Healthy ControlsPhase 1StatVaxNCT02097589
The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23
A Phase 1 study testing Atorvastatin and Pneumovax 23 in people with Healthy Controls, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to: Improve the effectiveness of vaccinations by identifying the effect of cholesterol medication, statins, on immune responses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- Atorvastatin and Pneumovax 23
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 24 subjects are healthy volunteers between the ages of 21 and 40.
Who cannot join
- Pregnant, planning to become pregnant, breastfeeding
- Taking any of the following medications at time of study: antacids, antifungals, antioxidants, colestipol, cyclosporine, digoxin, erythromycin, fibric acid derivatives, niacin, oral contraceptives containing norethindrone or ethinyl estradiol, statins, steroids
- Taking any immunosuppressive drugs including azathioprine, methotrexate, TNF inhibitors, cyclophosphamide, antimalarials, or sulfasalazine
- Currently have or history of cardiovascular disease, diabetes, diphtheria, high blood pressure, high cholesterol, immunodeficiencies, kidney disease, liver disease, low blood pressure, muscular disease, seizure disorders, systemic lupus erythematosus or other systemic autoimmune disorders
- Not immunized in childhood against streptococcus pneumoniae; received pneumovax vaccine within past year, or received 2 or more pneumovax boosters within the past 5 years
- Latex allergy or previous allergic reaction or severe side effects from any vaccine
Show all 9Show fewer
- Heavy drinking (more than 15 drinks/week), illegal drug use within past six months, unwillingness to abstain from alcohol, unwillingness to abstain from tobacco products (dip, cigarettes, cigars, electronic cigarettes, etc.), illegal drugs, or grapefruit juice for duration of study
- BMI over 30, abnormal values on lipid panel or liver function test
- Failure to pass pre-study medical screening
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Clinical Translational Research Building
Gainesville, Florida, 32610
About this study
The purpose of this research study is to: Improve the effectiveness of vaccinations by identifying the effect of cholesterol medication, statins, on immune responses.
Read the detailed description
Due to the anti-inflammatory action of statins, it was proposed that statin treatment would decrease the efficacy of vaccination. This response has yet to be explored following a primary vaccination such as pneumococcal pneumonia. In this study, healthy volunteers will be divided into 2 arms receiving treatment for 28 days: 40 mg atorvastatin or placebo.
Antibody titer for 23 serotypes, complete blood count (CBC), high-sensitivity c-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR), lipids, cytokines (TNF-alpha, IFN-gamma, interleukins, etc.) and key membrane receptors (toll-like receptors, etc.) will be measured for baseline before statin or placebo treatment. On day 7 of treatment, pre-vaccination measures of the above parameters will be taken and an immune response will be induced in all groups using Pneumovax 23 at Day 7. On days 8, 14, 21, and 28 post-vaccination measures will be compared to baseline and between groups.
- Conditions
- Healthy Controls
- Being tested
- Atorvastatin, Pneumovax 23, Placebo (lactose pill)
- Keywords
- Health Controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days.
Pneumovax 23Drug
Also called 23-valent pneumococcal polysaccharide vaccine
Pneumovax 23 injected once, intramuscularly at Day 7.
Placebo (lactose pill)Other
10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Pneumovax-Atorvastatin | Experimental | 10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days. Pneumovax 23 injected once, intramuscularly at Day 7. Receives: Drug: Atorvastatin; Drug: Pneumovax 23 |
| Pneumovax-Placebo | Placebo comparator | 10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days. Pneumovax 23 injected once, intramuscularly at Day 7. Receives: Drug: Pneumovax 23; Other: Placebo (lactose pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of atorvastatin treatment on pneumococcal antigen specific antibody production.
The 24 subjects will be randomized into 2 groups of 12 individuals (6 per gender) and will be assigned to receive either atorvastatin treatment (40mg/day) or placebo (lactose pill) control.
Subjects will be asked to fast after midnight prior to any morning blood draws. On day 1 of treatment, blood will be drawn for a baseline. Treatment with either atorvastatin or placebo will begin on day one and will continue until day 28. Subjects will be instructed to take the study medication once a day at the same time each day.
On day seven of treatment, subjects will be immunized with Pneumovax 23, administered intramuscularly into the arm. Blood will be drawn at several time points following Pneumovax 23 administration. Measurements on blood will be made to determine the effect of statins on immune factor gene expression, serum protein levels, as well as at the cellular level.
Measured: approximately 49 days
Secondary outcomes (1)
Determine the effect of atorvastatin treatment on immunogenic cytokine levels following pneumococcal vaccination.
The 24 subjects will be randomized into 2 groups of 12 individuals (6 per gender) and will be assigned to receive either atorvastatin treatment (40mg/day) or placebo (lactose pill) control.
Subjects will be asked to fast after midnight prior to any morning blood draws. On day 1 of treatment, blood will be drawn for a baseline. Treatment with either atorvastatin or placebo will begin on day one and will continue until day 28. Subjects will be instructed to take the study medication once a day at the same time each day.
On day seven of treatment, subjects will be immunized with Pneumovax 23, administered intramuscularly into the arm. Blood will be drawn at several time points following Pneumovax 23 administration. Measurements on blood will be made to determine the effect of statins on immune factor gene expression, serum protein levels, as well as at the cellular level.
