Zika Virus Purified Inactivated Vaccine (ZPIV) Accelerated Vaccination Schedule Study

NCT02937233 | Completed Phase 1 DMC

• 1 other identifier: 2016P000268
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 trial of one or more administrations of Zika Virus Purified Inactivated Vaccine (ZPIV). The trial will be conducted under a placebo controlled, double-blind, randomized allocation of study product. There are four groups in the study. Each group is testing a different vaccine schedule.

Conditions

Zika

Keywords

Zika; Vaccine; ZPIV

Outcome Measures

Primary Outcomes (3)

• Incidence, intensity, and relationship to vaccination of solicited local and systemic adverse events

  7 days following each vaccination

• Incidence, intensity, and relationship to vaccination of unsolicited local and systemic adverse events

  28 days following each vaccination

• Incidence, intensity, and relationship to vaccination of serious local and systemic adverse events

  365 days following each vaccination

Secondary Outcomes (4)

• ZIKV microneutralization Log10 MN50 titers

  28 days following last vaccination, and at 6 months

• Zika Env-specific Log10 endpoint ELISA titers

  28 days following last vaccination, and at 6 months

• Zika Plaque reduction neutralization test titer

  28 days following last vaccination, and at 6 months

• IFN-γ ELISPOT responses to prM, Env, Cap, and NS1 peptides

  28 days following last vaccination, and at 6 months

Study Arms (3)

4 Week Schedule

EXPERIMENTAL

Zika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 and Week 4

Biological: Zika Virus Purified Inactivated Vaccine; Other: Placebo

2 Week Schedule

EXPERIMENTAL

Zika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 and Week 2

Biological: Zika Virus Purified Inactivated Vaccine; Other: Placebo

Single Vaccination Schedule

EXPERIMENTAL

Zika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 only

Biological: Zika Virus Purified Inactivated Vaccine; Other: Placebo

Interventions

Zika Virus Purified Inactivated Vaccine BIOLOGICAL

2 Week Schedule; 4 Week Schedule; Single Vaccination Schedule

Placebo OTHER

2 Week Schedule; 4 Week Schedule; Single Vaccination Schedule

Eligibility Criteria

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

You may qualify if:

• Age 18-50 years old.
• Ability and willingness to provide informed consent.
• Assessment of understanding: completion of a questionnaire prior to first screening procedure; verbally demonstrate understanding of all questionnaire items answered incorrectly.
• Available for the duration of the trial.
• Good general health as shown by medical history, physical exam, and screening laboratory tests.
• The following laboratory parameters:
• Hematology
• Hemoglobin ≥10.5 g/dL for women; ≥11 g/dL for men
• Absolute Neutrophil Count (ANC): ≥1000/mm3
• Platelets: 125,000 to 550,000/mm3
• Chemistry
• Creatinine: \<1.1 x upper limit of normal (ULN)
• AST: \<1.25 x ULN
• ALT: \<1.25 x ULN
• Normal urinalysis

You may not qualify if:

• History of known flavivirus infection or previous receipt of flavivirus vaccine.
• Positive serology for HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment.
• Planned travel to areas with active Zika virus transmission during the study period.
• Recent (within 3 weeks) travel to an area with active Zika virus transmission.
• Current or planned participation in another clinical trial of an experimental agent during the study period.
• Pregnant or lactating.
• Any condition, including any clinically significant acute or chronic medical condition, for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• Use of anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months.
• Receipt of live-attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with Investigational Product (within 14 days for live attenuated influenza vaccine \[LAIV\]); or receipt of other vaccine (e.g., influenza, pneumococcal), allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product
• Receipt of blood transfusion or blood-derived products within the previous 3 months.
• Previous severe local or systemic reactions to vaccination.
• History of splenectomy
• History of seizure in the last 3 years (participants with a history of seizures who have neither required medications nor had a seizure for 3 years are not excluded)
• Known autoimmune disease
• Asthma other than mild, well-controlled asthma. Exclude participants who:

Sponsors & Collaborators

• Kathryn Stephenson: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Center for Virology and Vaccine Research Clinical Trials Unit, Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Stephenson KE, Tan CS, Walsh SR, Hale A, Ansel JL, Kanjilal DG, Jaegle K, Peter L, Borducchi EN, Nkolola JP, Makoni T, Fogel R, Bradshaw C, Tyler A, Moseley E, Chandrashekar A, Yanosick KE, Seaman MS, Eckels KH, De La Barrera RA, Thompson J, Dawson P, Thomas SJ, Michael NL, Modjarrad K, Barouch DH. Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2020 Sep;20(9):1061-1070. doi: 10.1016/S1473-3099(20)30085-2. Epub 2020 May 6.

  PMID: 32618279 DERIVED

• 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

Condition Hierarchy (Ancestors)

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

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: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 18, 2016
• Study Start: December 8, 2016
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

US (1)