Viral VaccinesPhase 1NCT01489358
Chikungunya Virus Vaccine Trial in Healthy Adults
A Phase 1 study testing VRC-CHKVLP059-00-VP in people with Viral Vaccines and Chikungunya Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Vaccines, Chikungunya Fever, Chikungunya Virus Infection
- What is being tested?
- VRC-CHKVLP059-00-VP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A participant must meet all of the following criteria:
- 18 to 50 years old
- Available for clinical follow-up through Week 44
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly
- Able and willing to complete the informed consent process
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- Willing to donate blood for sample storage to be used for future research
- In good general health, with a BMI less than or equal to 40, without clinically significant medical history, and has satisfactorily completed screening
- Physical examination and laboratory results without clinically significant findings within the 56 days prior to enrollment
- Laboratory Criteria within 56 days prior to enrollment:
- Hemoglobin greater than or equal to11.5 g/dL for women; greater than or equal to13.5 g/dL for men
- WBC: 3,000-12,000 cells/mm(3).
- Differential either within institutional normal range or accompanied by physician approval
- Total lymphocyte count: greater than or equal to 800 cells/mm(3)
- Platelets = 125,000-500,000/mm(3)
- Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal range
- Serum creatinine less than or equal to1x upper limit of normal (less than or equal to1.3 mg/dL for females; less than or equal to1.4 mg/dL for males).
- Negative FDA-approved HIV blood test
- Female-Specific Criteria
- Negative Beta-HCG pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential
- A woman of childbearing potential must agree to use an effective means of birth control from at least 21 days prior to enrollment through 12 weeks after last study vaccination
Who cannot join
- A participant will be excluded if one or more of the following conditions apply:
- Female-Specific Criteria
- Woman who is breast-feeding or planning to become pregnant during the time projected for individual study participation
- Systemic immunosuppressive medications or cytotoxic medications within 12 weeks prior to enrollment [with the exceptions that a short course of corticosteroids (less than or equal to10 days duration or a single injection) for a self-limited condition at least 2 weeks prior to enrollment will not exclude study participation]
- Blood products within 16 weeks prior to enrollment
- Immunoglobulin within 8 weeks prior to enrollment
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- Prior vaccinations with an investigational CHIKV vaccine
- Investigational research agents within 4 weeks prior to enrollment
- Live attenuated vaccines within 4 weeks prior to enrollment
- Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 2 weeks prior to enrollment
- Current anti-TB prophylaxis or therapy
- Subject has a history of any of the following clinically significant conditions:
- A history of confirmed or suspected CHIKV infection
- A history of immune-mediated or clinically significant arthritis
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
- Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Idiopathic urticaria within the past year
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active, or treated malignancy for which there is not reasonable assurance of sustained cure, or malignancy that is likely to recur during the period of the study
- Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Psychiatric condition that may preclude compliance with the protocol; past or present psychoses; disorder requiring lithium; or within five years prior to enrollment, a history of suicide plan or attempt
- Any medical condition (such as thyroid disease or hypertension that are not well controlled by medication, or viral hepatitis) that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: VRC 311: A Phase 1 Open Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
Background:
- Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy adults. Participants cannot develop CHIKV from this vaccine.
Read more
Objectives:
- To test the safety and effectiveness of a Chikungunya virus vaccine.
Eligibility:
- Healthy individuals between 18 and 50 years of age.
Design:
- This study, including vaccine doses and followup tests, will last about 44 weeks. Participants will have three vaccination visits, six followup clinic visits, and three telephone contacts during this study. Vaccination visits will take about 4 hours. Most other clinic visits will usually take 2 hours. The telephone contacts will take about 15 minutes.
- Participants will be screened with a physical exam and medical history. Blood samples will also be collected.
- Participants will be assigned to one of three dose groups. Information about doses will be provided before the start of the vaccinations.
- Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks. Participants will be asked to keep an eye on the injection site for 7 days and to notify researchers if there are any side effects.
- Participants will be monitored throughout the study with blood samples and clinic visits.
Read the detailed description
This is a Phase I, open-label, dose-escalation study to examine the safety, tolerability, and immune response to a Virus-Like Particle (VLP) Chikungunya Virus (CHIKV) vaccine in healthy adults ages 18 to 50 years old. The plan is for 25 subjects to receive 3 intramuscular vaccine injections at weeks 0, 4, and 20. The three groups will be enrolled sequentially starting with the lowest dose of 10 micrograms per injection in Group 1.
The hypothesis is that the vaccine is safe and induces immune responses to CHIKV. The primary objective is to evaluate the safety and tolerability of the investigational vaccine, VRC-CHKVLP059-00-VP, at three dosages, 10 micrograms (mcg), 20 mcg, and 40 mcg, in healthy adults. The secondary objective is to evaluate the antibody response against CHIKV VLPs four weeks after the third vaccine injection. The exploratory objectives relate to antigen-specific humoral and cellular immune responses throughout the study.
