Efficacy against pneumococcal carriage and the immunogenicity of reduced-dose (0 + 1 and 1 + 1) PCV10 and PCV13 schedules in Ho Chi Minh City, Viet Nam : a parallel, single-blind, randomised controlled trial
Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved..
BACKGROUND: Interest in reduced-dose pneumococcal conjugate vaccine (PCV) schedules is growing, but data on their ability to provide direct and indirect protection are scarce. We evaluated 1 + 1 (at 2 months and 12 months) and 0 + 1 (at 12 months) schedules of PCV10 or PCV13 in a predominately unvaccinated population.
METHODS: In this parallel, single-blind, randomised controlled trial, healthy infants aged 2 months were recruited from birth records in three districts in Ho Chi Minh City, Vietnam, and assigned (4:4:4:4:9) to one of five groups: PCV10 at 12 months of age (0 + 1 PCV10), PCV13 at 12 months of age (0 + 1 PCV13), PCV10 at 2 months and 12 months of age (1 + 1 PCV10), PCV13 at 2 months and 12 months of age (1 + 1 PCV13), and unvaccinated control. Outcome assessors were masked to group allocation, and the infants' caregivers and those administering vaccines were not. Nasopharyngeal swabs collected at 6 months, 12 months, 18 months, and 24 months were analysed for pneumococcal carriage. Blood samples collected from a subset of participants (200 per group) at various timepoints were analysed by ELISA and opsonophagocytic assay. The primary outcome was the efficacy of each schedule against vaccine-type carriage at 24 months, analysed by intention to treat for all those with a nasopharyngeal swab available. This trial is registered at ClinicalTrials.gov, NCT03098628.
FINDINGS: 2501 infants were enrolled between March 8, 2017, and July 24, 2018 and randomly assigned to study groups (400 to 0 + 1 PCV10, 400 to 0 + 1 PCV13, 402 to 1 + 1 PCV10, 401 to 1 + 1 PCV13, and 898 to control). Analysis of the primary endpoint included 341 participants for 0 + 1 PCV10, 356 0 + 1 PCV13, 358 1 + 1 PCV10, 350 1 + 1 PCV13, and 758 control. At 24 months, a 1 + 1 PCV10 schedule reduced PCV10-type carriage by 58% (95% CI 25 to 77), a 1 + 1 PCV13 schedule reduced PCV13-type carriage by 65% (42 to 79), a 0 + 1 PCV10 schedule reduced PCV10-type carriage by 53% (17 to 73), and a 0 + 1 PCV13 schedule non-significantly reduced PCV13-type carriage by 25% (-7 to 48) compared with the unvaccinated control group. Reactogenicity and serious adverse events were similar across groups.
INTERPRETATION: A 1 + 1 PCV schedule greatly reduces vaccine-type carriage and is likely to generate substantial herd protection and provide some degree of individual protection during the first year of life. Such a schedule is suitable for mature PCV programmes or for introduction in conjunction with a comprehensive catch-up campaign, and potentially could be most effective given as a mixed regimen (PCV10 then PCV13). A 0 + 1 PCV schedule has some effect on carriage along with a reasonable immune response and could be considered for use in humanitarian crises or remote settings.
FUNDING: Bill & Melinda Gates Foundation.
TRANSLATION: For the Vietnamese translation of the abstract see Supplementary Materials section.
| Errataetall: |
CommentIn: Lancet Infect Dis. 2023 Aug;23(8):884-885. - PMID 37062299 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
|---|---|
| Enthalten in: |
The Lancet. Infectious diseases - 23(2023), 8 vom: 01. Aug., Seite 933-944 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Temple, Beth [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
10-valent pneumococcal conjugate vaccine |
|---|
| Anmerkungen: |
Date Completed 31.07.2023 Date Revised 07.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT03098628 CommentIn: Lancet Infect Dis. 2023 Aug;23(8):884-885. - PMID 37062299 Citation Status MEDLINE |
|---|
| doi: |
10.1016/S1473-3099(23)00061-0 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM355663945 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM355663945 | ||
| 003 | DE-627 | ||
| 005 | 20240207232012.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/S1473-3099(23)00061-0 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1283.xml |
| 035 | |a (DE-627)NLM355663945 | ||
| 035 | |a (NLM)37062304 | ||
| 035 | |a (PII)S1473-3099(23)00061-0 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Temple, Beth |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy against pneumococcal carriage and the immunogenicity of reduced-dose (0 + 1 and 1 + 1) PCV10 and PCV13 schedules in Ho Chi Minh City, Viet Nam |b a parallel, single-blind, randomised controlled trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 31.07.2023 | ||
| 500 | |a Date Revised 07.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03098628 | ||
