Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates

ConditionMalaria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-25
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

Background:

\- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy.

Objectives:

\- To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women.

Eligibility:

\- Pregnant women ages 15-25

Design:

* The study site is an area in Mali, West Africa. * Participants: * Will have blood drawn. * Will give consent for the blood sample to be used for future research. * May have a physical exam. * Participants who have malaria or anemia will get treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women aged 15-25 years

Able to provide consent for self

Malaria positive by rapid diagnostic test (RDT)

Disqualifiers

Severe anemia defined as HGB<7 gr/dL, that may be worsened by 10 mL phlebotomy

Conditions that in the judgment of the investigator could increase the risk to the volunteer

Prior enrollment to the study during the same pregnancy

Trial population

Pregnant women age 15-25 years presenting for antenatal consultations or delivery at health centers or hospital in Ouelessebougou and neighboring districts@@@@@@

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

7,476 Participants
are grouped into 1 trial group
Group A: Pregnant Women 15-25 years old

Trial outcomes

Primary outcomes

1

Measure of functional activity of animal IgG against vaccine candidates to block binding of fresh pregnancy malaria isolates to the placental receptor CSA

Time frame
Approximately 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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