MalariaNCT01862783
Collection of Biological Material From Pregnant Women in a Malarial Region
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 1,270 participants
- Where
- 1 siteUganda
- Study dates
- 10 Feb 2013to 15 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Malaria
- Keywords
- Erythrocytes, Parasites, Plasmodium Falciparum, Placenta, Resistant
- Medical subject headings
- Malaria, Malaria, Falciparum
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start10 Feb 2013
- Primary completion19 Oct 2015
- Study completion15 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,270 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michal Fried, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862783
- Sponsor's protocol ID
- 999913074
- Other IDs
- 13-I-N074
- Status last verified
- 15 Mar 2016
- First submitted
- 23 May 2013
- Last updated
- 25 Nov 2019
- Results posted
- No
Publications
Brabin BJ, Hakimi M, Pelletier D. An analysis of anemia and pregnancy-related maternal mortality. J Nutr. 2001 Feb;131(2S-2):604S-614S; discussion 614S-615S. doi: 10.1093/jn/131.2.604S.
PubMed 11160593Buffet PA, Gamain B, Scheidig C, Baruch D, Smith JD, Hernandez-Rivas R, Pouvelle B, Oishi S, Fujii N, Fusai T, Parzy D, Miller LH, Gysin J, Scherf A. Plasmodium falciparum domain mediating adhesion to chondroitin sulfate A: a receptor for human placental infection. Proc Natl Acad Sci U S A. 1999 Oct 26;96(22):12743-8. doi: 10.1073/pnas.96.22.12743.
PubMed 10535993Duffy MF, Maier AG, Byrne TJ, Marty AJ, Elliott SR, O'Neill MT, Payne PD, Rogerson SJ, Cowman AF, Crabb BS, Brown GV. VAR2CSA is the principal ligand for chondroitin sulfate A in two allogeneic isolates of Plasmodium falciparum. Mol Biochem Parasitol. 2006 Aug;148(2):117-24. doi: 10.1016/j.molbiopara.2006.03.006. Epub 2006 Apr 7.
PubMed 16631964
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vitro Evaluation of Anti-Adhesion Activity by Antibodies to Pregnancy Malaria Vaccine Candidates
- ClinicalTrials.gov ID
- NCT01862783
- Acronym / sponsor ID
- 999913074
- Conditions
- Malaria
- Keywords
- Erythrocytes, Parasites, Plasmodium Falciparum, Placenta, Resistant
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Feb 2013
- Primary completion
- 19 Oct 2015 (actual)
- Study completion
- 15 Mar 2016 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Background: PubMed 11160593Brabin BJ, Hakimi M, Pelletier D. An analysis of anemia and pregnancy-related maternal mortality. J Nutr. 2001 Feb;131(2S-2):604S-614S; discussion 614S-615S. doi: 10.1093/jn/131.2.604S.
- Background: PubMed 10535993Buffet PA, Gamain B, Scheidig C, Baruch D, Smith JD, Hernandez-Rivas R, Pouvelle B, Oishi S, Fujii N, Fusai T, Parzy D, Miller LH, Gysin J, Scherf A. Plasmodium falciparum domain mediating adhesion to chondroitin sulfate A: a receptor for human placental infection. Proc Natl Acad Sci U S A. 1999 Oct 26;96(22):12743-8. doi: 10.1073/pnas.96.22.12743.
- Background: PubMed 16631964Duffy MF, Maier AG, Byrne TJ, Marty AJ, Elliott SR, O'Neill MT, Payne PD, Rogerson SJ, Cowman AF, Crabb BS, Brown GV. VAR2CSA is the principal ligand for chondroitin sulfate A in two allogeneic isolates of Plasmodium falciparum. Mol Biochem Parasitol. 2006 Aug;148(2):117-24. doi: 10.1016/j.molbiopara.2006.03.006. Epub 2006 Apr 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Fried, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862783, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.