Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343005
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Experimental Vaccine for Malaria in Adults in Mali
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Double-Blind Randomized Controlled Phase 1 Study of the Safety and Immunogenicity of AMA1-C1Alhydrogel Vaccine for Plasmodium Falciparum Malaria in Semi-Immune Adults in Doneguebougou Mali
Status:
COMPLETED
Status Verified Date:
2008-01-22
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 determine the highest dose of an experimental vaccine called AMA1-C1 that can safely be given to adults 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 under 5 years of age 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 as well as 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 Early tests of AMA1-C1 in 30 healthy people in the United States found no serious harmful side effects of the vaccine This study will look at the effect of AMA1-C1 in people in Mali who have been exposed to malaria
Residents of Don gu bougou Mali who are between 18 and 45 years of age and are in general good health may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests and urine pregnancy test for women
Participants are randomly assigned to receive three injections shots of either the experimental malaria vaccine or a hepatitis B vaccine that is approved and used in Mali All shots are given in an upper arm muscle After the first shot the second is given 1 month later and the third is given 12 months after the first Subjects receiving AMA1-C1 will get one of three different doses - low medium or high - to find the dose that is safest and gives the best antibody response to the vaccine After each shot participants remain in the clinic for 30 minutes for observation They return to the clinic 1 2 3 7 and 14 days after each shot for a physical examination and to check for side effects Blood samples are drawn before each shot and at selected return clinic visits to check for side effects and to measure the effect of the vaccine
During the rainy seasons after the second and third vaccinations subjects come to the clinic once a month for an examination and a blood test During the dry season subjects come to the clinic 3 months before the last shot is given for an examination and blood test Additional blood tests may be done on participants who develop malaria
If found to be safe in adults further studies with this vaccine will be done in children exposed to malaria as it is children who bear the brunt of this disease
Residents of Don gu bougou Mali who are between 18 and 45 years of age and are in general good health may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests and urine pregnancy test for women
Participants are randomly assigned to receive three injections shots of either the experimental malaria vaccine or a hepatitis B vaccine that is approved and used in Mali All shots are given in an upper arm muscle After the first shot the second is given 1 month later and the third is given 12 months after the first Subjects receiving AMA1-C1 will get one of three different doses - low medium or high - to find the dose that is safest and gives the best antibody response to the vaccine After each shot participants remain in the clinic for 30 minutes for observation They return to the clinic 1 2 3 7 and 14 days after each shot for a physical examination and to check for side effects Blood samples are drawn before each shot and at selected return clinic visits to check for side effects and to measure the effect of the vaccine
During the rainy seasons after the second and third vaccinations subjects come to the clinic once a month for an examination and a blood test During the dry season subjects come to the clinic 3 months before the last shot is given for an examination and blood test Additional blood tests may be done on participants who develop malaria
If found to be safe in adults further studies with this vaccine will be done in children exposed to malaria as it is children who bear the brunt of this disease
Detailed Description:
The purpose of this Phase 1 clinical trial is to evaluate the safety and immunogenicity of the Plasmodium falciparum malaria vaccine AMA1-C1Alhydrogel in healthy malaria-exposed adult volunteers Between 2-3 million deaths occur each year as a result of malaria Most of these deaths are a result of P falciparum malaria in children under five years of age in sub-Saharan Africa A safe and effective vaccine that would reduce both morbidity and mortality secondary to P falciparum would be a valuable resource in the fight against this disease The apical membrane antigen 1 AMA1 is a surface protein expressed during the asexual blood stage of P falciparum that is thought to play a role in parasite invasion of erythrocytes Clinical symptoms of malaria in humans are due to the asexual blood stage Therefore this vaccine was designed to protect an individual from illness due to the asexual stage of P falciparum infection by inhibiting parasite invasion of erythrocytes The AMA1-C1Alhydrogel vaccine preparations to be studied contain an equal mixture of AMA1 from two different clones of Plasmodium falciparum FVO and 3D7 both produced separately as recombinant proteins expressed by Pichia pastoris AMA1 FVO and AMA1 3D7 This vaccine has been tested in one clinical trial of 30 malaria-unexposed human adults in the United States and no clinically significant risks have been identified The study will be conducted in Don gu bougou Mali and will be a blinded randomized and controlled trial that will evaluate three dose levels of AMA1-C1 5 micro g 20 micro g 80 micro g Fifty-four healthy male and non-pregnant female volunteers ages 18 to 45 will be enrolled Eighteen volunteers will be assigned to each of the three dose groups Within each group twelve volunteers will be randomized to receive either a 5 micro g 20 micro g or 80 micro g dose of AMA1-ClAlhydrogel and 6 will be randomized to receive the tetanus toxoid vaccine Immunizations will be administered by intramuscular injection on months 0 1 and 12 The groups will be staggered such that adequate safety evaluation can be performed prior to dose escalation The duration of the study is 18 months per volunteer The primary objective of this trial is to determine the frequency and severity of vaccine-related adverse events for each dose The secondary objective is to determine the dose that generates the highest serum antibody levels to AMA1 antigen at Day 42
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 |
|---|---|---|---|
| 04-I-N175 | None | None | None |