Purpose

To determine whether metformin (MET) can improve the immune response to the pneumococcal conjugate vaccine (PCV-13) in older adults.

Category

IRB Number
20180171HU
NCT Number
NCT03713801
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Local Recruitment Point of Contact
Grace Lee
(210) 567-8355
leeg3@uthscsa.edu

Principal Investigator
Grace Lee

Regulatory Point of Contact
Grace Lee
(210) 567-8355
leeg3@uthscsa.edu



Eligibility

Eligible Ages
Between 63 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

    1. Age 63 to 89 years of age
    2. No history of pneumococcal vaccinations
    3. Able to take oral medications
    4. Able to provide informed consent
    5. Not currently taking metformin

Exclusion Criteria

    1. Previous vaccination with any pneumococcal vaccine
    2. Metformin within the last 6 months
    3. Contraindication for PCV13
    4. History of severe adverse reaction associated with any vaccine component
    5. Residence in long-term care facility
    6. Diagnosis of diabetes (diagnosis of pre-diabetes okay)
    7. Chronic renal disease (or eGFR <50 mL/min) or renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
    8. History of adverse reaction or contraindications associated with metformin
    9. Recent history or plan for radiocontrast
    10. Self-reported dementia or severe cognitive impairment
    11. Receipt of blood products within 6 months before enrollment
    12. History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG)
    13. History of chronic obstructive pulmonary disease
    14. Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg)
    15. History of an immunodeficiency
    16. Use of use of investigational products, antibiotics, probiotics, or systemic immunosuppressive therapy (systemic steroids) within 1 month of study start; patients who are taking these medications chronically, with no expected discontinuation during the study period would not be considered ineligible.
    17. Treatment with anticoagulants (warfarin)
    18. Donated blood within the last 2 months
    19. Subject is considered unsuitable for the study in the opinion of the investigator for any other reason

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)
Condition
  • Aging
  • Vaccine Response Impaired
  • Arm Groups

    ArmDescriptionIntervention
    Experimental

    Metformin

    Dosage is increased over the first 3 weeks up to three 500 mg tablets a day at 3 weeks, then continued on 3 tablets daily for a further 9 weeks.
  • Drug: Metformin

    Total daily dose titrated up to 1500 mg po q day over the course of 3 weeks and continued for a total exposure of 12 weeks.

    Other names:

    • Glucophage

  • Placebo Comparator

    Placebo

    Placebo tablet dosage is increased over the first 3 weeks up to three tablets a day at 3 weeks, then continued on 3 tablets daily for a further 9 weeks.
  • Drug: Placebo

    Placebo tablets titrated up to 3 tablets over the course of 3 weeks and then continued as 3 daily for a total exposure of 12 weeks

    Other names:

    • Placebo oral tablet