Chikungunya Virus InfectionPhase 1NCT03028441
Phase I Trial of Measles Vectored Chikungungya Vaccine
A Phase 1 study testing VRC-CHKVLP059-00-VP in people with Chikungunya Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- VRC-CHKVLP059-00-VP
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 May 2017to 17 Jan 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria must be assessed by a clinician licensed to make medical diagnoses. Subjects must meet all of the following inclusion criteria to participate in this study
- 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).
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- 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.
Who cannot join
- 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).
- A positive serum or urine pregnancy test at screening or within 24 hours prior to study injection, women who are planning to become pregnant, or women who are breastfeeding. If female of childbearing potential as defined in Inclusion Criterion 3. From 30 days prior to entering the study until 85 days after the final study injection.
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- 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.
- Received an experimental or investigational agent within 1 month before study injections or expectation to receive an experimental agent through 6 months following the last study injection. Vaccine, drug, biologic, device, blood product, or medication.
- Any condition that would, in the opinion of the investigator, place the subject at an unacceptable injury risk, render him/her unable to meet the requirements of the protocol, or that may interfere with successful study completion.
- A history of alcohol or drug abuse during the previous 3 years For example, daily excessive alcohol or marijuana use or frequent binge drinking as determined by the investigator.
- Presence of tattoos that, in the opinion of the investigator, would preclude evaluation of the injection site.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322-1014
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600
About this study
Official title: 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
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.
Read the detailed description
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 (5 x 10^4 or 5 x 10^5 TCID50) and 3 immunization schedules (days 1 and 29, days 1 and 85 or days 1 and 169) will be evaluated. The study will have 6 cohorts, each with 30 subjects, 25 of whom will receive study vaccine and 5 of whom will receive placebo. Cohorts 1-3 will receive the low dosage of the lyophilized vaccine product (5 x 10^4 TCID50) and cohorts 4-6 will receive the high dosage (5 x 10^5 TCID50) of the lyophilized vaccine product. Each subject will receive two study injections using one of the three dosing schedules outlined above. This study will enroll up to 180 healthy subjects aged 18 to 45 years (inclusive). Subjects will be counseled on the study and will then sign an informed consent prior to any study procedures. Screening will be performed which will include evaluation of medical history, travel history to countries with known CHIKV circulation, medication history, a physical examination and safety laboratory evaluations. 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. The secondary objectives are to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK and or placebo using three dose schedules (days 1 and 29, days 1 and 85, or days 1 and 169) on day 29 following the second dose, assess CHIKV serum PRNT50 antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on days 15, 85 and 169 following the second dose of vaccine, assess the CHIKV serum ELISA antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 29 following the first dose of vaccine and days 15, 29, 85 and 169 following the second dose of vaccine, and to assess the durability of CHIKV serum ELISA and PRNT50 antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 85 (Groups 2+5) and day 169 (Groups 3+6) following the first dose of vaccine.
