MalariaPhase 1NCT00414336
Phase I Study of Safety and Immunogenicity of AMA1-C1Alhydrogel + CPG 7909 Vaccine for Malaria
A Phase 1 study testing AMA1-C1/Alhydrogel + CPG 7909 Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
This study will evaluate the safety of an experimental vaccine can protect people from malaria and study its effects. Malaria, which affects many people in Mali and other countries in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading cause of death. Read more about this study
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.
- Known residents of the village of Don gu bougou, Mali.
- Good general health as determined by means of the screening procedure.
- Available for the duration of the trial (30 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Who cannot join
- Pregnancy as determined by a positive urine beta-hCG at any point during the study (if female).
- If female, participant and her spouse have not used or are unwilling to use reliable contraceptive methods such as: abstinence, birth control pills or birth control patches or vaginal ring, diaphragm with spermicide, IUD (intrauterine device), condom with spermicide, progestin implant or injection, or surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation) prior to enrollment to 3 months after the second vaccination. (At the time of vaccination a female participant must have a negative urine pregnancy test on two occasions at least two weeks apart, and must have used a reliable contraceptive method in the interim).
- Currently lactating and breast-feeding (if female).
- 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.
- Pre-existing known autoimmune diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia.
Show all 28Show fewer
- Laboratory evidence of possible autoimmune disease determined by anti-dsDNA titer that equals or exceeds 25 IU.
- 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.)
- 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 110,000/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 rapid diagnostic test for anti-Hepatitis C virus (HCV).
- Positive rapid diagnostic test for Hepatitis B surface antigen (HBsAg).
- Known immunodeficiency syndrome.
- 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 a 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.
- History of known allergy to yeast.
- History of use of chloroquine or related compounds (amodiaquine or primaquine) within 8 weeks of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Phase 1 Study of the Safety and Immunogenicity of the AMA1-C1/Alhydrogel + CPG 7909 Vaccine for Plasmodium Falciparum Malaria in Semi-Immune Malian Adults
This study will evaluate the safety of an experimental vaccine can protect people from malaria and study its effects. Malaria, which affects many people in Mali and other countries in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading cause of death. Researchers at the Malaria Research and Training Center at the University of Bamako are working with NIH to develop an experimental vaccine against the disease. The vaccine, called AMA1-C1Alhydrogel (or AMA1-C1), contains a small part of the malaria-causing germ. CPG-7909 is a product to improve the body's reactions to vaccines.
Patients ages 18 to 45 who are in good health, who live in Don gu bougou, Mali, and plan to stay there for the study duration, and who are not pregnant or breast feeding may be eligible for this study. There will be 24 participants.
Read more
At an initial evaluation of 2 to 3 hours, patients will have a physical examination and undergo blood and urine tests regarding the blood, kidneys, and liver. During the study, patients will receive two injections of one of the two experimental malaria vaccines. Injections of the same vaccine each time, 4 weeks apart, are given in an arm muscle. Patients will receive either AMA1-C1 or AMA1-C1 with CPG-7909 but will not know which of the vaccines they receive until the study's end. After each injection, patients will stay in the clinic for 30 minutes for observation. They will return after 1, 2, 3, 7, and 14 days to be examined and report how they are feeling. Blood and urine samples will be collected at some visits. Each clinic visit takes 1 to 2 hours. If for some reason a patient receives only one injection, he or she will be asked to return to the clinic for routine visits until the study's end. After the first 2 months, patients will return to the clinic once a month for 30 weeks. In that period, 12 blood samples will be taken. Researchers want to be sure that the vaccine is not harmful as well as to measure the vaccine's effects.
Risks in this study include pain, swelling, and redness at the injection site; fever; and gastrointestinal problems. Some people have had a temporary decrease in white blood cells after receiving the vaccine. There is a small chance of a severe allergic reaction. However, researchers will closely watch patients immediately after each injection and will give treatment if a serious reaction occurs.
Participants will receive 75 kilos of rice and 75 kilos of millet (165 lb. of ...
