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Published on: February 15, 2013
A neonatal pneumococcal conjugate vaccine trial in Papua New guinea: study population, methods and operational
S Phuanukoonnon1, J C Reeder, W S Pomat
1Papua New Guinea Institute of Medical Research, Goroka, Eastern Highlands Province, Australia.
Insights
This study evaluated the safety and effectiveness of a pneumococcal conjugate vaccine in infants in Papua New Guinea. Strong community engagement was key to the trial's success, ensuring high participant retention and data collection for future infant immunization strategies.
Area of Science:
- * Clinical Trials
- * Vaccinology
- * Global Health
Background:
- * Papua New Guinea faces a high burden of invasive pneumococcal disease in infants, particularly those under six months.
- * Neonatal immunization is crucial for maximizing the impact of the upcoming pneumococcal conjugate vaccine introduction.
- * Existing data on neonatal and early infant immunization safety and immunogenicity in this region is limited.
Purpose of the Study:
- * To assess the safety and immunogenicity of a 7-valent pneumococcal conjugate vaccine (7vPCV) in infants in Papua New Guinea.
- * To evaluate different neonatal and early infant immunization schedules.
- * To provide evidence supporting the optimal introduction of pneumococcal conjugate vaccines in PNG.
Main Methods:
- * An open, randomized controlled trial involving 318 infants.
- * Infants received 7vPCV at different neonatal or early infant schedules (0, 1, 2 months or 1, 2, 3 months).
- * All infants received 23-valent pneumococcal polysaccharide vaccine at 9 months, with extensive monitoring and biological sample collection over 18 months.
Main Results:
- * The trial successfully achieved its aims, with high follow-up rates (77%) and sample collection (over 80%).
- * Detailed results on vaccine safety and immunogenicity will be reported separately.
- * The study highlights the feasibility of conducting complex vaccine trials in this setting.
Conclusions:
- * Strong community engagement, equitable partnerships, and reciprocity were critical for the trial's success.
- * A two-stage consent process, while causing initial drop-out, ensured high retention of enrolled participants.
- * Effective community participation and relationships are as vital as technical aspects for successful vaccine trials in PNG.
Abstract:
Infants in Papua New Guinea (PNG) are at a high risk of invasive pneumococcal disease, and a substantial burden of this falls on children less than six months old. PNG is planning to introduce a pneumococcal conjugate vaccine for infants in the near future, but to make the maximum impact neonatal immunization will have to be considered. To provide evidence on safety and immunogenicity for neonatal and early infant immunization, we undertook an open randomized controlled trial of 7-valent pneumococcal conjugate vaccine (7vPCV). 318 children received 7vPCV at ages 0, 1 and 2 months or at 1, 2 and 3 months or not at all. All children received 23-valent pneumococcal polysaccharide vaccine at age 9 months. This was a large and complex trial: village reporters visited participants weekly during the first year and fortnightly for a further 6 months and nurses monitored self-reported morbidity and collected many thousands of biological samples. The study team was remarkably successful in achieving the study aims, with 18-month follow-up completed on 77% of enrolled children and over 80% of scheduled samples collected. While the results of the trial will be reported elsewhere, this paper discusses the design of the study and dissects out some of the main reasons for its successful completion. Strong community engagement was an essential factor in success and the principles of equitable partnership and service provision led to a strong research partnership. A two-stage consent process, comprising primary assent followed by later informed consent, led to a high drop-out before initial enrolment, but an outstanding retention of those enrolled in the study. We conclude that factors such as strong community participation, reciprocity and a good relationship between the study team and participants are just as important as the technical elements of laboratory testing and data handling in ensuring the success of a vaccine trial in PNG.
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