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Open Access 01-12-2023 | Whooping Cough | Study protocol

Optimising DTwP-containing vaccine infant immunisation schedules (OptImms) — a protocol for two parallel, open-label, randomised controlled trials

Authors: Sarah Kelly, Xinxue Liu, Katherine Theiss-Nyland, Merryn Voysey, Sarah Murphy, Grace Li, Mary Nyantaro, Meeru Gurung, Sudha Basnet, Bhishma Pokhrel, Sanjeev M. Bijukchhe, Agnes Eordogh, Ben Gombe, Ayoub Kakande, Simon Kerridge, Geofrey Kimbugwe, Sylvia Kusemererwa, Lawrence Lubyayi, Henry Luzze, Olga Mazur, Yama F. Mujadidi, Shamim Nabukenya, Walter-Rodney Nagumo, Tryphena Nareeba, Rabiullah Noristani, Peter O’Reilly, Andrew Roberts, Ganesh Shah, Sonu Shrestha, Laxman P. Shrestha, Surya B. Thapa, Freddie M. Kibengo, Arun K. Sharma, Alison Elliott, Shrijana Shrestha, Andrew J. Pollard

Published in: Trials | Issue 1/2023

Abstract

Background

Universal immunisation is the cornerstone of preventive medicine for children, The World Health Organisation (WHO) recommends diphtheria-tetanus-pertussis (DTP) vaccine administered at 6, 10 and 14 weeks of age as part of routine immunisation. However, globally, more than 17 unique DTP-containing vaccine schedules are in use. New vaccines for other diseases continue to be introduced into the infant immunisation schedule, resulting in an increasingly crowded schedule. The OptImms trial will assess whether antibody titres against pertussis and other antigens in childhood can be maintained whilst adjusting the current Expanded Programme on Immunisation (EPI) schedule to provide space for the introduction of new vaccines.

Methods

The OptImms studies are two randomised, five-arm, non-inferiority clinical trials in Nepal and Uganda. Infants aged 6 weeks will be randomised to one of five primary vaccination schedules based on age at first DTwP-vaccination (6 versus 8 weeks of age), number of doses in the DTwP priming series (two versus three), and spacing of priming series vaccinations (4 versus 8 weeks). Additionally, participants will be randomised to receive their DTwP booster at 9 or 12 months of age. A further sub-study will compare the co-administration of typhoid vaccine with other routine vaccines at one year of age. The primary outcome is anti-pertussis toxin IgG antibodies measured at the time of the booster dose. Secondary outcomes include antibodies against other vaccine antigens in the primary schedule and their safety.

Discussion

These data will provide key data to inform policy decisions on streamlining vaccination schedules in childhood.

Trial registrations

ISRCTN12240140 (Nepa1, 7^th January 2021) and ISRCTN6036654 (Uganda, 17^th February 2021).

Available only for authorised users

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Title: Optimising DTwP-containing vaccine infant immunisation schedules (OptImms) — a protocol for two parallel, open-label, randomised controlled trials
Authors: Sarah Kelly
Xinxue Liu
Katherine Theiss-Nyland
Merryn Voysey
Sarah Murphy
Grace Li
Mary Nyantaro
Meeru Gurung
Sudha Basnet
Bhishma Pokhrel
Sanjeev M. Bijukchhe
Agnes Eordogh
Ben Gombe
Ayoub Kakande
Simon Kerridge
Geofrey Kimbugwe
Sylvia Kusemererwa
Lawrence Lubyayi
Henry Luzze
Olga Mazur
Yama F. Mujadidi
Shamim Nabukenya
Walter-Rodney Nagumo
Tryphena Nareeba
Rabiullah Noristani
Peter O’Reilly
Andrew Roberts
Ganesh Shah
Sonu Shrestha
Laxman P. Shrestha
Surya B. Thapa
Freddie M. Kibengo
Arun K. Sharma
Alison Elliott
Shrijana Shrestha
Andrew J. Pollard
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Whooping Cough
Vaccination
Tetanus
Diphtheria
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07477-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Optimising DTwP-containing vaccine infant immunisation schedules (OptImms) — a protocol for two parallel, open-label, randomised controlled trials

Abstract

Background

Methods

Discussion

Trial registrations

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registrations

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