Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults

Study Overview
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Brief Summary
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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

Official Title
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A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults

Conditions
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Malaria

Intervention / Treatment
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* Biological: Pfs25 VLP- FhCMB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating female aged 18 - 50 years inclusive Able to give written informed consent obtained prior to screening Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose. Females should fulfill one of the following criteria: At least one year post-menopausal Surgically sterile Willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and then for the study duration Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the Investigator (e.g., intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination through 9 months after third vaccination Comprehension of the study requirements, as demonstrated by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial comprehension assessment will be given the opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will not be enrolled. Available and able to participate in all planned study visits and procedures. Exclusion Criteria: History of malaria or previous receipt of an investigational malaria vaccine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 µg + Alhydrogel<br>vaccine | Biological: Pfs25 VLP- FhCMB<br> <br> |
| Experimental: 10 µg + Alhydrogel<br>vaccine | Biological: Pfs25 VLP- FhCMB<br> <br> |
| Experimental: 30 µg + Alhydrogel<br>vaccine | Biological: Pfs25 VLP- FhCMB<br> <br> |
| Experimental: 100 µg + Alhydrogel<br>vaccine | Biological: Pfs25 VLP- FhCMB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With at Least One Adverse Event |  | 336 days | 
| Subjects With Solicited Systemic Adverse Events |  | 336 days | 
| Subjects With Solicited Local Adverse Events |  | 336 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Anti-Pfs25 IgG Following the Third Immunization. | Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay. | 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. | 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. | 196 days |