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Chikungunya Virus Vaccine Trial in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01489358
Recruitment Status : Completed
First Posted : December 9, 2011
Results First Posted : April 12, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Viral Vaccines
Chikungunya Fever
Chikungunya Virus Infection
Intervention Biological: VRC-CHKVLP059-00-VP
Enrollment 25
Recruitment Details Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland from December 12, 2011 to March 22, 2012
Pre-assignment Details  
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Period Title: Overall Study
Started 5 10 10
Completed 5 10 8
Not Completed 0 0 2
Reason Not Completed
Lost to Follow-up             0             0             2
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP Total
Hide Arm/Group Description Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 Total of all reporting groups
Overall Number of Baseline Participants 5 10 10 25
Hide Baseline Analysis Population Description
All enrolled participants
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 10 participants 25 participants
18-20 years 1 0 0 1
21-30 years 2 4 6 12
31-40 years 2 4 3 9
41-50 years 0 2 1 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 10 participants 25 participants
Female
3
  60.0%
3
  30.0%
4
  40.0%
10
  40.0%
Male
2
  40.0%
7
  70.0%
6
  60.0%
15
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 10 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  20.0%
1
  10.0%
1
  10.0%
3
  12.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
1
  10.0%
1
  10.0%
3
  12.0%
White
3
  60.0%
8
  80.0%
8
  80.0%
19
  76.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 10 participants 10 participants 25 participants
5 10 10 25
1.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Hide Description 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.
Time Frame 7 days after the first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received the first vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
Pain/Tenderness 0 1 1
Swelling 0 0 0
Redness 0 0 0
Any Local Symptom 0 1 1
2.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Hide Description 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.
Time Frame 7 days after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received the second vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
Pain/Tenderness 0 2 3
Swelling 0 0 0
Redness 0 0 0
Any Local Symptom 0 2 3
3.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Hide Description 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.
Time Frame 7 days after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who received the third vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 8
Measure Type: Number
Unit of Measure: participants
Pain/Tenderness 1 3 4
Swelling 0 0 0
Redness 0 0 0
Any Local Symptom 1 3 4
4.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Hide Description 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.
Time Frame 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
Pain/Tenderness 1 4 4
Swelling 0 0 0
Redness 0 0 0
Any Local Symptom 1 4 4
5.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Hide Description 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.
Time Frame 7 days after the first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received the first vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
Malaise 1 1 1
Myalgia 0 0 1
Headache 0 0 1
Chills 0 0 0
Nausea 0 0 2
Temperature 0 0 0
Joint Pain 0 0 0
Any Systemic Symptom 1 1 3
6.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Hide Description 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.
Time Frame 7 days after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received the second vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
Malaise 0 1 0
Myalgia 0 1 0
Headache 0 0 1
Chills 0 0 0
Nausea 1 0 1
Temperature 0 0 0
Joint Pain 0 0 0
Any Systemic Symptom 1 1 2
7.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Hide Description 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.
Time Frame 7 days after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who received the third vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 8
Measure Type: Number
Unit of Measure: participants
Malaise 0 2 1
Myalgia 0 1 0
Headache 1 0 1
Chills 0 0 0
Nausea 0 0 1
Temperature 0 0 0
Joint Pain 0 0 0
Any Systemic Symptom 1 2 2
8.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Hide Description 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.
Time Frame 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
Malaise 1 3 2
Myalgia 0 2 1
Headache 1 0 3
Chills 0 0 0
Nausea 1 0 3
Temperature 0 0 0
Joint Pain 0 0 0
Any Systemic Symptom 2 3 5
9.Primary Outcome
Title Number of Subjects With an Any Abnormal Laboratory Result
Hide Description Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44
Time Frame 44 weeks after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
ALT 1 2 2
WBC 3 3 0
Hemoglobin 1 2 1
Platelets 0 0 0
Neutrophil Count 2 1 2
Lymphocyte Count 1 1 0
Eosinophil Count 1 1 1
Any Abnormal Lab Result 4 5 5
10.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description 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.
Time Frame 44 weeks after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0
11.Primary Outcome
Title Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Hide Description

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.

