Status:
WITHDRAWN
Phase 1 Study of the Safety and Immunogenicity of a Malaria Transmission-blocking Pfs25-Pfs25 Conjugate Vaccine
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Malaria
Malaria Vaccines
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
Background: * Malaria, a disease transmitted by mosquitoes, affects millions of people with the highest frequency, morbidity, and mortality in infants and young children. Plasmodium falciparum and Pl...
Detailed Description
Malaria is a disease affecting millions of people in Africa, Asia, Central and South America . It has its highest frequency, morbidity, and mortality in infants and young children. For many reasons, a...
Eligibility Criteria
Inclusion
- ELIGIBILITY AND EXCULUSION CRITERIA
- Healthy adults, 18 to 49 years of age of either sex who do not have any of the following conditions will be eligible to participate:
- A chronic or progressive disease requiring chronic medication,
- History of surgical splenectomy or abnormal immune system,
- History of neurological symptoms or signs, or mental illness,
- Anaphylactic shock following administration of any vaccine or any other severe allergic reaction.,
- Women who are pregnant or intend to become pregnant during the vaccine study,
- Had malaria or received a malaria vaccine previously,
- Allergy to vaccine components or to nickel and yeast,
- Had cancer, HIV/AIDS, Hepatitis B or C, Guillain Barre Syndrome, chronic skin disease or have abnormal liver functions or blood counts.
Exclusion
Key Trial Info
Start Date :
August 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00977899
Start Date
August 20 2009
End Date
March 5 2013
Last Update
July 5 2018
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