VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents

Completed · Phase 2 · Has a placebo group

Conditions studied: Zika Virus, Zika Virus Infection, Virus Diseases, Flavivirus Infections, Flaviviral Diseases, Flaviviridae Infections, RNA Virus Infections

In brief

This was 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 was to evaluate the safety and tolerability of the vaccine in different vaccination regimens. In Part B, the primary objectives were to evaluate the safety and efficacy of the vaccine compared to placebo.

Key facts

Study ID

NCT03110770

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2428

Starts

2017-03-29

Expected to finish

2019-10-04

Last updated by the study team

2024-01-31

Who can join

Age: 15 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A participant must meet all of the following criteria:
• Part A:
• 18 to 35 years of age
• Available for clinical follow-up through Study Week 32
• Accessible injection sites on each limb as follows: 1 injection site in the deltoid muscle of each arm and 1 injection site in the vastus lateralis muscle of each anterolateral thigh
• Part B:
• 15 to 35 years of age
• Available for clinical follow-up through Study Week 96
• Accessible injection sites on the deltoid muscle of each arm. Injection in the vastus lateralis muscle of the anterolateral thighs may have been allowed with IND Sponsor approval if an injection site on each deltoid muscle was not available.
• Part A and B:
• Able to provide proof of identity to the satisfaction of the clinician completing the enrollment process
• Able and willing to complete the informed consent/assent process
• Able and willing to complete the Assessment of Understanding and to verbalize understanding of all questions answered incorrectly prior to signing consent/assent
• Willing to donate blood and urine to be stored and used for future research
• In good general health without clinically significant medical history
• Physical examination and laboratory results without clinically significant findings within the 56 days prior to randomization
• Weight >30 kilograms (kg)
• Agree not to receive any licensed or investigational flavivirus vaccines through 4 weeks after last product administration
• Laboratory Criteria within 56 days prior to randomization:
• Hemoglobin within site institutional normal limits
• Absolute neutrophil count (ANC) within site institutional normal limits
• Total lymphocyte count ≥800 cells/mm\^3
• Platelets = 125,000-510,000 cells/mm\^3
• Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN) based on site institutional normal range for respective age group
• Serum creatinine ≤1.2 x ULN based on site institutional normal range for respective age group

You may not qualify if…

• Criteria applicable to women and adolescents of childbearing potential:
• Breast-feeding or planning to become pregnant while participating through 12 weeks after the last product administration
• Participant has received any of the following:
• More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to randomization
• Any systemic immunosuppressive medications or cytotoxic medications within the 14 days prior to randomization
• Blood products within 16 weeks prior to randomization
• Immunoglobulin within 8 weeks prior to randomization
• Investigational research agents within 4 weeks prior to randomization or planning to receive investigational products while on the study
• Any vaccination within 2 weeks prior to randomization
• Any live attenuated vaccination within 4 weeks prior to randomization
• Current anti-tuberculosis (TB) prophylaxis or therapy
• Participant has any of the following:
• Confirmed history of ZIKV infection (as reported by participant)
• Serious reactions to vaccines
• Chronic angioedema or chronic urticaria
• Asthma that is not well-controlled
• Diabetes mellitus (type I or II)
• Clinically significant autoimmune disease or immunodeficiency
• Hypertension that is not well-controlled
• Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
• Significant bruising or bleeding difficulties with IM injections or blood draws
• Malignancy that is active or history of a malignancy that is likely to recur during the period of the study
• Seizure or treatment for a seizure disorder within the last 3 years
• Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
• History of Guillain-Barré Syndrome

Where it is running

• QPS-Miami Research Associates — Miami, Florida, United States
• Doctors Hospital at Renaissance — Edinburg, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Hospital Das Clinicas Da Universidade Federal de Minas Gerais — Belo Horizonte, Minas Gerais, Brazil
• Centro de Pesquisas Clínicas Do Instituto Central Do Hospital Das Clínicas Da FMUSP — São Paulo, São Paulo, Brazil
• Clinica de la Costa Ltda — Barranquilla, Atlántico, Colombia
• Centro de Atencion y Diagnostico de Enfermedades Infecciosas — Bucaramanga, Santander Department, Colombia
• CCIM Costa Rican Center Center of Medical Research, Sociedad Anonima — San José, Los Yoses, Costa Rica
• AGA Clinical Centro de Investigaciones — Guayaquil, Guayas, Ecuador
• Hospital Civil Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico
• Instituto Conmemorativo Gorgas — Panama City, San Miguelito Province, Panama
• Asociacion Civil Selva Amazonica — Iquitos, Maynas/Loreto, Peru
• Unidad de Ensayos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos — Lima, Peru
• Ponce Medical School Foundation Inc./CAIMED Center — Ponce, Puerto Rico
• Fundación de Investigación de Diego — San Juan, Puerto Rico
• San Juan Hospital Research Unit — San Juan, Puerto Rico
• Puerto Rico Clinical and Translational Research Consortium — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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