Prophylaxis Against Plasmodium Falciparum MalariaPhase 1NCT00284973
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
A Phase 1 study testing Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720 in people with Prophylaxis Against Plasmodium Falciparum Malaria, run by Shanghai Wanxing Bio-Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and immunogenicity of 3 doses and 2 vaccination schedules. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis Against Plasmodium Falciparum Malaria
- What is being tested?
- Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female ≥ 18 and ≤ 45 years of age
- Agrees not to donate blood during the course of the trial.
- Signed written informed consent provided.
- Available to participate for the study duration.
Who cannot join
- History of allergic reactions following any vaccination.
- Involvement in drug or other vaccine trial within four weeks prior to the trial.
- Acute illness within four weeks prior to the trial.
- Presence of fever at the time of vaccination, i.e. body temperature (by axillary) > 37.5 C.
- Presence of any chronic illness/disease including diabetes mellitus, tuberculosis, leprosy, epilepsy and hypertension determined by medical history or examination.
- Persons on systemic corticosteroids, immunomodulators or anticoagulants within four weeks prior to vaccination.
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- Persons with a history of allergic manifestations requiring treatment with injectable antihistamines, adrenaline or steroids.
- Pregnancy. Women should not be pregnant, lactating, or planning pregnancy throughout the study period. A urinary pregnancy test (immuno-chromatography) will be performed for all women of child-bearing potential at entry and prior to each vaccination. Adequate contraception throughout the study should be used if applicable.
- Sexually active woman not using contraceptives.
- Current smoker ( ≥ 20 cigarettes/day).
- History of malaria: persons with a known history of malaria or with positive markers for antibodies to malaria parasite by IFA and/or ELISA.
- History of residing in a malaria endemic region or malaria exposure (travel) within last two years.
- Abnormal hematology and clinical chemistry considered to be clinically significant.
- Abnormal urine routine test considered to be clinically significant
- Persons with positive markers for HBV (HBsAg) and/or HCV (Anti-HCV) infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ph-1 Double-Blind Randomized Control Study-Evaluate Safety & Immunogenicity of Wanxing Bio-Pharmaceuticals AMA-1/MSP-1 Recombinant Malaria Vaccine (PfCP-2.9) Adj. w/ Montanide ISA 720 Compared to Montanide ISA 720 Alone in Adult Volunteers
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and immunogenicity of 3 doses and 2 vaccination schedules.
This blood stage candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.
Read the detailed description
This is a double blind, randomized, controlled Phase I study of PfCp2.9, an experimental malaria vaccine candidate, adjuvanted with Montanide ISA 720.
The primary objective of this study is to assess the safety and reactogenicity of the vaccine in healthy Chinese adult volunteers.
- Being tested
- Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
- Keywords
- malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers.
Secondary outcomes (6)
To assess the immunogenicity of the PfCP-2.9/Montanide ISA 720 vaccine in healthy adult volunteers by evaluating and comparing antigen-specific antibody responses (anti-PfCP-2.9 ELISA) after each vaccination.
For exploratory analysis:
To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA
To assess the relationship between antibody levels as measured by ELISA with the corresponding degree of in vitro parasite growth inhibition as measured by GIA
To assess antigen-specific antibody responses by IFA after each vaccination
To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis Against Plasmodium Falciparum 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Second Military Medical University, World Health Organization, PATH
- Investigators
- Jinhong Hu, Dr., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284973
- Sponsor's protocol ID
- WanMal002
- Status last verified
- Apr 2007
- First submitted
- 30 Jan 2006
- Last updated
- 14 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph-1 Double-Blind Randomized Control Study-Evaluate Safety & Immunogenicity of Wanxing Bio-Pharmaceuticals AMA-1/MSP-1 Recombinant Malaria Vaccine (PfCP-2.9) Adj. w/ Montanide ISA 720 Compared to Montanide ISA 720 Alone in Adult Volunteers
- ClinicalTrials.gov ID
- NCT00284973
- Acronym / sponsor ID
- WanMal002
- Keywords
- malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Second Military Medical University, World Health Organization, PATH
- Study start
- Jan 2006
- First posted
- 1 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and immunogenicity of 3 doses and 2 vaccination schedules.
This blood stage candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.
Detailed description
This is a double blind, randomized, controlled Phase I study of PfCp2.9, an experimental malaria vaccine candidate, adjuvanted with Montanide ISA 720.
The primary objective of this study is to assess the safety and reactogenicity of the vaccine in healthy Chinese adult volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female ≥ 18 and ≤ 45 years of age
- Agrees not to donate blood during the course of the trial.
- Signed written informed consent provided.
- Available to participate for the study duration.
Key exclusion criteria (15 listed)
- History of allergic reactions following any vaccination.
- Involvement in drug or other vaccine trial within four weeks prior to the trial.
- Acute illness within four weeks prior to the trial.
- Presence of fever at the time of vaccination, i.e. body temperature (by axillary) > 37.5 C.
- Presence of any chronic illness/disease including diabetes mellitus, tuberculosis, leprosy, epilepsy and hypertension determined by medical history or examination.
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 |
|---|---|---|
| Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720 | Biological | – |
Primary outcome
To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers.
6 secondary outcomes
To assess the immunogenicity of the PfCP-2.9/Montanide ISA 720 vaccine in healthy adult volunteers by evaluating and comparing antigen-specific antibody responses (anti-PfCP-2.9 ELISA) after each vaccination.
For exploratory analysis:
To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA
To assess the relationship between antibody levels as measured by ELISA with the corresponding degree of in vitro parasite growth inhibition as measured by GIA
To assess antigen-specific antibody responses by IFA after each vaccination
To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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.
Jinhong Hu, Dr. principal investigator
Changhai Hospital
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 Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720 in people with Prophylaxis Against Plasmodium Falciparum Malaria, run by Shanghai Wanxing Bio-Pharmaceutical Co. Ltd. at 1 site in China.
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 4 inclusion and 15 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 14 Apr 2015. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2015.