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

NCT03611946 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CIR 318
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 1 double-blind, placebo controlled trial designed 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.

Conditions

Zika Virus

Keywords

Zika virus; Vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Solicited Local and General Adverse Events (AEs)

  Evaluated using the Adverse Event Grading Table in the study protocol.

  Solicited AE's assessed every visit through Day 28

• To Determine the Immunogenicity of a Single Dose of rZIKV/D4Δ30-713

  Determination of the serum plaque reduction neutralization titer 50% (PRNT50) to ZIKV for each subject at Study Day 28 post-inoculation. Seroconversion will be defined as achieving a PRNT50 ≥ 1:10 at any time-point through Study Day 28. The peak PRNT50 to ZIKV through Study Day 28 will be calculated for each subject included in the per-protocol an intent-to-treat analysis and the geometric mean peak titer for vaccinated subjects will be calculated.

  Measured through Day 28

Secondary Outcomes (5)

• Viremia Induced by Vaccine (Number of Participants With Detectable Virus at Any Time Point)

  Measured through Day 90

• Number of Vaccinees Infected With rZIKV/D4Δ30-713

  Measured through Day 180

• Immunogenicity of rZIKV/D4Δ30-713 in Flavivirus-naïve Subjects

  Measured through Day 180

• Durability of Antibody Response

  26 Weeks post vaccination

• Quantity and Duration of ZIKV Presence

  90 days post vaccination

Study Arms (4)

Cohort 1: Vaccine

EXPERIMENTAL

Single dose of rZIKV/D4Δ30-713 (10\^3 PFU) via subcutaneous injection (0.5ml).

Biological: Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)

Cohort 1 - Placebo

PLACEBO COMPARATOR

Single dose of placebo via subcutaneous injection (0.5ml).

Biological: Single dose of placebo via subcutaneous injection (0.5ml).

Cohort 2 - Vaccine

EXPERIMENTAL

Single dose of rZIKV/D4Δ30-713 (10\^4 PFU) via subcutaneous injection (0.5ml).

Biological: Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)

Cohort 2 - Placebo

PLACEBO COMPARATOR

Single dose of placebo via subcutaneous injection (0.5ml).

Biological: Single dose of placebo via subcutaneous injection (0.5ml).

Interventions

Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) BIOLOGICAL

Administered at a dose of 10\^3 plaque-forming units (PFUs) by subcutaneous injection

Cohort 1: Vaccine

Single dose of placebo via subcutaneous injection (0.5ml). BIOLOGICAL

Administered by subcutaneous injection.

Cohort 1 - Placebo; Cohort 2 - Placebo

Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml) BIOLOGICAL

Administered at a dose of using 10\^4 plaque-forming units (PFUs) by subcutaneous injection.

Cohort 2 - Vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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. Women must have been on an effective method of birth control for at least 30 days prior to enrollment. All female subjects will be considered as having childbearing potential, except for women who exclusively have sex with women, 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 and have sex with men 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 and women whose partners have had a vasectomy will not be required to use contraception, however they will be required to use female condoms and/or dental dams for at least 1 month following vaccination. For women whose sexual partner has had a vasectomy, the vasectomy must have been performed 30 days or more prior to enrollment.
• Males only: Males of reproductive potential should be willing to use barrier contraception for the first 3 months following vaccination\* and agree to not donate sperm for the duration of the study.
• Based on CDC guidance for men returning from ZIKV-endemic areas

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Johns Hopkins University, Bloomberg School of Public Health

Baltimore, Maryland, 21202, United States

Location

University of Vermont Medical Center (UVMMC), Clinical Research Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Dr Anna Durbin
• Organization: Johns Hopkins CIR

adurbin1@jhu.edu

410-955-7283

Study Officials

• Anna Durbin, MD

  Center for Immunization Research, Johns Hopkins School of Public Health

  PRINCIPAL INVESTIGATOR

• Kristen Pierce, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: July 6, 2018
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Locations

US (2)