Phase 2, Randomized, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• Adults 18 to 55 years of age

• Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition.

• Able to comply with the protocol schedule and procedures

• Able and willing to provide written informed consent

• If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through three months following the final trial injection

⁃ A premenopausal woman who has at least one of the following is considered not of childbearing potential:

• Documented hysterectomy

• Documented bilateral salpingectomy

• Documented bilateral oophorectomy

• Documented and current bilateral tubal ligation or occlusion

Locations
United States
Florida
AMR- Miami
NOT_YET_RECRUITING
Miami
Kansas
AMR- El Dorado
RECRUITING
El Dorado
Nevada
AMR- Las Vegas
RECRUITING
Las Vegas
Contact Information
Primary
Ouzama Henry, MD, Vice President, Clinical Development
ohenry@dynavax.com
510-848-5100
Time Frame
Start Date: 2025-09-11
Estimated Completion Date: 2026-10-16
Participants
Target number of participants: 148
Treatments
Experimental: Arm 1
Experimental: Arm 2
Experimental: Arm 3
Experimental: Arm 4
Experimental: Arm 5
Experimental: Arm 6
Related Therapeutic Areas
Sponsors
Leads: Dynavax Technologies Corporation
Collaborators: United States Department of Defense

This content was sourced from clinicaltrials.gov