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ZikaPhase 1Z001NCT02937233

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

A Phase 1 study testing Zika Virus Purified Inactivated Vaccine in people with Zika, run by Kathryn Stephenson at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Zika
What is being tested?
Zika Virus Purified Inactivated Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
8 Dec 2016to 4 Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
Show all 27Show fewer
  • 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
  • Negative urine glucose.
  • Negative or trace urine protein.
  • Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis within institutional range).
  • All female participants must be willing to undergo serum or urine beta human chorionic gonadotropin pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to vaccination.
  • All sexually active males (unless anatomically sterile) must be willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until Week 12.
  • If a woman of child-bearing potential, committed to use an effective method of contraception when sexually active with men until Week 12, including:
  • Condoms (male or female) with or without spermicide.
  • Diaphragm or cervical cap with spermicide.
  • Intrauterine device.
  • Hormonal contraception.
  • Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy).
  • Not be of reproductive potential, such as having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.

Who cannot join

  • 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.
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  • 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:
  • Use a bronchodilator (beta 2 agonist) daily, or
  • In the past year have (any of the following):
  • Had > 1 exacerbation of symptoms treated with oral steroids ii. Routinely used moderate to high dose inhaled corticosteroids (e.g., more than the equivalent of 250 mcg fluticasone; 400 mcg budesonide; 500 mcg beclomethasone; or 1000 mcg triamcinolone/flunisolide, as a daily dose) or theophylline iii. Needed emergency care, urgent care, hospitalization, or intubation for asthma c. Prophylactic bronchodilator use prior to exercise is not exclusionary
  • Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
  • Thyroidectomy, or thyroid disease requiring medication during the last 12 months
  • Angioedema within the last 3 years if episodes are considered serious or have required medication within the last 2 years
  • Uncontrolled Hypertension:
  • If a person has been diagnosed with hypertension during screening or previously, exclude for hypertension that is not well controlled. Well- controlled hypertension is defined as blood pressure consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm
  • If a person has NOT been diagnosed with hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 90 mm Hg at enrolment
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  • Malignancy (Not excluded: a participant with a surgical excision and subsequent observation period that in the investigator's estimation has a reasonable assurance of sustained cure or is unlikely to recur during the study period)
  • Psychiatric condition that compromises safety of the participant or precludes compliance with the protocol, specifically excluding persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of an Accelerated Vaccination Schedule With a Zika Virus Purified Inactivated Vaccine Plus Alum Adjuvant in Healthy Adults

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
Being tested
Zika Virus Purified Inactivated Vaccine, Placebo
Keywords
Zika, Vaccine, ZPIV
Medical subject headings
Zika Virus Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zika Virus Purified Inactivated VaccineBiological

  • PlaceboOther

Study groups in NCT02937233
Study groupRoleWhat they receive
4 Week ScheduleExperimentalZika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 and Week 4
Receives: Biological: Zika Virus Purified Inactivated Vaccine; Other: Placebo
2 Week ScheduleExperimentalZika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 and Week 2
Receives: Biological: Zika Virus Purified Inactivated Vaccine; Other: Placebo
Single Vaccination ScheduleExperimentalZika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 only
Receives: Biological: Zika Virus Purified Inactivated Vaccine; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 7 days following each vaccination

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

    Measured: 28 days following each vaccination

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

    Measured: 365 days following each vaccination

Secondary outcomes (4)

  1. ZIKV microneutralization Log10 MN50 titers

    Measured: 28 days following last vaccination, and at 6 months

  2. Zika Env-specific Log10 endpoint ELISA titers

    Measured: 28 days following last vaccination, and at 6 months

  3. Zika Plaque reduction neutralization test titer

    Measured: 28 days following last vaccination, and at 6 months

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

    Measured: 28 days following last vaccination, and at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study start8 Dec 2016
  3. Primary completion4 Jun 2018
  4. Study completion4 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02937233
Sponsor's protocol ID
2016P000268
Acronym
Z001
Status last verified
Aug 2018
First submitted
12 Oct 2016
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32618279

  • 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.

    PubMed 29217375

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zika Virus Purified Inactivated Vaccine in people with Zika, run by Kathryn Stephenson at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, intensity, and relationship to vaccination of solicited local and systemic adverse events (time frame: 7 days following each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02937233, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.

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