MalariaNCT02206451
Assessing Human-to-Mosquito Transmission in Volunteers Participating in Malaria Vaccine Candidate Trials in Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
Background: Malaria is a disease that affects many people in Mali and in Africa. It is caused by germs that are spread by mosquito bites. Researchers are creating vaccines that they hope will prevent malaria infection and/or the spread of it. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 87 participants
- Where
- 1 siteMali
- Study dates
- 16 Jul 2014to 16 Jul 2014
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently enrolled in the PfSPZ Vaccine trial.
- Willingness to participate in the study as evidenced by signing the informed consent document, or by fingerprinting the consent document and obtaining the signature of a witness.
Who cannot join
- Refusal to participate
- Known history of abnormal reaction to mosquito bites
- Any condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the DSF or EH procedures or would render the volunteer unable to comply with the Feeding Assay Protocol.
- Pregnancy
- Any condition that in the opinion of the investigator would withdraw the volunteer from vaccine trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Human-to-Mosquito Transmission in Volunteers Participating in Malaria Vaccine Candidate Trials in Don(SqrRoot)(Copyright)gu(SqrRoot)(Copyright)Bougou Mali
Background:
- Malaria is a disease that affects many people in Mali and in Africa. It is caused by germs that are spread by mosquito bites. Researchers are creating vaccines that they hope will prevent malaria infection and/or the spread of it.
Read more
Objective:
- To test if the PfSPZ vaccine can stop malaria spread by mosquitoes.
Eligibility:
- People currently enrolled in the ongoing PfSPZ malaria vaccine trial. Participants must be willing to have uninfected mosquitoes bite them.
Design:
- Participants will be able to take part in this study at every visit after receiving all scheduled vaccinations.
- Participants will be asked whether they are willing to participate in the procedures. Female participants will have a pregnancy test.
- Researchers will put about 60 mosquitoes in 2 or 3 cups (20 or 30 in each cup). They will hold each cup to the participant s leg or arm so the mosquitoes can bite. These mosquitoes do not carry germs and will take about 3 drops of blood total.
- Participants will get a cream for any swelling or itching.
- Participants will be checked the next day for any discomfort.
- Participants may take part in this feeding test multiple times, if they are willing.
- If participants have malaria parasites in their blood, they may be asked to take part in another study. For this, they will sleep alone in their hut the night after the feeding test. A study team will set up nets to collect mosquitoes that may have bitten the participant overnight.
Read the detailed description
A vaccine which interrupts malaria transmission (VIMT) is a critical tool to achieve the ultimate goal of eradication of this disease. VIMTs work by inducing humoral responses in vaccinated individuals that inhibit the development of malaria parasites in the mosquito, and combined humoral and cellular responses that inhibit the establishment of infection in humans. Overall efficacy of these vaccines is evaluated by measuring reduction of infection and clinical cases among vaccinees and the parasite infectivity to mosquitoes, (human-to-mosquito transmissibility), before and after vaccination, and with or without vaccination. One of the candidate VIMTs, the PfSPZ Vaccine, is currently being tested in Mali for safety, tolerance, and immunogenicity.
The objective of this Feeding Assay Protocol is to explore the effect of the PfSPZ Vaccine, on interrupting human-to-mosquito transmission. Individuals from the the PfSPZ Vaccine trial in 2014 who also consent to be enrolled in this Feeding Assay Protocol will be eligible to participate in procedures including direct skin feeds (DSF) and experimental huts (EH). The human-to-mosquito transmission will be evaluated by examining the presence of malaria parasites in the midgut of mosquitoes fed on study participants. The human-to-mosquito transmission by DSF and EH assay methods will be analyzed for potential correlation.
- Conditions
- Malaria
- Keywords
- Assay, Infection, Direct Skin Feed, Midgut, Parasite
- Medical subject headings
- Malaria, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of infection/infectivity incidences
Measured: 1 year
Secondary outcomes (1)
Measurement of infection intensity for a given mosquito that was fed on a given subject
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study start16 Jul 2014
- Primary completion16 Jul 2014
- Study completion16 Jul 2014
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sara A Healy, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206451
- Sponsor's protocol ID
- 999914159
- Other IDs
- 14-I-N159
- Status last verified
- 29 Jun 2016
- First submitted
- 31 Jul 2014
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Diallo M, Toure AM, Traore SF, Niare O, Kassambara L, Konare A, Coulibaly M, Bagayogo M, Beier JC, Sakai RK, Toure YT, Doumbo OK. Evaluation and optimization of membrane feeding compared to direct feeding as an assay for infectivity. Malar J. 2008 Dec 2;7:248. doi: 10.1186/1475-2875-7-248.
PubMed 19055715Gouagna LC, Yao F, Yameogo B, Dabire RK, Ouedraogo JB. Comparison of field-based xenodiagnosis and direct membrane feeding assays for evaluating host infectiousness to malaria vector Anopheles gambiae. Acta Trop. 2014 Feb;130:131-9. doi: 10.1016/j.actatropica.2013.10.022. Epub 2013 Nov 18.
PubMed 24262642Moorthy VS, Newman RD, Duclos P, Okwo-Bele JM, Smith PG. Assessment of the RTS,S/AS01 malaria vaccine. Lancet Infect Dis. 2013 Apr;13(4):280-2. doi: 10.1016/S1473-3099(13)70047-1. Epub 2013 Mar 1. No abstract available.
