MalariaPhase 1NCT00487916
Phase 1 Study of the Safety, Reactogenicity, and Immunogenicity of AMA1-C1/ISA 720: Blood Stage Vaccine for Plasmodium Falciparum
A Phase 1 study testing AMA1-C1/ISA 720 in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Australia.
Trial summary
This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA. Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500 million malaria cases worldwide each year. About 2 to 3 million deaths annually are from malaria alone or along with other diseases. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Malaria
- What is being tested?
- AMA1-C1/ISA 720
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Jun 2007to 5 Feb 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females between 18 and 45 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of the trial (48 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
- For female subjects: Negative pregnancy tests at Screening and Day 0, in conjunction with a history indicating a low probability of pregnancy in the opinion of the physician. Sexually active females of childbearing potential will be required to be correctly using an efficacious method of contraception for at least 1 month before randomization and during the on-study phase to Month 7. Female subjects unable to become pregnant must have this documented (e.g. tubal ligation, hysterectomy, or postmenopausal [at least one year since last menstrual period]).
Who cannot join
- History of malaria, residence for more than 1 month in a malaria endemic area (as determined by interview), or plans to visit a malaria endemic area during the study period.
- For female subjects: Positive pregnancy test at screening or Day 0, as well as those currently lactating and breast feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
- 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 confirmed by repeat testing of clean-catch, midstream sample). (More than trace blood on urine dipstick will not exclude a female who is actively menstruating).
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- Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 11,500/mm(3); hemoglobin less than 0.9 times the lower limit of normal of the testing laboratory, by gender; absolute granulocyte count less than 1300/mm(3); absolute lymphocyte count less than 1000/mm(3); or platelet count less than 11,000/mm(3)).
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing.
- Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma. This will be defined as:
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or parenteral corticosteroids.
- Clinically significant reactive airway disease that does not respond to bronchodilators.
- Positive ELISA for anti-HCV.
- Positive hepatitis B surface antigen (HBsAg) by ELISA.
- Positive ELISA for anti-HIV.
- Use of systemic corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
- Receipt of a live vaccine within past 4 weeks or non-live vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- Previous receipt of an investigational malaria vaccine.
- History of a known allergy to nickel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of the Safety, Reactogenicity and Immunogenicity of AMA1-C1/ISA 720: A Blood Stage Vaccine for Plasmodium Falciparum
This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA. Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500 million malaria cases worldwide each year. About 2 to 3 million deaths annually are from malaria alone or along with other diseases. Researchers hope to find a vaccine to fight malaria.
Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no history of malaria, and have not lived for more than 1 month in an area where malaria is prevalent may be eligible for this study. There will be 28 participants, each assigned to one of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1 formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and causing disease. This study is the first time the vaccine will be given to human beings for testing.
Read more
Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests. The study will last 48 weeks. One or two vaccinations are given by injection, at least 12 weeks apart. After each vaccination, patients will be asked to stay in the clinic for at least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and 56 after each vaccination. There will be a check of vital signs, brief physical exam, history of symptoms and medications taken since the last visit, and blood tests to check for vaccine safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients will receive a thermometer, diary card, and plastic measuring device. Each day they will record their temperatures and any symptoms, and measure the size of any reactions at the vaccination site. They will be asked to do this for 27 days after vaccinations.
After injections, there may be pain, swelling, and redness at the vaccination site, and limitation of arm movement. General side effects from the vaccine may be fever, chills, headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have researchers keep any unused serum samples, for use only in research into malaria and other diseases. Genetic testing would not be done on those samples. Stored samples will be labeled with a code, and information is kept private.
Read the detailed description
AMA1-C1 with Montanide ISA 720, is a blood stage malaria vaccine candidate. The objectives of this phase 1 trial are to study the safety, reactogenicity, and immunogenicity of this vaccine and to assess the level, kinetics, and the in vitro biological activity of the antibody response it induces. The study is an open label, dose escalation, phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 28 participants will be enrolled into 3 dose cohorts. Cohort 1 will receive 5 micrograms of AMA1-C1/ISA 720 at each injection, Cohort 2 will receive 20 micrograms, and Cohort 3 will receive 80 micrograms. Cohorts 1 and 2 will receive 2 injections, 3 months apart. Cohort 3 will receive only 1 vaccination. Safety outcome measures are local and systemic (including laboratory) adverse events. Immune responses to vaccination will be measured by enzyme-linked immunosorbent assay (ELISA) and parasite growth inhibition assay (GIA), and will be compared among dose groups.
- Conditions
- Malaria
- Being tested
- AMA1-C1/ISA 720
- Keywords
- Blood Stage, Investigational, Vaccine, Malaria, Healthy Volunteer, HV
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMA1-C1/ISA 720Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety and reactogenicity of the AMA1-C1/ISA 720 vaccine; and to determine the frequency of systemic and local AEs as recorded for 28 days following each vaccination.
Secondary outcomes (1)
Assessment of the level, kinetics and the in-vitro biological activity of the antibody response to AMA1-FVO and AMA1-3D7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study start13 Jun 2007
- Primary completion5 Feb 2009
- Study completion5 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487916
- Sponsor's protocol ID
- 999907170
- Other IDs
- 07-I-N170
- Status last verified
- 22 Sep 2009
- First submitted
- 16 Jun 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Narum DL, Thomas AW. Differential localization of full-length and processed forms of PF83/AMA-1 an apical membrane antigen of Plasmodium falciparum merozoites. Mol Biochem Parasitol. 1994 Sep;67(1):59-68. doi: 10.1016/0166-6851(94)90096-5.
