MalariaNCT01322581
A Longitudinal Systems Biological Analysis of Naturally Acquired Malaria Immunity in Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Read more about this study
- Who is it for?
- Ages 3 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 1,188 participants
- Where
- 1 siteMali
- Study dates
- 1 May 2011to 29 Mar 2022
- 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 3 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All study subjects will be selected from the village of Kalifabougou, Mali. Male and female volunteers 3 months to 40 years of age will be included. This age range captures the period over which immunity to malaria is acquired in areas of intense Pf transmission like Mali. There is no exclusion based on race, ethnicity, or gender.@@@
Who may be able to join
- Individuals 3 months to 40 years of age are eligible to enter the study if they agree to:
- Live in Kalifabougou for the duration of the study (12 months).
- Have blood specimens stored for future studies.
Who cannot join
- The following eligibility criteria are exclusionary:
- Anemia (hemoglobin less than 7 g/dL).
- Current use of antimalarials, corticosteroids, or other immuno-suppressants.
- Underlying heart disease, bleeding disorder, or other conditions that, in the judgment of the clinical investigators, could increase the risk to the study subjects.
- Fever greater than or equal to 37.5 degrees Celsius or evidence of an acute infection.
- Currently pregnant or planning to become pregnant during the study period.
- (Asymptomatic Pf infection at enrollment is not exclusionary).
Trial locations and contacts
1 site in 1 country.
Mali1 site
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
Bamako
About this study
Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Optimism that an effective malaria vaccine can be developed is derived in part from the observation that repeated Pf infections can induce protective immunity; however, the mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study is to apply systems biological tools to an observational cohort in an area of intense seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired malaria immunity. This year-long observational-cohort study of 700 individuals (3 months and 25 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be detected by passive and active surveillance. Immune parameters of malaria-protected and -susceptible individuals will be assayed from blood samples collected at strategic time points relative to the malaria season. The primary objective is to identify genome-wide expression profiles induced by Pf infection that are associated with protection from malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific antibody profiles that are associated with protection from malaria using a protein microarray representing 2000 Pf proteins (40 percent of the Pf proteome). Exploratory objectives for this study are to compare the magnitude and quality of the Pf-specific CD4 plus T cell response in malaria-protected and -susceptible individuals and determine how this response varies with age and among individuals before, during, and after malaria season, as well as compare various immune parameters in Pf-infected and uninfected individuals at the end of the dry season to investigate host immune factors associated with chronic asymptomatic Pf infection....
Read the detailed description
Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Optimism that an effective malaria vaccine can be developed is derived in part from the observation that repeated Pf infections can induce protective immunity; however, the mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study is to apply systems biological tools to an observational cohort in an area of intense seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired malaria immunity. This observational-cohort study of individuals (3 months and 40 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be detected by passive and active surveillance. Immune parameters of malaria-protected and -susceptible individuals will be assayed from blood samples collected at strategic time points relative to the malaria season. The primary objective is to identify genome-wide expression profiles induced by Pf infection that are associated with protection from malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific antibody profiles that are associated with protection from malaria using a protein microarray representing 2000 Pf proteins (approximately 40% of the Pf proteome). Exploratory objectives for this study are to compare the magnitude and quality of the Pf-specific CD4+ T cell response in malaria-protected and -susceptible individuals and determine how this response varies with age and among individuals before, during, and after malaria season, as well as compare various immune parameters in Pf-infected and uninfected individuals at the end of the dry season to investigate host immune factors associated with chronic asymptomatic Pf infection.
- Conditions
- Malaria
- Keywords
- Plasmodium, PBMC, Natural History, Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational cohort | This observational-cohort study of individuals (3 months and 40 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pf expression profiles
Identify genome-wide progression profiles induced by Plasmonium falciparum infection that are assocaited with malaria immunity
Measured: Triannual cross-sectional surveys and convalescence visits
Secondary outcomes (2)
serum cytokine profiles
Examine the relationship between age (surrogate for cumulative Pf exposure) and the gene-expression and serum cytokine profilesinduced by Pf infection.
