NCT02013687

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 18, 2017

Completed
Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

November 25, 2013

Results QC Date

November 21, 2016

Last Update Submit

January 25, 2017

Conditions

Malaria

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Assessment of Anti-Pfs25 IgG Following the Third Immunization.

    196 days

  • Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite

    84 days

  • Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite

    196 days

Study Arms (4)

2 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: Pfs25 VLP- FhCMB

10 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: Pfs25 VLP- FhCMB

30 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: Pfs25 VLP- FhCMB

100 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: Pfs25 VLP- FhCMB

Interventions

Pfs25 VLP- FhCMBBIOLOGICAL
10 µg + Alhydrogel100 µg + Alhydrogel2 µg + Alhydrogel30 µg + Alhydrogel

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accelovance

Rockville, Maryland, 20850, United States

Location

Related Publications (1)

  • 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.

    PMID: 30126674DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Results Point of Contact

Title
Dr. Jessica Chichester, Senior Scientist Immunology
Organization
Fraunhofer USA Center for Molecular Biotechnology
jessica.chichester@fhcmb.org
302-369-3635

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 17, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

January 1, 2015

Last Updated

March 8, 2017

Results First Posted

January 18, 2017

Record last verified: 2017-01

Locations

US(1)