PubMed 7838184Crewther PE, Culvenor JG, Silva A, Cooper JA, Anders RF. Plasmodium falciparum: two antigens of similar size are located in different compartments of the rhoptry. Exp Parasitol. 1990 Feb;70(2):193-206. doi: 10.1016/0014-4894(90)90100-q.
PubMed 2404781Waters AP, Thomas AW, Deans JA, Mitchell GH, Hudson DE, Miller LH, McCutchan TF, Cohen S. A merozoite receptor protein from Plasmodium knowlesi is highly conserved and distributed throughout Plasmodium. J Biol Chem. 1990 Oct 15;265(29):17974-9.
PubMed 2211675
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety, Reactogenicity and Immunogenicity of AMA1-C1/ISA 720: A Blood Stage Vaccine for Plasmodium Falciparum
- ClinicalTrials.gov ID
- NCT00487916
- Acronym / sponsor ID
- 999907170
- Conditions
- Malaria
- Keywords
- Blood Stage, Investigational, Vaccine, Malaria, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 13 Jun 2007
- Primary completion
- 5 Feb 2009 (actual)
- Study completion
- 5 Feb 2009 (actual)
- First posted
- 19 Jun 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 evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA. Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500 million malaria cases worldwide each year. About 2 to 3 million deaths annually are from malaria alone or along with other diseases. Researchers hope to find a vaccine to fight malaria.
Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no history of malaria, and have not lived for more than 1 month in an area where malaria is prevalent may be eligible for this study. There will be 28 participants, each assigned to one of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1 formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and causing disease. This study is the first time the vaccine will be given to human beings for testing.
Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests. The study will last 48 weeks. One or two vaccinations are given by injection, at least 12 weeks apart. After each vaccination, patients will be asked to stay in the clinic for at least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and 56 after each vaccination. There will be a check of vital signs, brief physical exam, history of symptoms and medications taken since the last visit, and blood tests to check for vaccine safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients will receive a thermometer, diary card, and plastic measuring device. Each day they will record their temperatures and any symptoms, and measure the size of any reactions at the vaccination site. They will be asked to do this for 27 days after vaccinations.
After injections, there may be pain, swelling, and redness at the vaccination site, and limitation of arm movement. General side effects from the vaccine may be fever, chills, headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have researchers keep any unused serum samples, for use only in research into malaria and other diseases. Genetic testing would not be done on those samples. Stored samples will be labeled with a code, and information is kept private.
Detailed description
AMA1-C1 with Montanide ISA 720, is a blood stage malaria vaccine candidate. The objectives of this phase 1 trial are to study the safety, reactogenicity, and immunogenicity of this vaccine and to assess the level, kinetics, and the in vitro biological activity of the antibody response it induces. The study is an open label, dose escalation, phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 28 participants will be enrolled into 3 dose cohorts. Cohort 1 will receive 5 micrograms of AMA1-C1/ISA 720 at each injection, Cohort 2 will receive 20 micrograms, and Cohort 3 will receive 80 micrograms. Cohorts 1 and 2 will receive 2 injections, 3 months apart. Cohort 3 will receive only 1 vaccination. Safety outcome measures are local and systemic (including laboratory) adverse events. Immune responses to vaccination will be measured by enzyme-linked immunosorbent assay (ELISA) and parasite growth inhibition assay (GIA), and will be compared among dose groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (23 listed)
- History of malaria, residence for more than 1 month in a malaria endemic area (as determined by interview), or plans to visit a malaria endemic area during the study period.
- For female subjects: Positive pregnancy test at screening or Day 0, as well as those currently lactating and breast feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
- Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25 times the upper limit of normal of the testing laboratory).
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 |
|---|---|---|
| AMA1-C1/ISA 720 | Drug | – |
Primary outcome
Assessment of the safety and reactogenicity of the AMA1-C1/ISA 720 vaccine; and to determine the frequency of systemic and local AEs as recorded for 28 days following each vaccination.
1 secondary outcome
Assessment of the level, kinetics and the in-vitro biological activity of the antibody response to AMA1-FVO and AMA1-3D7.
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 2 Jul 2017.
- Background: PubMed 7838184Narum DL, Thomas AW. Differential localization of full-length and processed forms of PF83/AMA-1 an apical membrane antigen of Plasmodium falciparum merozoites. Mol Biochem Parasitol. 1994 Sep;67(1):59-68. doi: 10.1016/0166-6851(94)90096-5.
- Background: PubMed 2404781Crewther PE, Culvenor JG, Silva A, Cooper JA, Anders RF. Plasmodium falciparum: two antigens of similar size are located in different compartments of the rhoptry. Exp Parasitol. 1990 Feb;70(2):193-206. doi: 10.1016/0014-4894(90)90100-q.
- Background: PubMed 2211675Waters AP, Thomas AW, Deans JA, Mitchell GH, Hudson DE, Miller LH, McCutchan TF, Cohen S. A merozoite receptor protein from Plasmodium knowlesi is highly conserved and distributed throughout Plasmodium. J Biol Chem. 1990 Oct 15;265(29):17974-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AMA1-C1/ISA 720 in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Australia.
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 5 inclusion and 23 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 2 Jul 2017. 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 Australia. 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?
Assessment of the safety and reactogenicity of the AMA1-C1/ISA 720 vaccine; and to determine the frequency of systemic and local AEs as recorded for 28 days following 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 NCT00487916, which also lists 3 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 2 Jul 2017.