| 500 | |a CommentIn: Lancet Infect Dis. 2023 Aug;23(8):884-885. - PMID 37062299 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a BACKGROUND: Interest in reduced-dose pneumococcal conjugate vaccine (PCV) schedules is growing, but data on their ability to provide direct and indirect protection are scarce. We evaluated 1 + 1 (at 2 months and 12 months) and 0 + 1 (at 12 months) schedules of PCV10 or PCV13 in a predominately unvaccinated population | ||
| 520 | |a METHODS: In this parallel, single-blind, randomised controlled trial, healthy infants aged 2 months were recruited from birth records in three districts in Ho Chi Minh City, Vietnam, and assigned (4:4:4:4:9) to one of five groups: PCV10 at 12 months of age (0 + 1 PCV10), PCV13 at 12 months of age (0 + 1 PCV13), PCV10 at 2 months and 12 months of age (1 + 1 PCV10), PCV13 at 2 months and 12 months of age (1 + 1 PCV13), and unvaccinated control. Outcome assessors were masked to group allocation, and the infants' caregivers and those administering vaccines were not. Nasopharyngeal swabs collected at 6 months, 12 months, 18 months, and 24 months were analysed for pneumococcal carriage. Blood samples collected from a subset of participants (200 per group) at various timepoints were analysed by ELISA and opsonophagocytic assay. The primary outcome was the efficacy of each schedule against vaccine-type carriage at 24 months, analysed by intention to treat for all those with a nasopharyngeal swab available. This trial is registered at ClinicalTrials.gov, NCT03098628 | ||
| 520 | |a FINDINGS: 2501 infants were enrolled between March 8, 2017, and July 24, 2018 and randomly assigned to study groups (400 to 0 + 1 PCV10, 400 to 0 + 1 PCV13, 402 to 1 + 1 PCV10, 401 to 1 + 1 PCV13, and 898 to control). Analysis of the primary endpoint included 341 participants for 0 + 1 PCV10, 356 0 + 1 PCV13, 358 1 + 1 PCV10, 350 1 + 1 PCV13, and 758 control. At 24 months, a 1 + 1 PCV10 schedule reduced PCV10-type carriage by 58% (95% CI 25 to 77), a 1 + 1 PCV13 schedule reduced PCV13-type carriage by 65% (42 to 79), a 0 + 1 PCV10 schedule reduced PCV10-type carriage by 53% (17 to 73), and a 0 + 1 PCV13 schedule non-significantly reduced PCV13-type carriage by 25% (-7 to 48) compared with the unvaccinated control group. Reactogenicity and serious adverse events were similar across groups | ||
| 520 | |a INTERPRETATION: A 1 + 1 PCV schedule greatly reduces vaccine-type carriage and is likely to generate substantial herd protection and provide some degree of individual protection during the first year of life. Such a schedule is suitable for mature PCV programmes or for introduction in conjunction with a comprehensive catch-up campaign, and potentially could be most effective given as a mixed regimen (PCV10 then PCV13). A 0 + 1 PCV schedule has some effect on carriage along with a reasonable immune response and could be considered for use in humanitarian crises or remote settings | ||
| 520 | |a FUNDING: Bill & Melinda Gates Foundation | ||
| 520 | |a TRANSLATION: For the Vietnamese translation of the abstract see Supplementary Materials section | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a 10-valent pneumococcal conjugate vaccine |2 NLM | |
| 650 | 7 | |a Pneumococcal Vaccines |2 NLM | |
| 650 | 7 | |a Vaccines, Conjugate |2 NLM | |
| 700 | 1 | |a Tran, Hau Phuc |e verfasserin |4 aut | |
| 700 | 1 | |a Dai, Vo Thi Trang |e verfasserin |4 aut | |
| 700 | 1 | |a Smith-Vaughan, Heidi |e verfasserin |4 aut | |
| 700 | 0 | |a VPT-II Collaborator Group |e verfasserin |4 aut | |
| 700 | 1 | |a Licciardi, Paul Vincent |e verfasserin |4 aut | |
| 700 | 1 | |a Satzke, Catherine |e verfasserin |4 aut | |
| 700 | 1 | |a Nguyen, Thuong Vu |e verfasserin |4 aut | |
| 700 | 1 | |a Mulholland, Kim |e verfasserin |4 aut | |
| 700 | 1 | |a Balloch, Anne |e investigator |4 oth | |
| 700 | 1 | |a Beissbarth, Jemima |e investigator |4 oth | |
| 700 | 1 | |a Bright, Kathryn |e investigator |4 oth | |
| 700 | 1 | |a Higgins, Rachel Ann |e investigator |4 oth | |
| 700 | 1 | |a Hinds, Jason |e investigator |4 oth | |
| 700 | 1 | |a Hoan, Pham Thi |e investigator |4 oth | |
| 700 | 1 | |a Nation, Monica Larissa |e investigator |4 oth | |
| 700 | 1 | |a Nguyen, Cattram Duong |e investigator |4 oth | |
| 700 | 1 | |a Ortika, Belinda Daniela |e investigator |4 oth | |
| 700 | 1 | |a Phan, Thanh V |e investigator |4 oth | |
| 700 | 1 | |a Phuong, Tran Linh |e investigator |4 oth | |
| 700 | 1 | |a Spry, Leena |e investigator |4 oth | |
| 700 | 1 | |a Thuy, Ho Nguyen Loc |e investigator |4 oth | |
| 700 | 1 | |a Toan, Nguyen Trong |e investigator |4 oth | |
| 700 | 1 | |a Uyen, Doan Y |e investigator |4 oth | |
| 700 | 1 | |a Vy, Le Thi Tuong |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t The Lancet. Infectious diseases |d 2001 |g 23(2023), 8 vom: 01. Aug., Seite 933-944 |w (DE-627)NLM117564362 |x 1474-4457 |7 nnns |
| 773 | 1 | 8 | |g volume:23 |g year:2023 |g number:8 |g day:01 |g month:08 |g pages:933-944 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/S1473-3099(23)00061-0 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 23 |j 2023 |e 8 |b 01 |c 08 |h 933-944 | ||