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Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])

Primary Purpose

Malaria

Status

Unknown status

Phase

Phase 1

Locations

Mali

Study Type

Interventional

Intervention

Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]

AMA1

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria, vaccine, Apical Membrane Antigene, Mali, Adults

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Malaria Research and Training CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I, AMA1 vaccine

Arm Description

20 volunteers will receive 3 doses of the vaccine

Outcomes

Primary Outcome Measures

*Safety evaluation through:

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 Events 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 Outcome Measures

*Immunogenicity evaluation through:

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.

Full Information

NCT ID

NCT00431808

First Posted

February 5, 2007

Last Updated

April 1, 2008

Sponsor

African Malaria Network Trust

1. Study Identification

Unique Protocol Identification Number

NCT00431808

Brief Title

Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

June 2008 (Anticipated)

Study Completion Date

June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

African Malaria Network Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Malaria, vaccine, Apical Membrane Antigene, Mali, Adults

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

I, AMA1 vaccine

Arm Type

Experimental

Arm Description

20 volunteers will receive 3 doses of the vaccine

Intervention Type

Biological

Intervention Name(s)

Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]

Intervention Description

3 doses of AMA 1 vaccine

Intervention Type

Biological

Intervention Name(s)

AMA1

Intervention Description

50 micrograms of AMA1

Primary Outcome Measure Information:

Title

*Safety evaluation through:

Time Frame

1 year

Title

Solicited adverse events measured from day 0 to day 7 after each dose;

Time Frame

7 days

Title

Unsolicited adverse events measured up to one month after each dose;

Time Frame

84 days

Title

Serious Adverse Events measured during the 12 months of study duration.

Time Frame

1 year

Title

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

Title

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

Secondary Outcome Measure Information:

Title

*Immunogenicity evaluation through:

Time Frame

84 days

Title

The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA.

Time Frame

84 days

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahamadou A Thera, MD MPH

Organizational Affiliation

Malaria Research and Training Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Malaria Research and Training Center

City

Bandiagara

Country

Mali

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahamadou A Thera, MD MPH

Phone

+223 221 6361

mthera@mrtcbko.org

First Name & Middle Initial & Last Name & Degree

Ogobara K Doumbo, MD PhD

Phone

+223 222 8109

okd@ikatelnet.net

First Name & Middle Initial & Last Name & Degree

Drissa Coulibaly, MD

First Name & Middle Initial & Last Name & Degree

Mahamadou A Thera, MD MPH

12. IPD Sharing Statement

Citations:

PubMed Identifier

27577237

Citation

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.

Results Reference

derived

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Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])

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