ZIKA Vaccine in Naive Subjects

NCT02952833 | Completed Phase 1 FDA Drug

• 1 other identifier: 16-0033
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a study to evaluate the safety of ZPIV. Three dose levels may be evaluated. The entire duration of each subject's participation is approximately 14 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and samples for the assessment of immunogenicity. This study is expected to take approximately 30 months to complete from initiation through availability of a final report on the primary outcomes of safety and the secondary outcomes of humoral immunity to ZIKV. The Primary objectives of this study are to 1. Assess the safety and reactogenicity of a homologous prime boost regimen of ZPIV given at three different dose levels and 2. Compare the safety and reactogenicity profile of ZPIV after each vaccination and between dosage groups.

Conditions

Zika Virus Infection

Keywords

Inactivated; Phase I; placebo-controlled; Vaccine; ZIKA

Outcome Measures

Primary Outcomes (15)

• Comparison between dosage groups of the duration of vaccine-related Grade 2 or greater local or systemic reactogenicity

  8 Days after each vaccination

• Comparison between dosage groups of the duration overall and in each dosage group of vaccine-related Grade 3 local, systemic, or laboratory AE

  8 Days after each vaccination

• Comparison between dosage groups of the frequency of vaccine-related Grade 2 or greater local or systemic reactogenicity

  8 Days after each vaccination

• Comparison between dosage groups of the frequency of vaccine-related Grade 3 local, systemic, or laboratory AE

  8 Days after each vaccination

• Comparison between dosage groups of the type of vaccine-related Grade 2 or greater local or systemic reactogenicity

  8 Days after each vaccination

• Comparison between dosage groups of the type overall and each dosage group of vaccine-related Grade 3 local, systemic, or laboratory AE

  8 Days after each vaccination

• Comparison of study withdrawals, and discontinuation of study vaccination due to any reason between dosage groups.

  14 Months

• Duration overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination

  14 Months

• Frequency of new onset chronic medical conditions

  14 Months

• Frequency overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination

  14 Months

• Frequency overall and in each dosage group of solicited injection site and systemic reactogenicity.

  Day of vaccine administration to day 8 after each vaccination

• Frequency overall and in each dosage group of unsolicited vaccine-related adverse events (AE), including vaccine-related laboratory AE.

  28 Days after each vaccination

• Severity overall and in each dosage group of solicited injection site and systemic reactogenicity.

  Day of vaccine administration to day 8 after each vaccination

• Severity overall and in each dosage group of unsolicited vaccine-related adverse events (AE), including vaccine-related laboratory AE.

  28 Days after each vaccination

• Type overall and in each dosage group of serious adverse events (SAE) and adverse events of special interest (AESI) considered related to study vaccination

  14 Months

Secondary Outcomes (4)

• Peak GMT overall and by dosage group as measured by ZIKV ELISA and neutralization assay.

  At all post-vaccination visits, an average of 14 months

• Per visit GMT overall and by dosage group as measured by ZIKV ELISA and neutralization assay.

  At all post-vaccination visits, an average of 14 months

• Proportion of subjects overall and by dosage group that seroconvert to ZIKV at each post-vaccination visit by assessing ELISA responses in comparison with baseline

  At all post-vaccination visits, an average of 14 months

• Proportion of subjects overall and by dosage group that seroconvert to ZIKV at each post-vaccination visit by assessing neutralization titers in comparison with baseline

  At all post-vaccination visits, an average of 14 months

Study Arms (3)

Group 1

EXPERIMENTAL

5.0 mcg ZPIV will be administered in a homologous prime-boost regimen on Day 1 and Day 29, n=25 (2 Sentinel subjects will receive intervention prior to remaining 23 subjects), Placebo for 5 subjects

Drug: Saline; Biological: Zika Virus Purified Inactivated Vaccine (ZPIV)

Group 2

EXPERIMENTAL

2.5 mcg ZPIV will be administered in a homologous prime-boost regimen on Day 1 and Day 29, n=25, Placebo for 5 subjects

Drug: Saline; Biological: Zika Virus Purified Inactivated Vaccine (ZPIV)

Group 3

EXPERIMENTAL

10 mcg of ZPIV will be administered in a homologous prime-boost regimen on Day 1 and Day 29, n=25, (2 Sentinel subjects will receive intervention prior to remaining 23 subjects) Placebo for 5 subjects

Drug: Saline; Biological: Zika Virus Purified Inactivated Vaccine (ZPIV)

Interventions

Saline DRUG

Sodium chloride solution.

