A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5
2 other identifiers
interventional
26
1 country
2
Brief Summary
The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.
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 Aug 2014
2 active sites
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
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 3, 2015
December 1, 2015
1.2 years
July 1, 2014
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5
Occurrence of solicited and unsolicited adverse events will be monitored at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results.
240 days
Secondary Outcomes (1)
To assess the cellular and humoral immunogenicity of ChAd63 RH5 when administered alone, and in heterologous prime-boost with MVA RH5 in healthy volunteers.
240 days
Study Arms (4)
Group 1 (ChAd63 RH5 low dose)
EXPERIMENTAL1 dose of ChAd63 RH5 5 x 10\^9 vp intramuscularly
Group 2A (ChAd63 RH5 full dose)
EXPERIMENTAL1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly
Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose)
EXPERIMENTAL1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 1 x 10\^8 pfu 8 weeks later intramuscularly
Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose)
EXPERIMENTAL1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 2 x 10\^8 pfu 8 weeks later intramuscularly
Interventions
ChAd63 RH5 at 5 x 10\^9 vp
ChAd63 RH5 at 5 x 10\^10 vp
MVA RH5 at 1 x 10\^8 pfu
MVA RH5 at 2 x 10\^8 pfu
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
- For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
You may not qualify if:
- Participation in another research study involving receipt of 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 human immunodeficiency virus (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)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
- Any history of anaphylaxis in reaction to vaccination
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- 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
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- History of clinical malaria (any species)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- European Commissioncollaborator
Study Sites (2)
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, OX3 7LE, United Kingdom
Wellcome Trust CRF, Southampton General Hospital, University of Southampton
Southampton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
July 1, 2014
First Posted
July 3, 2014
Study Start
August 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 3, 2015
Record last verified: 2015-12