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

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ClinicalTrials.gov Identifier: NCT01926860
Recruitment Status : Unknown
Verified August 2013 by Anu Kantele, Helsinki University Central Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Anu Kantele, 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.

Condition or disease Intervention/treatment Phase
Measurement of Immune Response to Prevenar13 Measurement of Immune Response to Hepatitis A Biological: Prevenar13 Biological: Hepatitis A vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis A Vaccine at the Same Time
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015


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: Prevenar13
Biological: Hepatitis A vaccine
Other Name: Epaxal

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 Name: Epaxal




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926860


Contacts
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Contact: Anu Kantele, Assoc. prof. +358503097640 anu.kantele@hus.fi
Contact: Tuija Oksanen tuija.oksanen@aava.fi

Locations
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Finland
Aava Medical Centre Not yet recruiting
Helsinki, Finland, 00100
Contact: Tuija Oksanen       tuija.oksanen@aava.fi   
Principal Investigator: Anu Kantele, Assoc. prof.         
Sweden
Department of Infectious Diseases Not yet recruiting
Eskilstuna, Sweden, 63188
Contact: Elisabeth S Karlsson, reg. nurse       elisabeth.s.karlsson@dll.se   
Principal Investigator: Lars Rombo, Professor         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Anu Kantele, Assoc. prof. Helsinki University Central Hospital
Principal Investigator: Lars Rombo, Professor Sörmland County Council, Centre for Clinical Research

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Responsible Party: Anu Kantele, Associate Professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01926860     History of Changes
Other Study ID Numbers: PCV13 adults + Hep A
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Anu Kantele, Helsinki University Central Hospital:
Prevenar13
pneumococcal conjugate vaccine
Epaxal
hepatitis A vaccine

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs