Clinical trial NCT02013687: Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Official title: A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Lead sponsor: Fraunhofer, Center for Molecular Biotechnology
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Subjects With at Least One Adverse Event
timeFrame: 336 days
measure: Subjects With Solicited Systemic Adverse Events
timeFrame: 336 days
measure: Subjects With Solicited Local Adverse Events
timeFrame: 336 days
Secondary outcomes:
measure: Assessment of Anti-Pfs25 IgG Following the Third Immunization.
timeFrame: 196 days
measure: Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
timeFrame: 84 days
measure: Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
timeFrame: 196 days
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Accelovance
state: Maryland
Study officials:
References:
citation: 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.