- Conditions
- Chikungunya Virus Infection
- Being tested
- Placebo, VRC-CHKVLP059-00-VP
- Keywords
- Chikungunya, Immunogenicity, Measles, Vaccine
- Medical subject headings
- Chikungunya Fever, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo
VRC-CHKVLP059-00-VPBiological
Measles-vectored Chikungunya vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1- low dose | Experimental | 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day1 and at Day 29 for 25 subjects, placebo for 5 subjects Receives: Other: Placebo; Biological: VRC-CHKVLP059-00-VP |
| Group 2-low dose | Experimental | 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1 and at Day 85 for 25 subjects, placebo for 5 subjects Receives: Other: Placebo; Biological: VRC-CHKVLP059-00-VP |
| Group 3-low dose | Experimental | 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects Receives: Other: Placebo; Biological: VRC-CHKVLP059-00-VP |
| Group 4 -high dose | Experimental | 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1 and at Day 29 for 25 subjects, placebo for 5 subjects Receives: Other: Placebo; Biological: VRC-CHKVLP059-00-VP |
| Group 5-high dose | Experimental | 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 85 for 25 subjects, placebo for 5 subjects Receives: Other: Placebo; Biological: VRC-CHKVLP059-00-VP |
| Group 6-dose-High Dose | Experimental | 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects Receives: Other: Placebo; Biological: VRC-CHKVLP059-00-VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHIKV serum antibody Geometric Mean Titer using PRNT50
Measured: On Day 29 post dose 1
Mean fold change in PRNT50 anti-CHIKV antibody responses
Measured: On Day 29 post dose 1
The number of solicited injection site reactions
Measured: Day 1 through Day 15 following both study injections
The number of solicited systemic reactions
Measured: Day 1 through Day 15 following both study injections
The number of vaccine-related serious adverse events
Measured: Day 1-660
The number of vaccine-related unsolicited adverse events
Measured: 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)
Measured: 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
Measured: On Day 85
Anti-CHIKV antibody Geometric Mean Titer using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Measured: On Day 169
CHIKV serum antibody Geometric Mean Titer using ELISA
Measured: On Day 29 following the first dose
CHIKV serum ELISA antibody Geometric Mean Titer
Measured: On Day 15, 29, 85, and 169 following the second dose
CHIKV serum PRNT50 antibody Geometric Mean Titer
Measured: On Day 15, 85, and 169 following the second dose
CHIKV serum PRNT50 antibody Geometric Mean Titer
Measured: On Day 29 following the second dose
Mean fold change from baseline to CHIKV using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
Measured: On Day 85
Mean fold change from baseline to CHIKV using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Measured: On Day 169
Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
Measured: On Day 15, 29, 85, and 169 following the second dose
Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
Measured: On Day 29 following the first dose
Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
Measured: On Day 15, 85, and 169 following the second dose
Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
Measured: On Day 29 following the second dose
The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
Measured: On Day 85
The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Measured: On Day 169
The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using ELISA
Measured: On Day 29 following the first dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum ELISA antibody titer
Measured: On Day 15, 29, 85, and 169 following the second dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
Measured: On Day 15, 85, and 169 following the second dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
Measured: On Day 29 following the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start30 May 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028441
- Sponsor's protocol ID
- 15-0038
- Other IDs
- HHSN272201300015I
- Status last verified
- 12 Oct 2017
- First submitted
- 29 Dec 2016
- Last updated
- 27 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03028441
- Acronym / sponsor ID
- 15-0038
- Conditions
- Chikungunya Virus Infection
- Keywords
- Chikungunya, Immunogenicity, Measles, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 30 May 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (5 x 10^4 or 5 x 10^5 TCID50) and 3 immunization schedules (days 1 and 29, days 1 and 85 or days 1 and 169) will be evaluated. The study will have 6 cohorts, each with 30 subjects, 25 of whom will receive study vaccine and 5 of whom will receive placebo. Cohorts 1-3 will receive the low dosage of the lyophilized vaccine product (5 x 10^4 TCID50) and cohorts 4-6 will receive the high dosage (5 x 10^5 TCID50) of the lyophilized vaccine product. Each subject will receive two study injections using one of the three dosing schedules outlined above. This study will enroll up to 180 healthy subjects aged 18 to 45 years (inclusive). Subjects will be counseled on the study and will then sign an informed consent prior to any study procedures. Screening will be performed which will include evaluation of medical history, travel history to countries with known CHIKV circulation, medication history, a physical examination and safety laboratory evaluations. 