Malaria Clinical Trial
Official title:
Malaria Transmission-Blocking Pfs25-Pfs25 Conjugate Vaccine
Verified date | March 5, 2013 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Plasmodium vivax, the most common and severe forms of malaria, have host-
and stage-specific proteins that can induce immunity to the disease.
- Vaccines against stages that infect mosquitoes will prevent the spread of malaria.
Researchers have developed a vaccine composed of a single protein, Pfs25, to induce
antibodies in the human host that will be ingested by the mosquito and prevent the
malaria parasite from reproducing and stop transmission of the disease. Because Pfs25 is
present only in the mosquito, humans do not develop antibodies to this antigen even in
endemic areas. Repeated injections of this vaccine may be necessary.
Objectives:
- To establish the safety and optimal dosage of a malaria vaccine developed with the Pfs25
protein.
Eligibility:
- Healthy adults between 18 and 49 years of age who have never had malaria or received a
malaria vaccine.
Design:
- Two doses of Pfs25 conjugate (10 micrograms and 25 micrograms) will be evaluated in this
study. Participants will receive only one of these doses in order to provide the best
scientific data for evaluation.
- To determine eligibility, participants will provide a medical history and have a
physical examination, and will provide blood and urine samples to test for HIV/AIDS,
hepatitis, and other conditions that would prevent them from participating.
- Eligible participants will receive one injection of the vaccine. The injection will be
followed 30 minutes later with a temperature reading and an inspection of the vaccine
site.
- Upon leaving the clinic, participants will receive diary forms, a digital thermometer, a
ruler, and instructions about how to take their temperature and to measure redness and
swelling (if any) at the injection site. About 6 hours later, and daily for 3 days,
participants will take their temperature at home and examine the injection site.
Participants will be examined at the clinic at 48 to 72 hours and on day 7 after an
injection. A blood sample will be taken 1 week after immunization. - Participants will
receive a second and third injection of the same vaccine at 6-week intervals, and will
follow the same recording procedure given above. Further blood samples will be taken at
regular intervals for up to 12 months after the vaccination, as directed by the study
researchers.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 5, 2013 |
Est. primary completion date | March 5, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility |
- 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: 1. A chronic or progressive disease requiring chronic medication, 2. History of surgical splenectomy or abnormal immune system, 3. History of neurological symptoms or signs, or mental illness, 4. Anaphylactic shock following administration of any vaccine or any other severe allergic reaction., 5. Women who are pregnant or intend to become pregnant during the vaccine study, 6. Had malaria or received a malaria vaccine previously, 7. Allergy to vaccine components or to nickel and yeast, 8. Had cancer, HIV/AIDS, Hepatitis B or C, Guillain Barre Syndrome, chronic skin disease or have abnormal liver functions or blood counts. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Carter R, Mendis KN, Miller LH, Molineaux L, Saul A. Malaria transmission-blocking vaccines--how can their development be supported? Nat Med. 2000 Mar;6(3):241-4. Review. — View Citation
Fernando SD, Gunawardena DM, Bandara MR, De Silva D, Carter R, Mendis KN, Wickremasinghe AR. The impact of repeated malaria attacks on the school performance of children. Am J Trop Med Hyg. 2003 Dec;69(6):582-8. — View Citation
Snow RW, Guerra CA, Noor AM, Myint HY, Hay SI. The global distribution of clinical episodes of Plasmodium falciparum malaria. Nature. 2005 Mar 10;434(7030):214-7. — View Citation
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---|---|---|---|---|
Primary | Antibody | |||
Secondary | Transmission-blocking activity |
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