Dataset Information

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

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).

SUBMITTER: Kelly S

PROVIDER: S-EPMC10360224 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

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

Kelly Sarah S Liu Xinxue X Theiss-Nyland Katherine K Voysey Merryn M Murphy Sarah S Li Grace G Nyantaro Mary M Gurung Meeru M Basnet Sudha S Pokhrel Bhishma B Bijukchhe Sanjeev M SM Eordogh Agnes A Gombe Ben B Kakande Ayoub A Kerridge Simon S Kimbugwe Geofrey G Kusemererwa Sylvia S Lubyayi Lawrence L Luzze Henry H Mazur Olga O Mujadidi Yama F YF Nabukenya Shamim S Nagumo Walter-Rodney WR Nareeba Tryphena T Noristani Rabiullah R O'Reilly Peter P Roberts Andrew A Shah Ganesh G Shrestha Sonu S Shrestha Laxman P LP Thapa Surya B SB Kibengo Freddie M FM Sharma Arun K AK Elliott Alison A Shrestha Shrijana S Pollard Andrew J AJ

Trials 20230721 1

<h4>Background</h4>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 OptIm ...[more]

PMID: 37480110

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Project description:ObjectiveThe purpose of this double-blind, randomised, controlled trial is to compare allergic outcomes in children following vaccination with acellular pertussis (aP) antigen (standard of care in Australia) given at 2 months of age versus whole cell pertussis (wP) in the infant vaccine schedule.ParticipantsUp to 3000 Australian infants 6 to <12 weeks of age born ≥32 weeks gestation.InterventionsThe intervention is a wP containing vaccine as the first scheduled pertussis vaccine dose instead of an aP containing vaccine.OutcomesThe primary outcome is a binary indicator of history of IgE-mediated food allergy at the age of 12 months confirmed, where necessary, with an oral food challenge before 18 months of age. Secondary outcomes include (1) history of parent-reported clinician-diagnosed new onset of atopic dermatitis by 6 or 12 months of age with a positive skin prick test to any allergen before 12 months of age, (2) geometric mean concentration in pertussis toxin-specific IgG before and 21 to 35 days after a booster dose of aP at 18 months of age, and (3) sensitisation to at least one allergen by 12 months of age.ResultsOperating characteristics of trial decision rules were evaluated by trial simulation. The selected rules for success and futility approximately maintain type I error of 0.05 and achieved power 0.85 for a reduction in the primary outcome from 10% in the control group to 7% in the intervention group.DiscussionA detailed, prospective statistical analysis plan (SAP) is presented for this Bayesian adaptive design. The plan was written by the trial statistician and details the study design, pre-specified adaptive elements, decision thresholds, statistical methods, and the simulations used to evaluate the operating characteristics of the trial. Application of this SAP will minimise bias and supports transparent and reproducible research.Trial registrationAustralia & New Zealand Clinical Trials Registry, ACTRN12617000065392 . Registered on 12 January 2017 STUDY PROTOCOL: https://doi.org/10.1136/bmjopen-2020-042838.

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Dataset Information

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

Background

Methods

Discussion

Trial registrations

Publications

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

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