Trial Outcomes & Findings for Systems Biological Assessment of Statin Effect on Vaccine Responses (NCT NCT06024096)
NCT ID: NCT06024096
Last Updated: 2026-01-14
Results Overview
Magnitude of neutralizing antibody responses against influenza vaccine strains at 29 days after vaccination among participants.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
Up to 29 days after vaccine administration
Results posted on
2026-01-14
Participant Flow
Participants were recruited from the Hope Clinic in Atlanta, Georgia, USA. Participant enrollment began September 20, 2023, and all follow-up was completed by December 16, 2024.
Participant milestones
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Systems Biological Assessment of Statin Effect on Vaccine Responses
Baseline characteristics by cohort
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
n=30 Participants
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
n=33 Participants
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=9 Participants
|
33 Participants
n=6 Participants
|
63 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
32.10 years
STANDARD_DEVIATION 8.10 • n=9 Participants
|
32.67 years
STANDARD_DEVIATION 7.80 • n=6 Participants
|
32.40 years
STANDARD_DEVIATION 7.87 • n=9 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=9 Participants
|
15 Participants
n=6 Participants
|
33 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=9 Participants
|
32 Participants
n=6 Participants
|
56 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=9 Participants
|
14 Participants
n=6 Participants
|
29 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=9 Participants
|
33 participants
n=6 Participants
|
63 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 29 days after vaccine administrationMagnitude of neutralizing antibody responses against influenza vaccine strains at 29 days after vaccination among participants.
Outcome measures
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
n=25 Participants
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
n=21 Participants
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
|---|---|---|
|
Magnitude of the Antibody (Ab) Response to QIV in Statin Recipients and Non-recipients.
H1N1
|
1.33 log fold-change (logFC)
Standard Deviation 0.36
|
1.46 log fold-change (logFC)
Standard Deviation 0.65
|
|
Magnitude of the Antibody (Ab) Response to QIV in Statin Recipients and Non-recipients.
H3N2
|
1.35 log fold-change (logFC)
Standard Deviation 0.41
|
1.28 log fold-change (logFC)
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Until day 29 after vaccine administrationAdverse events of grade 2 or higher (AE, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the vaccine, without any judgment about causality) will be identified during questioning or examination of participants during study visits or receiving a safety contact from a participant.
Outcome measures
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
n=30 Participants
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
n=33 Participants
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
|---|---|---|
|
Number of Adverse Events (AEs) Grade 2 or Higher
|
1 Adverse events
|
4 Adverse events
|
SECONDARY outcome
Timeframe: Until day 29 after vaccine administrationAdverse events (AE) will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0
Outcome measures
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
n=30 Participants
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
n=33 Participants
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
|---|---|---|
|
Number of Adverse Events (AEs)
Grade 1
|
0 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events (AEs)
Grade 2
|
1 Adverse events
|
3 Adverse events
|
|
Number of Adverse Events (AEs)
Grade 3
|
0 Adverse events
|
1 Adverse events
|
|
Number of Adverse Events (AEs)
Grade 4
|
0 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events (AEs)
Grade 5
|
0 Adverse events
|
0 Adverse events
|
SECONDARY outcome
Timeframe: Up to 181 days after vaccine administrationSerious adverse events (SAE, defined as an AE that in the view of the investigator results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect) will be identified during questioning or examination of participants during study visits or receiving a safety contact from a participant any time during the study.
Outcome measures
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
n=30 Participants
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
n=33 Participants
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Seasonal Quadrivalent Influenza Vaccine (QIV)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Seasonal Quadrivalent Influenza Vaccine (QIV)
n=30 participants at risk
Participants will receive the seasonal QIV
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
Statin Therapy and a Seasonal Quadrivalent Influenza Vaccine (QIV)
n=33 participants at risk
Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.
Atorvastatin: Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.
The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination.
Quadrivalent seasonal influenza vaccine: The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting (Grade 2)
|
3.3%
1/30 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
0.00%
0/33 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
|
Hepatobiliary disorders
Elevation in transaminases (Grade 2)
|
0.00%
0/30 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
3.0%
1/33 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
|
Hepatobiliary disorders
Elevation in bilirubin (Grade 2)
|
0.00%
0/30 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
3.0%
1/33 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
|
Renal and urinary disorders
Elevation in Creatine (Grade 2)
|
0.00%
0/30 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
3.0%
1/33 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
|
Musculoskeletal and connective tissue disorders
Elevation in Creatine Kinase (Grade 3, asymptomatic)
|
0.00%
0/30 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
3.0%
1/33 • Information on adverse events was collected from the time consent to participate in the study was obtained, through up to 181 days after vaccine administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place