Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine 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: NCT04439695|
Recruitment Status : Active, not recruiting
First Posted : June 19, 2020
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Low dose Biological: Intermediate dose Biological: High dose Biological: Placebo||Phase 1|
Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.
On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.
Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC) will convene to review Day 8 safety data before any additional subjects will be enrolled. If there are no safety concerns in the IDMC meeting, study enrollment will continue.
Blood and serum samples for safety laboratory tests and HAI titers will be obtained at baseline on Day 1 before administration of vaccine dose and after vaccination.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults|
|Actual Study Start Date :||June 25, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Low Dose KBP-V001
Subjects in this group will receive the low dose of KBP-V001.
Biological: Low dose
Low dose of KBP-V001
Experimental: Intermediate KBP-V001
Subjects in this group will receive the intermediate dose of KBP-V001.
Biological: Intermediate dose
Intermediate dose of KBP-V001
Experimental: High Dose KBP-V001
Subjects in this group will receive the high dose of KBP-V001.
Biological: High dose
High dose of KBP-V001
Placebo Comparator: Placebo
Subjects in this group will receive placebo
Buffered Saline Solution
- Solicited administration site reactions [ Time Frame: 7 days after vaccination ]Occurrences of Adverse Events
- Solicited systemic events [ Time Frame: 7 days after vaccination ]Occurrences of Adverse Events
- Number of Unsolicited Adverse Events [ Time Frame: 43 days after vaccination ]Safety Endpoint
- Number of Serious Adverse Events and Medically Attended Events [ Time Frame: 181 days after vaccination ]Safety Endpoint
- Vaccine HAI antibody Titers [ Time Frame: Day 1, 29, 43, 181 ]Vaccine HAI antibody Titers for each treatment group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439695
|United States, Nebraska|
|Meridian Clinical Research|
|Omaha, Nebraska, United States, 68134|
|Study Director:||Hugh Haydon||Kentucky BioProcessing|
|Principal Investigator:||Brandon Essink, MD||Meridian Clinical Research|