Chikungunya Virus Vaccine Trial in Healthy Adults

NCT01489358 | Completed Phase 1 Results

• 2 other identifiers: 12004112-I-0041
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Viral Vaccines; Chikungunya Fever; Chikungunya Virus Infection

Keywords

Vaccine-Mediated Protection; Antibody Response; Chikungunya Virus; Immune Response; Healthy Volunteer; Humoral Inmunity; Virus-like Particles

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  28 days after each vaccination

Secondary Outcomes (3)

• Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)

  24 weeks after the first vaccination

• Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)

  Pre-vaccination (Week 0)

• Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)

  24 weeks after the first vaccination

Study Arms (3)

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.

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.

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.

Biological: VRC-CHKVLP059-00-VP

Interventions

VRC-CHKVLP059-00-VP BIOLOGICAL

VRC-CHKVLP059-00-VP is a VLP vaccine that consists of the E1, E2 and capsid proteins of the Chikungunya Virus

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A participant must meet all of the following criteria:
• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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.

  PMID: 7968923 BACKGROUND

• Powers 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.

  PMID: 17698645 BACKGROUND

• Volk 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.

  PMID: 20410280 BACKGROUND

• Chang 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.

  PMID: 25132507 DERIVED

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: Dr Julie E Ledgerwood
• Organization: Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health

ledgerwood@mail.nih.gov

Study Officials

• Julie E Ledgerwood, D.O.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 9, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 25, 2016
• Results First Posted: April 12, 2016

Record last verified: 2016-03

Locations

US (1)