VRC5283 is a Zika Virus DNA Vaccine candidate. It is composed of a single closed-circular DNA plasmid that encodes with wild type precursor transmembrane M and envelope proteins from the H/PF/2013 strain of ZIKV. The vaccine was developed by the Vaccine Research Center (VRC), NIAID
VRC5283 is a new vaccine candidate that instructs the body to make a small amount of Zika virus protein. The body may use this to build an immune response.
The vaccine is supplied in single-dose vials at a concentration of 4 mg/mL. ZIKV DNA vaccine dose will be 4 mg administered as an intramuscular (IM) injection in the deltoid muscle.
Clinical Trial NCT03110770: VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents (DNA) PHASE 2
- This is a multicenter, randomized study to evaluate the safety, immunogenicity, and efficacy of a 3-dose vaccination regimen with the Zika virus wildtype (ZIKVwt) DNA vaccine,
- VRC-ZKADNA090-00-VP (VRC5283) or placebo (VRC-PBSPLA043-00-VP). The placebo is a sterile phosphate-buffered saline (PBS). The hypotheses are that the ZIKVwt DNA vaccine will be safe and will elicit a ZIKV-specific immune response.
- Participants will receive study product intramuscularly (IM) in the limbs as specified by the group assignment by PharmaJet needle-free device.
- In Part A, 90 participants will be randomized to vaccine at a 1:1:1 ratio to receive a 4 mg or 8 mg dose of vaccine split between 2 or 4 injections.
- In Part B, about 2400 participants will be randomized to vaccine or placebo in a 1:1 ratio to receive a 4 mg dose of vaccine or 1 mL of placebo split between 2 injections.
- Vaccine safety and tolerability will be assessed by monitoring of clinical and laboratory parameters throughout the study. Solicited reactogenicity symptoms will be collected for 7 days after each product administration. The study schedule will include clinic visits with safety and immunogenicity blood samples collected at particular time points.
- The vaccine dose and administration plan for Part B was selected based on Part A and Phase 1 data.
- Vaccine efficacy will be evaluated in Part B by comparing incidence of ZIKV cases between vaccine and placebo groups.
- During the study, when participants exhibit any possible symptom of ZIKV infection, they will be evaluated by blood and urine ZIKV polymerase chain reaction (PCR). Stored blood and urine samples will also be assessed retrospectively by ZIKV PCR to identify possible asymptomatic cases.
- A Data and Safety Monitoring Board (DSMB) will oversee the study.
Clinical Trial NCT02840487: Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP (VRC5283), in Healthy Adults - PHASE 1/1b
- This is a Phase I/Ib, randomized, multicenter clinical study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against Zika virus (ZIKV) disease.
- Vaccination regimens with the VRC-ZKADNA085-00-VP (VRC5283) (ZIKV DNA) vaccine administered on Day 0 and Week 8 (Group 1); on Day 0 and Week 12 (Group 2); on Day 0, Weeks 4 and 8 (Group 3); and on Day 0, Weeks 4 and 20 (Group 4) will be tested.
- The primary hypothesis is that the ZIKV DNA vaccine will be safe and well-tolerated in healthy adults.
- A secondary hypothesis is that all vaccine regimens will elicit a ZIKV-specific immune response.
- The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens in healthy adults.
- Secondary objectives are related to the immunogenicity of the vaccination regimens.