PCV13 + Hepatitis a Vaccine for Adults (PCV13+HepA)

December 3, 2024 updated by: Anu Kantele, Helsinki University Central Hospital

Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis a Vaccine At the Same Time

The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control groups of adults receiving either hepatitis A or PCV13 vaccines only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

305

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00100
        • Aava Medical Centre
  • Sweden
      • Eskilstuna, Sweden, 63188
        • Department of Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female subjects aged ≥50
  2. General good health as established by medical history and physical examination
  3. Written informed consent
  4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
  5. Available for all visits scheduled in this study.
  6. No previous Pnc vaccination
  7. No previous hepatitis A vaccine
  8. No other vaccines administered 30 days prior to or during the study

Exclusion Criteria:

  1. Previous pneumococcal or hepatitis A vaccination
  2. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
  3. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of vaccine; patients using oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
  4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  5. Pregnancy or lactation
  6. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °C).
  7. Alcohol or drug abuse
  8. Suspected non-compliance
  9. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
  10. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
  11. Employee at the investigational site, relative or spouse of the investigator
  12. Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group - Prevenar®13 and Hepatitis A vaccines
Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
Biological: Hepatitis A vaccine
Other Names:
  • Epaxal
Biological: Prevenar13
Active Comparator: Pneumococcal conjugate vaccine -Control group - Prevenar®13
PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0
Biological: Prevenar13
Active Comparator: HepA -Control group - Hepatitis A vaccine
HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0
Biological: Hepatitis A vaccine
Other Names:
  • Epaxal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response to PCV13
Time Frame: 2 years
- To study whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control group of adults receiving PCV13 vaccine only.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response to Hep A vaccine
Time Frame: 2 years
- To study whether a simultaneously given PCV13 vaccine will have an impact on the immune response to hepatitis A vaccine in adults. The immune response to hepatitis A vaccine is measured as levels of serum antibodies (ELISA). The results of volunteers receiving PCV13 and hepatitis A will be compared to that in a control group of adults receiving hepatitis A vaccine only.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Lars Rombo, Professor, Sörmland County Council, Centre for Clinical Research
  • Principal Investigator: Anu Kantele, Assoc. prof., Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2013

Primary Completion (Actual)

October 28, 2019

Study Completion (Actual)

April 28, 2020

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimated)

August 21, 2013

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCV13 adults + Hep A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Measurement of Immune Response to Prevenar13

Clinical Trials on Hepatitis A vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe