NCT02840487

Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults

Completed Phase 1 Last updated 18 March 2019

What this trial tests

Phase 1 trial testing VRC-ZKADNA085-00-VP in Prevention of Zika Infection in 80 participants. Completed in 14 March 2019.

Timeline

2 August 2016

Primary endpoint
14 March 2019

14 March 2019

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	80
Start date	2 August 2016
Primary completion	14 March 2019
Estimated completion	14 March 2019
Sites	3 locations across United States

Drugs / interventions tested

• VRC-ZKADNA085-00-VP — full drug profile →

Conditions studied

• Prevention of Zika Infection — all drugs for Prevention of Zika Infection →
• Zika-Specific Immune Response — all drugs for Zika-Specific Immune Response →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 35, any sex, with Prevention of Zika Infection or Zika-Specific Immune Response. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with Zika virus infection. There is currently no cure for or vaccine against the infection. VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika virus protein. The body may use this to build an immune response.

Objective:

To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.

Eligibility:

Healthy people ages 18 35

Design:

Participants will be screened through a separate protocol with:

* Medical history
* Physical exam
* Lab and urine tests

Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic visits over 2 years. Most will occur in the first year, with long-term follow-up visits at months 18 and 24. Visits include a physical exam and blood and urine tests.

Participants will have vaccine injections. A high-pressure device pushes the vaccine through the skin and into the muscle of the upper arm. They will have 2-3 injections depending on their group.

Vaccine visits last 4-6 hours. Others last 1-2 hours.

Participants will keep a diary for 7 days after each injection. They will record their temperature and measure any skin changes at the injection site each day.

Participants might have extra visits and blood tests if they have health changes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modified mRNA Vaccines Protect against Zika Virus Infection.
   Richner JM, Himansu S, Dowd KA, Butler SL, et al · · 2017 · cited 601× · PMID 28222903 · DOI 10.1016/j.cell.2017.02.017
2. New Vaccine Technologies to Combat Outbreak Situations.
   Rauch S, Jasny E, Schmidt KE, Petsch B. · · 2018 · cited 380× · PMID 30283434 · DOI 10.3389/fimmu.2018.01963
3. Rapid development of a DNA vaccine for Zika virus.
   Dowd KA, Ko SY, Morabito KM, Yang ES, et al · · 2016 · cited 332× · PMID 27708058 · DOI 10.1126/science.aai9137
4. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials.
   Gaudinski MR, Houser KV, Morabito KM, Hu Z, et al · · 2018 · cited 237× · PMID 29217376 · DOI 10.1016/s0140-6736(17)33105-7
5. Personalized vaccinology: A review.
   Poland GA, Ovsyannikova IG, Kennedy RB. · · 2018 · cited 119× · PMID 28774561 · DOI 10.1016/j.vaccine.2017.07.062
6. Viral Emerging Diseases: Challenges in Developing Vaccination Strategies.
   Trovato M, Sartorius R, D'Apice L, Manco R, et al · · 2020 · cited 87× · PMID 33013898 · DOI 10.3389/fimmu.2020.02130
7. Zika virus vaccines.
   Abbink P, Stephenson KE, Barouch DH. · · 2018 · cited 85× · PMID 29921914 · DOI 10.1038/s41579-018-0039-7
8. Zika Virus Vaccine: Progress and Challenges.
   Shan C, Xie X, Shi PY. · · 2018 · cited 79× · PMID 30008291 · DOI 10.1016/j.chom.2018.05.021