A PHASE 2/2B, RANDOMIZED TRIAL TO EVALUATE THE SAFETY, IMMUNOGENICITY AND EFFICACY OF A ZIKA VIRUS DNA VACCINE IN HEALTHY ADULTS AND ADOLESCENTS

Not Applicable

Recruiting

• Conditions: -A92 Other mosquito-borne viral fevers; Other specified salmonella infections; Other mosquito-borne viral fevers; A028; A92

• Registration Number: PER-022-17
• Lead Sponsor: Institutos Nacionales de Salud (NIH, siglas en ingles) de los Estados Unidos de America, Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID). EEUU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-03
• Study Completion: 2019-10-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1086

Inclusion Criteria

(1) Part B: 15 to 35 years of age ;(*)
(2) Part B: Available for clinical follow-up through Study Week 96;
(3) Provide proof of identity;
(4) informed consent process;
(5) Able to understand questions;
(6) Willing to donate blood and urine to be stored and used for future research;
(7) In good general health;
(8) No clinical or laboratory significant findings within the 56 days prior to randomization;
(9) Weight > 30 kg;
(10) Agree not to receive any flavivirus vaccines;
(11) Accessible injection sites on each limb;

(12 – 18) Laboratory criteria within 56 days prior to randomization as listed in protocol. :
(19 – 20) Criteria applicable to women and adolescents of childbearing potential:

(*) In Peru, the restriction of the Ministry of Health D.S. 20-2015-SA., will be taken into account, of not enrolling minors until a new clinical trial regulation is published.

Exclusion Criteria

A subject will be excluded if one or more of the following conditions apply:
Criteria applicable to women and adolescents of childbearing potential:
(1) Breast-feeding or pregnancy plans;
Subject has received any of the following products within the timeframe excluded by protocol:
(2 – 3 ) Use of immunosuppressive medications or cytotoxic medications
(4) Blood products;
(5) Immunoglobulin;
(6) Investigational research agents;
(7) Any vaccination;
(8) Any live attenuated vaccination;
(9) Current anti-TB prophylaxis or therapy;
Subject has any of the following conditions excluded by protocol:
(10) Confirmed history of ZIKV infection;
(11) Serious reactions to vaccines;
(12) Chronic angioedema or chronic urticaria;
(13) Uncontrolled Asthma;
(14) Diabetes mellitus;
(15) Autoimmune disease or immunodeficiency;
(16) Uncontrolled Hypertension;
(17) Bleeding disorder;
(18) Significant bruising or bleeding difficulties;
(19) Malignancy that is active or history of a malignancy;
(20) Seizure or treatment;
(21) Asplenia, functional asplenia;
(22) History of Guillain-Barre Syndrome;
(23) Psychiatric condition;
(24) Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject’s ability to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified