Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults (NCT06507605) | Clinical Trial Compass
CompletedPhase 1
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
Mali240 participantsStarted 2024-08-30
Plain-language summary
This is a Phase 1, individually randomized, double-blind, dose escalating study designed to evaluate the safety, tolerability, and immunogenicity of Pfs230D1 conjugate vaccines, R21 nanoparticle vaccine, or their combination conjugate vaccines, formulated on Matrix-M in healthy African adults aged 18 to 50 years.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Age: 18 to 50 years old.
✓. Provides written informed consent.
✓. Able to understand and comply with planned study procedures and be available for the duration of the trial.
✓. In good general health and without clinically significant medical history in the opinion of the investigator.
✓. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 1 and until 1 month after the last vaccination.
Exclusion criteria
✕. Pregnant and breastfeeding females.
✕. Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory-defined reference ranges.
✕. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of reference range.
✕. Infected with HIV, hepatitis B, hepatitis C.
✕. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies.
✕. Current or planned participation in an investigational product study until the time period of the last required study visit under this protocol.
✕
What they're measuring
1
Number of Participants with Immediate adverse events
Timeframe: within 30-minutes following each dose
2
Number of Participants with Solicited local adverse events
Timeframe: for 7 days following each dose
3
Number of Participants with Solicited systemic adverse events
Timeframe: for 7 days following each dose
4
Number of Participants with Unsolicited adverse events
Timeframe: for 28 days following each dose
5
Number of Participants with Abnormal Laboratory Values post-vaccination
Timeframe: within 7 days following each dose
6
Number of Participants with Serious adverse events