MalariaPhase 1NCT00431808
Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])
A Phase 1 study testing Malaria vaccine AMA1 (PfAMA-1-FVO[25-545] and AMA1 in people with Malaria, run by African Malaria Network Trust at 1 site in Mali.
Trial summary
This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Malaria vaccine AMA1 (PfAMA-1-FVO[25-545] and AMA1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMali
- Study dates
- May 2007to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55 years inclusive at the time of screening
- Residing in Bandiagara for the duration of the study
- Separate written informed consent obtained before screening and study start, respectively
- Available to participate in follow-up for the duration of study (14 months)
- General good health based on history and clinical examination
- Willingness not to become pregnant during the first five months of the study for female participants
Who cannot join
- Previous vaccination with a investigational vaccine or a rabies vaccine
- Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids
- Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Confirmed or suspected autoimmune disease
- History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
Show all 16Show fewer
- History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
- History of allergy to vaccines components
- History of splenectomy
- Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25 times the upper limit of normal of the testing laboratory).
- Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing).
- Laboratory evidence of hematologic disease (absolute leukocyte count <4000/mm3 or >14,500/mm3, absolute lymphocyte count <1500/mm3, platelet count <120,000/mm3, or hemoglobin <10.0 g/dL).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period.
- Simultaneous participation in any other interventional clinical trial
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, malnutrition, or any other clinical findings that in the opinion of the PI may increase the risk of participating in the study
- Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
Mali1 site, 1 recruiting
- Recruiting
Malaria Research and Training Center
Bandiagara
Mahamadou A Thera, MD MPH, +223 221 6361, mthera@mrtcbko.org
Ogobara K Doumbo, MD PhD, +223 222 8109, okd@ikatelnet.net
About this study
Official title: Randomized Controlled Trial to Evaluate the Safety and Immunogenicity of Recombinant Pichia Pastoris-Expressed P. Falciparum Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) Versus Tetanus Toxoid, in Healthy Malian Adult in Bandiagara
This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be follow-up up for immediate reactions to vaccination, and also over a longer term of one year. Blood will be taken to evaluate the biological safety parameters and also immune responses.
Read the detailed description
This will be a randomized controlled trial to evaluate the Safety and Immunogenicity of recombinant pichia pastoris blood stage malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) versus tetanus toxoid, in healthy Malian adults in Bandiagara.
A phase Ia trial is currently ongoing and its interim results will be used to select the best dose/adjuvant combination to be brought to Africa. The trial is evaluating safety and immunogenicity of AMA-1 (10 µg or 50 µg) adjuvanted with aluminum hydroxide or Montanide ISA 720, or ASO2.
- Primary objective:
- To evaluate the safety of one dose of AMA-1 (10 µg or 50 µg) adjuvanted with aluminum hydroxide or Montanide ISA 720, or ASO2, given at D0, D28 and D56 in healthy Malian adults.
- Secondary Objectives:
- To assess the humoral response to the vaccine antigen by measuring the variation in the level of IgG and its ability to recognize the native protein on merozoites.
- To assess the cellular immune response by measuring the T cell proliferation and cytokine production following in vitro stimulation with the vaccine antigen.
The primary immunizations will be administered on days 0, 28 and a boost given at day 56. The participants will be followed up actively during the vaccination phase, and passively for one another 9 months. The will be 19 scheduled clinic visits and following will the the schedule for obtaining serology data D-28, D0, D28, D56, D84, D140 and D365
- The primary evaluation will include the following:
- Solicited adverse events measured from day 0 to day 7 after each dose;
- Unsolicited adverse events measured up to one month after each dose;
- Serious Adverse Event (SAE) measured during the 12 months of study duration.
- Biological safety: two and four weeks after each vaccination, and thereafter every 12 weeks, in reference with the baseline before the first dose, by measuring the following RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, platelets, WBC with differential counts, potassium, sodium, ASAT, ALAT, total bilirubin, alkaline phosphatase, γGT, creatinin.
- Secondary evaluation criteria:
- The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA.
- An IFA for at least two parasite strains will be used to verify that the antibodies elicited by the vaccine recognize the native protein on merozoites
- Statistical methods:
Descriptive methods shall be employed to evaluate the above criteria.
