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Published on: December 15, 2023
Case-control study of risk factors for abscess development following hepatitis B vaccination in children in
Mariano da Silva Marques1,2, Filipe de Neri Machado1, Marcelo Amaral Mali1
1Instituto Nacional da Saúde Pública, Dili, Timor-Leste.
Insights
A study in Timor-Leste found no significant risk factors for infant injection-site abscesses after hepatitis B vaccination. Due to a small sample size, findings are hypothesis-generating, emphasizing improved injection practices and surveillance.
Area of Science:
- Public Health
- Immunization Practices
- Pediatric Infectious Diseases
Background:
- Hepatitis B vaccination is crucial for preventing chronic infection.
- A high proportion of adverse events following immunization (AEFI) in Timor-Leste involved injection-site abscesses in infants receiving the birth dose.
- Understanding abscess formation factors is vital for improving immunization safety.
Purpose of the Study:
- To explore potential factors associated with injection-site abscesses following hepatitis B birth-dose vaccination in infants.
- To inform improvements in immunization practices in Timor-Leste.
Main Methods:
- Retrospective matched case-control study in Timor-Leste.
- 12 infant pairs (cases with abscesses, matched controls) were analyzed.
- Data collected via caregiver interviews, record reviews, and facility assessments.
Main Results:
- No statistically significant associations found between examined variables and abscess formation.
- Extremely wide confidence intervals due to small sample size (12 pairs).
- Findings are descriptive and hypothesis-generating, not confirmatory.
Conclusions:
- This study did not identify significant risk factors for injection-site abscesses after hepatitis B birth dose.
- Small sample size limits inferential capacity; findings are exploratory.
- Strengthening safe injection practices, vial management, and AEFI surveillance is critical; larger studies are needed.
Background:
Hepatitis B vaccination is essential for preventing chronic hepatitis B infection and its long-term complications. In 2024, a high proportion of reported adverse events following immunization (AEFI) in Timor-Leste involved injection-site abscesses among infants who received the hepatitis B birth dose. This study aimed to explore potential factors associated with abscess formation to inform improvements in immunization practices.
Methods:
We conducted a retrospective matched case-control study in public health facilities across 10 municipalities in Timor-Leste. Cases were infants aged <12 months with a clinically confirmed injection-site abscess occurring within 14 days after receiving the hepatitis B birth dose in 2024. Each case was matched 1:1 with a control by vaccination facility, approximate vaccination date, infant age group, and sex. Data on recipient characteristics, provider practices, vaccine handling, and cold chain management were collected through caregiver interviews, review of clinical and vaccination records, and facility assessments. Matched bivariate associations were evaluated using the exact McNemar test.
Results:
None of the examined variables showed statistically significant associations with injection-site abscess formation; confidence intervals were extremely wide, reflecting the small sample size (12 pairs) and the very small number of discordant pairs (≤4 for all comparisons). Findings should therefore be interpreted as descriptive and hypothesis-generating only.
Conclusions:
This exploratory matched case-control study did not identify any statistically significant risk factors for injection-site abscesses following hepatitis B birth-dose vaccination. Due to the very small sample size, inferential estimates were highly unstable; therefore, the findings should be interpreted as descriptive and hypothesis-generating rather than confirmatory. Despite these limitations, strengthening safe injection practices, appropriate multidose vial management, and adverse events following immunization (AEFI) surveillance systems remains critical. Larger prospective studies are needed to reliably investigate potential determinants of abscess formation.
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