Phase I Trial of Measles Vectored Chikungungya Vaccine
A Phase 1, Double Blinded, Placebo Controlled, Dose Comparison Trial to Evaluate the Safety, Immunogenicity and Schedule of Measles-Vectored Chikungunya Virus Vaccine (MV-CHIK) in Healthy Adults
2 other identifiers
interventional
180
1 country
3
Brief Summary
This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration is approximately 8-13 months. The primary objectives are to evaluate the safety and tolerability of 5 x 10\^4 TCID50 and 5 x 10\^5 TCID50 MV-CHIK and placebo following two consecutive intramuscular injections and to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 of MV-CHIK or placebo on day 29 following the first dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2016
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedStudy Start
First participant enrolled
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2019
CompletedNovember 27, 2020
October 12, 2017
1.6 years
December 29, 2016
November 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
CHIKV serum antibody Geometric Mean Titer using PRNT50
On Day 29 post dose 1
Mean fold change in PRNT50 anti-CHIKV antibody responses
On Day 29 post dose 1
The number of solicited injection site reactions
Day 1 through Day 15 following both study injections
The number of solicited systemic reactions
Day 1 through Day 15 following both study injections
The number of vaccine-related serious adverse events
Day 1-660
The number of vaccine-related unsolicited adverse events
Day 1 through Day 29 following each study vaccination
The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using PRNT50 (Plaque Reduction Neutralization Test)
On Day 29 post dose 1
Secondary Outcomes (18)
anti-CHIKV antibody Geometric Mean Titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5
On Day 85
Anti-CHIKV antibody Geometric Mean Titer using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
On Day 169
CHIKV serum antibody Geometric Mean Titer using ELISA
On Day 29 following the first dose
CHIKV serum ELISA antibody Geometric Mean Titer
On Day 15, 29, 85, and 169 following the second dose
CHIKV serum PRNT50 antibody Geometric Mean Titer
On Day 15, 85, and 169 following the second dose
- +13 more secondary outcomes
Study Arms (6)
Group 1- low dose
EXPERIMENTAL30 Subjects: 5 x 10\^4 TCID50 MV-CHIK at Day1 and at Day 29 for 25 subjects, placebo for 5 subjects
Group 2-low dose
EXPERIMENTAL30 Subjects: 5 x 10\^4 TCID50 MV-CHIK at Day 1 and at Day 85 for 25 subjects, placebo for 5 subjects
Group 3-low dose
EXPERIMENTAL30 Subjects: 5 x 10\^4 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects
Group 4 -high dose
EXPERIMENTAL30 Subjects: 5 x 10\^5 TCID50 MV-CHIK at Day 1 and at Day 29 for 25 subjects, placebo for 5 subjects
Group 5-high dose
EXPERIMENTAL30 Subjects: 5 x 10\^5 TCID50 MV-CHIK at Day 1and at Day 85 for 25 subjects, placebo for 5 subjects
Group 6-dose-High Dose
EXPERIMENTAL30 Subjects: 5 x 10\^5 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects
Interventions
Placebo
Measles-vectored Chikungunya vaccine
Eligibility Criteria
You may qualify if:
- Males and non-pregnant females between the ages of 18 and 45 years (at study start), inclusive.
- Provide written informed consent before initiation of any study procedures.
- Women of childbearing potential must agree to practice adequate contraception during the 30 days prior to Day 1, the first injection, through 85 days after the second study injection. A woman is considered of childbearing potential unless surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal (\> /= 1 year) or successful Essure placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure. Acceptable birth control methods include but are not limited to: abstinence from sexual intercourse with men; monogamous relationship with a vasectomized partner; double-barrier methods (condoms, diaphragms, spermicides; and intrauterine devices); and licensed hormonal methods.
- In good health, as judged by the investigator and determined by vital signs, medical history, and a physical examination. Temperature 37.8°C, heart rate 50-110bpm (inclusive), systolic blood pressure 85-150 mmHg (inclusive), diastolic blood pressure 55-95 mmHg (inclusive). Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity. NOTE: Athletically trained subjects with a pulse \> \\= 45 - 49 may be enrolled if an ECG shows no evidence of first, second or third degree heart block.
- Screening laboratory values must be within site normal limits, though trace urine protein is acceptable. Screening labs will include: Blood hemoglobin, White blood cell (WBC) count, Absolute neutrophil count, Platelets, Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (total), Glucose (random, must be less than 140), Urine dipstick for protein and glucose (negative to trace protein are acceptable), Negative HIV 1/2 antibody/antigen test, Hepatitis B surface antigen (HBsAg), and Hepatitis C virus (HCV) antibody NOTE: Creatinine values lower than the normal range may be acceptable if the PI or a designated licensed clinician determines that these laboratory findings are not clinically significant. HIV and hepatitis C viral load PCR testing may be performed for individuals suspected of having indeterminate antibody/antigen testing (Sites will use the standard HIV testing protocol for their institution).
- Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.
- Willing to abstain from donating whole blood or blood derivatives until 90 days after the final study injection.
- History of measles vaccination.
You may not qualify if:
- History of known chikungunya infection.
- Previous vaccination with an investigational chikungunya vaccine.
- Past residence in, or travel for greater than 1 consecutive month within the past 6 months to, a location known to have local CHIKV transmission. (Examples of countries with local chikungunya virus transmission include, but are not limited to, countries in sub-Saharan Africa, South Asia, the Indian and Pacific Ocean). Residence in or travel to Central and South America, the Caribbean, Florida, Puerto Rico and the U.S. Virgin islands, if prior to 2013, will be permitted.
- Plan to travel to a location known to have local CHIKV transmission during the course of the study or history of travel to one of these countries within 30 days prior to screening. Travel to Florida will be permitted. Those planning travel to Florida will be provided information on mosquito bite protection.
- Body temperature \>/ =100 °F (\>/ =37.8°C) or acute illness within 3 days before study injection days (subject may be rescheduled).
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation. E.g., History of seizure disorders (other than febrile seizures as an infant), autoimmune disease, immunodeficiency, any spleen disease, active malignancy, active asthma, known cardiac disease, pulmonary disease, liver disease, renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients.
- History of thrombocytopenia, idiopathic thrombocytopenic purpura or other platelet disorder.
- A history of chronic arthritis or chronic arthralgia symptoms.
- Used an immunosuppressive or immunomodulatory drug for 2 or more consecutive weeks within 6 months prior to the first study injection (nasal and topical steroids are allowed). Such as \>/ =20 mg total dose/day of prednisone orally or \> 840 µg of inhaled beclomethasone.
- A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt.
- A history of treatment for any other psychiatric disorder in the past 3 years that increases the risk to the subject in the opinion of the investigator Treatment for mild depression or anxiety using a single antidepressant or anti-anxiety medication will be allowed so long as the subject has been on stable doses for 3 months.
- Received immunoglobulin or other blood product within 3 months prior to enrollment or planned receipt of immunoglobulin or a blood product through study day 169 following the second dose of vaccine.
- Received or plan to receive any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks of any study injection.
- Received or plans to receive measles-containing vaccine within 3 months prior to enrollment or planned to receive through study day 29 following the second dose of vaccine. measles, mumps, rubella vaccine.
- History of anaphylaxis or severe allergic reaction to vaccines or history of allergic reaction to any components in the MV-CHIK vaccine.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322-1014, United States
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600, United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2016
First Posted
January 23, 2017
Study Start
May 30, 2017
Primary Completion
January 17, 2019
Study Completion
January 17, 2019
Last Updated
November 27, 2020
Record last verified: 2017-10-12