Status:
ACTIVE_NOT_RECRUITING
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
Lead Sponsor:
Serum Institute of India Pvt. Ltd.
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Prevention of Malaria Transmission and Clinical Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 vacci...
Detailed Description
240 healthy adults (18-50 years of age) will be enrolled from Mali, Africa in a staggered manner by increasing Pfs230D1 dosing. Participants will be randomized by cohorts as (detailed below) to one o...
Eligibility Criteria
Inclusion
- 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
- 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.
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Known: Severe asthma, Autoimmune or antibody-mediated disease, Immunodeficiency, Seizure disorder, Asplenia or functional asplenia, Use of chronic oral or intravenous corticosteroids (excluding topical or nasal), Sickle cell disease.
- Any other condition that in the opinion of the investigator might jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or might render the subject unable to comply with the protocol.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06507605
Start Date
August 30 2024
End Date
October 1 2025
Last Update
August 17 2025
Active Locations (1)
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1
University of Science, Technique and Technology of Bamako (Usttb)
Bamako, Mali