MalariaPhase 1NCT02013687
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
A Phase 1 study testing Pfs25 VLP- FhCMB in people with Malaria, run by Fraunhofer, Center for Molecular Biotechnology at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Pfs25 VLP- FhCMB
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- History of malaria or previous receipt of an investigational malaria vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
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
- Conditions
- Malaria
- Being tested
- Pfs25 VLP- FhCMB
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfs25 VLP- FhCMBBiological
| Study group | Role | What they receive |
|---|---|---|
| 2 µg + Alhydrogel | Experimental | vaccine Receives: Biological: Pfs25 VLP- FhCMB |
| 10 µg + Alhydrogel | Experimental | vaccine Receives: Biological: Pfs25 VLP- FhCMB |
| 30 µg + Alhydrogel | Experimental | vaccine Receives: Biological: Pfs25 VLP- FhCMB |
| 100 µg + Alhydrogel | Experimental | vaccine Receives: Biological: Pfs25 VLP- FhCMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With at Least One Adverse Event
Measured: 336 days
Subjects With Solicited Systemic Adverse Events
Measured: 336 days
Subjects With Solicited Local Adverse Events
Measured: 336 days
Secondary outcomes (3)
Assessment of Anti-Pfs25 IgG Following the Third Immunization.
Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.
Measured: 196 days
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
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.
Measured: 84 days
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
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.
Measured: 196 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer, Center for Molecular Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013687
- Sponsor's protocol ID
- FhCMB Pfs25-001
- Status last verified
- Jan 2017
- First submitted
- 25 Nov 2013
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 30126674
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT02013687
- Acronym / sponsor ID
- FhCMB Pfs25-001
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fraunhofer, Center for Molecular BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 µg + Alhydrogel | Experimental | Biological: Pfs25 VLP- FhCMBvaccine |
| 10 µg + Alhydrogel | Experimental | Biological: Pfs25 VLP- FhCMBvaccine |
| 30 µg + Alhydrogel | Experimental | Biological: Pfs25 VLP- FhCMBvaccine |
| 100 µg + Alhydrogel | Experimental | Biological: Pfs25 VLP- FhCMBvaccine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (1 listed)
- History of malaria or previous receipt of an investigational malaria vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pfs25 VLP- FhCMB | Biological | 10 µg + Alhydrogel, 100 µg + Alhydrogel, 2 µg + Alhydrogel, 30 µg + Alhydrogel |
Primary outcome
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
3 secondary outcomes
Assessment of Anti-Pfs25 IgG Following the Third Immunization.
Time frame: 196 days
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
Time frame: 84 days
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
Time frame: 196 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30126674Chichester 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pfs25 VLP- FhCMB in people with Malaria, run by Fraunhofer, Center for Molecular Biotechnology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects With at Least One Adverse Event (time frame: 336 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.