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

Phase 1

Completed

• Conditions: Malaria
• Interventions: Biological: Pfs25 VLP- FhCMB

• Registration Number: NCT02013687
• Lead Sponsor: Fraunhofer, Center for Molecular Biotechnology

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Results First Submitted: 2016-11-21
• Results First Submitted QC: 2016-11-21
• Status Verified: 2017-01
• Results First Posted: 2017-01-18
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 µg + Alhydrogel	Pfs25 VLP- FhCMB	vaccine
10 µg + Alhydrogel	Pfs25 VLP- FhCMB	vaccine
30 µg + Alhydrogel	Pfs25 VLP- FhCMB	vaccine
2 µg + Alhydrogel	Pfs25 VLP- FhCMB	vaccine

Primary Outcome Measures

Name	Time	Method
Subjects With Solicited Systemic Adverse Events	336 days
Subjects With Solicited Local Adverse Events	336 days
Subjects With at Least One Adverse Event	336 days

Secondary Outcome Measures

Name	Time	Method
Assessment of Anti-Pfs25 IgG Following the Third Immunization.	196 days	Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite	196 days	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.

Trial Locations

Locations (1)

Accelovance; 🇺🇸 Rockville, Maryland, United States