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Chikungunya Virus Vaccine Trial in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01489358
First received: December 7, 2011
Last updated: June 9, 2016
Last verified: March 2016
Results First Received: March 11, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Viral Vaccines
Chikungunya Fever
Chikungunya Virus Infection
Intervention: Biological: VRC-CHKVLP059-00-VP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland from December 12, 2011 to March 22, 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: 10 mcg VRC-CHKVLP059-00-VP 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: 20 mcg VRC-CHKVLP059-00-VP 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: 40 mcg VRC-CHKVLP059-00-VP Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140

Participant Flow:   Overall Study
    Group 1: 10 mcg VRC-CHKVLP059-00-VP   Group 2: 20 mcg VRC-CHKVLP059-00-VP   Group 3: 40 mcg VRC-CHKVLP059-00-VP
STARTED   5   10   10 
COMPLETED   5   10   8 
NOT COMPLETED   0   0   2 
Lost to Follow-up                0                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants

Reporting Groups
  Description
Group 1: 10 mcg VRC-CHKVLP059-00-VP 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: 20 mcg VRC-CHKVLP059-00-VP 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: 40 mcg VRC-CHKVLP059-00-VP 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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 5   10   10   25 
Age, Customized 
[Units: 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 
Gender 
[Units: Participants]
       
Female   3   3   4   10 
Male   2   7   6   15 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   1   1   1   3 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   1   1   1   3 
White   3   8   8   19 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   5   10   10   25 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination   [ Time Frame: 7 days after the first vaccination ]

2.  Primary:   Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination   [ Time Frame: 7 days after the second vaccination ]

3.  Primary:   Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination   [ Time Frame: 7 days after the third vaccination ]

4.  Primary:   Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination   [ Time Frame: 7 days after any vaccination ]

5.  Primary:   Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination   [ Time Frame: 7 days after the first vaccination ]

6.  Primary:   Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination   [ Time Frame: 7 days after the second vaccination ]

7.  Primary:   Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination   [ Time Frame: 7 days after the third vaccination ]

8.  Primary:   Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination   [ Time Frame: 7 days after any vaccination ]

9.  Primary:   Number of Subjects With an Any Abnormal Laboratory Result   [ Time Frame: 44 weeks after first vaccination ]

10.  Primary:   Number of Subjects Reporting Serious Adverse Events   [ Time Frame: 44 weeks after first vaccination ]

11.  Primary:   Number of Subjects Reporting 1 or More Unsolicited Adverse Event   [ Time Frame: 28 days after each vaccination ]

12.  Secondary:   Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)   [ Time Frame: 24 weeks after the first vaccination ]

13.  Secondary:   Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)   [ Time Frame: Pre-vaccination (Week 0) ]

14.  Secondary:   Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)   [ Time Frame: 24 weeks after the first vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Julie E Ledgerwood
Organization: Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
e-mail: ledgerwood@mail.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01489358     History of Changes
Other Study ID Numbers: 120041
12-I-0041 ( Other Identifier: NIH )
Study First Received: December 7, 2011
Results First Received: March 11, 2016
Last Updated: June 9, 2016
Health Authority: United States: Food and Drug Administration