Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)

NCT03635086 | Completed Phase 2 Results

• 3 other identifiers: V184-0052018-000211-25MV-CHIK-205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.

Conditions

Chikungunya Virus Infection

Keywords

Chikungunya fever

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination

  Participant serum was collected for determination of antibody responses by 50% plaque reduction neutralization test (PRNT50). Geometric Mean Titer (GMT) of functional antibodies as measured by PRNT50 were assessed. Geometric mean titers and GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2 sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer.

  28 days after last vaccination (Up to Day 56)

Secondary Outcomes (15)

• Percentage of Participants With Solicited and Unsolicited Adverse Events

  Up to Day 56

• Percentage of Participants With at Least 1 Serious Adverse Event

  Up to Day 56

• Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50

  Up to Day 365

• Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells

  Up to Day 56

• Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells

  Up to Day 56

Study Arms (5)

Group A: Two MV-CHIK lyophilized low dose

EXPERIMENTAL

Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28.

Biological: MV-CHIK lyophilised formulation, low dose

Group B: Two MV-CHIK liquid frozen low dose

EXPERIMENTAL

Participants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28.

Biological: MV-CHIK liquid frozen formulation, low dose

Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®)

EXPERIMENTAL

Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28.

Biological: MV-CHIK SPS® formulation, low dose

Group D: Two MV-CHIK liquid frozen high dose

EXPERIMENTAL

Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28.

Biological: MV-CHIK liquid frozen formulation, high dose

Group E: One MV-CHIK liquid frozen high dose/placebo

EXPERIMENTAL

Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28.

Biological: MV-CHIK liquid frozen formulation, high dose; Other: Placebo

Interventions

MV-CHIK lyophilised formulation, low dose BIOLOGICAL

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.

Group A: Two MV-CHIK lyophilized low dose

MV-CHIK liquid frozen formulation, low dose BIOLOGICAL

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.

Group B: Two MV-CHIK liquid frozen low dose

MV-CHIK SPS® formulation, low dose BIOLOGICAL

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.

Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®)

MV-CHIK liquid frozen formulation, high dose BIOLOGICAL

MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.

Group D: Two MV-CHIK liquid frozen high dose; Group E: One MV-CHIK liquid frozen high dose/placebo

Placebo OTHER

Sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.

Group E: One MV-CHIK liquid frozen high dose/placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is able 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
• Has a negative serum pregnancy test at screening (for female participants)
• Has a willingness not to become pregnant or to father a child during the entire study period by practicing reliable methods of contraception
• Has availability during the duration of the trial

You may not qualify if:

• Has participated 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
• Has a history of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
• Has a history of drug addiction including alcohol dependence within the last 2 years
• Has an inability or unwillingness to avoid intake of more than around 20 grams alcohol per day during 48 hours after each vaccination (equals roughly 0.5 liter beer or 0.25 liter of wine)
• Has had a vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until end of treatment period
• Has had a prior receipt of any Chikungunya vaccine
• Has a history of moderate or severe arthritis or arthralgia within the past 3 months prior to screening
• Has had a recent infection within 1 week prior to screening
• Has made blood donations including plasma donations, 90 days prior to screening visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until end of treatment period
• Has clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, 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
• Has a history of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy
• Has behavioral, 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
• Has a 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
• Has a history of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the participant.
• 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.

Sponsors & Collaborators

• Themis Bioscience GmbH: lead

Study Sites (1)

Celerion Belfast

Belfast, Northern Ireland, BT9 6 AD, United Kingdom

Location

Related Publications (1)

• Ramsauer K, Schwameis M, Firbas C, Mullner M, Putnak RJ, Thomas SJ, Despres P, Tauber E, Jilma B, Tangy F. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. Lancet Infect Dis. 2015 May;15(5):519-27. doi: 10.1016/S1473-3099(15)70043-5. Epub 2015 Mar 2.

  PMID: 25739878 RESULT

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• 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: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 24, 2018
• First Posted: August 17, 2018
• Study Start: August 22, 2018
• Primary Completion: January 25, 2019
• Study Completion: November 16, 2019
• Last Updated: October 22, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)