Group 1; Group 2; Group 3

Zika Virus Purified Inactivated Vaccine (ZPIV) BIOLOGICAL

Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be a male or non-pregnant, non-breastfeeding female between the age of 18 and 49 years, inclusive at the time of screening and enrollment
• Must be willing and able to read, sign and date the informed consent document before study related procedures are performed
• Must be willing and able to comply with study requirements and available for follow-up visits for the entire study
• Must have a means to be contacted by telephone
• Must have a body mass index (BMI) \>/=18.1 and \<35.0 kg/m\^2
• Must have acceptable\* screening laboratory findings within 28 days before enrollment
• Acceptable clinical laboratory parameters include:
• Hemoglobin: women: \>11.5 g/dL; men \>12.5 g/d
• White blood cell count: \>3,400 cells/mm\^3 but \<11,000 cells/mm\^3
• Platelets: \>139,000 but \<450,000 per mm\^3
• Urine dipstick (clean urine sample): protein \<1+, glucose negative
• Serum creatinine \</=1 x institutional upper limit of normal (ULN)
• Blood urea nitrogen (BUN) \<25
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<1.25 x institutional ULN
• Total bilirubin \<1.25 x institutional ULN

You may not qualify if:

• Note 3: Vital signs must be normal by protocol toxicity grading scale or determined to be normal-variant by investigator. In the event of an abnormal heart rate or blood pressure due to physiological variation or activity, the subject may rest for 10 minutes in a quiet room, and then blood pressure and/or heart rate may be re-measured. Repeated vital signs may be used to determine eligibility 8. Women of childbearing potential\* must have a negative serum pregnancy test at screening and a negative urine pregnancy test immediately prior to each vaccination
• Note: All female subjects are considered of childbearing potential unless postmenopausal or surgically sterilized and \>/=3 months have passed since sterilization procedure. Postmenopausal is defined as amenorrhea for \>/=12 months without an alternative medical cause. Permanent female sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, bilateral oophorectomy, or successful Essure placement.
• \. Women of childbearing potential must use an acceptable method of contraception\* from one month (30 days) prior to the first vaccination until at least 60 days after the last vaccination.
• Acceptable methods of contraception include the following:
• Use highly effective contraceptive methods, defined by \<1% failure rate per year independent of user adherence, including long-acting reversible contraception (LARC): progestin-releasing subdermal implants and intrauterine devices (IUD), OR
• Use effective contraceptive methods, defined by 5-9% failure rate with typical use and \<1% failure rate with consistent and correct use, including:
• prescription oral contraceptives, contraceptive injections, combined pill, progestin-only pill, hormone-releasing transdermal patch or vaginal ring, and depot medroxyprogesterone acetate injection (Depo-Provera), OR
• Male sex partners must have had a vasectomy \>/=3 months prior to first vaccination, OR
• Practice abstinence defined as refraining from heterosexual intercourse from 30 days before first vaccination until at least 60 days after 2nd vaccination 10. Female subjects must agree to not donate eggs (ova, oocytes) from the start of screening period until at least 60 days after receiving the last vaccination 11. Subjects must provide concurrent consent at the time of enrollment and 1st vaccination to future use of stored blood samples to measure immunity to ZIKV
• Has plans to become pregnant during the course of the study, or is currently pregnant or breastfeeding.
• Has plans to travel to an area with active Zika virus, DENV, YFV or JEV transmission\* during the study or returned from travel to an area with active transmission\* within 30 days of screening.
• \* NOTE: Refer to CDC website for areas with active Zika, DENV, YFV, or JEV virus transmission: http://www.cdc.gov
• Has history of vaccination with a licensed or investigational flavivirus vaccine\* or reportedly diagnosed with a flavivirus infection or disease.
• Includes subject's verbal history of vaccination or disease with any of the following flaviviruses:
• Yellow Fever virus (YFV): YF-VAX, Stamaril, or Bio-Manguinhos YF vaccine

Sponsors & Collaborators

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

Study Sites (1)

Saint Louis University Center for Vaccine Development

St Louis, Missouri, 63104-1015, United States

Location

Related Publications (1)

• Modjarrad K, Lin L, George SL, Stephenson KE, Eckels KH, De La Barrera RA, Jarman RG, Sondergaard E, Tennant J, Ansel JL, Mills K, Koren M, Robb ML, Barrett J, Thompson J, Kosel AE, Dawson P, Hale A, Tan CS, Walsh SR, Meyer KE, Brien J, Crowell TA, Blazevic A, Mosby K, Larocca RA, Abbink P, Boyd M, Bricault CA, Seaman MS, Basil A, Walsh M, Tonwe V, Hoft DF, Thomas SJ, Barouch DH, Michael NL. Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials. Lancet. 2018 Feb 10;391(10120):563-571. doi: 10.1016/S0140-6736(17)33106-9. Epub 2017 Dec 5.

  PMID: 29217375 DERIVED

MeSH Terms

Conditions

Zika Virus Infection

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: November 2, 2016
• Study Start: October 14, 2016
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: July 29, 2025

Record last verified: 2017-06-27

Locations

US (1)