Plasmodium Falciparum MalariaPhase 1NCT00730782
Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers
A Phase 1 study testing PfAMA-1-FVO[25-545] in people with Plasmodium Falciparum Malaria, run by European Vaccine Initiative at 2 sites in Netherlands.
Trial summary
The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- PfAMA-1-FVO[25-545]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2005to Aug 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 and < 45 years healthy volunteers.
- General good health based on history and clinical examination.
- All volunteers have to sign the informed consent form.
- Negative pregnancy test.
- Use of adequate contraception for females up to three months after the third injection (D140).
- Reachable by phone during the whole study period (18 months).
Who cannot join
- History of malaria or residence in malaria endemic areas within the past six months.
- Positive serology for malaria antigen PfAMA-1
- Previously participated in any malaria vaccine study
- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers.
- Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests.
- Volunteers should not be enrolled in any other clinical trial during the whole trial period.
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- Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period.
- Pregnant or lactating women.
- Volunteers unable to give written informed consent.
- Volunteers unable to be closely followed for social, geographic or psychological reasons.
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrollment in the study.
- Volunteers should not perform exercise four hours before blood draw and should not donate blood for non study-related purposes during the entire duration of the study.
- Known hypersensitivity to any of the vaccine components (adjuvant or peptide).
- Volunteers are not allowed to receive any vaccination or gammaglobulin during a period three months prior to the first immunization and up to six months after the 3rd immunization. If a vaccination is necessary during this period, the volunteer will be withdrawn from the study.
- Volunteers are not allowed to travel to malaria endemic countries during the study period.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboud University Nijmegen Medical Centre
Nijmegen
Biomedical Primate Research Centre
Rijswijk
About this study
Official title: Assessment of the Safety and Immunogenicity of Three Formulations of the Recombinant Pichia Pastoris Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]), Blood-Stage Malaria Vaccine in Healthy Dutch Adult Volunteers : a Phase 1, Single- Blind, Randomised, Dose-Escalating, Unicentre Trial
The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium falciparum.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- PfAMA-1-FVO[25-545]
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfAMA-1-FVO[25-545]Biological
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The experimental vaccine PfAMA1 formulated in Alhydrogel Receives: Biological: PfAMA-1-FVO[25-545] |
| 2 | Active comparator | The experimental vaccine PfAMA1 formulated in Montanide ISA720 Receives: Biological: PfAMA-1-FVO[25-545] |
| 3 | Active comparator | The experimental vaccine PfAMA1 formulated in ASO2A Receives: Biological: PfAMA-1-FVO[25-545] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactogenicity
Measured: Day 0-14 after each vaccination
Secondary outcomes (2)
Biological Safety
Measured: 28 days after each vaccination
Humoral and Cellular immunogenicity
Measured: until 365 days after the first immunisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Vaccine Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Biomedical Primate Research Centre, GlaxoSmithKline, Seppic
- Investigators
- Robert Sauerwein, Prof. MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730782
- Sponsor's protocol ID
- AMA-1_1_03
- Other IDs
- EUDRACT No 2005-00232-24
- Status last verified
- Aug 2008
- First submitted
- 6 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Remarque EJ, Roestenberg M, Younis S, Walraven V, van der Werff N, Faber BW, Leroy O, Sauerwein R, Kocken CH, Thomas AW. Humoral immune responses to a single allele PfAMA1 vaccine in healthy malaria-naive adults. PLoS One. 2012;7(6):e38898. doi: 10.1371/journal.pone.0038898. Epub 2012 Jun 29.
PubMed 22768052Roestenberg M, Remarque E, de Jonge E, Hermsen R, Blythman H, Leroy O, Imoukhuede E, Jepsen S, Ofori-Anyinam O, Faber B, Kocken CH, Arnold M, Walraven V, Teelen K, Roeffen W, de Mast Q, Ballou WR, Cohen J, Dubois MC, Ascarateil S, van der Ven A, Thomas A, Sauerwein R. Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1 malaria vaccine adjuvanted with Alhydrogel, Montanide ISA 720 or AS02. PLoS One. 2008;3(12):e3960. doi: 10.1371/journal.pone.0003960. Epub 2008 Dec 18.
PubMed 19093004
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Immunogenicity of Three Formulations of the Recombinant Pichia Pastoris Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]), Blood-Stage Malaria Vaccine in Healthy Dutch Adult Volunteers : a Phase 1, Single- Blind, Randomised, Dose-Escalating, Unicentre Trial
- ClinicalTrials.gov ID
- NCT00730782
- Acronym / sponsor ID
- AMA-1_1_03
- Conditions
- Plasmodium Falciparum Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- European Vaccine InitiativeUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Biomedical Primate Research Centre, GlaxoSmithKline, Seppic
- Study start
- Nov 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Aug 2008 (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.
The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium falciparum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: PfAMA-1-FVO[25-545]The experimental vaccine PfAMA1 formulated in Alhydrogel |
| 2 | Active comparator | Biological: PfAMA-1-FVO[25-545]The experimental vaccine PfAMA1 formulated in Montanide ISA720 |
| 3 | Active comparator | Biological: PfAMA-1-FVO[25-545]The experimental vaccine PfAMA1 formulated in ASO2A |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age > 18 and < 45 years healthy volunteers.
- General good health based on history and clinical examination.
- All volunteers have to sign the informed consent form.
- Negative pregnancy test.
- Use of adequate contraception for females up to three months after the third injection (D140).
Key exclusion criteria (15 listed)
- History of malaria or residence in malaria endemic areas within the past six months.
- Positive serology for malaria antigen PfAMA-1
- Previously participated in any malaria vaccine study
- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers.
- Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests.
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 |
|---|---|---|
| PfAMA-1-FVO[25-545]Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1 | Biological | 1, 2, 3 |
Primary outcome
Local and systemic reactogenicity
Time frame: Day 0-14 after each vaccination
2 secondary outcomes
Biological Safety
Time frame: 28 days after each vaccination
Humoral and Cellular immunogenicity
Time frame: until 365 days after the first immunisation
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 8 Aug 2008.
- Derived from this study: PubMed 22768052Remarque EJ, Roestenberg M, Younis S, Walraven V, van der Werff N, Faber BW, Leroy O, Sauerwein R, Kocken CH, Thomas AW. Humoral immune responses to a single allele PfAMA1 vaccine in healthy malaria-naive adults. PLoS One. 2012;7(6):e38898. doi: 10.1371/journal.pone.0038898. Epub 2012 Jun 29.
- Derived from this study: PubMed 19093004Roestenberg M, Remarque E, de Jonge E, Hermsen R, Blythman H, Leroy O, Imoukhuede E, Jepsen S, Ofori-Anyinam O, Faber B, Kocken CH, Arnold M, Walraven V, Teelen K, Roeffen W, de Mast Q, Ballou WR, Cohen J, Dubois MC, Ascarateil S, van der Ven A, Thomas A, Sauerwein R. Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1 malaria vaccine adjuvanted with Alhydrogel, Montanide ISA 720 or AS02. PLoS One. 2008;3(12):e3960. doi: 10.1371/journal.pone.0003960. Epub 2008 Dec 18.
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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.
Robert Sauerwein, Prof. MD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PfAMA-1-FVO[25-545] in people with Plasmodium Falciparum Malaria, run by European Vaccine Initiative at 2 sites in Netherlands.
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 6 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 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Local and systemic reactogenicity (time frame: Day 0-14 after each vaccination). 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 NCT00730782, which also lists 2 linked publications.
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 Aug 2008.