Collection of Biological Material From Pregnant Women in a Malarial Region

November 22, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

In-Vitro Evaluation of Anti-Adhesion Activity by Antibodies to Pregnancy Malaria Vaccine Candidates

Background:

- Malaria is a disease caused by a parasite that infects the blood. It affects millions of people every year and frequently harms or kills pregnant woman and infants. Researchers are looking for treatments that may help pregnant women in areas of the world where malaria is common. To do so, they want to collect blood and other samples from pregnant women in south-central Uganda. They will also collect samples from newborn babies if the mother agrees to it.

Objectives:

- To collect biological material such as blood samples from pregnant women and newborns.

Eligibility:

  • Women between 14 and 45 years of age who are pregnant or are in labor.
  • Participants will be from the Kalisizio area of south-central Uganda.

Design:

  • Women who are pregnant will provide blood and urine samples.
  • Women who are in labor will allow researchers to collect samples from their baby after the delivery. Samples will be taken of placenta tissue and umbilical cord blood. The baby will also be weighed and measured. Researchers will look at the baby's physical appearance and muscle strength.
  • Treatment will not be offered as part of this study.

Study Overview

Status

Terminated

Conditions

Detailed Description

Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. Pregnancy malaria is associated with low birth weight, maternal anemia, and gestational hypertension, and both inflammation and the fetal response to infection may contribute to these poor outcomes. Pregnancy malaria 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 1500 pregnant women will be recruited into a cross sectional study that will be conducted in Rakai, Uganda. Women presenting for delivery and their newborns and women presenting for antenatal visit at Kalisizo Hospital, Rakai District will be enrolled. Samples collected from the women will be used in in-vitro assays to assess the functional activity of antisera raised against pregnancy malaria vaccine candidates as the primary outcome of this study. For our secondary outcomes, we will examine various factors that can lead to poor outcomes such as low birth weight of infants by measuring newborns for birth weight and physical and muscular maturity using the Dubowitz Ballard Exam for Gestational Age. We will also study the effects of intermittent preventive therapy during pregnancy (IPTp) on immune responses in the mother as well as the effect of HIV infection on the acquisition of immunity to pregnancy malaria. Clinical, parasitological and host response endpoints (including naturally acquired functional antibodies against CSA-binding parasites) will be analyzed using appropriate statistical methods, including adjustment for possible confounders, to determine factors associated with malaria infection and disease in pregnant women, as well as pregnancy outcomes.

Study Type

Observational

Enrollment (Actual)

1270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Rakai District, Uganda
        • Kalisizo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

  • INCLUSION CRITERIA:<TAB>

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

  • Pregnant women aged 14-45 years or newborns of pregnant women enrolled at parturition
  • Able to provide consent for self and newborn (if enrolled at parturition)

EXCLUSION CRITERIA:<TAB>

  • Clinically symptomatic or apparent severe anemia, active bleeding, or any other condition that may be worsened by 10 mL phlebotomy or any other study procedure
  • History of involvement in a malaria vaccine study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Samples collected from the women will be used in in-vitro assays to assess the functional activity of antisera raised against pregnancy malaria vaccine candidates as the primary outcome of this study.
Time Frame: ongoing
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 10, 2013

Primary Completion (Actual)

October 19, 2015

Study Completion (Actual)

March 15, 2016

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

March 15, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999913074
  • 13-I-N074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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