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Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults

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ClinicalTrials.gov Identifier: NCT03611946
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.

Condition or disease Intervention/treatment Phase
Zika Virus Biological: rZIKV/D4Δ30-713 Biological: Placebo Phase 1

Detailed Description:

This study will evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.

Participants will be randomly assigned to receive a single dose of either rZIKV/D4Δ30-713 or placebo at study entry (Day 0).

Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, and 180. Visits may include a physical examination; blood, urine, saliva, vaginal secretions, and semen collection; and pregnancy testing.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase I Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Arm Intervention/treatment
Experimental: rZIKV/D4Δ30-713
Participants will receive a single dose of rZIKV/D4Δ30-713 at study entry (Day 0).
Biological: rZIKV/D4Δ30-713
Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection

Placebo Comparator: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Biological: Placebo
Administered by subcutaneous injection




Primary Outcome Measures :
  1. Frequency of solicited local and general adverse events (AEs) [ Time Frame: Measured through Day 28 ]
    Evaluated using the Adverse Event Grading Table in the study protocol

  2. Frequency of unsolicited AEs [ Time Frame: Measured through Day 28 ]
    Evaluated using the Adverse Event Grading Table in the study protocol

  3. Frequency of medically-attended AEs and serious adverse events (SAEs) [ Time Frame: Measured through Day 90 ]
    Evaluated using the Adverse Event Grading Table in the study protocol

  4. Peak neutralizing antibody titer to ZIKV [ Time Frame: Measured through Day 90 ]
    Determined by seropositivity and seroconversion frequencies


Secondary Outcome Measures :
  1. Frequency of viremia [ Time Frame: Measured through Day 180 ]
    Measured by tissue culture (infectious virus) and PCR

  2. Determination of the neutralizing antibody titer to ZIKV [ Time Frame: Measured through Day 180 ]
    Determined by seropositivity and seroconversion frequencies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult male or female between 18 and 50 years of age, inclusive.
  • Good general health as determined by physical examination, laboratory screening, and review of medical history.
  • Available for the duration of the study, which is approximately 26 weeks.
  • Willingness to participate in the study as evidenced by signing the informed consent document.
  • Females only: Female subjects of childbearing potential, with the exception noted below, should be willing to use effective contraception and have no plans to undergo IVF (in vitro fertilization) during participation in the trial. Reliable methods of contraception include hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, and intrauterine device. All female subjects will be considered as having childbearing potential, except for those who have had a hysterectomy, tubal ligation, or tubal coil (at least 3 months prior to vaccination), or are considered to be post-menopausal, as documented by at least 1 year since last menstrual period with a follicle-stimulating hormone (FSH) level in the menopausal range or at least 24 consecutive months of amenorrhea. Transgender men who have internal female organs will be considered of childbearing potential and should be willing to use effective contraception during the trial. Exception: Females who have sex with females (exclusively) and have no intention of conceiving a child during the study will not be required to use contraception.
  • Males only: Males of reproductive potential should be willing to use barrier contraception for the duration of the study and agree to not donate sperm for the duration of the study.

Exclusion Criteria:

  • Females only: Currently pregnant, as determined by positive β-human choriogonadotropin (HCG) test, or breast-feeding.
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history, physical examination, and/or laboratory studies.
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
  • Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol.
  • Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.
  • Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history.
  • History of a severe allergic reaction or anaphylaxis.
  • Severe asthma (emergency room visit or hospitalization within the last 6 months).
  • HIV infection, as indicated by screening and confirmatory assays.
  • Hepatitis C virus (HCV) infection, as indicated by screening and confirmatory assays.
  • Hepatitis B virus (HBV) infection, as indicated by hepatitis B surface antigen (HBsAg) screening.
  • Any known immunodeficiency syndrome.
  • History of Guillain-Barrè syndrome.
  • Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
  • Use of immunosuppressive corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following inoculation. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg of a prednisone equivalent per day for greater than or equal to 14 days.
  • Receipt of a live vaccine within 28 days or a killed vaccine within 14 days prior to inoculation, or anticipated receipt of any vaccine during the 28 days following inoculation.
  • Asplenia.
  • Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following inoculation.
  • History or serologic evidence of previous ZIKV or other flavivirus infection (e.g., dengue, yellow fever virus, St. Louis Encephalitis virus, or West Nile virus).
  • Previous receipt of a flavivirus vaccine (licensed or experimental).
  • Anticipated receipt of any investigational agent in the 28 days before or after inoculation.
  • Refusal to allow specimen storage for future research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611946


Locations
United States, Maryland
Johns Hopkins University, Bloomberg School of Public Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Jennifer Han    410-955-0054    jhan20@jhu.edu   
United States, Vermont
University of Vermont Medical Center (UVMMC), Clinical Research Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Patricia Lutton    802-656-0013    Patricia.lutton@med.uvm.edu   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Anna Durbin, MD Center for Immunization Research, Johns Hopkins School of Public Health
Principal Investigator: Kristen Pierce, MD University of Vermont

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03611946     History of Changes
Other Study ID Numbers: CIR 318
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Zika virus
Vaccine

Additional relevant MeSH terms:
Zika Virus Infection
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs