Plasmodium FalciparumPhase 1NCT00295581
PpPfs25/ISA51 and ScPvs25/ISA51 Vaccines for Malaria
A Phase 1 study testing PpPfs25/ISA51 & ScPvs25/ISA51 in people with Plasmodium Falciparum and Plasmodium Vivax Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This study, conducted at Johns Hopkins University Center for Immunization Research in Washington DC, will test the safety and immune response of healthy volunteers to two experimental malaria vaccines. Malaria is a disease of red blood cells caused by a parasite that spreads from person to person by mosquitoes. 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, Plasmodium Vivax Malaria
- What is being tested?
- PpPfs25/ISA51 & ScPvs25/ISA51
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2005to 17 Jun 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 a result of review of medical history and/or clinical tests at screening.
- Available for the duration of the trial (78 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 chronic gonadotrophin (B-hCG), if female.
- Volunteer unwilling to use reliable contraception methods for the duration of the trial, if female. (Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence, and post-menopause)
- Currently breast-feeding (if female).
- 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.
- Laboratory evidence of liver disease (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] greater than 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).
Show all 22Show fewer
- Laboratory evidence of hematologic disease (absolute neutrophil count less than 1,500/mm(3); hemoglobin less than the lower limit of normal of the testing laboratory, by sex; or platelet count less than 140,000/mm(3)).
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis (greater than trace protein, or any glucose on urine dip will be confirmed negative prior to enrollment).
- 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 had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- 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.
- Receipt of blood products within the past 6 months.
- Previous receipt of an investigational malaria vaccine.
- History of a known allergy to nickel.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Phase 1 Study of the Safety and Immunogenicity of PpPfs25/ISA51 and ScPvs25/ISA51: Transmission Blocking Vaccines for Plasmodium Falciparum and Plasmodium Vivax Malaria
This study, conducted at Johns Hopkins University Center for Immunization Research in Washington DC, will test the safety and immune response of healthy volunteers to two experimental malaria vaccines. Malaria is a disease of red blood cells caused by a parasite that spreads from person to person by mosquitoes. It affects people of all ages, but is particularly severe in children. Patients may have a high fever, chills and muscle aches. They sometimes can have severe complications that may even result in death.
The vaccines in this study are called "transmission blocking" vaccines. These vaccines stimulate the person's immune system to produce antibodies against malaria. When a mosquito bites a vaccinated person, it ingests some of the person's blood. The antibodies in the ingested blood stop the malaria parasite from developing inside the mosquito. The mosquito would not be able to transmit malaria to other people. PpPfs25/ISA51 (Vaccine A) stimulates production of antibodies against the malaria parasite Plasmodium falciparum, and ScPvs25/ISA51 (Vaccine B) stimulates antibodies against the malaria parasite Plasmodium vivax. The vaccines also contain a substance called Montanide ISA51, which boosts the immune response to the vaccine.
Read more
Healthy volunteers between 18 and 50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Women who are able to become pregnant have a urine pregnancy test before each immunization.
Participants are randomly assigned to receive two injections, spaced 4 months apart, of either Vaccine A or Vaccine B at one of three doses-high, medium, or low. Two subjects in each dose group additionally serve as "controls" and receive only Montanide ISA51 mixed with saline. The vaccine is injected into the muscle of the upper arm. Subjects are monitored for 30 minutes after each injection for possible side effects and take home a diary card to record their temperature and any symptoms that may appear over the next 13 days.
A blood sample is drawn before and on several occasions after each vaccination to check the subject's health and to evaluate the immune response to the vaccine. At 1, 3, 7, 14, and 21 days after each vaccination, participants come to the clinic for a check of vital signs (temperature, pulse, respiration, and blood pressure), brief physical examination, and history of symptoms since the previous visit.
