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

Fraunhofer, Center for Molecular Biotechnology1 site in 1 country44 target enrollmentOctober 2013

ConditionsMalaria

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Malaria
Sponsor: Fraunhofer, Center for Molecular Biotechnology
Enrollment: 44
Locations: 1
Primary Endpoint: Subjects With Solicited Systemic Adverse Events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

January 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fraunhofer, Center for Molecular Biotechnology

Responsible Party

Sponsor

Eligibility Criteria

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.

Exclusion Criteria

•History of malaria or previous receipt of an investigational malaria vaccine

Outcomes

Primary Outcomes

Subjects With Solicited Systemic Adverse Events

Time Frame: 336 days

Subjects With Solicited Local Adverse Events

Time Frame: 336 days

Subjects With at Least One Adverse Event

Time Frame: 336 days

Secondary Outcomes

Assessment of Anti-Pfs25 IgG Following the Third Immunization.(196 days)
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite(196 days)