MalariaPhase 1/2NCT00341250
Malaria Vaccine in Children in Mali
A Phase 1/2 study testing AMA1-C1/Alhydrogel Malaria Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Mali.
Trial summary
This study will test an experimental vaccine called AMA1-C1 in children to see if it is safe and if it reduces episodes of malaria parasitemia (parasites in the blood) in children exposed to malaria. Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- AMA1-C1/Alhydrogel Malaria Vaccine
- Type of treatment
- Vaccines
- How many people
- 900 participants
- Where
- 2 sitesMali
- Study dates
- 19 Jan 2006to 8 Dec 2006
- Phase
- Phase 1/2
- 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 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or females aged 2 to less than 4 years old. Children must be born no earlier than September 1, 2002 and must have had their second birthday prior to first vaccination.
- Known residents of the village of Doneguebougou, Mali or Bancoumana.
- Good general health as determined by means of the screening procedures.
- Available for the duration of the trial (52 weeks).
- Willingness to participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document.
Who cannot join
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, 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 or the parent/legal guardian 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).
- Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less 120,000/mm(3), or hemoglobin less than 8.5 g/dL).
- 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.
Show all 22Show fewer
- Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma (emergency room visit or hospitalization within the last 6 months).
- Positive ELISA for HCV.
- Positive HBsAg by ELISA.
- Known immunodeficiency syndrome.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
- Receipt of a live vaccine within past 4 weeks (e.g. measles/mumps/rubella (MMR)) or a non-live vaccine (e.g. diphtheria/pertussis/tetanus (DPT)) within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of a blood transfusion 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.
- Known hypersensitivity to any component of the Hib vaccine (tetanus toxoid, lactose).
- Previous administration of Hib vaccines.
- Known thrombocytopenia or bleeding disorders.
Trial locations and contacts
2 sites in 1 country.
Mali2 sites
Bancoumana Clinical Trial Center
Bankoumana
Doneguebougou Malaria Vaccine Center
Donéguébougou
About this study
Official title: Randomized, Controlled, Phase 1/2 Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel Vaccine for Plasmodium Falciparum Malaria in Children in Doneguebougou and Bancoumana, Mali
This study will test an experimental vaccine called AMA1-C1 in children to see if it is safe and if it reduces episodes of malaria parasitemia (parasites in the blood) in children exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each year, causing from 2 million to 3 million deaths, mostly among children less than 5 in sub-Saharan Africa. It is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to the malaria parasite and widespread resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability to control malaria through these strategies. A vaccine that could reduce illness and death from malaria would be a valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine developed by the NIAID. Tests of AMA1-C1 in 87 healthy people in the United States and in Mali found no serious harmful side effects of the vaccine.
Two- and three-year-old children who live in Don gu bougou or Bancoumana, Mali, and are in general good health may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.
Read more
Participants are randomly assigned to receive two injections (shots) of either AMA1-C1 or a Haemophilus influenzae type B vaccine called Hiberix® (Registered Trademark), which is approved and used in Mali. All shots are given in the thigh muscle. Before the first shot, a small blood sample is obtained to make sure the child is well and to see if he or she has antibodies to the malaria parasite. The second shot is given 4 weeks after the first. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic 1, 2, 3, 7 and 14 days after each shot for a physical examination. Blood samples are drawn at some visits to check for side effects of the vaccine and to measure the response to it.
During the rainy season after the second vaccination, subjects come to the clinic once a month for an examination. Any child who has been ill with a disease that could be malaria has a blood sample collected by fingerstick to test for malaria and to learn about the malaria parasites causing the infection. Every fourth visit a fingerstick sample is taken regardless of whether the child has been sick. If a child becomes sick at any time during the study, he or she will be brought to the clinic for examination a...
Read the detailed description
Apical membrane antigen-1 (AMA1) is a surface protein expressed during the asexual blood stage of P. falciparum. It is produced as an 83-kDa polypeptide by mature schizonts in infected erythrocytes. In clinical studies in malaria-unexposed adults in the USA and in malaria-exposed adults in Mali, AMA1-C1/Alhydrogel was safe and immunogenic. This study will evaluate its safety and immunogenicity in malaria-exposed children living in an area of seasonal malaria transmission.
- Conditions
- Malaria
- Being tested
- AMA1-C1/Alhydrogel Malaria 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 Malaria VaccineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start19 Jan 2006
- Study completion8 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 1/2
- Primary purpose
- Treatment
- Enrolment
- 900 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341250
- Sponsor's protocol ID
- 999906081
- Other IDs
- 06-I-N081
- Status last verified
- 29 Apr 2009
- First submitted
- 19 Jun 2006
- 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 2211675Dicko A, Sagara I, Ellis RD, Miura K, Guindo O, Kamate B, Sogoba M, Niambele MB, Sissoko M, Baby M, Dolo A, Mullen GE, Fay MP, Pierce M, Diallo DA, Saul A, Miller LH, Doumbo OK. Phase 1 study of a combination AMA1 blood stage malaria vaccine in Malian children. PLoS One. 2008 Feb 13;3(2):e1563. doi: 10.1371/journal.pone.0001563.
PubMed 18270560
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 1/2 Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel Vaccine for Plasmodium Falciparum Malaria in Children in Doneguebougou and Bancoumana, Mali
- ClinicalTrials.gov ID
- NCT00341250
- Acronym / sponsor ID
- 999906081
- Conditions
- Malaria
- Keywords
- Blood Stage, Investigational, Endemic, Malaria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Jan 2006
- Study completion
- 8 Dec 2006
- First posted
- 21 Jun 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 test an experimental vaccine called AMA1-C1 in children to see if it is safe and if it reduces episodes of malaria parasitemia (parasites in the blood) in children exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each year, causing from 2 million to 3 million deaths, mostly among children less than 5 in sub-Saharan Africa. It is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to the malaria parasite and widespread resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability to control malaria through these strategies. A vaccine that could reduce illness and death from malaria would be a valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine developed by the NIAID. Tests of AMA1-C1 in 87 healthy people in the United States and in Mali found no serious harmful side effects of the vaccine.
Two- and three-year-old children who live in Don gu bougou or Bancoumana, Mali, and are in general good health may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.
Participants are randomly assigned to receive two injections (shots) of either AMA1-C1 or a Haemophilus influenzae type B vaccine called Hiberix® (Registered Trademark), which is approved and used in Mali. All shots are given in the thigh muscle. Before the first shot, a small blood sample is obtained to make sure the child is well and to see if he or she has antibodies to the malaria parasite. The second shot is given 4 weeks after the first. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic 1, 2, 3, 7 and 14 days after each shot for a physical examination. Blood samples are drawn at some visits to check for side effects of the vaccine and to measure the response to it.
During the rainy season after the second vaccination, subjects come to the clinic once a month for an examination. Any child who has been ill with a disease that could be malaria has a blood sample collected by fingerstick to test for malaria and to learn about the malaria parasites causing the infection. Every fourth visit a fingerstick sample is taken regardless of whether the child has been sick. If a child becomes sick at any time during the study, he or she will be brought to the clinic for examination a...
Detailed description
Apical membrane antigen-1 (AMA1) is a surface protein expressed during the asexual blood stage of P. falciparum. It is produced as an 83-kDa polypeptide by mature schizonts in infected erythrocytes. In clinical studies in malaria-unexposed adults in the USA and in malaria-exposed adults in Mali, AMA1-C1/Alhydrogel was safe and immunogenic. This study will evaluate its safety and immunogenicity in malaria-exposed children living in an area of seasonal malaria transmission.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females aged 2 to less than 4 years old. Children must be born no earlier than September 1, 2002 and must have had their second birthday prior to first vaccination.
- Known residents of the village of Doneguebougou, Mali or Bancoumana.
- Good general health as determined by means of the screening procedures.
- Available for the duration of the trial (52 weeks).
- Willingness to participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document.
Key exclusion criteria (22 listed)
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, 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 or the parent/legal guardian 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).
- Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less 120,000/mm(3), or hemoglobin less than 8.5 g/dL).
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 Malaria Vaccine | Drug | – |
Primary outcome
Not reported in the source record.
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.
- Derived from this study: PubMed 18270560Dicko A, Sagara I, Ellis RD, Miura K, Guindo O, Kamate B, Sogoba M, Niambele MB, Sissoko M, Baby M, Dolo A, Mullen GE, Fay MP, Pierce M, Diallo DA, Saul A, Miller LH, Doumbo OK. Phase 1 study of a combination AMA1 blood stage malaria vaccine in Malian children. PLoS One. 2008 Feb 13;3(2):e1563. doi: 10.1371/journal.pone.0001563.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMA1-C1/Alhydrogel Malaria Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 22 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 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341250, which also lists 4 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.