Malaria
Conditions
Interventions
Placebo group
Sponsors
Office of Clinical Research Policy and Regulatory Operations NIAID NIH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy infants aged 10 weeks of age (allowable range: 9 weeks to 13 weeks) 2. Weight =4.0 kg on day of dosing 3. Hemoglobin level =7 g/dL. 4. Height and weight Z-scores >-2. 5. Living within the catchment areas of the recruiting facilities. 6. Able to participate for the duration of the trial. 7. Parent and/or guardian of participant able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of an investigational malaria vaccine or MAb. 2. Participation or planned participation in any other interventional trial with an investigational product prior to the last required protocol visit or receipt of an investigational product within the past 30 days. (Note: Past, current, or planned participation in observational studies is NOT exclusionary.) 3. Clinically significant or serious congenital anomaly or documented or suspected serious medical illness, or immediate life-threatening condition in the infant that may interfere with the ability to complete study requirements, as judged by the examining clinician. 4. Current significant medical condition (neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, immunodeficiency, renal, oncologic, or hematological) or evidence of any serious underlying medical condition identified by medical history, physical examination, or laboratory examination OR history of any illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the participant’s participation in the protocol or compromise the scientific objectives, or other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol. a. Known sickle cell disease. (Note: Known sickle cell trait is NOT exclusionary.) b. White blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal for age. Participants may be included at the investigator’s discretion for values that are not clinically significant (i.e., do not require any repeat or follow-up). c. ALT or creatinine (Cr) level above the local laboratory-defined upper limit of normal for age. (Participants may be included at the investigator’s discretion for values that are not clinically sig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Incidence and severity of local and systemic AEs occurring within 7 days after the administration of L9LS, and incidence of unsolicited AEs and SAEs throughout the study period. 2.Clinical malaria (definition 1, see section 2.3.4) over 14 weeks after administration of L9LS or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical malaria (definition 1, see section 2.3.4) over 26 and 38 weeks after administration of L9LS or placebo. 2. Pf blood-stage infection as detected by microscopic examination of thick blood smear over 14, 26, and 38 weeks after administration of L9LS or placebo. 3. Pf blood-stage infection as detected by RT-PCR over 14, 26, and 38 weeks after administration of L9LS or placebo. 4. Incidence and severity of systemic adverse events (AEs) occurring within 7 days after the administration of each malaria vaccine dose 5. Total IgG anti-NANP antibody titers measured by ELISA 28 days and 72 days after the third malaria vaccination. 6. Measurement of ADA to L9LS in sera of recipients. 7. PK analysis of L9LS and the association of L9LS concentration with Pf infection risk. | — |
Countries
Kenya
Contacts
Public ContactTitus Kwambai
CoPI
Outcome results
None listed