Haematological Disorders Malaria Paediatrics
Conditions
Interventions
R21Matrix vaccine and Dihydroartemisinin piperaquine DHAPPQ
R21Matrix vaccine
Sponsors
Kumasi Center for Collaborative Research in Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. for Group A and B: The child will be 6 – 60 months of age at the time of first vaccination, has been admitted to the children`s ward of Saint Francis Xavier Hospital (SFXH) with severe anaemia (haemoglobin level <7.0 g/dL) or with severe P. falciparum malaria (WHO criteria for severe disease) 2. for Group C: healthy children aged 6 – 60 months of age at the time of first vaccination and from the same community irrespective of their hb level. 3. Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial. 4. The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study. 5. The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial.
Exclusion criteria
Exclusion criteria: 1. The child has previously received a malaria vaccine. 2. The child has received an investigational drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period. 3. The child is currently participating in another malaria intervention trial or any other clinical intervention trial likely to affect data interpretation of this trial. 4. The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria or control vaccine. 5. The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations or the study drug DHA-PPQ. 6. The child has a family history of sudden death or of congenital prolongation of the QTc interval, or takes concomitant medication known to prolong QTc interval, or has a prolonged QTc interval >440 ms in the baseline ECG. 7. Pathological biochemistry results (renal and liver function) of more than Grade 1 according to DAIDS Toxicity Scale for the Groups A and B (no biochemistry required for Group C). 8. The child has major congenital defects. 9. The child has severe anaemia associated with clinical signs or symptoms of decompensation, or a haemoglobin of = 5.0 g/dL with indication of blood transfusion. 10. The child has had a blood transfusion or any other blood product within three months of enrolment. 11. The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. 12. The child has severe malnutrition requiring hospital admission, taking into consideration weight-for-length/height and/or mid-upper arm circumference, presence of oedema (kwashiorkor) with or without severe wasting. 13. The child has a known severe acute or chronic disease, resulting in clinically significant pulmonary, cardiovascular and gastrointestinal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome Anti-NANP IgG GMT at Day 84 - the sole primary endpoint. It's tested two ways, hierarchically ordered: Superiority - Group A (R21/Matrix-M + DHA-PPQ) vs. Group B (DHA-PPQ alone), on anti-NANP IgG GMT at Day 84 (±3 days), as the correlate of protection. Non-inferiority - Group A vs. Group C (age-/sex-matched healthy vaccinated controls), same timepoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity (booster durability and response)- Anti-NANP IgG GMT in Groups A and C at Day 421 (pre-booster, ~12 months post-primary series) and Day 449 (28 days post-booster); booster response reported as GMT ratio (Day 449 ÷ Day 421).";Safety - solicited local/systemic AEs, unsolicited AEs, SAEs, and SUSARs, monitored continuously from Day 0 (first dose) through Day 449 (28 days post-booster), across Groups A, B, and C;Clinical outcomes - death, hospital readmission, clinical malaria, and severe anaemia, tracked from Day 0 (enrolment) to Day 449 (study end), across Groups A, B, and C.;Haemoglobin concentration (g/dL) at Day 0 (pre-intervention baseline), Day 84 (post-primary series), Day 421 (pre-booster, ~12 months post-primary series), and Day 449 (post-booster), across Groups A, B, and C. | — |
Countries
Ghana
Contacts
Public ContactIsaac Agyiri
Study Coordinator
Outcome results
None listed