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| Name | Class |
|---|---|
| The University of Western Australia | OTHER |
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The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.
The primary aim of the study is to determine whether PCV10 and PCV13 are safe and immunogenic in PNG infants for the serotypes in the respective vaccines. This study is important for the following reasons:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorix or PCV10 | Other | 130 children will receive Synflorix at 1-2-3 months |
|
| Prevenar 13 | Other | 130 children will receive Prevenar 13 at 1-2-3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenar 13 and Synflorix | Biological | 260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children with serotype-specific IgG concentration >= 0.35ug/ml at 4 and 9 months of age for 90% of PCV vaccine serotypes and proportion of children with OPA >=1:8 titres at 4, 10 and 24 months | IgG concentration to vaccine serotypes are >= 0.35ug/ml post-dose 3 at 4 and 9 months. Serotype-specific IgG concentration >=0.35ug/ml is protective level against invasive pneumococcal diseases. Opsonophagocytic titre of >=1:8 examined at 4, 10 and 24 months will inform on functional antibodies induced by vaccination. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Compare antibody concentrations to pneumococcal and Haemophilus influenzae protein antigens. | Measure antibody titres to surface proteins of pneumococci and Hi including Hi protein D, the carrier protein in PCV10 (Synflorix). | 2 years |
| Determine carriage rates and bacterial load of pneumococci and H.influenzae |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Pomat, PhD | Contact | +6755322800 | 206 | william.pomat@pngimr.org.pg |
| Name | Affiliation | Role |
|---|---|---|
| William S Pomat, PhD | Papua New Guinea Institute of Medical Research | Principal Investigator |
| Deborah Lehmann, MSc | Telethon Institute for Child Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papua New Guinea Institute of Medical Research | Recruiting | Goroka | Eastern Highlands Province | 441 | Papua New Guinea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37479616 | Derived | Orami T, Aho C, Ford RL, Pomat WS, Greenhill A, Kirkham LA, Masiria G, Nivio B, Britton KJ, Jacoby P, Richmond PC, van den Biggelaar AHJ, Lehmann D. Pneumococcal carriage, serotype distribution, and antimicrobial susceptibility in Papua New Guinean children vaccinated with PCV10 or PCV13 in a head-to-head trial. Vaccine. 2023 Aug 23;41(37):5392-5399. doi: 10.1016/j.vaccine.2023.07.026. Epub 2023 Jul 20. | |
| 34447389 |
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Proportion of carriage before and after vaccination will be measured using conventional culture methods. Bacterial load will be measured using PCR to determine impact of vaccines |
| 3 years |
| Determine rates of hospital admission for acute respiratory tract infections at 9 and 23 months | Admissions and morbidity for acute respiratory tract infections will be documented at 9 and 23 months. | 2 yrs |
| Peter Richmond, MD |
| The University of Western Australia |
| Principal Investigator |
| Derived |
| Martinovich KM, Rahman T, de Gier C, Seppanen EJ, Orami T, Granland CM, Francis J, Yoannes M, Corscadden KJ, Ford R, Jacoby P, van den Biggelaar AHJ, Bakaletz LO, Cripps AW, Lehmann D, Richmond PC, Pomat WS, Kirkham LS, Thornton RB. Differences in Pneumococcal and Haemophilus influenzae Natural Antibody Development in Papua New Guinean Children in the First Year of Life. Front Immunol. 2021 Aug 10;12:725244. doi: 10.3389/fimmu.2021.725244. eCollection 2021. |
| 34024658 | Derived | Rahman T, de Gier C, Orami T, Seppanen EJ, Granland CM, Francis JP, Michael A, Yoannes M, Corscadden KJ, Ford RL, Martinovich KM, Jacoby P, van den Biggelaar AHJ, Lehmann D, Richmond PC, Pomat WS, Thornton RB, Kirkham LS. PCV10 elicits Protein D IgG responses in Papua New Guinean children but has no impact on NTHi carriage in the first two years of life. Vaccine. 2021 Jun 11;39(26):3486-3492. doi: 10.1016/j.vaccine.2021.05.022. Epub 2021 May 21. |
| 30184183 | Derived | Pomat WS, van den Biggelaar AHJ, Wana S, Francis JP, Solomon V, Greenhill AR, Ford R, Orami T, Passey M, Jacoby P, Kirkham LA, Lehmann D, Richmond PC; 10v13v PCV Trial Team. Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants. Clin Infect Dis. 2019 Apr 24;68(9):1472-1481. doi: 10.1093/cid/ciy743. |
| 29299402 | Derived | Lehmann D, Kirarock W, van den Biggelaar AHJ, Passey M, Jacoby P, Saleu G, Masiria G, Nivio B, Greenhill A, Orami T, Francis J, Ford R, Kirkham LA, Solomon V, Richmond PC, Pomat WS; 10v13v PCV trial team. Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea. Pneumonia (Nathan). 2017 Dec 25;9:20. doi: 10.1186/s41479-017-0044-z. eCollection 2017. |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D008581 | Meningitis |
| D014115 | Toxemia |
| D018805 | Sepsis |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| C547294 | PHiD-CV vaccine |
| C586648 | 10-valent pneumococcal conjugate vaccine |
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