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Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (MV-ZIKA-RSP)

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ClinicalTrials.gov Identifier: NCT04033068
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Themis Bioscience GmbH

Brief Summary:
This study is designed to investigate, at first, safety and tolerability of a novel liquid vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years

Condition or disease Intervention/treatment Phase
Zika Virus Infection Biological: Two MV-ZIKA-RSP vaccinations (high dose) Biological: Two MV-ZIKA-RSP vaccination (low dose) Biological: One MV-ZIKA-RSP vaccination (high dose) and one placebo Other: Two placebo injection Phase 1

Detailed Description:

This is an observer-blinded, block-randomized, dose-finding, phase I trial, comparing different dose levels of MV-ZIKA-RSP to evaluate the safety, tolerability, and immunogenicity, of this novel ZIKA-RSP vaccine. Placebo (physiological saline solution) will be applied to blind the different treatment schedules.

After the screening procedures, 48 healthy male and female volunteers aged 18-55 years will be randomly assigned to one of four treatment groups (A, B, C or D). Participants will be assessed for immunogenicity on days 0, 28 and 56 (treatment period), as confirmed by the presence of functional anti-zika-rsp antibodies determined by (PRNT50) and by ELISA, at the same time safety will be also assessed. After the treatment period, participants will be called by phone (day 182) for evaluation of safety follow-up.

The investigator and site personnel assessing AEs, all participants, as well as one of the sponsor's representatives involved in the monitoring and conduct of the study will be blinded to which vaccine was administered. Only the unblinded monitor, site personnel performing randomization, preparation and administration of IMP will be unblinded.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Arm Intervention/treatment
Experimental: Two MV-ZIKA-RSP vaccinations (high dose)
14 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and day 28
Biological: Two MV-ZIKA-RSP vaccinations (high dose)

In this arm of the study, 14 participants will receive:

  1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
  2. V2= day 28; dose vaccination with MV-ZIKA-RSP (high dose).

Description:

Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (high dose)


Experimental: Two MV-ZIKA-RSP vaccination (low dose)
14 Participants will receive MV-ZIKA-RSP 2,5 x10E4 /dose on day 0 and day 28
Biological: Two MV-ZIKA-RSP vaccination (low dose)

In this arm of the study, 14 participants will receive:

  1. V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose).
  2. V2= day 28; dose vaccination with MV-ZIKA-RSP (low dose).

Description:

Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (low dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (low dose)


Experimental: One MV-ZIKA-RSP vaccination (high dose) and one placebo
12 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and placebo on day 28
Biological: One MV-ZIKA-RSP vaccination (high dose) and one placebo

In this arm of the study, 12 participants will receive:

  1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
  2. V2= day 28; treatment with placebo

Description:

Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second treatment with placebo


Placebo Comparator: Two placebo injection
8 Participants will receive placebo on day 0 and placebo on day 28
Other: Two placebo injection

In this arm of the study, 8 participants will receive:

  1. V1= day 0; placebo treatment
  2. V2= day 28; placebo treatment

Description:

Visit 1: Participants will receive their first treatment with placebo Visit 2: Participants will receive their second treatment with placebo

Other Name: Placebo arm




Primary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: 56 days after first vaccination ]
    Measurement of the Rate of adverse events after vaccination


Secondary Outcome Measures :
  1. Functional anti-zika antibodies as measured by PRNT50 and ELISA [ Time Frame: Study days 0, 28 and 56 ]
    Immunogenicity of the vaccine will be confirmed by the presence of functional anti-zika antibodies as determined by PRNT50 and by ELISA

  2. Induction of Zika specific T-cells assessed by FN-ɣIL-2 ELISPOT and FACS assays [ Time Frame: Study days 0, 28 and 56 ]

    Cell-mediated immunity will be evaluated in PBMCs with respect to their specificities for Zika structural proteins prM/M and E in IFN-ɣIL-2 ELISPOT assays.

    Further investigations of CD4 and CD8 T-cell responses will be performed on a subpopulation of cell-mediated immunity responders using FACS analysis.


  3. Adverse Events and Serious Adverse Events [ Time Frame: 182 days after first vaccination ]
    Rate of solicited and unsolicited AEs, as well as, reported serious adverse events (SAEs) up to study day 182 (long-term safety) compared between the 4 different treatment groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed informed consent obtained before any trial-related activities
  2. Healthy men or women aged 18 to 55 years on the day of consenting
  3. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study
  4. All female participants must have a negative urine pregnancy serum pregnancy test at screening
  5. Willingness not to become pregnant or to father a child during the entire study period by practising reliable methods of contraception as specified in protocol section 8.11.4
  6. Availability during the duration of the trial
  7. Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant
  8. Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)

Exclusion Criteria:

  1. Participation in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period (day 56)
  2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
  3. Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus
  4. History of drug addiction including alcohol dependence within the last 2 years
  5. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine)
  6. Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until the end of the treatment period (day 56)
  7. Prior receipt of any Zika or Chikungunya vaccine
  8. History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit
  9. Recent infection within 1 week prior to Screening Visit (possibility of deferral)
  10. Blood donations including plasma donations, 90 days prior to Screening Visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until the end of the treatment period (day 56)
  11. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
  12. History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any haematological malignancy
  13. Behavioural, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
  14. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine
  15. History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer
  16. Abnormal laboratory values which, at the discretion of the investigator should lead to the exclusion of the subject
  17. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants. (Prior to taking any medication within 72 h before study vaccination, the subject should consult the investigator)
  18. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to first IMP administration, or anticipated use until completion of the end of treatment visit Receipt of blood products or immunoglobulins within 120 days prior to the Screening Visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period (day 56)
  19. Pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
  20. Unreliable contraception methods (for details please refer to protocol section 8.11.4)
  21. Persons in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor

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): NCT04033068


Contacts
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Contact: Souyet Chang-Rodriguez, PhD/MSc +43012367151 ext 763 souyet.chang-rodriguez@themisbio.com
Contact: Raimund M. Vielnascher, MSc +43012367151 raimund.vielnascher@themisbio.com

Locations
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Austria
Institute of Specific Prophylaxis and Tropical Medicine Recruiting
Vienna, Austria, 1090
Contact: Ines Zwazl, CTA    +43 (0) 1 40160 938293    ines.zwazl@meduniwien.ac.at   
Contact: Romana Hricova, MSc    +43 (0) 1 40160 938293    isptm-studien@meduniwien.ac.at   
Sponsors and Collaborators
Themis Bioscience GmbH
Investigators
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Principal Investigator: Ursula Wiedermann-Schmidt, Professor Institute of Specific Prophylaxis and Tropical Medicine

Additional Information:
Publications of Results:
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Responsible Party: Themis Bioscience GmbH
ClinicalTrials.gov Identifier: NCT04033068     History of Changes
Other Study ID Numbers: MV-ZIKA-RSP
2019-000840-93 ( EudraCT Number )
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Themis Bioscience GmbH:
Zika virus
mosquito-borne pathogen
Zika fever
Additional relevant MeSH terms:
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Zika Virus Infection
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs