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

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

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 Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Biological: Pfs25 VLP- FhCMB

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Accelovance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2 µg + Alhydrogel; vaccine	Biological: Pfs25 VLP- FhCMB
EXPERIMENTAL: 10 µg + Alhydrogel; vaccine	Biological: Pfs25 VLP- FhCMB
EXPERIMENTAL: 30 µg + Alhydrogel; vaccine	Biological: Pfs25 VLP- FhCMB
EXPERIMENTAL: 100 µg + Alhydrogel; vaccine	Biological: Pfs25 VLP- FhCMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fraunhofer, Center for Molecular Biotechnology

Publications and helpful links

General Publications

• Chichester JA, Green BJ, Jones RM, Shoji Y, Miura K, Long CA, Lee CK, Ockenhouse CF, Morin MJ, Streatfield SJ, Yusibov V. Safety and immunogenicity of a plant-produced Pfs25 virus-like particle as a transmission blocking vaccine against malaria: A Phase 1 dose-escalation study in healthy adults. Vaccine. 2018 Sep 18;36(39):5865-5871. doi: 10.1016/j.vaccine.2018.08.033. Epub 2018 Aug 17.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (ESTIMATE): December 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: FhCMB Pfs25-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED