Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340431
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Experimental Vaccine for Plasmodium Falciparum Malaria
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase 1 Study of the Safety and Immunogenicity of MSP142-FVOAlhydrogel and MSP142-3D7Alhydrogel Asexual Blood-Stage Vaccines for Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2008-02-06
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 evaluate the safety of two experimental malaria vaccines in healthy volunteers and examine their immune response to them Safety will be assessed by comparing vaccine side effects in groups of volunteers who receive increasing doses of the same vaccine dose-escalating study Immune response will be evaluated by comparing the levels of antibody production with each dose Antibodies are infection-fighting proteins produced by the immune system The two vaccines in this study contain different types of a malaria protein called MSP1 one type is MSP142FVO and the other is MSP1423D7
Malaria parasites are spread from person to person by mosquitoes There are four types of malaria parasites The vaccine tested in this study is designed to work against Plasmodium falciparum the parasite responsible for most deaths in children due to malaria in sub-Saharan Africa The vaccine stimulates the body to produce antibodies that prevent P falciparum from entering the persons red blood cells
Healthy normal volunteers between 18 and 50 years of age may be eligible for this 12-month study conducted at Quintiles Phase 1 Services in Lenexa Kansas Candidates are screened with a medical history physical examination and blood and urine tests
Participants receive three doses of the vaccine-on the first day of the study day 0 at 1 month day 28 and at 6 months day 180 -through injection into an arm muscle The first group of subjects receives 5 micrograms of vaccine the second group receives 20 micrograms and the third group receives 80 micrograms All participants are observed in the clinic for 30 minutes after each immunization for immediate reactions to the vaccine and keep a record of their temperature and of any reactions and side effects they experience for 6 days after the vaccination At various intervals throughout the study participants undergo a brief physical examination and blood tests Women of childbearing potential have a urine pregnancy test on the day of each injection
Malaria parasites are spread from person to person by mosquitoes There are four types of malaria parasites The vaccine tested in this study is designed to work against Plasmodium falciparum the parasite responsible for most deaths in children due to malaria in sub-Saharan Africa The vaccine stimulates the body to produce antibodies that prevent P falciparum from entering the persons red blood cells
Healthy normal volunteers between 18 and 50 years of age may be eligible for this 12-month study conducted at Quintiles Phase 1 Services in Lenexa Kansas Candidates are screened with a medical history physical examination and blood and urine tests
Participants receive three doses of the vaccine-on the first day of the study day 0 at 1 month day 28 and at 6 months day 180 -through injection into an arm muscle The first group of subjects receives 5 micrograms of vaccine the second group receives 20 micrograms and the third group receives 80 micrograms All participants are observed in the clinic for 30 minutes after each immunization for immediate reactions to the vaccine and keep a record of their temperature and of any reactions and side effects they experience for 6 days after the vaccination At various intervals throughout the study participants undergo a brief physical examination and blood tests Women of childbearing potential have a urine pregnancy test on the day of each injection
Detailed Description:
The purpose of this Phase 1 clinical trial is to evaluate the safety and immunogenicity of two asexual blood stage vaccines for Plasmodium falciparum malaria MSP142-FVOAlhydrogel and MSP142-3D7Alhydrogel in healthy 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 infection would be a valuable resource in the fight against this disease The merozoite surface protein 1 MSP1 is the first protein to be identified on the surface of the blood stage parasite A portion of MSP1 is carried into the newly invaded erythrocyte on the surface of the parasite 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 MSP142Alhydrogel vaccines have been used in five preclinical animal trials and no clinically significant risks have been identified The study will be conducted at Quintiles Phase I Services Lenexa KS We will evaluate three dose levels of both the MSP142-FVOAlhydrogel and the MSP142-3D7Alhydrogel vaccines 5 micro g 20 micro g 80 micro g Sixty healthy male and non-pregnant female volunteers ages 18 to 50 will be enrolled Ten volunteers in each group will receive a 5 micro g 20 micro g or 80 mirco g dose of either MSP142-FVO or MSP142-3D7 vaccines by intramuscular injection in an open label study on months 0 1 and 6 The groups will be staggered such that adequate safety evaluation can be performed prior to dose escalation The duration of the study is 12 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 homologous MSP142 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-N216 | None | None | None |