PCV13 + Hepatitis a Vaccine for Adults

NCT01926860 | Completed Phase 4 DMC

• 1 other identifier: PCV13 adults + Hep A
• Study Type: interventional
• Target: 305
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Measurement of Immune Response to Prevenar13; Measurement of Immune Response to Hepatitis a

Keywords

Prevenar13; pneumococcal conjugate vaccine; Epaxal; hepatitis A vaccine

Outcome Measures

Primary Outcomes (1)

• Immune response to PCV13

  \- 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 Outcomes (1)

• Immune response to Hep A vaccine

  2 years

Study Arms (3)

Study group - Prevenar®13 and Hepatitis A vaccines

EXPERIMENTAL

Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0

Biological: Prevenar13; Biological: Hepatitis A vaccine

Pneumococcal conjugate vaccine -Control group - Prevenar®13

ACTIVE COMPARATOR

PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0

Biological: Prevenar13

HepA -Control group - Hepatitis A vaccine

ACTIVE COMPARATOR

HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0

Biological: Hepatitis A vaccine

Interventions

Prevenar13 BIOLOGICAL

Pneumococcal conjugate vaccine -Control group - Prevenar®13; Study group - Prevenar®13 and Hepatitis A vaccines

Hepatitis A vaccine BIOLOGICAL

Also known as: Epaxal

HepA -Control group - Hepatitis A vaccine; Study group - Prevenar®13 and Hepatitis A vaccines

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous pneumococcal or hepatitis A vaccination
• Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
• 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
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• Pregnancy or lactation
• 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).
• Alcohol or drug abuse
• Suspected non-compliance
• Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
• Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
• Employee at the investigational site, relative or spouse of the investigator
• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

Aava Medical Centre

Helsinki, 00100, Finland

Location

Department of Infectious Diseases

Eskilstuna, 63188, Sweden

Location

Related Publications (1)

• Riekkinen M, Pakkanen SH, Hutse V, Roukaerts I, Ollgren J, Kayhty H, Herzog C, Rombo L, Kantele A. Coadministered pneumococcal conjugate vaccine decreases immune response to hepatitis A vaccine: a randomized controlled trial. Clin Microbiol Infect. 2023 Dec;29(12):1553-1560. doi: 10.1016/j.cmi.2023.08.006. Epub 2023 Aug 10.

  PMID: 37572831 BACKGROUND

MeSH Terms

Conditions

Hepatitis

Interventions

13-valent pneumococcal vaccine; Hepatitis A Vaccines; epaxal berna

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Anu Kantele, Assoc. prof.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Lars Rombo, Professor

  Sörmland County Council, Centre for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 21, 2013
• Study Start: August 24, 2013
• Primary Completion: October 28, 2019
• Study Completion: April 28, 2020
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

FI (1); SE (1)