Status:
COMPLETED
PpPfs25/ISA51 and ScPvs25/ISA51 Vaccines for Malaria
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Plasmodium Falciparum
Plasmodium Vivax Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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...
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....
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
March 7 2005
Trial Type :
INTERVENTIONAL
End Date :
June 17 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00295581
Start Date
March 7 2005
End Date
June 17 2008
Last Update
July 2 2017
Active Locations (2)
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1
Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892