Read the detailed description
AMA1-C1 + CPG 7909 is a blood stage malaria vaccine candidate. The primary objective of this Phase 1 study is to evaluate safety and reactogenicity of the vaccine in semi-immune adults in Mali. Secondary objectives are to evaluate the immunogenicity of the vaccine. The study is a double blind Phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 24 participants will be enrolled and randomly assigned to one of the two groups: 12 volunteers will receive two doses of 80 microgram AMA1-C1/Alhydrogel + 500 microgram CPG; 12 volunteers will receive 80 microgram AMA1-C1/Alhydrogel, both at a 1-month dosing interval. 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 growth inhibition assay (GIA), and will be compared between groups. Peripheral blood lymphocytes will be assayed for the presence of AMA-1-specific memory B cells and for the total number of memory B cells.
- Conditions
- Malaria
- Being tested
- AMA1-C1/Alhydrogel + CPG 7909 Vaccine
- Keywords
- Blood Stage, Investigational, Endemic, Malaria
- Medical subject headings
- Malaria, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMA1-C1/Alhydrogel + CPG 7909 VaccineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and reactogenicity.
Secondary outcomes (1)
To determine the level and kinetics of the antibody response elicited by AMA1-C1/Alhydrogel + CPG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study start15 Dec 2006
- Primary completion15 Dec 2006
- Study completion15 Dec 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414336
- Sponsor's protocol ID
- 999907051
- Other IDs
- 07-I-N051
- Status last verified
- 4 Aug 2009
- First submitted
- 20 Dec 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Hodder AN, Crewther PE, Anders RF. Specificity of the protective antibody response to apical membrane antigen 1. Infect Immun. 2001 May;69(5):3286-94. doi: 10.1128/IAI.69.5.3286-3294.2001.
PubMed 11292751Malkin EM, Diemert DJ, McArthur JH, Perreault JR, Miles AP, Giersing BK, Mullen GE, Orcutt A, Muratova O, Awkal M, Zhou H, Wang J, Stowers A, Long CA, Mahanty S, Miller LH, Saul A, Durbin AP. Phase 1 clinical trial of apical membrane antigen 1: an asexual blood-stage vaccine for Plasmodium falciparum malaria. Infect Immun. 2005 Jun;73(6):3677-85. doi: 10.1128/IAI.73.6.3677-3685.2005.
PubMed 15908397Cooper CL, Davis HL, Morris ML, Efler SM, Adhami MA, Krieg AM, Cameron DW, Heathcote J. CPG 7909, an immunostimulatory TLR9 agonist oligodeoxynucleotide, as adjuvant to Engerix-B HBV vaccine in healthy adults: a double-blind phase I/II study. J Clin Immunol. 2004 Nov;24(6):693-701. doi: 10.1007/s10875-004-6244-3.
PubMed 15622454
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
- Randomized, Controlled, Phase 1 Study of the Safety and Immunogenicity of the AMA1-C1/Alhydrogel + CPG 7909 Vaccine for Plasmodium Falciparum Malaria in Semi-Immune Malian Adults
- ClinicalTrials.gov ID
- NCT00414336
- Acronym / sponsor ID
- 999907051
- Conditions
- Malaria
- Keywords
- Blood Stage, Investigational, Endemic, Malaria
- 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
- 15 Dec 2006
- Primary completion
- 15 Dec 2006 (actual)
- Study completion
- 15 Dec 2006 (actual)
- First posted
- 21 Dec 2006 (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 of an experimental vaccine can protect people from malaria and study its effects. Malaria, which affects many people in Mali and other countries in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading cause of death. Researchers at the Malaria Research and Training Center at the University of Bamako are working with NIH to develop an experimental vaccine against the disease. The vaccine, called AMA1-C1Alhydrogel (or AMA1-C1), contains a small part of the malaria-causing germ. CPG-7909 is a product to improve the body's reactions to vaccines.
Patients ages 18 to 45 who are in good health, who live in Don gu bougou, Mali, and plan to stay there for the study duration, and who are not pregnant or breast feeding may be eligible for this study. There will be 24 participants.
At an initial evaluation of 2 to 3 hours, patients will have a physical examination and undergo blood and urine tests regarding the blood, kidneys, and liver. During the study, patients will receive two injections of one of the two experimental malaria vaccines. Injections of the same vaccine each time, 4 weeks apart, are given in an arm muscle. Patients will receive either AMA1-C1 or AMA1-C1 with CPG-7909 but will not know which of the vaccines they receive until the study's end. After each injection, patients will stay in the clinic for 30 minutes for observation. They will return after 1, 2, 3, 7, and 14 days to be examined and report how they are feeling. Blood and urine samples will be collected at some visits. Each clinic visit takes 1 to 2 hours. If for some reason a patient receives only one injection, he or she will be asked to return to the clinic for routine visits until the study's end. After the first 2 months, patients will return to the clinic once a month for 30 weeks. In that period, 12 blood samples will be taken. Researchers want to be sure that the vaccine is not harmful as well as to measure the vaccine's effects.
Risks in this study include pain, swelling, and redness at the injection site; fever; and gastrointestinal problems. Some people have had a temporary decrease in white blood cells after receiving the vaccine. There is a small chance of a severe allergic reaction. However, researchers will closely watch patients immediately after each injection and will give treatment if a serious reaction occurs.
Participants will receive 75 kilos of rice and 75 kilos of millet (165 lb. of ...
Detailed description
AMA1-C1 + CPG 7909 is a blood stage malaria vaccine candidate. The primary objective of this Phase 1 study is to evaluate safety and reactogenicity of the vaccine in semi-immune adults in Mali. Secondary objectives are to evaluate the immunogenicity of the vaccine. The study is a double blind Phase 1 clinical trial in healthy adult volunteers. Volunteers will be screened and 24 participants will be enrolled and randomly assigned to one of the two groups: 12 volunteers will receive two doses of 80 microgram AMA1-C1/Alhydrogel + 500 microgram CPG; 12 volunteers will receive 80 microgram AMA1-C1/Alhydrogel, both at a 1-month dosing interval. 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 growth inhibition assay (GIA), and will be compared between groups. Peripheral blood lymphocytes will be assayed for the presence of AMA-1-specific memory B cells and for the total number of memory B cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 (28 listed)
- Pregnancy as determined by a positive urine beta-hCG at any point during the study (if female).
- If female, participant and her spouse have not used or are unwilling to use reliable contraceptive methods such as: abstinence, birth control pills or birth control patches or vaginal ring, diaphragm with spermicide, IUD (intrauterine device), condom with spermicide, progestin implant or injection, or surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation) prior to enrollment to 3 months after the second vaccination. (At the time of vaccination a female participant must have a negative urine pregnancy test on two occasions at least two weeks apart, and must have used a reliable contraceptive method in the interim).
- Currently lactating and breast-feeding (if female).
- 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.
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/Alhydrogel + CPG 7909 Vaccine | Drug | – |
Primary outcome
Safety and reactogenicity.
1 secondary outcome
To determine the level and kinetics of the antibody response elicited by AMA1-C1/Alhydrogel + CPG
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 11292751Hodder AN, Crewther PE, Anders RF. Specificity of the protective antibody response to apical membrane antigen 1. Infect Immun. 2001 May;69(5):3286-94. doi: 10.1128/IAI.69.5.3286-3294.2001.
- Background: PubMed 15908397Malkin EM, Diemert DJ, McArthur JH, Perreault JR, Miles AP, Giersing BK, Mullen GE, Orcutt A, Muratova O, Awkal M, Zhou H, Wang J, Stowers A, Long CA, Mahanty S, Miller LH, Saul A, Durbin AP. Phase 1 clinical trial of apical membrane antigen 1: an asexual blood-stage vaccine for Plasmodium falciparum malaria. Infect Immun. 2005 Jun;73(6):3677-85. doi: 10.1128/IAI.73.6.3677-3685.2005.
- Background: PubMed 15622454Cooper CL, Davis HL, Morris ML, Efler SM, Adhami MA, Krieg AM, Cameron DW, Heathcote J. CPG 7909, an immunostimulatory TLR9 agonist oligodeoxynucleotide, as adjuvant to Engerix-B HBV vaccine in healthy adults: a double-blind phase I/II study. J Clin Immunol. 2004 Nov;24(6):693-701. doi: 10.1007/s10875-004-6244-3.
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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/Alhydrogel + CPG 7909 Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 5 inclusion and 28 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 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?
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 and reactogenicity.. 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 NCT00414336, 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; AzTrials last refreshed its copy on 8 Nov 2026.