Safety and immune response of the malaria vaccine, R21/Matrix-M™, in Thai adults
- Conditions
- Malaria vaccine in healthy volunteersNot Applicable
- Registration Number
- ISRCTN57717892
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 127
1. Participant is a healthy adult, aged 18 to 55 years (both inclusive), of Thai origin.
2. Participant is willing and able to voluntarily give informed consent to participate in the trial
3. Able, in the investigator’s opinion, and willing to comply with the study requirements and follow-up.
4. 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.)
1. Pregnancy or breastfeeding, or planned pregnancy during the course of the study.
2. 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
3. Any confirmed or suspected immunosuppressive or immunodeficient condition. Including: history of splenectomy, human immunodeficiency virus (HIV) infection
4. 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*)
5. History of an autoimmune disease
6. Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (b*) detected in serum.
7. HIV antibody detected in serum
8. Screening electrocardiogram (ECG) demonstrating a QTc interval = 450 ms
9. Finding on safety laboratory values as defined below:
9.1. AST > 2 x upper normal limit
9.2. ALT > 2 x upper normal limit
9.3. Anaemia (Hb < 10 g/dL),
9.4. Platelets < 150,000
9.5. Total bilirubin > 2 x upper normal limit
10. 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)
11. Positive malaria parasitaemia (RDT) at screening or baseline (Month 0, Day 0).
12. Receipt or planned receipt of an investigational medical product or participation in an interventional clinical trial during the study period
13. Contraindications to the use of artemisinins, piperaquine or primaquine*.
14. Use of medications with known potential interactions, prior allergic reactions to one or more components of the drug regimen.
15. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products)
16. History of clinically significant contact dermatitis.
17. Contraindication to intramuscular (IM) injection*
18. Administration of a vaccine not included in the study protocol within 7 days of a study vaccine (c*).
19. History of anaphylaxis post-vaccination.
20. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety measured using patient records:<br>1. Occurrence of solicited from the date of each vaccination to 7 days of each vaccination.<br>2. Occurrence of unsolicited adverse events (AEs) from the date of the first vaccination to 28 days after the last vaccination, according to the MedDRA classification.<br>3. Occurrence of serious adverse events (SAEs) during the whole study period, i.e. during a 6-month follow up period from the receipt of first vaccination, according to the MedDRA classification. <br>
- Secondary Outcome Measures
Name Time Method 1. For Arms 1 and 2, the concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody), one month after the first dose (at Study month 1), one month after the second dose (at Study month 2), one month after the third dose (at Study Month 3) and six months after the first dose (at Study Month 6). <br>2. Exploratory immunology endpoints including but not limited to cellular immunity at baseline, months 1, 2, 3, 6<br>3. For Arms 1 and 3, piperaquine levels following the administration of the antimalarials with or without vaccine<br><br>