Impact of Metformin on Immunity

NCT03713801 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20180171H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging; Vaccine Response Impaired

Outcome Measures

Primary Outcomes (1)

• Change in antibody responses to PCV13

  The primary outcome will be antibody responses to PCV13. Antibody levels of each of the 13 different serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) will be compared between the pre-treatment values and the post treatment values.

  Change from 4 weeks to 8 weeks

Secondary Outcomes (1)

• Measure of immunophenotypes

  Baseline, 4 weeks and 8 weeks

Study Arms (2)

Metformin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Metformin DRUG

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.

Also known as: Glucophage

Metformin

Placebo DRUG

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

Also known as: Placebo oral tablet

Placebo

Eligibility Criteria

• Age: 63 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 63 to 89 years of age
• No history of pneumococcal vaccinations
• Able to take oral medications
• Able to provide informed consent
• Not currently taking metformin

You may not qualify if:

• Previous vaccination with any pneumococcal vaccine
• Metformin within the last 6 months
• Contraindication for PCV13
• History of severe adverse reaction associated with any vaccine component
• Residence in long-term care facility
• Diagnosis of diabetes (diagnosis of pre-diabetes okay)
• Chronic renal disease (or eGFR \<50 mL/min) or renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
• History of adverse reaction or contraindications associated with metformin
• Recent history or plan for radiocontrast
• Self-reported dementia or severe cognitive impairment
• Receipt of blood products within 6 months before enrollment
• History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG)
• History of chronic obstructive pulmonary disease
• Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg)
• History of an immunodeficiency

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Grace Lee, PhD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: January 14, 2019
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)