A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 )
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-55
SponsorUniversity of Oxford
About this trial
This project is the third part of a 5-year research program entitled "Malaria Infection Studies in Thailand (MIST)" and known as MIST3. MIST3's primary objectives are to assess the safety of the PvRII/Matrix-M vaccine candidate in healthy adult Thai volunteers and to establish whether the PvRII/Matrix-M vaccine can demonstrate a reduced parasite multiplication rate in vaccinated volunteers compared to a controlled group (placebo vaccine) in a blood-stage controlled human malaria infection model. This study will recruit up to 36 eligible healthy volunteers aged 20-55 in Thailand at the Faculty of Tropical Medicine, Mahidol University. Eighteen volunteers will receive three doses of the PvRII/Matrix-M candidate vaccine, and 18 volunteers will receive three doses of the placebo vaccine. Safety and immunogenicity will be evaluated after each dose as per protocol. Approximately four weeks after receiving the third vaccination, 24 volunteers will undergo blood-stage CHMI with Plasmodium vivax. The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases and treated according to the Research Proposal Submission Form.
This study is funded by the UK Wellcome Trust. The grant reference number are Oxford/MORU: 212336/Z/18/Z and 212336/Z/18/A, and Mahidol University: 212336/A/18/Z and 212336/A/18/A
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy Thai adults aged 20 to 55 years
Minimum educational level of high school or equivalent
Red blood cells positive for the Duffy antigen/chemokine receptor (DARC)
Women only: Must practice continuous effective contraception for the duration of the study period until 3 months post-challenge.
Disqualifiers
Positive malaria qPCR OR malaria film prior to vaccination and challenge
Presence of any medical condition (either physical or psychological) that, in the judgment of the investigator, would place the participant at undue risk (including the history of clinically significant contact dermatitis) or interfere with the results of the study (e.g., underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)
Presence of chronic disease or chronic use of medication
Prior receipt of other investigational vaccine which is likely to impact the interpretation of the trial data as assessed by the Investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Malaria Vaccine
Biological/Vaccineblood stage Plasmodium vivax malaria vaccine
HBV vaccine
Biological/VaccineHBV Vaccine
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Malaria VaccineExperimental treatment 1 intervention
Group B: controlOther 1 intervention
Trial outcomes
Primary outcomes
1
solicited local adverse event
occurrence of solicited local reactogenicity signs and symptoms
Time frame
7 days following each vaccination2
solicited systemic adverse event
occurrence of solicited systemic reactogenicity signs and symptoms
Time frame
7 days following each vaccination3
unsolicited adverse events
Occurrence of unsolicited adverse events
Time frame
28 days following each vaccination4
safety laboratory measures
Number of participants with abnormal laboratory test results
Time frame
28 days following each vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
Mahidol University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: