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

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ClinicalTrials.gov Identifier: NCT02471378
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

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.

Condition or disease
Malaria

Detailed Description:
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. Pregnancy malaria is associated with low birth weight (LBW), maternal anemia, and gestational hypertension; and both inflammation and the fetal response to infection may contribute to these poor outcomes. Pregnancy malaria (PM) is caused by P. falciparum-infected erythrocytes that bind to the placental receptor chondroitin sulfate A (CSA) and sequester in the placenta, where they cause disease and death for the mother and her offspring. Women become resistant to pregnancy malaria as they acquire antibodies that target surface proteins of placental parasites. Malaria vaccine candidates targeting the parasite s liver stage or blood stage may not protect pregnant women and their unborn children. The primary hypothesis in this study is that antibodies raised in animals against recombinant pregnancy malaria vaccine candidates will have a similar functional activity as naturally acquired antibodies. Up to 1597 malaria-infected pregnant women will be recruited into a cross sectional study that will be conducted in Ouelessebougou and neighboring districts, Mali. Women presenting for antenatal visit at the health centers in Ouelessebougou District will be enrolled. Samples collected from the women will be used in in-vitro assays to assess the functional activity of immunoglobulin G (IgG) raised against pregnancy malaria vaccine candidates as the primary outcome of this study. For our secondary outcomes, we will examine functional activity of naturally acquired antibodies specific to the vaccine candidates. Functional activity by IgG to vaccine candidates will be compared to the activity obtained with control proteins using appropriate statistical methods, including adjustment for possible confounders such as parasite density in the assay, to determine if the candidates elicit the type of immune response observed in naturally exposed population.

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Study Type : Observational
Estimated Enrollment : 4791 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: In-Vitro Testing of Pregnancy Malaria Vaccine Candidates
Actual Study Start Date : July 28, 2015
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort
Pregnant Women 15-25 years old
Malaria-infected pregnant Women



Primary Outcome Measures :
  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 Outcome Measures :
  1. Measurement of parasite density in the in-vitro binding inhibition assay [ Time Frame: Approximately 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women age 15-25 years presenting for antenatal consultations or delivery at health centers or hospital in Ouelessebougou and neighboring districts@@@@@@
Criteria
  • INCLUSION CRITERIA:

A study participant must satisfy the following criteria to be enrolled in this study:

  • Pregnant women aged 15-25 years
  • Able to provide consent for self
  • Malaria positive by rapid diagnostic test (RDT)

EXCLUSION CRITERIA:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471378


Contacts
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Contact: Michal Fried, Ph.D. (301) 402-0763 michal.fried@nih.gov

Locations
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Mali
Ouelessebougou Clinical Research Center Recruiting
Bamako, Mali
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Michal Fried, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02471378    
Other Study ID Numbers: 999915147
15-I-N147
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 26, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Assays
Women
Infected
Antibodies
Plasmodium Falciparum
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases