NCT03641339 is a NA clinical trial of One vector feeding in Zika, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT03641339?

NCT03641339 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT03641339?

Interventions in NCT03641339: One vector feeding, Four vector feeding.

What condition does NCT03641339 study?

NCT03641339 studies Zika, Dengue, Malaria, Chikungunya, Leishmaniasis.

Is NCT03641339 still recruiting?

NCT03641339 is currently completed. Last updated 8 December 2021.

Are results published for NCT03641339?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-08 · How we verify

NCT03641339

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Defining Skin Immunity of a Bite of Key Insect Vectors in Humans

Completed NA Results posted Last updated 8 December 2021

What this trial tests

NA trial testing One vector feeding in Zika in 95 participants. Completed in 20 May 2020.

Timeline

5 September 2018

Primary endpoint
20 May 2020

20 May 2020

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	95
Start date	5 September 2018
Primary completion	20 May 2020
Estimated completion	20 May 2020
Sites	1 location across United States

Drugs / interventions tested

One vector feeding
Four vector feeding

Conditions studied

Zika — all drugs for Zika →
Dengue — all drugs for Dengue →
Malaria — all drugs for Malaria →
Chikungunya — all drugs for Chikungunya →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 64, any sex, with Zika or Dengue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Differentially Expressed Genes Between Bitten (Case) Versus Unbitten (Control) Skin for Each of the Three Vector Groups Primary · Up to 48 hours post bite

Number of differentially expressed genes between bitten and unbitten skin with adjusted p-values (adjusted for multiple comparisons) of \< 0.05 and a minimum absolute fold change \> 4 in samples derived from skin biopsies for the three vector groups - Aedes aegypti, Anopheles gambiae, Lutzomyia longipalpis

30 minutes post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	18
Multiple Exposure Cohort B: Aedes Aegypti	NA
Single Exposure Cohort A: Anopheles Gambiae	1
Multiple Exposure Cohort B: Anopheles Gambiae	NA
Single Exposure Cohort A: Lutzomyia Longipalpis	5
Multiple Exposure Cohort B: Lutzomyia Longipalpis	NA

4 hours post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	227
Multiple Exposure Cohort B: Aedes Aegypti	179
Single Exposure Cohort A: Anopheles Gambiae	12
Multiple Exposure Cohort B: Anopheles Gambiae	72
Single Exposure Cohort A: Lutzomyia Longipalpis	172
Multiple Exposure Cohort B: Lutzomyia Longipalpis	204

48 hours post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	NA
Multiple Exposure Cohort B: Aedes Aegypti	503
Single Exposure Cohort A: Anopheles Gambiae	NA
Multiple Exposure Cohort B: Anopheles Gambiae	982
Single Exposure Cohort A: Lutzomyia Longipalpis	NA
Multiple Exposure Cohort B: Lutzomyia Longipalpis	797

Participants With Local Skin Adaptive Immune Response After Multiple Exposures Over Time to Bites of Each of the Three Vector Groups Primary · Up to 48 hours post bite

Number of participants with certain types of inflammatory cell infiltrates, which includes neutrophils, mononuclear cells, and eosinophils, in the skin biopsies of bitten skin at 30 minutes, 4 hours, and 48 hours post bite for each of the three vector groups - Aedes aegypti, Anopheles gambiae, and Lutzomyia longipalpis

Neutrophils 30 minutes post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	3
Multiple Exposure Cohort B: Aedes Aegypti	NA
Single Exposure Cohort A: Anopheles Gambiae	2
Multiple Exposure Cohort B: Anopheles Gambiae	NA
Single Exposure Cohort A: Lutzomyia Longipalpis	0
Multiple Exposure Cohort B: Lutzomyia Longipalpis	NA

Mononuclear Cells 30 minutes post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	3
Multiple Exposure Cohort B: Aedes Aegypti	NA
Single Exposure Cohort A: Anopheles Gambiae	1
Multiple Exposure Cohort B: Anopheles Gambiae	NA
Single Exposure Cohort A: Lutzomyia Longipalpis	3
Multiple Exposure Cohort B: Lutzomyia Longipalpis	NA

Eosinophils 30 minutes post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	4
Multiple Exposure Cohort B: Aedes Aegypti	NA
Single Exposure Cohort A: Anopheles Gambiae	0
Multiple Exposure Cohort B: Anopheles Gambiae	NA
Single Exposure Cohort A: Lutzomyia Longipalpis	0
Multiple Exposure Cohort B: Lutzomyia Longipalpis	NA

Neutrophils 4 hours post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	5
Multiple Exposure Cohort B: Aedes Aegypti	6
Single Exposure Cohort A: Anopheles Gambiae	1
Multiple Exposure Cohort B: Anopheles Gambiae	3
Single Exposure Cohort A: Lutzomyia Longipalpis	3
Multiple Exposure Cohort B: Lutzomyia Longipalpis	3

