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Optimising DTwP-containing vaccine infant immunisation schedules (OptImms) - a protocol for two parallel, open-label,
Sarah Kelly1,2, Xinxue Liu1,2, Katherine Theiss-Nyland1,2
1Oxford Vaccine Group, University of Oxford, Oxford, UK.
Insights
This study tested adjusted infant vaccination schedules to see if antibody levels against pertussis can be maintained. Findings will inform decisions on streamlining childhood immunization programs.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Public Health Policy
Background:
- Universal childhood immunisation is crucial for preventive medicine, with the WHO recommending the diphtheria-tetanus-pertussis (DTP) vaccine at specific ages.
- The increasing introduction of new vaccines leads to crowded infant immunization schedules globally, with over 17 DTP-containing vaccine schedules in use.
- The OptImms trial aims to assess if antibody titres can be maintained with adjusted schedules, creating space for new vaccines.
Purpose of the Study:
- To evaluate the immunogenicity of modified infant vaccination schedules.
- To determine if antibody titres against pertussis and other antigens can be maintained with adjusted schedules.
- To inform policy decisions on optimizing childhood immunization schedules.
Main Methods:
- Two randomized, five-arm, non-inferiority clinical trials conducted in Nepal and Uganda.
- Infants randomized to different DTwP vaccination schedules (start age, doses, spacing) and booster timing (9 vs. 12 months).
- Primary outcome: anti-pertussis toxin IgG antibodies at booster dose; secondary outcomes: other antigen antibodies and safety.
Main Results:
- The study is designed to assess antibody titres against pertussis and other vaccine antigens.
- Safety data for the modified vaccination schedules will be collected and analyzed.
- The primary outcome measure is anti-pertussis toxin IgG antibodies at the time of the booster dose.
Conclusions:
- The trial's findings will provide crucial data for policy-making regarding vaccination schedules.
- Streamlining childhood immunization schedules can facilitate the integration of new vaccines.
- Evidence generated will support optimized public health strategies for child immunization.
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, 7th January 2021) and ISRCTN6036654 (Uganda, 17th February 2021).