Measured: Triannual cross-sectional surveys and convalescence visits
Pf-specific antibody profiles
Identify Pf-specific antibody profiles that are associated with malaria immunity by using a protein microarray representing 2000 Pf proteins (approx. 40% of the Pf proteome), and determine how these profiles change with age. The objective is to validate and extend findings from a preliminary study performed in the nearby village of Kambila, Mali, where a protein microarray containing approx. 23% of the Pf proteome was used to profile Pf-specific antibody responses in children and adults before and after the 6-month malaria season
Measured: Triannual cross-sectional surveys and convalescence visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study start1 May 2011
- Primary completion28 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,188 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter D Crompton, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322581
- Sponsor's protocol ID
- 999911126
- Other IDs
- 11-I-N126
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2011
- Last updated
- 31 Mar 2022
- Results posted
- No
Publications
Tran TM, Aghili A, Li S, Ongoiba A, Kayentao K, Doumbo S, Traore B, Crompton PD. A nested real-time PCR assay for the quantification of Plasmodium falciparum DNA extracted from dried blood spots. Malar J. 2014 Oct 4;13:393. doi: 10.1186/1475-2875-13-393.
PubMed 25282516Tran TM, Ongoiba A, Coursen J, Crosnier C, Diouf A, Huang CY, Li S, Doumbo S, Doumtabe D, Kone Y, Bathily A, Dia S, Niangaly M, Dara C, Sangala J, Miller LH, Doumbo OK, Kayentao K, Long CA, Miura K, Wright GJ, Traore B, Crompton PD. Naturally acquired antibodies specific for Plasmodium falciparum reticulocyte-binding protein homologue 5 inhibit parasite growth and predict protection from malaria. J Infect Dis. 2014 Mar 1;209(5):789-98. doi: 10.1093/infdis/jit553. Epub 2013 Oct 16.
PubMed 24133188Doumbo S, Tran TM, Sangala J, Li S, Doumtabe D, Kone Y, Traore A, Bathily A, Sogoba N, Coulibaly ME, Huang CY, Ongoiba A, Kayentao K, Diallo M, Dramane Z, Nutman TB, Crompton PD, Doumbo O, Traore B. Co-infection of long-term carriers of Plasmodium falciparum with Schistosoma haematobium enhances protection from febrile malaria: a prospective cohort study in Mali. PLoS Negl Trop Dis. 2014 Sep 11;8(9):e3154. doi: 10.1371/journal.pntd.0003154. eCollection 2014 Sep.
PubMed 25210876Cho H, Seo Y, Sohn H, Choudhary SK, Skinner J, Zhao M, Krymskaya L, Zhong W, Lack J, Li S, Traore B, Tan J, Commins SP, Crompton PD. Human monoclonal antibodies targeting alpha-Gal restrict IgE engagement of alpha-Gal syndrome allergens. J Clin Invest. 2026 Sep 1;136(17):e192370. doi: 10.1172/JCI192370. eCollection 2026 Sep 1.
PubMed 42677844Molina-Cruz A, Raytselis N, Withers R, Dwivedi A, Crompton PD, Traore B, Carpi G, Silva JC, Barillas-Mury C. A genotyping assay to determine geographic origin and transmission potential of Plasmodium falciparum malaria cases. Commun Biol. 2021 Sep 30;4(1):1145. doi: 10.1038/s42003-021-02667-0.
PubMed 34593959Guha R, Mathioudaki A, Doumbo S, Doumtabe D, Skinner J, Arora G, Siddiqui S, Li S, Kayentao K, Ongoiba A, Zaugg J, Traore B, Crompton PD. Plasmodium falciparum malaria drives epigenetic reprogramming of human monocytes toward a regulatory phenotype. PLoS Pathog. 2021 Apr 6;17(4):e1009430. doi: 10.1371/journal.ppat.1009430. eCollection 2021 Apr.
PubMed 33822828Obeng-Adjei N, Larremore DB, Turner L, Ongoiba A, Li S, Doumbo S, Yazew TB, Kayentao K, Miller LH, Traore B, Pierce SK, Buckee CO, Lavstsen T, Crompton PD, Tran TM. Longitudinal analysis of naturally acquired PfEMP1 CIDR domain variant antibodies identifies associations with malaria protection. JCI Insight. 2020 Jun 18;5(12):e137262. doi: 10.1172/jci.insight.137262.
PubMed 32427581Liu EW, Skinner J, Tran TM, Kumar K, Narum DL, Jain A, Ongoiba A, Traore B, Felgner PL, Crompton PD. Protein-Specific Features Associated with Variability in Human Antibody Responses to Plasmodium falciparum Malaria Antigens. Am J Trop Med Hyg. 2018 Jan;98(1):57-66. doi: 10.4269/ajtmh.17-0437.
