Plasmodium Falciparum MalariaPhase 1/2DG002NCT01031524
Trial to Assess the Efficacy of Malaria Vaccine PfCS 102
A Phase 1/2 study testing PfCS102 and Montanide ISA 720 in people with Plasmodium Falciparum Malaria, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
Trial summary
Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- PfCS102 and Montanide ISA 720
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2004to Nov 2004
- Phase
- Phase 1/2
- 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
- resident in or near Lausanne;
- age >18 and <45 years;
- written informed consent;
- >10/12 correct responses to the questionnaire of understanding.
Who cannot join
- history of malaria; possible exposure to malaria within the previous 6 months;
- positive serology for PfCS102by ELISA;
- history of severe reactions or allergy to mosquito bites, artemether/lumefantrine (Riamet®) or vaccines;
- pregnant or lactating female;
- any confirmed or suspected immunodeficient condition;
- seropostivity for HIV;
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- chronic or active neurological, gastrointestinal, cardio-vascular or respiratory disease;
- hemoglobinopathies;
- history of >2 hospitalisations for invasive bacterial infections;
- requirement of any chronic medication;
- suspected or known current alcohol or illegal drug abuse (excluding cannabis);
- any other significant finding which, in the opinion of the investigator, would significantly increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study;
- a body mass index < 18kg/m2 or > 32 kg/m2;
- evidence of past or present psychiatric condition;
- seropositivity for HIV, hepatitis C or B (other than HBs Ab);
- 10-year risk of coronary heart disease <10%;
- any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ambulatory Care and Community Medicine; University Hospital
Lausanne, 1011
About this study
Official title: Randomized Double-blind Controlled Phase I/IIa Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (282-383) to Protect Against Artificial Challenge With P. Falciparum
Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- PfCS102, Montanide ISA 720
- Keywords
- Plasmodium falciparum malaria
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfCS102Biological
Antigen of the sporozoite protein
Montanide ISA 720Biological
adjuvant alone
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Experimental | 30 µg of PfCS102 formulated in Montanide ISA 720 Receives: Biological: PfCS102 |
| adjuvant | Placebo comparator | Montanide ISA 720 Receives: Biological: Montanide ISA 720 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy
Measured: 1month
Secondary outcomes (1)
Incidence of adverse events
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startMar 2004
- Primary completionJul 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Radboud University Medical Center
- Investigators
- Blaise Genton, MD PhD, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031524
- Sponsor's protocol ID
- 09/04
- Acronym
- DG002
- Status last verified
- Dec 2009
- First submitted
- 9 Dec 2009
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Phase I/IIa Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (282-383) to Protect Against Artificial Challenge With P. Falciparum
- ClinicalTrials.gov ID
- NCT01031524
- Acronym / sponsor ID
- DG002 / 09/04
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Plasmodium falciparum malaria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Radboud University Medical Center
- Study start
- Mar 2004
- Primary completion
- Jul 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 14 Dec 2009 (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.
Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccine | Experimental | Biological: PfCS10230 µg of PfCS102 formulated in Montanide ISA 720 |
| adjuvant | Placebo comparator | Biological: Montanide ISA 720Montanide ISA 720 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- resident in or near Lausanne;
- age >18 and <45 years;
- written informed consent;
- >10/12 correct responses to the questionnaire of understanding.
Key exclusion criteria (17 listed)
- history of malaria; possible exposure to malaria within the previous 6 months;
- positive serology for PfCS102by ELISA;
- history of severe reactions or allergy to mosquito bites, artemether/lumefantrine (Riamet®) or vaccines;
- pregnant or lactating female;
- any confirmed or suspected immunodeficient condition;
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 |
|---|---|---|
| PfCS102Antigen of the sporozoite protein | Biological | vaccine |
| Montanide ISA 720adjuvant alone | Biological | adjuvant |
Primary outcome
Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy
Time frame: 1month
1 secondary outcome
Incidence of adverse events
Time frame: 15 days
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 Dec 2009.
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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.
Blaise Genton, MD PhD principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PfCS102 and Montanide ISA 720 in people with Plasmodium Falciparum Malaria, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
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 17 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 Dec 2009. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy (time frame: 1month). 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 Dec 2009.