaxis post vaccination.
- History of clinically significant contact dermatitis.
- History of sickle cell anaemia, sickle cell trait, thalassemia or thalassemia trait or any haematological condition that could affect susceptibility to malaria infection.
- Pregnancy, lactation or intention to become pregnant during the study.
- Contraindications to the use of all three proposed anti-malarial medications; Malarone, Riamet and Chloroquine.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Infection and Immunity Section, Imperial College of Science, Technology and Medicine
London, SW7 2AZ, United Kingdom
Wellcome Trust CRF, Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Hodgson SH, Ewer KJ, Bliss CM, Edwards NJ, Rampling T, Anagnostou NA, de Barra E, Havelock T, Bowyer G, Poulton ID, de Cassan S, Longley R, Illingworth JJ, Douglas AD, Mange PB, Collins KA, Roberts R, Gerry S, Berrie E, Moyle S, Colloca S, Cortese R, Sinden RE, Gilbert SC, Bejon P, Lawrie AM, Nicosia A, Faust SN, Hill AV. Evaluation of the efficacy of ChAd63-MVA vectored vaccines expressing circumsporozoite protein and ME-TRAP against controlled human malaria infection in malaria-naive individuals. J Infect Dis. 2015 Apr 1;211(7):1076-86. doi: 10.1093/infdis/jiu579. Epub 2014 Oct 21.
PMID: 25336730DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian V S Hill, MD
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2012
First Posted
June 20, 2012
Study Start
April 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 16, 2015
Record last verified: 2015-02