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. The secondary objectives are to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK and or placebo using three dose schedules (days 1 and 29, days 1 and 85, or days 1 and 169) on day 29 following the second dose, assess CHIKV serum PRNT50 antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on days 15, 85 and 169 following the second dose of vaccine, assess the CHIKV serum ELISA antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 29 following the first dose of vaccine and days 15, 29, 85 and 169 following the second dose of vaccine, and to assess the durability of CHIKV serum ELISA and PRNT50 antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 85 (Groups 2+5) and day 169 (Groups 3+6) following the first dose of vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1- low dose | Experimental | Other: Placebo, Biological: VRC-CHKVLP059-00-VP30 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 | Experimental | Other: Placebo, Biological: VRC-CHKVLP059-00-VP30 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 | Experimental | Other: Placebo, Biological: VRC-CHKVLP059-00-VP30 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 | Experimental | Other: Placebo, Biological: VRC-CHKVLP059-00-VP30 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 | Experimental | Other: Placebo, Biological: VRC-CHKVLP059-00-VP30 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 | Experimental | Other: Placebo, Biological: VRC-CHKVLP059-00-VP30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Inclusion criteria must be assessed by a clinician licensed to make medical diagnoses. Subjects must meet all of the following inclusion criteria to participate in this study
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Other | Group 1- low dose, Group 2-low dose, Group 3-low dose, Group 4 -high dose, Group 5-high dose, Group 6-dose-High Dose |
| VRC-CHKVLP059-00-VPMeasles-vectored Chikungunya vaccine | Biological | Group 1- low dose, Group 2-low dose, Group 3-low dose, Group 4 -high dose, Group 5-high dose, Group 6-dose-High Dose |
Primary outcome
CHIKV serum antibody Geometric Mean Titer using PRNT50
Time frame: On Day 29 post dose 1
Mean fold change in PRNT50 anti-CHIKV antibody responses
Time frame: On Day 29 post dose 1
The number of solicited injection site reactions
Time frame: Day 1 through Day 15 following both study injections
The number of solicited systemic reactions
Time frame: Day 1 through Day 15 following both study injections
The number of vaccine-related serious adverse events
Time frame: Day 1-660
The number of vaccine-related unsolicited adverse events
Time frame: 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)
Time frame: On Day 29 post dose 1
18 secondary outcomes
anti-CHIKV antibody Geometric Mean Titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5
Time frame: On Day 85
Anti-CHIKV antibody Geometric Mean Titer using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Time frame: On Day 169
CHIKV serum antibody Geometric Mean Titer using ELISA
Time frame: On Day 29 following the first dose
CHIKV serum ELISA antibody Geometric Mean Titer
Time frame: On Day 15, 29, 85, and 169 following the second dose
CHIKV serum PRNT50 antibody Geometric Mean Titer
Time frame: On Day 15, 85, and 169 following the second dose
CHIKV serum PRNT50 antibody Geometric Mean Titer
Time frame: On Day 29 following the second dose
Mean fold change from baseline to CHIKV using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
Time frame: On Day 85
Mean fold change from baseline to CHIKV using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Time frame: On Day 169
Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
Time frame: On Day 15, 29, 85, and 169 following the second dose
Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
Time frame: On Day 29 following the first dose
Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
Time frame: On Day 15, 85, and 169 following the second dose
Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
Time frame: On Day 29 following the second dose
The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
Time frame: On Day 85
The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Time frame: On Day 169
The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using ELISA
Time frame: On Day 29 following the first dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum ELISA antibody titer
Time frame: On Day 15, 29, 85, and 169 following the second dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
Time frame: On Day 15, 85, and 169 following the second dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
Time frame: On Day 29 following the second dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
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Not yet recruitingPhase 2
Evaluation of IXCHIQ® Vaccine Immunogenicity
Healthy Adult, Healthy Adolescents
RecruitingPhase 4
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
Chikungunya Virus Infection
Recruiting
Against Chikungunya Virus and Neonatal Infection
Chikungunya Virus Infection, Neonatal
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-CHKVLP059-00-VP in people with Chikungunya Virus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 9 inclusion and 20 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
CHIKV serum antibody Geometric Mean Titer using PRNT50 (time frame: On Day 29 post dose 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2020.