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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02013687
• Other study ID #: FhCMB Pfs25-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 25, 2013
• Last updated: June 16, 2015
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: June 2015
• Source: Fraunhofer, Center for Molecular Biotechnology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• Pfs25 VLP- FhCMB

Locations

Country	Name	City	State
United States	Accelovance	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Fraunhofer, Center for Molecular Biotechnology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		420 days	No