- Being tested
- VRC-CHKVLP059-00-VP
- Keywords
- Vaccine-Mediated Protection, Antibody Response, Chikungunya Virus, Immune Response, Healthy Volunteer, Humoral Inmunity, Virus-like Particles
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-CHKVLP059-00-VPBiological
VRC-CHKVLP059-00-VP is a VLP vaccine that consists of the E1, E2 and capsid proteins of the Chikungunya Virus
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will receive three IM injections of VRC-CHKVLP059-00-VP (at weeks 0,4, and 20) at a dose of 10 mcg. Receives: Biological: VRC-CHKVLP059-00-VP |
| Group 2 | Experimental | Group 2 will receive three IM injections of VRC-CHKVLP059-00-VP (at weeks 0,4, and 20) at a dose of 20 mcg. Receives: Biological: VRC-CHKVLP059-00-VP |
| Group 3 | Experimental | Group 3 will receive three IM injections of VRC-CHKVLP059-00-VP (at weeks 0,4, and 20) at a dose of 40 mcg. Receives: Biological: VRC-CHKVLP059-00-VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Measured: 7 days after the first vaccination
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Measured: 7 days after the second vaccination
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Measured: 7 days after the third vaccination
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Measured: 7 days after any vaccination
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Measured: 7 days after the first vaccination
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Measured: 7 days after the second vaccination
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Measured: 7 days after the third vaccination
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Measured: 7 days after any vaccination
Number of Subjects With an Any Abnormal Laboratory Result
Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44
Measured: 44 weeks after first vaccination
Number of Subjects Reporting Serious Adverse Events
Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 44 weeks after the first vaccination.
Measured: 44 weeks after first vaccination
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Unsolicited adverse events were recorded from enrollment through 28 days after the second vaccination; and from the third vaccination through 28 days after this vaccination.
Between and after the indicated time periods, through the last expected study visit (i.e., 24 weeks after the third vaccination), only SAEs and new chronic medical conditions were recorded. The number of unsolicited events reported for Group 3 here is lower than the total number of adverse events in the Adverse Event Module, which reports both solicited and unsolicited adverse events.
Measured: 28 days after each vaccination
Secondary outcomes (3)
Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)
ELISA titer (strain 37997) For ELISA, week 0 values were used to background correct titres for subsequent weeks.
Measured: 24 weeks after the first vaccination
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
Neutralisation IC50 titre (strain OPY1)
Measured: Pre-vaccination (Week 0)
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
Neutralisation IC50 titre (strain OPY1)
Measured: 24 weeks after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Viral VaccinesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Julie E Ledgerwood, D.O., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489358
- Sponsor's protocol ID
- 120041
- Other IDs
- 12-I-0041
- Status last verified
- Mar 2016
- First submitted
- 7 Dec 2011
- Last updated
- 25 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Strauss JH, Strauss EG. The alphaviruses: gene expression, replication, and evolution. Microbiol Rev. 1994 Sep;58(3):491-562. doi: 10.1128/mr.58.3.491-562.1994.
PubMed 7968923Powers AM, Logue CH. Changing patterns of chikungunya virus: re-emergence of a zoonotic arbovirus. J Gen Virol. 2007 Sep;88(Pt 9):2363-2377. doi: 10.1099/vir.0.82858-0. No abstract available.
PubMed 17698645Volk SM, Chen R, Tsetsarkin KA, Adams AP, Garcia TI, Sall AA, Nasar F, Schuh AJ, Holmes EC, Higgs S, Maharaj PD, Brault AC, Weaver SC. Genome-scale phylogenetic analyses of chikungunya virus reveal independent emergences of recent epidemics and various evolutionary rates. J Virol. 2010 Jul;84(13):6497-504. doi: 10.1128/JVI.01603-09. Epub 2010 Apr 21.
PubMed 20410280Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.
PubMed 25132507
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 311: A Phase 1 Open Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
- ClinicalTrials.gov ID
- NCT01489358
- Acronym / sponsor ID
- 120041
- Keywords
- Vaccine-Mediated Protection, Antibody Response, Chikungunya Virus, Immune Response, Healthy Volunteer, Humoral Inmunity, Virus-like Particles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Posted 12 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy adults. Participants cannot develop CHIKV from this vaccine.
Objectives:
- To test the safety and effectiveness of a Chikungunya virus vaccine.
Eligibility:
- Healthy individuals between 18 and 50 years of age.
Design:
- This study, including vaccine doses and followup tests, will last about 44 weeks. Participants will have three vaccination visits, six followup clinic visits, and three telephone contacts during this study. Vaccination visits will take about 4 hours. Most other clinic visits will usually take 2 hours. The telephone contacts will take about 15 minutes.
- Participants will be screened with a physical exam and medical history. Blood samples will also be collected.
- Participants will be assigned to one of three dose groups. Information about doses will be provided before the start of the vaccinations.
- Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks. Participants will be asked to keep an eye on the injection site for 7 days and to notify researchers if there are any side effects.
