PCV13 + Hepatitis a Vaccine for Adults

Phase 4

Completed

• Conditions: Measurement of Immune Response to Prevenar13; Measurement of Immune Response to Hepatitis a
• Interventions: Biological: Prevenar13; Biological: Hepatitis A vaccine

• Registration Number: NCT01926860
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-21
• Study Start: 2013-08-24
• Primary Completion: 2019-10-28
• Study Completion: 2020-04-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group - Prevenar®13 and Hepatitis A vaccines	Prevenar13	Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
Study group - Prevenar®13 and Hepatitis A vaccines	Hepatitis A vaccine	Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
Pneumococcal conjugate vaccine -Control group - Prevenar®13	Prevenar13	PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0
HepA -Control group - Hepatitis A vaccine	Hepatitis A vaccine	HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0

Primary Outcome Measures

Name	Time	Method
Immune response to PCV13	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.

Secondary Outcome Measures

Name	Time	Method
Immune response to Hep A vaccine	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.

Trial Locations

Locations (2)

Aava Medical Centre; 🇫🇮 Helsinki, Finland

Department of Infectious Diseases; 🇸🇪 Eskilstuna, Sweden