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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-01-31

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

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2 µg + Alhydrogel

vaccine

Group Type EXPERIMENTAL

Pfs25 VLP- FhCMB

Intervention Type BIOLOGICAL

10 µg + Alhydrogel

vaccine

Group Type EXPERIMENTAL

Pfs25 VLP- FhCMB

Intervention Type BIOLOGICAL

30 µg + Alhydrogel

vaccine

Group Type EXPERIMENTAL

Pfs25 VLP- FhCMB

Intervention Type BIOLOGICAL

100 µg + Alhydrogel

vaccine

Group Type EXPERIMENTAL

Pfs25 VLP- FhCMB

Intervention Type BIOLOGICAL

Interventions

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Pfs25 VLP- FhCMB

Intervention Type BIOLOGICAL

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:

1. At least one year post-menopausal
2. Surgically sterile
3. Willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and then for the study duration
4. 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.