Status:
COMPLETED
Safety and Immunogenicity of the Malaria Vaccine, R21/MatrixM, in Healthy Thai Adults
Lead Sponsor:
University of Oxford
Conditions:
Malaria,Falciparum
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Malaria remains one of the leading causes of morbidity and mortality worldwide. Plasmodium falciparum is a complex pathogen with numerous immune evasion mechanisms which has added layers of complexity...
Detailed Description
This is a randomized, open label, single centre, Phase 2 study. Screening and eligibility assessment (Screening visit) All potential volunteers will have a screening visit, which may take place up to...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- The participant is eligible to enter the study if all of the following apply:
- Participant is a healthy adult, aged 18 to 55 years (inclusive), of Thai origin.
- Participant is willing and able to give informed consent to participate in the trial
- Able, in the investigator's opinion, and willing to comply with the study requirements and follow-up.
- Women of childbearing potential: must agree to practice continuous, effective contraception for the duration of the trial, and have a negative pregnancy test before each vaccination. (Costs for contraceptives will be reimbursed by the trial.)
- Exclusion criteria
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Pregnancy or breastfeeding, or planned pregnancy during the course of the study.
- Presence of any medical condition (physical or mental) which, may place the participant at undue risk or interfere with the results of the study\*. Including: serious cardiac, renal, hepatic or neurological disease, severe malnutrition
- Any confirmed or suspected immunosuppressive or immunodeficient condition. Including: history of splenectomy, human immunodeficiency virus (HIV) infection
- Chronic administration (\>14 days in total) of immunosuppressants or other immune-modifying drugs within six months of enrollment. Including: oral corticosteroids equivalent to prednisone \> 20 mg/day (a)
- History of an autoimmune disease
- Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody(b) detected in serum.
- Screening electrocardiogram (ECG) demonstrating a QTc interval ≥ 450 ms
- Seropositivity for hepatitis C virus (antibodies to HCV) at screening (b)
- Finding on safety laboratory values as defined below:
- AST \> 2 x upper normal limit
- ALT \> 2 x upper normal limit
- Anaemia (Hb \< 10 g/dL),
- Platelets \< 150,000
- Total bilirubin \> 2 x upper normal limit
- Abnormalities of examination or investigations at screening. Including: hepatomegaly, right upper quadrant abdominal pain or tenderness, abnormal blood tests (as defined in the protocol which are not listed above)
- Positive malaria parasitaemia (RDT) at screening or baseline (Month 0, Day 0).
- Receipt or planned receipt of an investigational medical product or participation in an interventional clinical trial during the study period
- Contraindications to the use of artemisinins, piperaquine or primaquine\*. Including: use of medications with known potential interactions, prior allergic reactions to one or more components of the drug regimen.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products)
- History of clinically significant contact dermatitis.
- Contraindication to intramuscular (IM) injection\*
- Administration of a vaccine not included in the study protocol within 30 days of a study vaccine (c).
- History of anaphylaxis post-vaccination.
- Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
- subject to the investigator's judgement
- Exceptions:
- a Inhaled and topical steroids. b Participation in hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study c The following vaccinations may be administered more than 7 days before or after a study vaccination: polio, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG vaccine), measles, influenza, pneumococcal disease, COVID-19 or yellow fever
Exclusion
Key Trial Info
Start Date :
January 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2023
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT05252845
Start Date
January 4 2023
End Date
September 18 2023
Last Update
July 3 2025
Active Locations (1)
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1
Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400