This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
44
Accelovance
Rockville, Maryland, United States
Subjects With at Least One Adverse Event
Time frame: 336 days
Subjects With Solicited Systemic Adverse Events
Time frame: 336 days
Subjects With Solicited Local Adverse Events
Time frame: 336 days
Assessment of Anti-Pfs25 IgG Following the Third Immunization.
Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.
Time frame: 196 days
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.
Time frame: 84 days
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), showing ≥80% reduction of oocysts in Anopheles mosquito gut in ≥50% of the subjects with Study Day 196 sera (one month after the third vaccination) (Study Day 196) in either the 30 μg or 100 μg dose groups.
Time frame: 196 days
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