A Phase 1 Study Evaluating the Safety, Tolerability, and Immunogenicity of V4020 Vaccine in Healthy Volunteers

Conditions

• Venezuelan Equine Encephalitis
• Venezuelan Equine Encephalitis Virus Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• V4020 — BIOLOGICAL
  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).

Study Details

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.

Key Dates

Start date

Aug 15, 2025

Status verified

Jul 2025

Primary completion

Feb 28, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

39 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1
  Group 1 will receive an administration on day 0 (and possibly also day 56) of Subcutaneous route of dose escalation. 1. Low dose: A single dose of plaque forming units (PFU) administered 10\^4 subcutaneously. 2. Medium dose: A single dose of 10\^5 PFU administered subcutaneously. 3. High dose: A single dose of 10\^6 PFU administered subcutaneously
• Experimental: Group 2
  Group 2 will receive an administration on day 0 (and possibly also day 56) of Intramuscular route of dose escalation. 1. Low dose: A single dose of plaque forming units (PFU) administered 10\^3 PFU intramuscularly. 2. Medium dose: A single dose of 10\^4 PFU intramuscularly. 3. High dose: A single dose 10\^5 PFU intramuscularly.
• Experimental: Group 3
  Group 3 will receive an administration on day 0 (and possibly also day 56) of placebo (10:3 allocation).

Primary Outcome Measure

Safety [ Time Frame: 28 days ]

Central Contacts

• Roshila Mohammed, MBBS
  301-318-6024
  [email protected]
• David Saunders, MD, MPH
  [email protected]

Locations (1)

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