Time Frame 28 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Measure Type: Number
Unit of Measure: participants
Any AE 4 9 6
Blood and Lymphatic System Disorders 2 2 1
Infections and Infestations 3 5 4
Injury, Poisoning and Procedural Complications 0 2 0
Investigations 1 0 2
Musculoskeletal and Connective Tissue Disorders 1 1 0
Surgical and Medical Procedures 0 0 1
Vascular Disorders 0 1 0
12.Secondary Outcome
Title Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)
Hide Description ELISA titer (strain 37997) For ELISA, week 0 values were used to background correct titres for subsequent weeks.
Time Frame 24 weeks after the first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: titre
40960
(40960 to 40960)
15521
(6058 to 39763)
34443
(22862 to 51890)
13.Secondary Outcome
Title Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
Hide Description Neutralisation IC50 titre (strain OPY1)
Time Frame Pre-vaccination (Week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: titre
50
(50 to 50)
51
(49 to 52)
52
(50 to 54)
14.Secondary Outcome
Title Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
Hide Description Neutralisation IC50 titre (strain OPY1)
Time Frame 24 weeks after the first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one vaccination
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description:
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
Overall Number of Participants Analyzed 5 10 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: titre
8745
(1514 to 50516)
4525
(2252 to 9093)
5390
(1865 to 15573)
Time Frame Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
Adverse Event Reporting Description For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
 
Arm/Group Title Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Hide Arm/Group Description Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140 Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
All-Cause Mortality
Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: 10 mcg VRC-CHKVLP059-00-VP Group 2: 20 mcg VRC-CHKVLP059-00-VP Group 3: 40 mcg VRC-CHKVLP059-00-VP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/5 (80.00%)   9/10 (90.00%)   8/10 (80.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/5 (20.00%)  2/10 (20.00%)  1/10 (10.00%) 
Leukopenia * 1  1/5 (20.00%)  1/10 (10.00%)  0/10 (0.00%) 
Neutropenia * 1  1/5 (20.00%)  1/10 (10.00%)  1/10 (10.00%) 
Gastrointestinal disorders       
Nausea  1  1/5 (20.00%)  0/10 (0.00%)  3/10 (30.00%) 
General disorders       
Pain/Tenderness  1  1/5 (20.00%)  4/10 (40.00%)  4/10 (40.00%) 
Malaise  1  1/5 (20.00%)  3/10 (30.00%)  2/10 (20.00%) 
Infections and infestations       
Gastroenteritis * 1  0/5 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Herpes Zoster * 1  0/5 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Pharyngitis * 1  1/5 (20.00%)  1/10 (10.00%)  0/10 (0.00%) 
Upper respiratory tract infection * 1  2/5 (40.00%)  3/10 (30.00%)  2/10 (20.00%) 
Viral Infection * 1  0/5 (0.00%)  1/10 (10.00%)  1/10 (10.00%) 
Injury, poisoning and procedural complications       
Excoriation * 1  0/5 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Ligament sprain * 1  0/5 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  1/5 (20.00%)  0/10 (0.00%)  2/10 (20.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia * 1  1/5 (20.00%)  1/10 (10.00%)  0/10 (0.00%) 
Myalgia  1  0/5 (0.00%)  2/10 (20.00%)  1/10 (10.00%) 
Nervous system disorders       
Headache  1  1/5 (20.00%)  0/10 (0.00%)  3/10 (30.00%) 
Surgical and medical procedures       
Incisional drainage * 1  0/5 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Vascular disorders       
Hypertension * 1  0/5 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Julie E Ledgerwood
Organization: Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
EMail: ledgerwood@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01489358    
Other Study ID Numbers: 120041
12-I-0041 ( Other Identifier: NIH )
First Submitted: December 7, 2011
First Posted: December 9, 2011
Results First Submitted: March 11, 2016
Results First Posted: April 12, 2016
Last Update Posted: July 25, 2016