Actively Recruiting

Phase Not Applicable
Age: 20Years - 55Years
All Genders
Healthy Volunteers
NCT04083508

Vivax Malaria Human Infection Studies in Thailand

Led by University of Oxford · Updated on 2026-01-12

6

Participants Needed

1

Research Sites

290 weeks

Total Duration

On this page

Sponsors

U

University of Oxford

Lead Sponsor

M

Mahidol University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Vivax Malaria Human Infection Studies in Thailand

Who Can Participate

Age: 20Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults aged 20 to 55 years weighing 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
  • Normal Glucose-6-phosphate dehydrogenase (G6PDH) levels
  • At least two doses of WHO-approved COVID-19 vaccine
  • Agree to use effective contraception during the study and for 3 months post-challenge
  • Agree to refrain from blood donation during the study and for 1 year after
  • Willing to take curative antimalarial treatment after challenge
  • Willing to be admitted to Hospital for Tropical Diseases for monitoring and treatment
  • Willing to live in Bangkok during the study until treatment completion
  • Reachable by mobile phone 24/7 between challenge and treatment completion
  • Able to read and write Thai and answer informed consent questions correctly
  • Provided written informed consent
  • At least undergraduate education level
  • Low cardiovascular risk (less than 10% in next 10 years)
Not Eligible

You will not qualify if you...

  • History of clinical malaria
  • Positive malaria PCR, film, or serology indicating recent exposure
  • History of severe allergy to mosquito bites
  • Any physical or psychological medical condition posing risk or interfering with study
  • Chronic disease or chronic medication use
  • Plans to travel outside Bangkok during challenge and 3 months after
  • Use of antibiotics with antimalarial activity within 30 days before challenge
  • Use of immunoglobulins or blood products in the past year
  • Inability for venipuncture to allow blood donation
  • Receipt or planned receipt of investigational products or vaccines impacting study
  • Immunosuppressive or immunodeficient states including HIV, asplenia, splenectomy
  • Immunosuppressant medication use in past 6 months (except inhaled/topical steroids)
  • History of allergic diseases worsened by malaria
  • Female participants who are pregnant, lactating, or planning pregnancy
  • Contraindications to antimalarial drugs used in study
  • Use of medications interacting with study antimalarials
  • Use of medications causing QT interval prolongation
  • Family history of early cardiac disease or congenital QT prolongation
  • History of cardiac arrhythmia or bradycardia
  • QTc interval ≥ 450 ms on ECG
  • History or suspicion of alcohol or drug abuse
  • Participation in another clinical study during this study
  • Low hemoglobin levels (men <13 g/dL, women <12 g/dL)
  • Abnormal liver, kidney, calcium, magnesium, or blood sugar lab values
  • Thalassemia or hemoglobinopathies
  • Positive tests for blood- or vector-borne infections including HIV, HBV, HCV, dengue, Zika, chikungunya, filariasis, JE, malaria antigen, HTLV, syphilis
  • Positive COVID-19 test by RT-PCR

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Tropical Medicine

Bangkok, Thailand, 10400

Actively Recruiting

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Research Team

N

Nicholas Day, MD

CONTACT

J

Jetsumon Sattabongkot Prachumsri, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Vivax Malaria Human Infection Studies in Thailand | DecenTrialz