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

Fraunhofer, Center for Molecular Biotechnology

Status and phase: Completed; Phase 1

Conditions: Malaria

Treatments: Biological: Pfs25 VLP- FhCMB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013687

FhCMB Pfs25-001

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

2 µg + Alhydrogel

Experimental group

Description:

vaccine

Treatment:

Biological: Pfs25 VLP- FhCMB

10 µg + Alhydrogel

Experimental group

Description:

vaccine

Treatment:

Biological: Pfs25 VLP- FhCMB

30 µg + Alhydrogel

Experimental group

Description:

vaccine

Treatment:

Biological: Pfs25 VLP- FhCMB

100 µg + Alhydrogel

Experimental group

Description:

vaccine

Treatment:

Biological: Pfs25 VLP- FhCMB