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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPEC |
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Last refreshed on:
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4 September 2023 |
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Main ID: |
PER-022-17 |
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Date of registration:
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03/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A PHASE 2/2B, RANDOMIZED TRIAL TO EVALUATE THE SAFETY, IMMUNOGENICITY AND EFFICACY OF A ZIKA VIRUS DNA VACCINE IN HEALTHY ADULTS AND ADOLESCENTS
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Scientific title:
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A PHASE 2/2B, RANDOMIZED TRIAL TO EVALUATE THE SAFETY, IMMUNOGENICITY AND EFFICACY OF A ZIKA VIRUS DNA VACCINE IN HEALTHY ADULTS AND ADOLESCENTS |
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Date of first enrolment:
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06/10/2017 |
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Target sample size:
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900 |
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Recruitment status: |
Recruiting |
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URL:
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https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=022-17 |
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Study type:
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Interventional |
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Study design:
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This is a multicenter , randomized, study to evaluate the safety, immunogenicity, and efficacy of VRC-ZKADNA090-00-VP (Zika virus wildtype DNA vaccine) or placebo. In Part A, the primary objective is to evaluate the safety and tolerability of the vaccine. In Part B, the primary objectives are to evaluate the safety and efficacy of the vaccine compared to placebo. Peru is expected to participate only in Part B.
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Phase:
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II
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Countries of recruitment
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Brazil
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Colombia
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Costa Rica
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Ecuador
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Mexico
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Panama
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Peru
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Puerto Rico
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United States
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Contacts
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Name:
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Juanita Bernal
Aching |
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Address:
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Av. Republica de Panama 3461, Interior 1801 Urb. El palomar
San Isidro Lima Lima
Peru |
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Telephone:
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6134100 |
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Email:
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Juanita.Aching@ppdi.com |
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Affiliation:
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PPD Peru S.A.C. |
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Name:
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Juanita Bernal
Aching |
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Address:
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Av. Republica de Panama 3461, Interior 1801 Urb. El palomar
San Isidro Lima Lima
Peru |
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Telephone:
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6134100 |
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Email:
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Juanita.Aching@ppdi.com |
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Affiliation:
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PPD Peru S.A.C. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Other mosquito-borne viral fevers
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Other specified salmonella infections
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A028
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-A92 Other mosquito-borne viral fevers
Other specified salmonella infections
Other mosquito-borne viral fevers
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A92
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Intervention(s)
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Group name:Group 4 Type of group;1 N° of participants:1200 Intervention(s) description:Experimental: Part B, Group 4
ZIKV vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days), 4 mg of vaccine.
Group name:Group 5 Type of group;2 N° of participants:1200 Intervention(s) description:Placebo Comparator: Part B, Group 5
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days), 1 mL of placebo.
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Secondary ID(s)
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NCT03110770
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Source(s) of Monetary Support
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INSTITUTOS NACIONALES DE SALUD (NIH, SIGLAS EN INGLES) DE LOS ESTADOS UNIDOS DE AMERICA
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Ethics review
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Status: Approved
Approval date: 24/05/2017
Contact:
andresparedesleon@yahoo.com
Asociacion Civil Impacta Salud y Educacion
2423072 anexo 130
andresparedesleon@yahoo.com
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Status: Approved
Approval date: 22/08/2017
Contact:
opshi@vialibre.org.pe
Via Libre
4331396
opshi@vialibre.org.pe
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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04/10/2019 |
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URL:
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