Hi all,
I am writing to invite data partners / collaborators to participate in a network study on comparative effectiveness for different dosing schedules of the pneumococcal conjugate vaccine (PCV 13) among children under 5 years old. The PCV is a vaccine that protects against 13 types of bacteria that cause pneumococcal disease, including pneumonia, meningitis, and bacteremia. It is recommended as part of the routine vaccination for children in many countries, usually in a 3+1 or 2+1 dosing schedule (3 or 2 doses in year 1 & 1 booster in year 2).
This study is particularly relevant and time-sensitive as we are hoping to present supporting evidence to the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) by early 2025. The WHO SAGE group is scheduled in early 2025 to provide recommendation about switching from the existing 2+1 or 3+0 PCV dosing schedules to the 1+1 schedule. WHO SAGE have been actively gathering data to investigate the potential impact of this change, and results of a large-scale study based on real-world evidence (which OHDSI is uniquely positioned to produce) will potentially make great impact.
For this study, we are also proposing to implement a new target trial emulation method for population-level estimation, namely the clone-censor weight analysis [1-4]. As shown in a number of previous studies [1-3], this method is able to compare dosing schedules for the entire course of vaccination, including inter-dose intervals, while increasing statistical power by using records from all eligible patients. We plan to also assess the performance of this analytical method, or generate necessary artifacts so that we can evaluate its performance in a follow-up study.
Please refer to this linked file for a rough draft of the study protocol. We would be excited to hear your thoughts and feedback.
Please let me know by replying or emailing (fanbu42@gmail.com) if you are interested in joining the study as a data partner or collaborator!
References:
[1] Maringe C, Benitez Majano S, Exarchakou A, et al. Reflection on modern methods: Trial emulation in the presence of immortal-time bias. Assessing the benefit of major surgery for elderly lung cancer patients using observational data. International Journal of Epidemiology 2020;49 :1719–29.
[2] Zhao SS, Lyu H, Yoshida K. Versatility of the clone-censor-weight approach: Response to ‘trial emulation in the presence of immortal-time bias’. International Journal of Epidemiology 2021;50 :694–5.
[3] Shioda K, Breskin A, Harati P, et al. Comparative effectiveness of alternative intervals between first and second doses of the mRNA COVID-19 vaccines. Nat Commun 2024;15 :1214.
[4] Butler AM, Breskin A, Sahrmann JM, et al. Estimating the effectiveness of rotavirus vaccine schedules. Epidemiology 2021;32 :598–606.