- Conditions
- Malaria
- Being tested
- Malaria vaccine AMA1 (PfAMA-1-FVO[25-545], AMA1
- Keywords
- Malaria, vaccine, Apical Membrane Antigene, Mali, Adults
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]Biological
3 doses of AMA 1 vaccine
AMA1Biological
50 micrograms of AMA1
| Study group | Role | What they receive |
|---|---|---|
| I, AMA1 vaccine | Experimental | 20 volunteers will receive 3 doses of the vaccine Receives: Biological: Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]; Biological: AMA1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
*Safety evaluation through:
Measured: 1 year
Solicited adverse events measured from day 0 to day 7 after each dose;
Measured: 7 days
Unsolicited adverse events measured up to one month after each dose;
Measured: 84 days
Serious Adverse Events measured during the 12 months of study duration.
Measured: 1 year
Biological safety: two and four weeks after each vaccination, and thereafter every 12 weeks, in reference with the baseline before the first dose, by measuring the following :
Measured: 1 year
RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, platelets, WBC with differential counts, potassium, sodium, ASAT, ALAT, total bilirubin, alkaline phosphatase, γGT, creatinin
Measured: 1 year
Secondary outcomes (3)
*Immunogenicity evaluation through:
Measured: 84 days
The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA.
Measured: 84 days
An IFA for at least two parasite strains will be used to verify that the antibodies elicited by the vaccine recognize the native protein on merozoites.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
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 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- African Malaria Network Trust
- Sponsor type
- Research network
- Investigators
- Mahamadou A Thera, MD MPH, Principal investigator, Malaria Research and Training Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431808
- Sponsor's protocol ID
- AMA1_02_07
- Other IDs
- MU-08
- Status last verified
- Apr 2008
- First submitted
- 5 Feb 2007
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thera MA, Coulibaly D, Kone AK, Guindo AB, Traore K, Sall AH, Diarra I, Daou M, Traore IM, Tolo Y, Sissoko M, Niangaly A, Arama C, Baby M, Kouriba B, Sissoko MS, Sagara I, Toure OB, Dolo A, Diallo DA, Remarque E, Chilengi R, Noor R, Sesay S, Thomas A, Kocken CH, Faber BW, Imoukhuede EB, Leroy O, Doumbo OK. Phase 1 randomized controlled trial to evaluate the safety and immunogenicity of recombinant Pichia pastoris-expressed Plasmodium falciparum apical membrane antigen 1 (PfAMA1-FVO [25-545]) in healthy Malian adults in Bandiagara. Malar J. 2016 Aug 30;15(1):442. doi: 10.1186/s12936-016-1466-4.
PubMed 27577237
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Safety and Immunogenicity of Recombinant Pichia Pastoris-Expressed P. Falciparum Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) Versus Tetanus Toxoid, in Healthy Malian Adult in Bandiagara
- ClinicalTrials.gov ID
- NCT00431808
- Acronym / sponsor ID
- AMA1_02_07
- Conditions
- Malaria
- Keywords
- Malaria, vaccine, Apical Membrane Antigene, Mali, Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- African Malaria Network TrustResearch network
- Study start
- May 2007
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 6 Feb 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 study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be follow-up up for immediate reactions to vaccination, and also over a longer term of one year. Blood will be taken to evaluate the biological safety parameters and also immune responses.
Detailed description
This will be a randomized controlled trial to evaluate the Safety and Immunogenicity of recombinant pichia pastoris blood stage malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) versus tetanus toxoid, in healthy Malian adults in Bandiagara.
A phase Ia trial is currently ongoing and its interim results will be used to select the best dose/adjuvant combination to be brought to Africa. The trial is evaluating safety and immunogenicity of AMA-1 (10 µg or 50 µg) adjuvanted with aluminum hydroxide or Montanide ISA 720, or ASO2.
- Primary objective:
- To evaluate the safety of one dose of AMA-1 (10 µg or 50 µg) adjuvanted with aluminum hydroxide or Montanide ISA 720, or ASO2, given at D0, D28 and D56 in healthy Malian adults.
- Secondary Objectives:
- To assess the humoral response to the vaccine antigen by measuring the variation in the level of IgG and its ability to recognize the native protein on merozoites.
- To assess the cellular immune response by measuring the T cell proliferation and cytokine production following in vitro stimulation with the vaccine antigen.