PubMed 29141757
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Systems Biological Analysis of Naturally Acquired Malaria Immunity in Mali
- ClinicalTrials.gov ID
- NCT01322581
- Acronym / sponsor ID
- 999911126
- Conditions
- Malaria
- Keywords
- Plasmodium, PBMC, Natural History, Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,188 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 1 May 2011 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 24 Mar 2011 (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.
Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Optimism that an effective malaria vaccine can be developed is derived in part from the observation that repeated Pf infections can induce protective immunity; however, the mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study is to apply systems biological tools to an observational cohort in an area of intense seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired malaria immunity. This year-long observational-cohort study of 700 individuals (3 months and 25 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be detected by passive and active surveillance. Immune parameters of malaria-protected and -susceptible individuals will be assayed from blood samples collected at strategic time points relative to the malaria season. The primary objective is to identify genome-wide expression profiles induced by Pf infection that are associated with protection from malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific antibody profiles that are associated with protection from malaria using a protein microarray representing 2000 Pf proteins (40 percent of the Pf proteome). Exploratory objectives for this study are to compare the magnitude and quality of the Pf-specific CD4 plus T cell response in malaria-protected and -susceptible individuals and determine how this response varies with age and among individuals before, during, and after malaria season, as well as compare various immune parameters in Pf-infected and uninfected individuals at the end of the dry season to investigate host immune factors associated with chronic asymptomatic Pf infection....
Detailed description
Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality worldwide. A malaria vaccine would contribute towards efforts to control and eliminate malaria. Optimism that an effective malaria vaccine can be developed is derived in part from the observation that repeated Pf infections can induce protective immunity; however, the mechanisms underlying acquired malaria immunity remain unclear. The goal of the current study is to apply systems biological tools to an observational cohort in an area of intense seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired malaria immunity. This observational-cohort study of individuals (3 months and 40 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be detected by passive and active surveillance. Immune parameters of malaria-protected and -susceptible individuals will be assayed from blood samples collected at strategic time points relative to the malaria season. The primary objective is to identify genome-wide expression profiles induced by Pf infection that are associated with protection from malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining Pf-specific antibody profiles that are associated with protection from malaria using a protein microarray representing 2000 Pf proteins (approximately 40% of the Pf proteome). Exploratory objectives for this study are to compare the magnitude and quality of the Pf-specific CD4+ T cell response in malaria-protected and -susceptible individuals and determine how this response varies with age and among individuals before, during, and after malaria season, as well as compare various immune parameters in Pf-infected and uninfected individuals at the end of the dry season to investigate host immune factors associated with chronic asymptomatic Pf infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational cohort | – | –This observational-cohort study of individuals (3 months and 40 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf transmission is intense and seasonal |
Who may qualify
- Ages
- 3 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All study subjects will be selected from the village of Kalifabougou, Mali. Male and female volunteers 3 months to 40 years of age will be included. This age range captures the period over which immunity to malaria is acquired in areas of intense Pf transmission like Mali. There is no exclusion based on race, ethnicity, or gender.@@@
Key inclusion criteria (3 listed)
- Live in Kalifabougou for the duration of the study (12 months).
- Have blood specimens stored for future studies.
Key exclusion criteria (7 listed)
- Anemia (hemoglobin less than 7 g/dL).
- Current use of antimalarials, corticosteroids, or other immuno-suppressants.
- Underlying heart disease, bleeding disorder, or other conditions that, in the judgment of the clinical investigators, could increase the risk to the study subjects.
- Fever greater than or equal to 37.5 degrees Celsius or evidence of an acute infection.
- Currently pregnant or planning to become pregnant during the study period.
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
Pf expression profiles
Time frame: Triannual cross-sectional surveys and convalescence visits
Identify genome-wide progression profiles induced by Plasmonium falciparum infection that are assocaited with malaria immunity
2 secondary outcomes
serum cytokine profiles
Time frame: Triannual cross-sectional surveys and convalescence visits
Pf-specific antibody profiles
Time frame: Triannual cross-sectional surveys and convalescence visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 25282516Tran TM, Aghili A, Li S, Ongoiba A, Kayentao K, Doumbo S, Traore B, Crompton PD. A nested real-time PCR assay for the quantification of Plasmodium falciparum DNA extracted from dried blood spots. Malar J. 2014 Oct 4;13:393. doi: 10.1186/1475-2875-13-393.
