Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
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ClinicalTrials.gov Identifier: NCT02013687 |
Recruitment Status :
Completed
First Posted : December 17, 2013
Results First Posted : January 18, 2017
Last Update Posted : March 8, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malaria | Biological: Pfs25 VLP- FhCMB | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 Start Date : | October 2013 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: 2 µg + Alhydrogel
vaccine
|
Biological: Pfs25 VLP- FhCMB |
Experimental: 10 µg + Alhydrogel
vaccine
|
Biological: Pfs25 VLP- FhCMB |
Experimental: 30 µg + Alhydrogel
vaccine
|
Biological: Pfs25 VLP- FhCMB |
Experimental: 100 µg + Alhydrogel
vaccine
|
Biological: Pfs25 VLP- FhCMB |
- Subjects With at Least One Adverse Event [ Time Frame: 336 days ]
- Subjects With Solicited Systemic Adverse Events [ Time Frame: 336 days ]
- Subjects With Solicited Local Adverse Events [ Time Frame: 336 days ]
- Assessment of Anti-Pfs25 IgG Following the Third Immunization. [ Time Frame: 196 days ]Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.
- Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite [ Time Frame: 84 days ]Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.
- Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:
- 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.
Exclusion Criteria:
- History of malaria or previous receipt of an investigational malaria vaccine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013687
United States, Maryland | |
Accelovance | |
Rockville, Maryland, United States, 20850 |
Responsible Party: | Fraunhofer, Center for Molecular Biotechnology |
ClinicalTrials.gov Identifier: | NCT02013687 |
Other Study ID Numbers: |
FhCMB Pfs25-001 |
First Posted: | December 17, 2013 Key Record Dates |
Results First Posted: | January 18, 2017 |
Last Update Posted: | March 8, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases |