Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341250
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Malaria Vaccine in Children in Mali
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Randomized Controlled Phase 12 Study of the Safety and Immunogenicity of AMA1-C1Alhydrogel Vaccine for Plasmodium Falciparum Malaria in Children in Doneguebougou and Bancoumana Mali
Status:
COMPLETED
Status Verified Date:
2009-04-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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-C1Alhydrogel 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-N081 | None | None | None |