Measured: approximately 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark L Brantly, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097589
- Sponsor's protocol ID
- IRB201400208
- Acronym
- StatVax
- Status last verified
- Sep 2015
- First submitted
- 24 Mar 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wildes TJ, Grippin A, Fasanya H, Dyson KA, Brantly M. Effect of atorvastatin on humoral immune response to 23-valent pneumococcal polysaccharide vaccination in healthy volunteers: The StatVax randomized clinical trial. Vaccine. 2019 Feb 28;37(10):1313-1324. doi: 10.1016/j.vaccine.2019.01.023. Epub 2019 Jan 25.
PubMed 30686636
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23
- ClinicalTrials.gov ID
- NCT02097589
- Acronym / sponsor ID
- StatVax / IRB201400208
- Conditions
- Healthy Controls
- Keywords
- Health Controls
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to: Improve the effectiveness of vaccinations by identifying the effect of cholesterol medication, statins, on immune responses.
Detailed description
Due to the anti-inflammatory action of statins, it was proposed that statin treatment would decrease the efficacy of vaccination. This response has yet to be explored following a primary vaccination such as pneumococcal pneumonia. In this study, healthy volunteers will be divided into 2 arms receiving treatment for 28 days: 40 mg atorvastatin or placebo.
Antibody titer for 23 serotypes, complete blood count (CBC), high-sensitivity c-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR), lipids, cytokines (TNF-alpha, IFN-gamma, interleukins, etc.) and key membrane receptors (toll-like receptors, etc.) will be measured for baseline before statin or placebo treatment. On day 7 of treatment, pre-vaccination measures of the above parameters will be taken and an immune response will be induced in all groups using Pneumovax 23 at Day 7. On days 8, 14, 21, and 28 post-vaccination measures will be compared to baseline and between groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumovax-Atorvastatin | Experimental | Drug: Atorvastatin, Drug: Pneumovax 2310-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days. Pneumovax 23 injected once, intramuscularly at Day 7. |
| Pneumovax-Placebo | Placebo comparator | Drug: Pneumovax 23, Other: Placebo (lactose pill)10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days. Pneumovax 23 injected once, intramuscularly at Day 7. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 24 subjects are healthy volunteers between the ages of 21 and 40.
Key exclusion criteria (9 listed)
- Pregnant, planning to become pregnant, breastfeeding
- Taking any of the following medications at time of study: antacids, antifungals, antioxidants, colestipol, cyclosporine, digoxin, erythromycin, fibric acid derivatives, niacin, oral contraceptives containing norethindrone or ethinyl estradiol, statins, steroids
- Taking any immunosuppressive drugs including azathioprine, methotrexate, TNF inhibitors, cyclophosphamide, antimalarials, or sulfasalazine
- Currently have or history of cardiovascular disease, diabetes, diphtheria, high blood pressure, high cholesterol, immunodeficiencies, kidney disease, liver disease, low blood pressure, muscular disease, seizure disorders, systemic lupus erythematosus or other systemic autoimmune disorders
- Not immunized in childhood against streptococcus pneumoniae; received pneumovax vaccine within past year, or received 2 or more pneumovax boosters within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days. | Drug | Pneumovax-Atorvastatin |
| Pneumovax 23Also: 23-valent pneumococcal polysaccharide vaccinePneumovax 23 injected once, intramuscularly at Day 7. | Drug | Pneumovax-Atorvastatin, Pneumovax-Placebo |
| Placebo (lactose pill)10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days. | Other | Pneumovax-Placebo |
Primary outcome
Determine the effect of atorvastatin treatment on pneumococcal antigen specific antibody production.
Time frame: approximately 49 days
The 24 subjects will be randomized into 2 groups of 12 individuals (6 per gender) and will be assigned to receive either atorvastatin treatment (40mg/day) or placebo (lactose pill) control. Subjects will be asked to fast after midnight prior to any morning blood draws. On day 1 of treatment, blood will be drawn for a baseline. Treatment with either atorvastatin or placebo will begin on day one and will continue until day 28. Subjects will be instructed to take the study medication once a day at the same time each day. On day seven of treatment, subjects will be immunized with Pneumovax 23, administered intramuscularly into the arm. Blood will be drawn at several time points following Pneumovax 23 administration. Measurements on blood will be made to determine the effect of statins on immune factor gene expression, serum protein levels, as well as at the cellular level.
1 secondary outcome
Determine the effect of atorvastatin treatment on immunogenic cytokine levels following pneumococcal vaccination.
Time frame: approximately 49 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Derived from this study: PubMed 30686636Wildes TJ, Grippin A, Fasanya H, Dyson KA, Brantly M. Effect of atorvastatin on humoral immune response to 23-valent pneumococcal polysaccharide vaccination in healthy volunteers: The StatVax randomized clinical trial. Vaccine. 2019 Feb 28;37(10):1313-1324. doi: 10.1016/j.vaccine.2019.01.023. Epub 2019 Jan 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark L Brantly, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin and Pneumovax 23 in people with Healthy Controls, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of atorvastatin treatment on pneumococcal antigen specific antibody production. (time frame: approximately 49 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.