- Participants will be monitored throughout the study with blood samples and clinic visits.
Detailed description
This is a Phase I, open-label, dose-escalation study to examine the safety, tolerability, and immune response to a Virus-Like Particle (VLP) Chikungunya Virus (CHIKV) vaccine in healthy adults ages 18 to 50 years old. The plan is for 25 subjects to receive 3 intramuscular vaccine injections at weeks 0, 4, and 20. The three groups will be enrolled sequentially starting with the lowest dose of 10 micrograms per injection in Group 1.
The hypothesis is that the vaccine is safe and induces immune responses to CHIKV. The primary objective is to evaluate the safety and tolerability of the investigational vaccine, VRC-CHKVLP059-00-VP, at three dosages, 10 micrograms (mcg), 20 mcg, and 40 mcg, in healthy adults. The secondary objective is to evaluate the antibody response against CHIKV VLPs four weeks after the third vaccine injection. The exploratory objectives relate to antigen-specific humoral and cellular immune responses throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: VRC-CHKVLP059-00-VPGroup 1 will receive three IM injections of VRC-CHKVLP059-00-VP (at weeks 0,4, and 20) at a dose of 10 mcg. |
| Group 2 | Experimental | Biological: VRC-CHKVLP059-00-VPGroup 2 will receive three IM injections of VRC-CHKVLP059-00-VP (at weeks 0,4, and 20) at a dose of 20 mcg. |
| Group 3 | Experimental | Biological: VRC-CHKVLP059-00-VPGroup 3 will receive three IM injections of VRC-CHKVLP059-00-VP (at weeks 0,4, and 20) at a dose of 40 mcg. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 18 to 50 years old
- Available for clinical follow-up through Week 44
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly
- Able and willing to complete the informed consent process
Key exclusion criteria (25 listed)
- Female-Specific Criteria
- Woman who is breast-feeding or planning to become pregnant during the time projected for individual study participation
- Systemic immunosuppressive medications or cytotoxic medications within 12 weeks prior to enrollment [with the exceptions that a short course of corticosteroids (less than or equal to10 days duration or a single injection) for a self-limited condition at least 2 weeks prior to enrollment will not exclude study participation]
- Blood products within 16 weeks prior to enrollment
- Immunoglobulin within 8 weeks prior to enrollment
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 |
|---|---|---|
| VRC-CHKVLP059-00-VPVRC-CHKVLP059-00-VP is a VLP vaccine that consists of the E1, E2 and capsid proteins of the Chikungunya Virus | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Time frame: 7 days after the first vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Time frame: 7 days after the second vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Time frame: 7 days after the third vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Time frame: 7 days after any vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Time frame: 7 days after the first vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Time frame: 7 days after the second vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Time frame: 7 days after the third vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Time frame: 7 days after any vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Number of Subjects With an Any Abnormal Laboratory Result
Time frame: 44 weeks after first vaccination
Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44
Number of Subjects Reporting Serious Adverse Events
Time frame: 44 weeks after first vaccination
Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 44 weeks after the first vaccination.
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Time frame: 28 days after each vaccination
Unsolicited adverse events were recorded from enrollment through 28 days after the second vaccination; and from the third vaccination through 28 days after this vaccination. Between and after the indicated time periods, through the last expected study visit (i.e., 24 weeks after the third vaccination), only SAEs and new chronic medical conditions were recorded. The number of unsolicited events reported for Group 3 here is lower than the total number of adverse events in the Adverse Event Module, which reports both solicited and unsolicited adverse events.
3 secondary outcomes
Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)
Time frame: 24 weeks after the first vaccination
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
Time frame: Pre-vaccination (Week 0)
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
Time frame: 24 weeks after the first vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7968923Strauss JH, Strauss EG. The alphaviruses: gene expression, replication, and evolution. Microbiol Rev. 1994 Sep;58(3):491-562. doi: 10.1128/mr.58.3.491-562.1994.
- Background: PubMed 17698645Powers AM, Logue CH. Changing patterns of chikungunya virus: re-emergence of a zoonotic arbovirus. J Gen Virol. 2007 Sep;88(Pt 9):2363-2377. doi: 10.1099/vir.0.82858-0. No abstract available.
- Background: PubMed 20410280Volk SM, Chen R, Tsetsarkin KA, Adams AP, Garcia TI, Sall AA, Nasar F, Schuh AJ, Holmes EC, Higgs S, Maharaj PD, Brault AC, Weaver SC. Genome-scale phylogenetic analyses of chikungunya virus reveal independent emergences of recent epidemics and various evolutionary rates. J Virol. 2010 Jul;84(13):6497-504. doi: 10.1128/JVI.01603-09. Epub 2010 Apr 21.
- Derived from this study: PubMed 25132507Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.
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Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
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.
Julie E Ledgerwood, D.O. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site 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 Viral Vaccines and Chikungunya Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 21 inclusion and 25 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination (time frame: 7 days after the first vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489358, which also lists 4 linked publications.
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 25 Jul 2016.