Clinical trial NCT01926860: PCV13 + Hepatitis a Vaccine for Adults
Official title: Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis a Vaccine At the Same Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Measurement of Immune Response to Prevenar13
Measurement of Immune Response to Hepatitis a
Keywords: Prevenar13
pneumococcal conjugate vaccine
Epaxal
hepatitis A vaccine
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 305
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Immune response to PCV13
timeFrame: 2 years
Secondary outcomes:
measure: Immune response to Hep A vaccine
timeFrame: 2 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Aava Medical Centre
city: Eskilstuna
country: Sweden
facility: Department of Infectious Diseases
Study officials:
affiliation: Helsinki University Central Hospital
name: Anu Kantele, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sörmland County Council, Centre for Clinical Research
name: Lars Rombo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.