NCT04009824

Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine

Randomized, Double-Blind, Placebo-Controlled, Single-Center, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.

Detailed description

This study will evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers. Participants will be randomly assigned to five groups. Participants in Group 1 will receive placebo on Days 1 and 22. Participants in Group 2 will receive unadjuvanted AGS-v PLUS vaccine on Days 1 and 22. Participants in Group 3 will receive Montanide ISA-51 adjuvanted AGS-v PLUS vaccine on Day 1 and placebo on Day 22. Participants in Group 4 will receive Montanide ISA-51 adjuvanted AGS-v PLUS vaccine on Days 1 and 22. Participants in Group 5 will receive Alhydrogel® adjuvanted AGS-v PLUS vaccine on Days 1 and 22. Participants will be in the study for approximately 12 months. During this time, they will attend several study visits, which may include physical examinations, blood collection, skin biopsies, and a mosquito feeding procedure. Study staff will also follow up with participants by phone several times throughout the study.

Conditions

• Mosquito-Borne Infectious Diseases

Interventions

Type	Name	Description
BIOLOGICAL	AGS-v PLUS Vaccine	Administered by subcutaneous injection
BIOLOGICAL	Montanide ISA-51 Adjuvant	Administered by subcutaneous injection
BIOLOGICAL	Alhydrogel® Adjuvant	Administered by subcutaneous injection
BIOLOGICAL	Saline Placebo	Administered by subcutaneous injection

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-03-03
• Completion: 2021-02-23
• First posted: 2019-07-05
• Last updated: 2022-04-28
• Results posted: 2022-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study