The primary immunizations will be administered on days 0, 28 and a boost given at day 56. The participants will be followed up actively during the vaccination phase, and passively for one another 9 months. The will be 19 scheduled clinic visits and following will the the schedule for obtaining serology data D-28, D0, D28, D56, D84, D140 and D365
- The primary evaluation will include the following:
- Solicited adverse events measured from day 0 to day 7 after each dose;
- Unsolicited adverse events measured up to one month after each dose;
- Serious Adverse Event (SAE) measured during the 12 months of study duration.
- Biological safety: two and four weeks after each vaccination, and thereafter every 12 weeks, in reference with the baseline before the first dose, by measuring the following RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, platelets, WBC with differential counts, potassium, sodium, ASAT, ALAT, total bilirubin, alkaline phosphatase, γGT, creatinin.
- Secondary evaluation criteria:
- The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA.
- An IFA for at least two parasite strains will be used to verify that the antibodies elicited by the vaccine recognize the native protein on merozoites
- Statistical methods:
Descriptive methods shall be employed to evaluate the above criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I, AMA1 vaccine | Experimental | Biological: Malaria vaccine AMA1 (PfAMA-1-FVO[25-545], Biological: AMA120 volunteers will receive 3 doses of the vaccine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-55 years inclusive at the time of screening
- Residing in Bandiagara for the duration of the study
- Separate written informed consent obtained before screening and study start, respectively
- Available to participate in follow-up for the duration of study (14 months)
- General good health based on history and clinical examination
Key exclusion criteria (16 listed)
- Previous vaccination with a investigational vaccine or a rabies vaccine
- Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids
- Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Confirmed or suspected autoimmune disease
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 |
|---|---|---|
| Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]3 doses of AMA 1 vaccine | Biological | I, AMA1 vaccine |
| AMA150 micrograms of AMA1 | Biological | I, AMA1 vaccine |
Primary outcome
*Safety evaluation through:
Time frame: 1 year
Solicited adverse events measured from day 0 to day 7 after each dose;
Time frame: 7 days
Unsolicited adverse events measured up to one month after each dose;
Time frame: 84 days
Serious Adverse Events measured during the 12 months of study duration.
Time frame: 1 year
Biological safety: two and four weeks after each vaccination, and thereafter every 12 weeks, in reference with the baseline before the first dose, by measuring the following :
Time frame: 1 year
RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, platelets, WBC with differential counts, potassium, sodium, ASAT, ALAT, total bilirubin, alkaline phosphatase, γGT, creatinin
Time frame: 1 year
3 secondary outcomes
*Immunogenicity evaluation through:
Time frame: 84 days
The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA.
Time frame: 84 days
An IFA for at least two parasite strains will be used to verify that the antibodies elicited by the vaccine recognize the native protein on merozoites.
Time frame: 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
- Derived from this study: PubMed 27577237Thera MA, Coulibaly D, Kone AK, Guindo AB, Traore K, Sall AH, Diarra I, Daou M, Traore IM, Tolo Y, Sissoko M, Niangaly A, Arama C, Baby M, Kouriba B, Sissoko MS, Sagara I, Toure OB, Dolo A, Diallo DA, Remarque E, Chilengi R, Noor R, Sesay S, Thomas A, Kocken CH, Faber BW, Imoukhuede EB, Leroy O, Doumbo OK. Phase 1 randomized controlled trial to evaluate the safety and immunogenicity of recombinant Pichia pastoris-expressed Plasmodium falciparum apical membrane antigen 1 (PfAMA1-FVO [25-545]) in healthy Malian adults in Bandiagara. Malar J. 2016 Aug 30;15(1):442. doi: 10.1186/s12936-016-1466-4.
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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.
Mahamadou A Thera, MD MPH principal investigator
Malaria Research and Training 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 Malaria vaccine AMA1 (PfAMA-1-FVO[25-545] and AMA1 in people with Malaria, run by African Malaria Network Trust at 1 site in Mali.
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 16 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: status not confirmed, as of the sponsor's last update on 3 Apr 2008. 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 Mali. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
*Safety evaluation through: (time frame: 1 year). The study lists 6 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 NCT00431808, 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 3 Apr 2008.