Plasmodium Falciparum MalariaPhase 1NCT00340431
Experimental Vaccine for Plasmodium Falciparum Malaria
A Phase 1 study testing MSP1(42)-FVO & MSP1(42)-3D7 in people with Plasmodium Falciparum Malaria and Vaccines, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria, Vaccines
- What is being tested?
- MSP1(42)-FVO & MSP1(42)-3D7
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2004to 6 Feb 2008
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females between 18 and 50 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of the trial (52 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 human chorionic gonadotrophin (Beta-hCG), if female.
- Participant unwilling to use reliable contraception methods for the duration of the trial.
- Currently lactating and breast-feeding (if female).
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- Evidence of obesity; BMI must be less than 35. Body mass index equals ((weight in pounds)/(height in inches) x (height in inches)) x 703.
- 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.
Show all 27Show fewer
- Laboratory evidence of liver disease (aspartate aminotransferase [AST] and/or 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).
- Laboratory evidence of hematologic disease (absolute neutrophil count less than 1,5000/mm(3); hemoglobin less than 0.9 times the lower limit of normal of the testing laboratory, by sex; or platelet count less than 140,000/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 abused alcohol or illicit drugs during the past 6 months, by history and/or positive urine drug screen (any detectable levels) on Study Day 0 or 180.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma (emergency room visit or hospitalization within the last 6 months).
- Positive ELISA and confirmatory Western blot tests for HIV-1.
- Positive ELISA and confirmatory immunoblot tests 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 or while the study is ongoing.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy and/or abnormal splenic function.
- Receipt of blood products within the past 6 months.
- Previous receipt of an investigational malaria vaccine.
- Receipt of antimalarial prophylaxis during the past 12 months.
- Prior malaria infection.
- Travel to a malaria-endemic country during the past 12 months or planned travel to a malaria-endemic country during the course of the study.
- History of a known allergy to nickel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of the Safety and Immunogenicity of MSP1(42)-FVO/Alhydrogel and MSP1(42)-3D7/Alhydrogel, Asexual Blood-Stage Vaccines for Plasmodium Falciparum Malaria
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 person's red blood cells.
Read more
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.
Read the 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, MSP1(42)-FVO/Alhydrogel and MSP1(42)-3D7/Alhydrogel, 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 MSP1(42)/Alhydrogel 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 MSP1(42)-FVO/Alhydrogel and the MSP1(42)-3D7/Alhydrogel 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 MSP1(42)-FVO or MSP1(42)-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 MSP1(42) antigen at Day 42.
- Conditions
- Plasmodium Falciparum Malaria, Vaccines
- Being tested
- MSP1(42)-FVO & MSP1(42)-3D7
- Keywords
- Human, Clinical Trial, Mosquito
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP1(42)-FVO & MSP1(42)-3D7Drug
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 start9 Jun 2004
- Study completion6 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Falciparum 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
- Treatment
- Enrolment
- 0 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340431
- Sponsor's protocol ID
- 999904216
- Other IDs
- 04-I-N216
- Status last verified
- 6 Feb 2008
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
McBride JS, Heidrich HG. Fragments of the polymorphic Mr 185,000 glycoprotein from the surface of isolated Plasmodium falciparum merozoites form an antigenic complex. Mol Biochem Parasitol. 1987 Feb;23(1):71-84. doi: 10.1016/0166-6851(87)90189-7.
PubMed 2437453
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
- Phase 1 Study of the Safety and Immunogenicity of MSP1(42)-FVO/Alhydrogel and MSP1(42)-3D7/Alhydrogel, Asexual Blood-Stage Vaccines for Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00340431
- Acronym / sponsor ID
- 999904216
- Conditions
- Plasmodium Falciparum Malaria, Vaccines
- Keywords
- Human, Clinical Trial, Mosquito
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 Jun 2004
- Study completion
- 6 Feb 2008
- 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 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 person's 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, MSP1(42)-FVO/Alhydrogel and MSP1(42)-3D7/Alhydrogel, 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 MSP1(42)/Alhydrogel 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 MSP1(42)-FVO/Alhydrogel and the MSP1(42)-3D7/Alhydrogel 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 MSP1(42)-FVO or MSP1(42)-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 MSP1(42) antigen at Day 42.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or females between 18 and 50 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of the trial (52 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (27 listed)
- Pregnancy as determined by a positive urine human chorionic gonadotrophin (Beta-hCG), if female.
- Participant unwilling to use reliable contraception methods for the duration of the trial.
- Currently lactating and breast-feeding (if female).
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- Evidence of obesity; BMI must be less than 35. Body mass index equals ((weight in pounds)/(height in inches) x (height in inches)) x 703.
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 |
|---|---|---|
| MSP1(42)-FVO & MSP1(42)-3D7 | 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 2437453McBride JS, Heidrich HG. Fragments of the polymorphic Mr 185,000 glycoprotein from the surface of isolated Plasmodium falciparum merozoites form an antigenic complex. Mol Biochem Parasitol. 1987 Feb;23(1):71-84. doi: 10.1016/0166-6851(87)90189-7.
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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 MSP1(42)-FVO & MSP1(42)-3D7 in people with Plasmodium Falciparum Malaria and Vaccines, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 4 inclusion and 27 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340431, which also lists 1 linked publication.
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.