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

niversity of Oxford0 sites10 target enrollmentMay 22, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 22, 2009

End Date

October 28, 2010

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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

•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