Related Experiment Video
Updated: Aug 8, 2025
An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
Evaluation of ROTARIX® Booster Dose Vaccination at 9 Months for Safety and Enhanced Anti-Rotavirus Immunity in
Natasha Makabilo Laban1,2, Samuel Bosomprah2,3, Michelo Simuyandi2
1Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.
Insights
A third dose of the oral Rotavirus vaccine (ROTARIX®) was safe for Zambian infants when given with the measles vaccine. However, it did not significantly boost rotavirus-specific IgA levels by 12 months of age.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Oral rotavirus vaccines have lower immunogenicity in low-resource settings, where the burden of rotavirus disease is highest.
- Assessing strategies to improve rotavirus vaccine effectiveness in these vulnerable populations is crucial.
Purpose of the Study:
- To evaluate the safety and immune-boosting potential of an additional third dose of the oral ROTARIX® vaccine in Zambian infants.
- To determine if a third dose, administered at 9 months with the measles/rubella vaccine, enhances rotavirus-specific IgA (RV-IgA) response.
Main Methods:
- A randomized controlled trial involving 214 infants aged 6-12 weeks, comparing a standard two-dose ROTARIX® schedule with a three-dose schedule.
- Plasma samples were collected at multiple time points to measure RV-IgA titres.
- Safety was assessed by monitoring clinical adverse events following the third vaccine dose.
Main Results:
- No significant difference in geometric mean RV-IgA titres was observed at 12 months between the two-dose and three-dose groups.
- The third dose of ROTARIX® was found to be safe when administered concomitantly with the measles/rubella vaccine at 9 months of age.
- Rotavirus vaccines demonstrated immunogenicity in Zambian infants, albeit with modest seroconversion rates.
Conclusions:
- While a third dose of oral ROTARIX® did not significantly boost RV-IgA levels by 12 months, it proved safe in the study population.
- Findings suggest opportunities for optimizing rotavirus vaccine schedules within national immunization programs in low-resource settings.
- Further research may be needed to explore alternative dosing strategies for enhanced rotavirus vaccine immunity.
Abstract:
Oral rotavirus vaccines show diminished immunogenicity in low-resource settings where rotavirus burden is highest. This study assessed the safety and immune boosting effect of a third dose of oral ROTARIX® (GlaxoSmithKline) vaccine administered at 9 months of age. A total of 214 infants aged 6 to 12 weeks were randomised to receive two doses of ROTARIX® as per standard schedule with other routine vaccinations or an additional third dose of ROTARIX® administered at 9 months old concomitantly with measles/rubella vaccination. Plasma collected pre-vaccination, 1 month after first- and second-dose vaccination, at 9 months old before receipt of third ROTARIX® dose and/or measles/rubella vaccination, and at 12 months old were assayed for rotavirus-specific IgA (RV-IgA). Geometric mean RV-IgA at 12 months of age and the incidence of clinical adverse events 1 month following administration of the third dose of ROTARIX® among infants in the intervention arm were compared between infants in the two arms. We found no significant difference in RV-IgA titres at 12 months between the two arms. Our findings showed that rotavirus vaccines are immunogenic in Zambian infants but with modest vaccine seroconversion rates in low-income settings. Importantly, however, a third dose of oral ROTARIX® vaccine was shown to be safe when administered concomitantly with measles/rubella vaccine at 9 months of age in Zambia. This speaks to opportunities for enhancing rotavirus vaccine immunity within feasible schedules in the national immunization program.
