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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Pneumococcal conjugate vaccine -Control group - Prevenar®13 | Active Comparator | PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0 |
|
| HepA -Control group - Hepatitis A vaccine | Active Comparator | HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenar13 | Biological |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anu Kantele, Assoc. prof. | Helsinki University Central Hospital | Principal Investigator |
| Lars Rombo, Professor | Sörmland County Council, Centre for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aava Medical Centre | Helsinki | 00100 | Finland | |||
| Department of Infectious Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37572831 | Result | 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. |
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| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D022362 | Hepatitis A Vaccines |
| C530970 | epaxal berna |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Hepatitis A vaccine |
| Biological |
|
|
| 2 years |
| Eskilstuna |
| 63188 |
| Sweden |
| D045424 |
| Complex Mixtures |