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Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v, a Universal Mosquito-Borne Disease Vaccine
Sponsor study identifier
Secondary identifiers
OTHER · NIAID
interventional
49
1 country
1
Study Start
February 15, 2017
Actual (reported)Primary Completion
December 28, 2018
Actual (reported)Study Completion
December 28, 2018
Actual (reported)Background: Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person. Objective: To see if the AGS-v vaccine is safe in humans and how it affects the immune system. Eligibility: Healthy adults ages 18-50 Design: Participants will be screened another study. Participants will be randomly assigned to get either the vaccine with a booster vaccine, the vaccine without the booster, or a placebo. These are given through a needle in the upper arm. Participants will have visits that include medical history, physical exam, and blood and urine tests: Baseline: They will get the vaccine and be monitored for 2 hours. Follow-up visits 1 and 2 weeks after baseline. Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours. Follow-up visits 1 and 2 weeks after booster visit. Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the feeding. Phone follow-up a few days after the mosquito feeding. After the feeding visit, 5 follow-up visits about every 2 months Participants will keep a symptom diary for 7 days after each vaccine. They will record their temperature. They will measure any redness around the injection site. They will document and if possible photograph any mosquito bites they get.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 28, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 14, 2017
Actual (reported)February 15, 2017
Actual (reported)February 16, 2017
Actual (reported)December 28, 2018
Actual (reported)December 28, 2018
Actual (reported)August 3, 2020
Actual (reported)AEs Grade 3 or Higher
Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart.
1 year after vaccination (study duration)
GM-CSF Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
21 days after last vaccination
IL-10 Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
21 days after last vaccination
IL-1B Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
21 days after last vaccination
IL-2 Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
GM-CSF Cytokine Level as Measured by Luminex
60 days after Day 42 Mosquito Feeding
IL-10 Cytokine Level as Measured by Luminex
60 days after Day 42 Mosquito Feeding
IL-1B Cytokine Level as Measured by Luminex
60 days after Day 42 Mosquito Feeding
IL-2 Cytokine Level as Measured by Luminex
60 days after Day 42 Mosquito Feeding
IL-4 Cytokine Level as Measured by Luminex
60 days after Day 42 Mosquito Feeding
AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21
ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL)on Day 0 and on Day 21
WFI (0.5mL) on Day 0 and Day 21
AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21
ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Peng Z, Yang M, Simons FE. Immunologic mechanisms in mosquito allergy: correlation of skin reactions with specific IgE and IgG antibodies and lymphocyte proliferation response to mosquito antigens. Ann Allergy Asthma Immunol. 1996 Sep;77(3):238-44. doi: 10.1016/S1081-1206(10)63262-0.
Sidjanski S, Vanderberg JP. Delayed migration of Plasmodium sporozoites from the mosquito bite site to the blood. Am J Trop Med Hyg. 1997 Oct;57(4):426-9. doi: 10.4269/ajtmh.1997.57.426.
Matthew J Memoli, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
49 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2017
First Posted
February 16, 2017
Study Start
February 15, 2017
Actual (reported)21 days after last vaccination
IL-4 Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
21 days after last vaccination
IL-5 Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
21 days after last vaccination
Interferon-gamma Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
21 days after last vaccination
Number of Subjects With 1 or More Aes
Percent of people with an AE
1 year after vaccination (study duration)
Number of Subjects With 1 or More Grade 3 or Higher AE
Percent of people with a Grade 3 or higher AE
1 year after vaccination (study duration)
TNF-a Cytokine Level as Measured by Luminex
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
21 days after last vaccination
Total AGS-v Specific Immunoglobulin
Total AGS-v specific immunoglobulin measured in serum 14 days after the first and/or second vaccination.
21 days after last vaccination
WFI (0.5mL) on Day 0 and Day 21
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ribeiro JM. Role of saliva in blood-feeding by arthropods. Annu Rev Entomol. 1987;32:463-78. doi: 10.1146/annurev.en.32.010187.002335. No abstract available.
Manning JE, Oliveira F, Coutinho-Abreu IV, Herbert S, Meneses C, Kamhawi S, Baus HA, Han A, Czajkowski L, Rosas LA, Cervantes-Medina A, Athota R, Reed S, Mateja A, Hunsberger S, James E, Pleguezuelos O, Stoloff G, Valenzuela JG, Memoli MJ. Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial. Lancet. 2020 Jun 27;395(10242):1998-2007. doi: 10.1016/S0140-6736(20)31048-5. Epub 2020 Jun 11.
Primary Completion
December 28, 2018
Actual (reported)Study Completion
December 28, 2018
Actual (reported)Last Updated
August 11, 2020
Results First Posted
August 3, 2020
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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