Read the detailed description
The purpose of this Phase 1 clinical trial is to evaluate the safety, reactogenicity and immunogenicity of two malaria transmission-blocking vaccines, PpPfs25 and ScPvs25, in healthy adult volunteers. Of the four species of malaria that infect humans, Plasmodium falciparum is responsible for the majority of these deaths. However, outside of Africa, most of the malaria is caused by Plasmodium vivax; although these cases result in few deaths, they represent a major cause of morbidity and lead to a significant impact on the quality of life. The development of a safe and effective vaccine that prevents the transmission of P. falciparum or P. vivax would be an important addition to the current methods for controlling the spread of malaria parasites. A vaccine designed to prevent oocyst development in the mosquito by eliciting transmission-blocking antibodies in the vertebrate host would protect other individuals in the vicinity from becoming infected from the immunized person. Thus, despite no immediate role in personal protection, transmission-blocking vaccines are a potentially powerful component of a multifaceted public health approach to controlling or eliminating malaria. This study will be conducted at the Johns Hopkins University - Bloomberg School of Public Health, Center for Immunization Research. Seventy-two healthy male and non-pregnant female volunteers ages 18-50 will be enrolled. This study will be single blinded (to volunteers) and placebo-controlled. The study will evaluate three dose levels of both the PpPfs25 and ScPvs25 malaria vaccines (5 microg, 20 microg, 80 microg) emulsified with Montanide ISA51 as compared to Montanide ISA51 given alone. Seventy-two volunteers (60 vaccine and 12 placebo) will be enrolled and assigned to one of six cohorts. In each cohort, 10 volunteers will receive vaccine and 2 will receive placebo. Volunteers will be vaccinated by intramuscular injection on days 0 and 120. 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 objectives of this trial are to assess and compare, in a dose-escalating study, the safety and reactogenicity of the PpPfs25 and ScPvs25 transmission blocking vaccines as compared to adjuvant alone; and to assess and compare, in dose-escalating study, the duration of the antibody response over an 18 month period in each volunteer as well as the effect of boosting with a second vaccination at 4 months.
- Conditions
- Plasmodium Falciparum, Plasmodium Vivax Malaria
- Being tested
- PpPfs25/ISA51 & ScPvs25/ISA51
- Keywords
- Human, Clinical Trial, Mosquito, Healthy Volunteer, HV
- Medical subject headings
- Malaria, Falciparum, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PpPfs25/ISA51 & ScPvs25/ISA51Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study start7 Mar 2005
- Study completion17 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plasmodium FalciparumStudies 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
- NCT00295581
- Sponsor's protocol ID
- 050118
- Other IDs
- 05-I-0118
- Status last verified
- 17 Jun 2008
- First submitted
- 23 Feb 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Limsuwan A, Churdboonchart V, Moss RB, Sirawaraporn W, Sutthent R, Smutharaks B, Glidden D, Trauger R, Theofan G, Carlo D. Safety and immunogenicity of REMUNE in HIV-infected Thai subjects. Vaccine. 1998 Jan-Feb;16(2-3):142-9. doi: 10.1016/s0264-410x(97)88327-2.
PubMed 9607022Wu Y, Ellis RD, Shaffer D, Fontes E, Malkin EM, Mahanty S, Fay MP, Narum D, Rausch K, Miles AP, Aebig J, Orcutt A, Muratova O, Song G, Lambert L, Zhu D, Miura K, Long C, Saul A, Miller LH, Durbin AP. Phase 1 trial of malaria transmission blocking vaccine candidates Pfs25 and Pvs25 formulated with montanide ISA 51. PLoS One. 2008 Jul 9;3(7):e2636. doi: 10.1371/journal.pone.0002636.
PubMed 18612426
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 PpPfs25/ISA51 and ScPvs25/ISA51: Transmission Blocking Vaccines for Plasmodium Falciparum and Plasmodium Vivax Malaria
- ClinicalTrials.gov ID
- NCT00295581
- Acronym / sponsor ID
- 050118
- Conditions
- Plasmodium Falciparum, Plasmodium Vivax Malaria
- Keywords
- Human, Clinical Trial, Mosquito, Healthy Volunteer, HV
- 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
- 7 Mar 2005
- Study completion
- 17 Jun 2008
- First posted
- 23 Feb 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, conducted at Johns Hopkins University Center for Immunization Research in Washington DC, will test the safety and immune response of healthy volunteers to two experimental malaria vaccines. Malaria is a disease of red blood cells caused by a parasite that spreads from person to person by mosquitoes. It affects people of all ages, but is particularly severe in children. Patients may have a high fever, chills and muscle aches. They sometimes can have severe complications that may even result in death.
The vaccines in this study are called "transmission blocking" vaccines. These vaccines stimulate the person's immune system to produce antibodies against malaria. When a mosquito bites a vaccinated person, it ingests some of the person's blood. The antibodies in the ingested blood stop the malaria parasite from developing inside the mosquito. The mosquito would not be able to transmit malaria to other people. PpPfs25/ISA51 (Vaccine A) stimulates production of antibodies against the malaria parasite Plasmodium falciparum, and ScPvs25/ISA51 (Vaccine B) stimulates antibodies against the malaria parasite Plasmodium vivax. The vaccines also contain a substance called Montanide ISA51, which boosts the immune response to the vaccine.
Healthy volunteers between 18 and 50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Women who are able to become pregnant have a urine pregnancy test before each immunization.