Mononuclear Cells 4 hours post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	5
Multiple Exposure Cohort B: Aedes Aegypti	3
Single Exposure Cohort A: Anopheles Gambiae	0
Multiple Exposure Cohort B: Anopheles Gambiae	2
Single Exposure Cohort A: Lutzomyia Longipalpis	2
Multiple Exposure Cohort B: Lutzomyia Longipalpis	6

Eosinophils 4 hours post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	3
Multiple Exposure Cohort B: Aedes Aegypti	5
Single Exposure Cohort A: Anopheles Gambiae	0
Multiple Exposure Cohort B: Anopheles Gambiae	2
Single Exposure Cohort A: Lutzomyia Longipalpis	1
Multiple Exposure Cohort B: Lutzomyia Longipalpis	4

Neutrophils 48 hours post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	NA
Multiple Exposure Cohort B: Aedes Aegypti	1
Single Exposure Cohort A: Anopheles Gambiae	NA
Multiple Exposure Cohort B: Anopheles Gambiae	0
Single Exposure Cohort A: Lutzomyia Longipalpis	NA
Multiple Exposure Cohort B: Lutzomyia Longipalpis	0

Mononuclear Cells 48 hours post bite

Group	Value	95% CI
Single Exposure Cohort A: Aedes Aegypti	NA
Multiple Exposure Cohort B: Aedes Aegypti	8
Single Exposure Cohort A: Anopheles Gambiae	NA
Multiple Exposure Cohort B: Anopheles Gambiae	7
Single Exposure Cohort A: Lutzomyia Longipalpis	NA
Multiple Exposure Cohort B: Lutzomyia Longipalpis	8

Adverse events — posted to ClinicalTrials.gov

Time frame: Monitoring for adverse events was over a 7 day period for all Cohort A groups. Monitoring for adverse events was over a 51 day period for all Cohort B groups.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Exposure Cohort A: Aedes Aegypti

Serious: 0/15 (0%)

Deaths: 0/15

Multiple Exposure Cohort B: Aedes Aegypti

Serious: 0/15 (0%)

Deaths: 0/15

Single Exposure Cohort A: Anopheles Gambiae

Serious: 0/15 (0%)

Deaths: 0/15

Multiple Exposure Cohort B: Anopheles Gambiae

Serious: 0/14 (0%)

Deaths: 0/14

Single Exposure Cohort A: Lutzomyia Longipalpis

Serious: 0/15 (0%)

Deaths: 0/15

Multiple Exposure Cohort B: Lutzomyia Longipalpis

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (35 terms — click to expand)

Reaction	System	Single Exposure Cohort A: …	Multiple Exposure Cohort B…	Single Exposure Cohort A: …	Multiple Exposure Cohort B…	Single Exposure Cohort A: …	Multiple Exposure Cohort B…
Erythema at biopsy site	Injury, poisoning and procedural complications	—	—	—	—	—	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—	—
Drainage at biopsy site	Surgical and medical procedures	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—
Systolic hypertension	Vascular disorders	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—
Feverish	General disorders	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—	—	—
Latent Tuberculosis	Infections and infestations	—	—	—	—	—	—
Coryza	Infections and infestations	—	—	—	—	—	—
URI	Infections and infestations	—	—	—	—	—	—
Fractured metatarsal	Injury, poisoning and procedural complications	—	—	—	—	—	—
Knee pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Pain in hip	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Shoulder pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Muscle weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Foot pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Difficulty sleeping	Psychiatric disorders	—	—	—	—	—	—
Sinus pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
dry cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
ecchymosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03641339 adverse events section.

Sponsor's own description

Background: Mosquitoes and similar insects called sand flies carry parasites that can cause diseases. These viruses and parasites can spread quickly and be difficult to control. How people s bodies respond to insect bites may affect how they get infected. The response to bites is caused by the immune system, which helps fight off infections. Researchers want to study the immune response in skin to mosquito or sand fly bites and how the response changes after bites on multiple days. This may help researchers develop better vaccines. Objective: To study the immune response in skin to certain insect bites and how that changes after bites on multiple days. Eligibility: Healthy adults ages 18-64 Design: Participants will be screened under another protocol. Women must agree to practice effective contraception or abstinence. All participants must agree to not donate blood or use certain lotions or creams on visit days. Some participants will have 2 visits over a week. Others will have 5 visits over 8 weeks. All participants will have the following at least once: Medical history Physical exam Blood and urine collected Mosquito or sand fly feeding. Up to 10 insects will feed on participant s arm for up to 20 minutes. The insects are grown at NIH and do not carry any diseases. The skin will be checked and bites will be treated. Skin samples taken. The skin will be cleaned and numbed. A tool will remove a small piece of skin from 3 places on the arm. About a week after the last visit, participants will be called to see how they feel.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03641339 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 8 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03641339.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03641339

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Zika

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Verify against primary sources