Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chikungunya Virus Infection
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 400
- Locations
- 6
- Primary Endpoint
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and immunogenicity of a 2-injection vaccine Chikungunya virus (CHIKV) virus-like particle vaccine (CHIKV VLP) in healthy adults.
Detailed Description
This is a Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and immunogenicity of a 2-injection vaccine regimen (Day 0 and 28) with Chikungunya virus (CHIKV) virus-like particle vaccine (CHIKV VLP, VRC-CHKVLP059-00-VP) in healthy adults ages 18-60 years old that reside in CHIKV endemic regions. The hypothesis is that the vaccine regimen is safe and induces a neutralizing antibody response to CHIKV. The primary objectives are to evaluate safety and tolerability of a 2-injection investigational vaccine regimen of VRC-CHKVLP059-00-VP at 20 mcg compared to placebo (PBS) in healthy adults in CHIKV endemic areas. The secondary objective is to evaluate neutralizing antibody response in vaccine recipients. The exploratory objectives relate to assessing incidence of CHIKV infection in vaccine and placebo recipients, as well as antigen-specific humoral and cellular immune responses during the study. The expected study duration per subject is approximately 72 weeks with intramuscular (IM) injections scheduled at Day 0 and Day 28.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject must meet all of the following criteria:
- •18 to 60 years old
- •Available for clinical follow-up through Study Week 72
- •Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- •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 body mass index (BMI)≤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 either within institutional normal limits or accompanied by site physician approval as consistent with healthy adult status
Exclusion Criteria
- •A subject will be excluded if one or more of the following conditions apply:
- •Women Specific:
- •Planning to become pregnant during the 16 weeks after enrollment in the study
- •Subject has received any of the following substances:
- •Systemic immunosuppressive medications within 2 weeks prior to enrollment
- •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
- •Any vaccination within 2 weeks prior to enrollment
Outcomes
Primary Outcomes
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time Frame: Through study completion, an average of 72 weeks after first injection
Unsolicited AEs were reported from receipt of first study injection through 4 weeks after the last study injection administered. After the indicated time period through the last expected study visit at 72 weeks, only new chronic medical conditions and SAEs (reported as a separate outcome and in the AE module) were collected as unsolicited AEs. A subject with multiple experiences of the same event is counted once using the event of worst severity. The number reported for "Any AE" is the number of subjects reporting at least one or more AEs.
Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events
Time Frame: Through study completion, an average of 72 weeks after first injection
Confirmed Chikungunya infections by positive polymerase chain reaction (PCR) results reported from receipt of first study injection through the last expected study visit at 72 weeks.
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection
Time Frame: 7 days after any injection
Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: Through study completion, an average of 72 weeks after first injection
SAEs were reported from receipt of first study injection through the last expected study visit at 72 weeks. Grading (Mild, Moderate, Severe, Life-threatening, and Death) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple SAEs is counted only once.
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection
Time Frame: 7 days after any injection
Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Number of Subjects With an Abnormal Laboratory Result
Time Frame: 4 weeks after last injection
Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, red blood cell (RBC), white blood cell (WBC), neutrophil, monocyte, lymphocyte, basophil and eosinophil counts, mean corpuscular volume (MCV)) and chemistry (ALT). Complete blood count, differential, platelet and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and Days 28 and 56.
Secondary Outcomes
- Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population(Week 8)
- Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population(Week 8)
- Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat(4 weeks after last study injection)