A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria - AMA1-C1/CPG Blood Stage Challange
- Conditions
- Plasmodium falciparum malariaMedDRA version: 8.1 Level: LLT Classification code 10036655 Term: Prevention of malaria
- Registration Number
- EUCTR2007-005389-11-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
•Subject is willing and able to give informed consent for participation in the study
•Healthy, non pregnant adult aged 18 - 50 years
•Resident in or near Oxford for the duration of the challenge study
•Seropositive for CMV and EBV
•Female subjects of child bearing potential must be willing to ensure that they practice
effective contraception during the study
Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination
•Able (in the Investigator’s opinion) and willing to comply with all study requirements
•Willing to allow his or her General Practitioner and consultant, if appropriate, to be
notified of participation in the study
•Agreement to permanently refrain from blood donation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or
in urine analysis as defined in Appendix B
•Female patient/subject who is pregnant, lactating or planning pregnancy during the
course of the study
•Healthy volunteers who have participated in another research study involving an
investigational product in the past 12 weeks
•Subjects who have previously received an investigational malaria vaccine
•History of malaria chemoprophylaxis with chloroquine within 5 months prior to the
planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet®
within 2 weeks prior to the challenge
•Travel to a malaria endemic area within the previous 6 months
•Planned travel to malarious areas during the study period
•Any history of malaria
Contraindication to both ant-malarial drugs (Riamet and Chloroquine)
Concomitant use of other drugs known to cause QT-interval prolongation (e.g. macrolides, quinolones, amiodarone etc)
An estimated ten year risk of fatal cardiovascular disease of greater than or equal to 5%, as estimated by the Systemic Coronary Risk Evaluation (SCORE) system (Conroy 2003)
•Any history of severe allergic reaction or anaphylaxis
•History of a known allergy to nickel
•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
•History or evidence of pre-existing autoimmune or antibody mediated disease or
laboratory evidence of possible autoimmune disease (defined as anti-dsDNA = 25
IU/mL)
•Seropositive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus
•Any on-going chronic illness requiring hospital specialist supervision
•Administration of immunoglobulins and/or any blood products within the three
months preceding the planned administration of the vaccine candidate
•History of or current intravenous drug abuse
•Suspected or known current alcohol abuse as defined by an alcohol intake of greater
than 42 units every week
•Any other significant disease or disorder which, in the opinion of the Investigator,
may either put the subject at risk because of participation in the study, or may
influence the result of the study, or the subject’s ability to participate in the study.
•Investigator assessment of lack of willingness to participate and comply with all
requirements of the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To demonstrate a correlation between in vitro growth inhibition assay and parasite multiplication rate in vivo<br> ;<br> Secondary Objective: To detect differences in the multiplication rate responses between unvaccinated control subjects and volunteers vaccinated with AMA1-C1/Alhydrogel + CPG7909.<br> To assess levels of protection from blood stage malaria in volunteers vaccinated with AMA1-C1/Alhydrogel + CPG7909.<br><br> Tertiary Objectives<br> To assess the safety, reactogenicity of the AMA1-C1/Alhydrogel® + CPG 7909 vaccine.<br> To perform exploratory studies of B and T cell populations both before and after vaccination.<br> ;<br> Primary end point(s): Efficacy end point:<br> One thick smear positive for one or more parasites during the 12 day observation period<br>
- Secondary Outcome Measures
Name Time Method