- Background: PubMed 24133188Tran TM, Ongoiba A, Coursen J, Crosnier C, Diouf A, Huang CY, Li S, Doumbo S, Doumtabe D, Kone Y, Bathily A, Dia S, Niangaly M, Dara C, Sangala J, Miller LH, Doumbo OK, Kayentao K, Long CA, Miura K, Wright GJ, Traore B, Crompton PD. Naturally acquired antibodies specific for Plasmodium falciparum reticulocyte-binding protein homologue 5 inhibit parasite growth and predict protection from malaria. J Infect Dis. 2014 Mar 1;209(5):789-98. doi: 10.1093/infdis/jit553. Epub 2013 Oct 16.
- Background: PubMed 25210876Doumbo S, Tran TM, Sangala J, Li S, Doumtabe D, Kone Y, Traore A, Bathily A, Sogoba N, Coulibaly ME, Huang CY, Ongoiba A, Kayentao K, Diallo M, Dramane Z, Nutman TB, Crompton PD, Doumbo O, Traore B. Co-infection of long-term carriers of Plasmodium falciparum with Schistosoma haematobium enhances protection from febrile malaria: a prospective cohort study in Mali. PLoS Negl Trop Dis. 2014 Sep 11;8(9):e3154. doi: 10.1371/journal.pntd.0003154. eCollection 2014 Sep.
- Derived from this study: PubMed 42677844Cho H, Seo Y, Sohn H, Choudhary SK, Skinner J, Zhao M, Krymskaya L, Zhong W, Lack J, Li S, Traore B, Tan J, Commins SP, Crompton PD. Human monoclonal antibodies targeting alpha-Gal restrict IgE engagement of alpha-Gal syndrome allergens. J Clin Invest. 2026 Sep 1;136(17):e192370. doi: 10.1172/JCI192370. eCollection 2026 Sep 1.
- Derived from this study: PubMed 34593959Molina-Cruz A, Raytselis N, Withers R, Dwivedi A, Crompton PD, Traore B, Carpi G, Silva JC, Barillas-Mury C. A genotyping assay to determine geographic origin and transmission potential of Plasmodium falciparum malaria cases. Commun Biol. 2021 Sep 30;4(1):1145. doi: 10.1038/s42003-021-02667-0.
- Derived from this study: PubMed 33822828Guha R, Mathioudaki A, Doumbo S, Doumtabe D, Skinner J, Arora G, Siddiqui S, Li S, Kayentao K, Ongoiba A, Zaugg J, Traore B, Crompton PD. Plasmodium falciparum malaria drives epigenetic reprogramming of human monocytes toward a regulatory phenotype. PLoS Pathog. 2021 Apr 6;17(4):e1009430. doi: 10.1371/journal.ppat.1009430. eCollection 2021 Apr.
- Derived from this study: PubMed 32427581Obeng-Adjei N, Larremore DB, Turner L, Ongoiba A, Li S, Doumbo S, Yazew TB, Kayentao K, Miller LH, Traore B, Pierce SK, Buckee CO, Lavstsen T, Crompton PD, Tran TM. Longitudinal analysis of naturally acquired PfEMP1 CIDR domain variant antibodies identifies associations with malaria protection. JCI Insight. 2020 Jun 18;5(12):e137262. doi: 10.1172/jci.insight.137262.
- Derived from this study: PubMed 29141757Liu EW, Skinner J, Tran TM, Kumar K, Narum DL, Jain A, Ongoiba A, Traore B, Felgner PL, Crompton PD. Protein-Specific Features Associated with Variability in Human Antibody Responses to Plasmodium falciparum Malaria Antigens. Am J Trop Med Hyg. 2018 Jan;98(1):57-66. doi: 10.4269/ajtmh.17-0437.
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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.
Peter D Crompton, M.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 Mali.
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 7 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: finished, as of the sponsor's last update on 31 Mar 2022. 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 Mali. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pf expression profiles (time frame: Triannual cross-sectional surveys and convalescence visits). 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 NCT01322581, which also lists 8 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 31 Mar 2022.