Ad26.ZIKV.001 Zika Vaccine Description
Ad26.ZIKV.001 Zika Vaccine candidate is a replication-incompetent human adenovirus serotype 26 (ad26) vector.
Ad26.ZIKV.001 is an adenovirus serotype 26 vector encoding ZIKV M-Env, administered in 1- or 2-dose regimens of 5 × 1010 or 1 × 1011 viral particles (vp), or placebo.
Janssen Vaccines & Prevention B.V. is the vaccine candidate study sponsor.
Ad26.ZIKV.001 Zika Vaccine Indication
Ad26.ZIKV.001 Zika Vaccine candidate is indicated to induce neutralizing antibodies to prevent Zika virus (ZIKV) infection.
ZIKV is transmitted via Aedes aegypti mosquitoes and may cause severe congenital disease after maternal-fetal transmission.
Ad26.ZIKV.001 Zika Vaccine Dosage
In this phase 1 clinical trial, researchers found that 2 doses of Ad26.ZIKV.001 was safe causing mild to moderate reactogenicity and induced persistent neutralizing antibody responses. The single-dose had lower peak antibodies but were durable after 1 year.
Ad26.ZIKV.001 Zika Vaccine News
April 13. 2021 - Phase I Trial Of An Adenovirus Vector Vaccine for Zika Virus Shows High Immunogenicity And Safety
February 16, 2021 - A phase 1 trial of the Ad26.ZIKV.001 Zika vaccine candidate revealed no safety concerns. The antibodies peaked 14 days after the second vaccine and remained high for at least one year.
February 16, 2021 - Estimating the Effect of Discontinuing Universal Screening of Donated Blood for Zika Virus in the 50 U.S. States.
August 24, 2018 - RESEARCH ARTICLE: Adenoviral vector type 26 encoding Zika virus (ZIKV) M-Env antigen induces humoral and cellular immune responses and protects mice and nonhuman primates against ZIKV challenge. In NHP, a single immunization with a typical human dose of 1x1011 vp of Ad26.ZIKV.M-Env also induced Env-binding and ZIKV neutralizing antibodies and Env and M specific cellular immune responses that associated with complete protection against viremia from ZIKV challenge as measured in plasma and other body fluids. Together these data provide the rationale to progress the Ad26.ZIKV.M-Env candidate vaccine to clinical testing.
Ad26.ZIKV.001 Zika Vaccine Clinical Trials
Clinical Trial NCT03356561: A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.ZIKV.001 in 100 Healthy Adult Volunteers - Last Update Posted on October 15, 2019.
On May 16, 2021, the Annals of Internal Medicine reported on the clinical trial.
All regimens were well tolerated, with no safety concerns identified. In both 2-dose regimens, ZIKV neutralizing titers peaked 14 days after the second vaccination. However, this study was limited since it was conducted in a nonendemic area, so it did not assess safety and immunogenicity in a flavivirus-exposed population.
If the need for a ZIKA vaccine reemerges, Ad26.ZIKV.001 is a promising candidate based on the safety and immunogenicity profile.