NCT04033068

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

August 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 6, 2021

Completed
Last Updated

December 6, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

July 8, 2019

Results QC Date

October 28, 2021

Last Update Submit

October 28, 2021

Conditions

Zika Virus Infection

Keywords

Zika virusmosquito-borne pathogenZika fever

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56

    An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented.

    Up to Day 56

Secondary Outcomes (18)

  • Percentage of Participants Who Experienced a Solicited AE up to Day 182

    Up to Day 182

  • Percentage of Participants Who Experienced an Unsolicited AE up to Day 182

    Up to Day 182

  • Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182

    Up to Day 182

  • Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56

    Day 0, Day 28 and Day 56

  • GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56

    Day 0, Day 28 and Day 56

  • +13 more secondary outcomes

Study Arms (4)

Two MV-ZIKA-RSP vaccinations (high dose)

EXPERIMENTAL

14 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and day 28

Biological: Two MV-ZIKA-RSP vaccinations (high dose)

Two MV-ZIKA-RSP vaccination (low dose)

EXPERIMENTAL

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)

One MV-ZIKA-RSP vaccination (high dose) and one placebo

EXPERIMENTAL

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

Two placebo injection

PLACEBO COMPARATOR

8 Participants will receive placebo on day 0 and placebo on day 28

Other: Two placebo injection

Interventions

Two MV-ZIKA-RSP vaccinations (high dose)BIOLOGICAL

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)

Two MV-ZIKA-RSP vaccinations (high dose)
Two MV-ZIKA-RSP vaccination (low dose)BIOLOGICAL

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)

Two MV-ZIKA-RSP vaccination (low dose)
One MV-ZIKA-RSP vaccination (high dose) and one placeboBIOLOGICAL

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

One MV-ZIKA-RSP vaccination (high dose) and one placebo
Two placebo injectionOTHER

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

Also known as: Placebo arm
Two placebo injection

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent obtained before any trial-related activities
  • Healthy men or women aged 18 to 55 years on the day of consenting
  • 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
  • All female participants must have a negative urine pregnancy serum pregnancy test at screening
  • 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
  • Availability during the duration of the trial
  • Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant

You may not qualify if:

  • 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)
  • History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
  • Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus
  • History of drug addiction including alcohol dependence within the last 2 years
  • 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)
  • 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)
  • Prior receipt of any Zika or Chikungunya vaccine
  • History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit
  • Recent infection within 1 week prior to Screening Visit (possibility of deferral)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

Location

Related Publications (1)

  • Rossi SL, Comer JE, Wang E, Azar SR, Lawrence WS, Plante JA, Ramsauer K, Schrauf S, Weaver SC. Immunogenicity and Efficacy of a Measles Virus-Vectored Chikungunya Vaccine in Nonhuman Primates. J Infect Dis. 2019 Jul 31;220(5):735-742. doi: 10.1093/infdis/jiz202.

    PMID: 31053842RESULT

Related Links

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus Infections

Results Point of Contact

Title
Clinical Trials Disclosure
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 25, 2019

Study Start

August 2, 2019

Primary Completion

January 30, 2020

Study Completion

June 10, 2020

Last Updated

December 6, 2021

Results First Posted

December 6, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information

Locations

AU(1)