Falciparum MalariaPhase 1PMAL03NCT00513669
Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania
A Phase 1 study testing PEV 301& 302 in virosomes and Inflexal V (active comparator) in people with Falciparum Malaria, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial summary
This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and children. Read more about this study
- Who is it for?
- Ages 5 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Falciparum Malaria
- What is being tested?
- PEV 301& 302 in virosomes and Inflexal V (active comparator)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTanzania
- Study dates
- Jan 2008to Mar 2009
- 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 5 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male volunteers aged between 18 and 45 years for the adult group, and children of both sexes aged 5-9 years for schoolchildren group
- Written informed consent obtained from the volunteer (adult) or guardian/ legal representative (children). In case patient is illiterate, an impartial witness should be present during the entire consent procedure
- Free of obvious health problems as established by medical history and clinical examination before entering the study
- Body Mass Index between 18 and 30 for adults; MUAC less than 12 for children
Who cannot join
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
- Any chronic drug therapy to be continued during the study period
- Any confirmed or suspected acquired immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or history of congenital or hereditary immunodeficiency
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever (defined as temperature more than 37.5°C)
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- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
- Acute or chronic diabetes
- History of chronic alcohol consumption and/or intravenous drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Double-blind Randomized Placebo Controlled Age-deescalating Trial of Two Virosome Formulated Anti-malaria Vaccine Components (PEV 301 and PEV 302) Administered in Combination to Healthy Semi-immune Tanzanian Volunteers
This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and children.
Read the detailed description
Volunteers will be screened, enrolled, injected with the vaccine or comparator and followed by the clinicians at the Bagamoyo Research and Training Unit of the the Ifakara Health Research and Development Center (BRTU-IHRDC).
First, 10 adult males will be enrolled and randomized in 2 groups: Group AV (n=8) will be injected with the vaccine combination and group AP (n=2) will be vaccinated with the placebo=comparator (Inflexal V). 5 weeks later, 8 children will be enrolled first and randomized in 2 groups: Group CV (n=6) will be injected with the vaccine combination and group CP (n=2) will be vaccinated with comparator. 1 week later, the rest of the cohort (n=32) will be enrolled and randomized in 2 groups: Group CV (n=26) will be injected with the vaccine combination and group CP (n=6) will be vaccinated with comparator.
Immunogenicity assessments for humoral immune response will be made at baseline (days -10 to -2), day 30 (+4), day 90 (+4) (day of 2nd vaccination), 120 (+4), 180 (+7), and 365 (+14).
Cellular immune responses will be assessed before 1st vaccination (day 0), two weeks after 2nd vaccination (day 104 ±2), and one year after the 1st vaccination (day 365) Safety assessments will be made by the investigator at baseline (days -10 to -2, before the 1st immunization) and at day 1, 2, 3, 7, 14, 30 after each vaccination.
- Conditions
- Falciparum Malaria
- Being tested
- PEV 301& 302 in virosomes, Inflexal V (active comparator)
- Keywords
- Malaria, Vaccine, Falciparum, Trial, Phase I, Safety, Immunogenicity
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEV 301& 302 in virosomesBiological
PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90
Inflexal V (active comparator)Biological
Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90
| Study group | Role | What they receive |
|---|---|---|
| 1 PEV301&302 | Experimental | The vaccine includes two antigens (CSP and AMA1- derived)in combination and formulated with virosomes Receives: Biological: PEV 301& 302 in virosomes |
| 2 Influenza vaccine | Active comparator | Inflexal V is the comparator that includes 3 antigens from flu formulated in virosomes Receives: Biological: Inflexal V (active comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (incidence of local and systemic adverse events) Humoral immunity
Measured: 30 days post-injection
Secondary outcomes (1)
Cell-mediated immunity
Measured: 14 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mymetics Corporation, Pevion Biotech Ltd
- Responsible party
- Sponsor
- Investigators
- Blaise Genton, MD PhD, Principal investigator, Swiss tropical institute, Ifakara Health Research and Development Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513669
- Sponsor's protocol ID
- PMAL03
- Acronym
- PMAL03
- Status last verified
- Mar 2013
- First submitted
- 8 Aug 2007
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cech PG, Aebi T, Abdallah MS, Mpina M, Machunda EB, Westerfeld N, Stoffel SA, Zurbriggen R, Pluschke G, Tanner M, Daubenberger C, Genton B, Abdulla S. Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. PLoS One. 2011;6(7):e22273. doi: 10.1371/journal.pone.0022273. Epub 2011 Jul 22.
PubMed 21799810
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Double-blind Randomized Placebo Controlled Age-deescalating Trial of Two Virosome Formulated Anti-malaria Vaccine Components (PEV 301 and PEV 302) Administered in Combination to Healthy Semi-immune Tanzanian Volunteers
- ClinicalTrials.gov ID
- NCT00513669
- Acronym / sponsor ID
- PMAL03 / PMAL03
- Conditions
- Falciparum Malaria
- Keywords
- Malaria, Vaccine, Falciparum, Trial, Phase I, Safety, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Mymetics Corporation, Pevion Biotech Ltd
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Aug 2007 (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.
This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and children.
Detailed description
Volunteers will be screened, enrolled, injected with the vaccine or comparator and followed by the clinicians at the Bagamoyo Research and Training Unit of the the Ifakara Health Research and Development Center (BRTU-IHRDC).
First, 10 adult males will be enrolled and randomized in 2 groups: Group AV (n=8) will be injected with the vaccine combination and group AP (n=2) will be vaccinated with the placebo=comparator (Inflexal V). 5 weeks later, 8 children will be enrolled first and randomized in 2 groups: Group CV (n=6) will be injected with the vaccine combination and group CP (n=2) will be vaccinated with comparator. 1 week later, the rest of the cohort (n=32) will be enrolled and randomized in 2 groups: Group CV (n=26) will be injected with the vaccine combination and group CP (n=6) will be vaccinated with comparator.
Immunogenicity assessments for humoral immune response will be made at baseline (days -10 to -2), day 30 (+4), day 90 (+4) (day of 2nd vaccination), 120 (+4), 180 (+7), and 365 (+14).
Cellular immune responses will be assessed before 1st vaccination (day 0), two weeks after 2nd vaccination (day 104 ±2), and one year after the 1st vaccination (day 365) Safety assessments will be made by the investigator at baseline (days -10 to -2, before the 1st immunization) and at day 1, 2, 3, 7, 14, 30 after each vaccination.
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 |
|---|---|---|
| 1 PEV301&302 | Experimental | Biological: PEV 301& 302 in virosomesThe vaccine includes two antigens (CSP and AMA1- derived)in combination and formulated with virosomes |
| 2 Influenza vaccine | Active comparator | Biological: Inflexal V (active comparator)Inflexal V is the comparator that includes 3 antigens from flu formulated in virosomes |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male volunteers aged between 18 and 45 years for the adult group, and children of both sexes aged 5-9 years for schoolchildren group
- Written informed consent obtained from the volunteer (adult) or guardian/ legal representative (children). In case patient is illiterate, an impartial witness should be present during the entire consent procedure
- Free of obvious health problems as established by medical history and clinical examination before entering the study
- Body Mass Index between 18 and 30 for adults; MUAC less than 12 for children
Key exclusion criteria (9 listed)
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
- Any chronic drug therapy to be continued during the study period
- Any confirmed or suspected acquired immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or history of congenital or hereditary immunodeficiency
- History of allergic disease or reactions likely to be exacerbated by any component of the 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 |
|---|---|---|
| PEV 301& 302 in virosomesPEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90 | Biological | 1 PEV301&302 |
| Inflexal V (active comparator)Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90 | Biological | 2 Influenza vaccine |
Primary outcome
Safety (incidence of local and systemic adverse events) Humoral immunity
Time frame: 30 days post-injection
1 secondary outcome
Cell-mediated immunity
Time frame: 14 days post-injection
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 15 Mar 2013.
- Derived from this study: PubMed 21799810Cech PG, Aebi T, Abdallah MS, Mpina M, Machunda EB, Westerfeld N, Stoffel SA, Zurbriggen R, Pluschke G, Tanner M, Daubenberger C, Genton B, Abdulla S. Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. PLoS One. 2011;6(7):e22273. doi: 10.1371/journal.pone.0022273. Epub 2011 Jul 22.
- Website of the Swiss Tropical InstituteLink provided by the sponsor.
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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
Swiss tropical institute, Ifakara Health Research and Development Center
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 PEV 301& 302 in virosomes and Inflexal V (active comparator) in people with Falciparum Malaria, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
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 9 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 15 Mar 2013. 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 Tanzania. 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?
Safety (incidence of local and systemic adverse events) Humoral immunity (time frame: 30 days post-injection). 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 NCT00513669, 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 15 Mar 2013.