Assessing Human-to-Mosquito Transmission in Volunteers Participating in Malaria Vaccine Candidate Trials in Mali

NCT02206451 | Completed

• 2 other identifiers: 99991415914-I-N159
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Malaria

Keywords

Assay; Infection; Direct Skin Feed; Midgut; Parasite

Outcome Measures

Primary Outcomes (1)

• Measurement of infection/infectivity incidences

  1 year

Secondary Outcomes (1)

• Measurement of infection intensity for a given mosquito that was fed on a given subject

  1 year

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (3)

• 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.

  PMID: 19055715 BACKGROUND

• Gouagna 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.

  PMID: 24262642 BACKGROUND

• Moorthy 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.

  PMID: 23454165 BACKGROUND

MeSH Terms

Conditions

Malaria; Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Sara A Healy, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: July 16, 2014
• Primary Completion: July 16, 2014
• Study Completion: July 16, 2014
• Last Updated: December 17, 2019

Record last verified: 2016-06-29

Locations

MA (1)