PubMed 23454165
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Human-to-Mosquito Transmission in Volunteers Participating in Malaria Vaccine Candidate Trials in Don(SqrRoot)(Copyright)gu(SqrRoot)(Copyright)Bougou Mali
- ClinicalTrials.gov ID
- NCT02206451
- Acronym / sponsor ID
- 999914159
- Conditions
- Malaria
- Keywords
- Assay, Infection, Direct Skin Feed, Midgut, Parasite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 16 Jul 2014
- Primary completion
- 16 Jul 2014 (actual)
- Study completion
- 16 Jul 2014 (actual)
- First posted
- 1 Aug 2014 (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 that affects many people in Mali and in Africa. It is caused by germs that are spread by mosquito bites. Researchers are creating vaccines that they hope will prevent malaria infection and/or the spread of it.
Objective:
- To test if the PfSPZ vaccine can stop malaria spread by mosquitoes.
Eligibility:
- People currently enrolled in the ongoing PfSPZ malaria vaccine trial. Participants must be willing to have uninfected mosquitoes bite them.
Design:
- Participants will be able to take part in this study at every visit after receiving all scheduled vaccinations.
- Participants will be asked whether they are willing to participate in the procedures. Female participants will have a pregnancy test.
- Researchers will put about 60 mosquitoes in 2 or 3 cups (20 or 30 in each cup). They will hold each cup to the participant s leg or arm so the mosquitoes can bite. These mosquitoes do not carry germs and will take about 3 drops of blood total.
- Participants will get a cream for any swelling or itching.
- Participants will be checked the next day for any discomfort.
- Participants may take part in this feeding test multiple times, if they are willing.
- If participants have malaria parasites in their blood, they may be asked to take part in another study. For this, they will sleep alone in their hut the night after the feeding test. A study team will set up nets to collect mosquitoes that may have bitten the participant overnight.
Detailed description
A vaccine which interrupts malaria transmission (VIMT) is a critical tool to achieve the ultimate goal of eradication of this disease. VIMTs work by inducing humoral responses in vaccinated individuals that inhibit the development of malaria parasites in the mosquito, and combined humoral and cellular responses that inhibit the establishment of infection in humans. Overall efficacy of these vaccines is evaluated by measuring reduction of infection and clinical cases among vaccinees and the parasite infectivity to mosquitoes, (human-to-mosquito transmissibility), before and after vaccination, and with or without vaccination. One of the candidate VIMTs, the PfSPZ Vaccine, is currently being tested in Mali for safety, tolerance, and immunogenicity.
The objective of this Feeding Assay Protocol is to explore the effect of the PfSPZ Vaccine, on interrupting human-to-mosquito transmission. Individuals from the the PfSPZ Vaccine trial in 2014 who also consent to be enrolled in this Feeding Assay Protocol will be eligible to participate in procedures including direct skin feeds (DSF) and experimental huts (EH). The human-to-mosquito transmission will be evaluated by examining the presence of malaria parasites in the midgut of mosquitoes fed on study participants. The human-to-mosquito transmission by DSF and EH assay methods will be analyzed for potential correlation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Currently enrolled in the PfSPZ Vaccine trial.
- Willingness to participate in the study as evidenced by signing the informed consent document, or by fingerprinting the consent document and obtaining the signature of a witness.
Key exclusion criteria (5 listed)
- Refusal to participate
- Known history of abnormal reaction to mosquito bites
- Any condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the DSF or EH procedures or would render the volunteer unable to comply with the Feeding Assay Protocol.
- Pregnancy
- Any condition that in the opinion of the investigator would withdraw the volunteer from vaccine trial.
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
Measurement of infection/infectivity incidences
Time frame: 1 year
1 secondary outcome
Measurement of infection intensity for a given mosquito that was fed on a given subject
Time frame: 1 year
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 17 Dec 2019.
- Background: PubMed 19055715Diallo M, Toure AM, Traore SF, Niare O, Kassambara L, Konare A, Coulibaly M, Bagayogo M, Beier JC, Sakai RK, Toure YT, Doumbo OK. Evaluation and optimization of membrane feeding compared to direct feeding as an assay for infectivity. Malar J. 2008 Dec 2;7:248. doi: 10.1186/1475-2875-7-248.
- Background: PubMed 24262642Gouagna LC, Yao F, Yameogo B, Dabire RK, Ouedraogo JB. Comparison of field-based xenodiagnosis and direct membrane feeding assays for evaluating host infectiousness to malaria vector Anopheles gambiae. Acta Trop. 2014 Feb;130:131-9. doi: 10.1016/j.actatropica.2013.10.022. Epub 2013 Nov 18.
- Background: PubMed 23454165Moorthy VS, Newman RD, Duclos P, Okwo-Bele JM, Smith PG. Assessment of the RTS,S/AS01 malaria vaccine. Lancet Infect Dis. 2013 Apr;13(4):280-2. doi: 10.1016/S1473-3099(13)70047-1. Epub 2013 Mar 1. No abstract available.
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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.
Sara A Healy, 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 2 inclusion and 5 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 17 Dec 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 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?
Measurement of infection/infectivity incidences (time frame: 1 year). 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 NCT02206451, 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 17 Dec 2019.