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

NCT04009824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-04-28

Study results available
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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.

Conditions

  • Mosquito-Borne Infectious Diseases

Interventions

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

Sponsors & Collaborators

  • PepTcell Limited

    collaborator INDUSTRY
  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew B. Laurens, MD, MPH · University of Maryland, Baltimore

  • Matthew J. Memoli, MD, MS · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2020-03-03
Completion
2021-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009824 on ClinicalTrials.gov