A Phase 1 Study Evaluating the Safety, Tolerability, and Immunogenicity of V4020 Vaccine in Healthy Volunteers
Medigen, Inc.
Summary
The purpose of the study is to evaluate the safety and immunogenicity of a novel Venezuelan Equine Encephalitis virus (VEEV) vaccine (V4020) for the first time in humans compared to placebo when administered by subcutaneous or intramuscular injection.
Description
The primary objective of the study will be to measure safety. The primary endpoint measures to assess this objective will include but not be limited to * Frequency and nature of adverse events (AEs) reported or observed in participants; * Relatedness between AEs and vaccine administration; * Interventions or therapy required by participants experience vaccine related adverse events; * Resolution or outcome of AEs. Secondary Objectives and Endpoints Two main immunogenicity objectives will be assessed to include the number considered adequately immunized, and the magnitude and durability of tit…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants must meet all the following criteria to be included in the study: 1. 18-50 years old at time of consent. 2. Have VEE virus PRNT80 \< 1:10. 3. If biologic female of childbearing potential, must agree to have a serum pregnancy test 3 days before vaccine administration. (Exceptions for those with documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females of child-bearing potential must agree not to become pregnant for at least 3 months after receipt of vaccination. They must also agree to use an acceptable form of birth con…
Interventions
- BiologicalV4020
The V4020 vaccine was prepared using an iDNA® infectious clone that encodes the full-length rearranged genomic RNA downstream from the optimized CMV promoter. Compared to the wild type VEEV, V4020 contains genetic rearrangement within the genomic RNA, with the capsid gene placed downstream from the glycoprotein genes. V4020 also includes attenuating mutations from the VEE TC83 vaccine, nucleotide A at position 3 in the untranslated region and E2-120Arg in the E2 glycoprotein. Notably, the E2-120Arg attenuating mutation was genetically engineered in V4020 to prevent reversion mutations. The E2-120Arg was encoded in V4020 by a CGA codon instead of AGA in the TC83 virus. Therefore, in the V4020 vaccine, at least two mutations would be needed to revert to the wildtype ACA (E2-120Thr). In contrast, in the TC83 vaccine, an AGA codon encodes the attenuating mutation E2-120Arg, and a single point mutation would be sufficient to revert to the 213 VEEV wild type ACA (E2-120Thr).
Location
- Uniformed Services University of the Health SciencesBethesda, Maryland