PCV13 + Hepatitis A Vaccine for Adults (PCV13+HepA)
Primary Purpose
Measurement of Immune Response to Prevenar13, Measurement of Immune Response to Hepatitis A
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Prevenar13
Hepatitis A vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Measurement of Immune Response to Prevenar13 focused on measuring Prevenar13, pneumococcal conjugate vaccine, Epaxal, hepatitis A vaccine
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Aava Medical Centre
- Department of Infectious Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Study group - Prevenar®13 and Hepatitis A vaccines
Pneumococcal conjugate vaccine -Control group - Prevenar®13
HepA -Control group - Hepatitis A vaccine
Arm Description
Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0
HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Immune response to Hep A vaccine
- 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.
Full Information
NCT ID
NCT01926860
First Posted
August 19, 2013
Last Updated
August 20, 2013
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01926860
Brief Title
PCV13 + Hepatitis A Vaccine for Adults
Acronym
PCV13+HepA
Official Title
Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis A Vaccine at the Same Time
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measurement of Immune Response to Prevenar13, Measurement of Immune Response to Hepatitis A
Keywords
Prevenar13, pneumococcal conjugate vaccine, Epaxal, hepatitis A vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group - Prevenar®13 and Hepatitis A vaccines
Arm Type
Experimental
Arm Description
Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
Arm Title
Pneumococcal conjugate vaccine -Control group - Prevenar®13
Arm Type
Active Comparator
Arm Description
PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0
Arm Title
HepA -Control group - Hepatitis A vaccine
Arm Type
Active Comparator
Arm Description
HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0
Intervention Type
Biological
Intervention Name(s)
Prevenar13
Intervention Type
Biological
Intervention Name(s)
Hepatitis A vaccine
Other Intervention Name(s)
Epaxal
Primary Outcome Measure Information:
Title
Immune response to PCV13
Description
- 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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Immune response to Hep A vaccine
Description
- 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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anu Kantele, Assoc. prof.
Phone
+358503097640
Email
anu.kantele@hus.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Tuija Oksanen
Email
tuija.oksanen@aava.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu Kantele, Assoc. prof.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Rombo, Professor
Organizational Affiliation
Sörmland County Council, Centre for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aava Medical Centre
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuija Oksanen
Email
tuija.oksanen@aava.fi
First Name & Middle Initial & Last Name & Degree
Anu Kantele, Assoc. prof.
Facility Name
Department of Infectious Diseases
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth S Karlsson, reg. nurse
Email
elisabeth.s.karlsson@dll.se
First Name & Middle Initial & Last Name & Degree
Lars Rombo, Professor
12. IPD Sharing Statement
Learn more about this trial
PCV13 + Hepatitis A Vaccine for Adults
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