Participants are randomly assigned to receive two injections, spaced 4 months apart, of either Vaccine A or Vaccine B at one of three doses-high, medium, or low. Two subjects in each dose group additionally serve as "controls" and receive only Montanide ISA51 mixed with saline. The vaccine is injected into the muscle of the upper arm. Subjects are monitored for 30 minutes after each injection for possible side effects and take home a diary card to record their temperature and any symptoms that may appear over the next 13 days.
A blood sample is drawn before and on several occasions after each vaccination to check the subject's health and to evaluate the immune response to the vaccine. At 1, 3, 7, 14, and 21 days after each vaccination, participants come to the clinic for a check of vital signs (temperature, pulse, respiration, and blood pressure), brief physical examination, and history of symptoms since the previous visit.
Detailed description
The purpose of this Phase 1 clinical trial is to evaluate the safety, reactogenicity and immunogenicity of two malaria transmission-blocking vaccines, PpPfs25 and ScPvs25, in healthy adult volunteers. Of the four species of malaria that infect humans, Plasmodium falciparum is responsible for the majority of these deaths. However, outside of Africa, most of the malaria is caused by Plasmodium vivax; although these cases result in few deaths, they represent a major cause of morbidity and lead to a significant impact on the quality of life. The development of a safe and effective vaccine that prevents the transmission of P. falciparum or P. vivax would be an important addition to the current methods for controlling the spread of malaria parasites. A vaccine designed to prevent oocyst development in the mosquito by eliciting transmission-blocking antibodies in the vertebrate host would protect other individuals in the vicinity from becoming infected from the immunized person. Thus, despite no immediate role in personal protection, transmission-blocking vaccines are a potentially powerful component of a multifaceted public health approach to controlling or eliminating malaria. This study will be conducted at the Johns Hopkins University - Bloomberg School of Public Health, Center for Immunization Research. Seventy-two healthy male and non-pregnant female volunteers ages 18-50 will be enrolled. This study will be single blinded (to volunteers) and placebo-controlled. The study will evaluate three dose levels of both the PpPfs25 and ScPvs25 malaria vaccines (5 microg, 20 microg, 80 microg) emulsified with Montanide ISA51 as compared to Montanide ISA51 given alone. Seventy-two volunteers (60 vaccine and 12 placebo) will be enrolled and assigned to one of six cohorts. In each cohort, 10 volunteers will receive vaccine and 2 will receive placebo. Volunteers will be vaccinated by intramuscular injection on days 0 and 120. 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 objectives of this trial are to assess and compare, in a dose-escalating study, the safety and reactogenicity of the PpPfs25 and ScPvs25 transmission blocking vaccines as compared to adjuvant alone; and to assess and compare, in dose-escalating study, the duration of the antibody response over an 18 month period in each volunteer as well as the effect of boosting with a second vaccination at 4 months.
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 a result of review of medical history and/or clinical tests at screening.
- Available for the duration of the trial (78 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (22 listed)
- Pregnancy as determined by a positive urine human chronic gonadotrophin (B-hCG), if female.
- Volunteer unwilling to use reliable contraception methods for the duration of the trial, if female. (Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence, and post-menopause)
- Currently breast-feeding (if female).
- 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.
- Laboratory evidence of liver disease (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory).
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 |
|---|---|---|
| PpPfs25/ISA51 & ScPvs25/ISA51 | 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 9607022Limsuwan A, Churdboonchart V, Moss RB, Sirawaraporn W, Sutthent R, Smutharaks B, Glidden D, Trauger R, Theofan G, Carlo D. Safety and immunogenicity of REMUNE in HIV-infected Thai subjects. Vaccine. 1998 Jan-Feb;16(2-3):142-9. doi: 10.1016/s0264-410x(97)88327-2.
- Derived from this study: PubMed 18612426Wu Y, Ellis RD, Shaffer D, Fontes E, Malkin EM, Mahanty S, Fay MP, Narum D, Rausch K, Miles AP, Aebig J, Orcutt A, Muratova O, Song G, Lambert L, Zhu D, Miura K, Long C, Saul A, Miller LH, Durbin AP. Phase 1 trial of malaria transmission blocking vaccine candidates Pfs25 and Pvs25 formulated with montanide ISA 51. PLoS One. 2008 Jul 9;3(7):e2636. doi: 10.1371/journal.pone.0002636.
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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 study testing PpPfs25/ISA51 & ScPvs25/ISA51 in people with Plasmodium Falciparum and Plasmodium Vivax Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 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 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 NCT00295581, which also lists 2 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.