Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine

Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults

When two or more vaccines are administered concurrently, there is a concern on vaccine interaction, which can either enhance or suppress immune response to vaccine antigens. This study is designed to evaluate the immunogenicity and safety of tetanus-diphtheria (Td) and pneumococcal vaccines after concomitant administration in adults aged 50 years and older.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections; Tetanus; Diphtheria
• Intervention / Treatment: Biological: Tetanus-diphtheria (Td) and PCV13; Biological: PCV13 alone; Biological: Td alone

Detailed Description

Vaccination would be the most effective strategy to prevent diverse infectious diseases. Actually, The World Health Organization (WHO) estimate that vaccination averts 2-3 million deaths per year. In adults, several vaccines are recommended based on age and medical conditions if they have not receive vaccination before, and lack evidence of past infection: influenza, measles-mumps-rubella (MMR), varicella, human papilloma virus (HPV), tetanus-diphtheria (Td), pneumococcl vaccines and etc. In particular, when the patient visits a vaccination clinic, Td and the pneumococcal vaccines are commonly administered at the same time. In this study, we aimed to evaluate the immunogenicity and safety of Td vaccine and PCV13 after concomitant administration in adults aged 50 years. This single-center, open label randomized trial was conducted (Clinical Trial Number - NCT02215863) at Korea University Guro Hospital from November 2013 to April 2016. Adults ≥50 years of age were randomized in a 1:1:1 ratio to receive Td + PCV13 (Group 1), PCV13 alone (Group 2) or Td alone (Group 3).

• Study Type: Interventional
• Enrollment (Actual): 462
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged ≥50 years who signed the informed consent

Exclusion Criteria:

• history of S. pneumoniae infection within the previous 5 years
• previous pneumococcal vaccination
• previous tetanus-diphtheria (Td) vaccination within the last 10 years
• known immunodeficiency or immunosuppressant use or coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tetanus-diphtheria (Td) and PCV13	Biological: Tetanus-diphtheria (Td) and PCV13; 154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
Active Comparator: PCV13 alone	Biological: PCV13 alone; 154 PCV13 recipients: one vaccine injection administered on Day 0
Active Comparator: Td alone	Biological: Td alone; 437 Td recipients: one vaccine injection administered on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tetanus antibody titers at day 28 post-vaccination	IgG antibody titers by enzyme linked immunosorbent assay (ELISA) Seroprotection rate: percentage of subjects with a post-vaccination antibody levels ≥0.1 IU/mL	4 weeks after vaccination
Diphtheria antibody titers at day 28 post-vaccination	IgG antibody titers by enzyme linked immunosorbent assay (ELISA)	4 weeks after vaccination
Tetanus seroprotection rate at day 28 post-vaccination	Proportion of IgG antibody titers ≥0.1 IU/mL	4 weeks after vaccination
Diphtheria seroprotection rate at day 28 post-vaccination	Proportion of IgG antibody titers ≥0.1 IU/mL	4 weeks after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opsonophagocytic assay (OPA) titers for PCV13	Four capsule serotypes: 1, 5, 18C and 19A	4 weeks after vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and duration of local and systemic adverse events	The safety profiles of co-administration of Td and PCV13 will be compared to those of single vaccination.	During 4 weeks after vaccination

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital

Publications and helpful links

General Publications

• Song JY, Cheong HJ, Noh JY, Choi MJ, Yoon JG, Lee SN, Kang SH, Jeong EJ, Jo YM, Kim WJ. Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in >/= 50-year-old adults. BMC Infect Dis. 2018 Dec 5;18(1):628. doi: 10.1186/s12879-018-3479-9.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Neurologic Manifestations; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Pneumococcal Infections; Tetanus; Diphtheria; Tetany
• Other Study ID Numbers: 2013GR0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No