Health TrialsbyHealthPanel

Vivax Malaria Human Infection Studies in Thailand

ConditionPlasmodium Vivax Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorUniversity of Oxford

About this trial

This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P. vivax-infected blood for use in future controlled human P. vivax malaria infection studies. Additional objectives are to obtain data on host immune response to P. vivax infection and pre-treatment gametocytaemia.

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 volunteers

Qualifiers

Healthy adult aged 20 to 55 years with weight more than 50 kg.

Blood group O.

Red blood cells positive for the Duffy antigen/chemokine receptor (DARC).

CYP2D6 alleles consistent with normal metaboliser status

Disqualifiers

History of clinical malaria.

Positive malaria PCR OR malaria film OR malaria serology (recent exposure)

History of severe allergy to mosquito bite

Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)

Trial design

Design model

Single group

Treatments tested in this trial

  • Mosquito bites

    Other intervention

    Successful feeding of 5 infected P. vivax mosquitoes

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Malaria challengeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful infection of controlled P. vivax sporozoite human challenge

Measured by successful infection (development of detectable persistent parasitaemia) and malaria clinical symptoms, if any, after mosquito bite malaria sporozoite challenge

Time frame
up to 21 days after challenge
2

(Serious) Adverse Event(s) occurrences of controlled P. vivax sporozoite human challenge

Measured by (S)AE(s) occurrences after mosquito bite malaria sporozoite challenge.

Time frame
up to 90 days after challenge
3

Collection and freezing down of up to 250 mL P. vivax-infected blood from each of the 6 volunteers.

measured by successful collection and freezing down of up to 250 mL P. vivax-infected blood from each of the 6 volunteers.

Time frame
up to 21 days after challenge

Secondary outcomes

1

Cellular Immune response to primary P. vivax infection.

immune cells including Innate and adaptive immune cells react and express during the PV infection (profile and frequency)

Time frame
up to 1 year after challenge
2

Humoral Immune response to primary P. vivax infection.

Immune cells defense PV antigen by determining the level of antibody response and inflammatory cytokine

Time frame
up to 1 year after challenge
3

Gametocytaemia following primary P. vivax infection delivered by the mosquito bite

Gametocyte qPCR following primary P. vivax infection delivered by the mosquito bite

Time frame
up to 1 year after challenge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

Mahidol University

Collaborator

Source ClinicalTrials.gov
Apply now