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Dose-response study of RIT 4237 oral rotavirus vaccine in breast-fed and formula-fed infants
Insights
The RIT 4237 bovine rotavirus vaccine showed a 77% antibody response at 10(8.3) 50% tissue culture-infective doses (TCID50). A dose of at least 10(8) TCID50 is recommended for infants, regardless of feeding method.
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Immunology
Background:
- Rotavirus is a leading cause of severe gastroenteritis in infants globally.
- Live attenuated vaccines are crucial for preventing rotavirus infections.
- Understanding optimal dosing and administration for infant vaccines is essential.
Purpose of the Study:
- To evaluate the immunogenicity of the RIT 4237 live attenuated bovine rotavirus vaccine in infants.
- To determine the optimal dose and administration conditions for the RIT 4237 vaccine.
- To compare vaccine response rates in breast-fed, formula-fed, and fasting infants.
Main Methods:
- Oral administration of RIT 4237 vaccine at three dose levels (10(8.3), 10(7.2), 10(6.3) 50% tissue culture-infective doses [TCID50]) to infants aged 4-6 months.
- Categorization of infants into breast-fed, formula-fed, and fasting groups.
- Measurement of neutralizing antibody responses post-vaccination.
Main Results:
- The highest dose (10(8.3) TCID50) achieved a 77% overall neutralizing antibody response rate.
- Response rates varied by feeding method: 100% in formula-fed, 69% in breast-fed, and 63% in fasting infants.
- Significantly lower response rates (33%) were observed with the lowest dose (10(6.3) TCID50).
Conclusions:
- A RIT 4237 vaccine dose of at least 10(8) TCID50 is recommended for infants.
- Administration after feeding (breast milk or formula) appears optimal for vaccine response.
- The RIT 4237 vaccine demonstrates satisfactory immunogenicity in infants across different feeding types.
Abstract:
The RIT 4237 live attenuated bovine rotavirus vaccine was given orally at three dose levels to 75 breast-fed, 40 formula-fed and 24 fasting infants ages 4 to 6 months. Vaccine of 10(8.3) (50% tissue culture-infective doses) (TCID50) per dose gave a neutralizing antibody response in 14 of 14 (100%) formula-fed, in 18 of 26 (69%) breast-fed and in 5 of 8 (63%) fasting infants, or an overall response rate of 77% (37 of 48). The overall response rate to a vaccine of 10(7.2) TCID50 per dose was 61% (33 of 49), or slightly but not significantly lower than that at the higher dose level. On the other hand a vaccine of 10(6.3) TCID50 per dose gave a significantly (P less than 0.01) lower composite response rate of 33% (14 of 42). The overall serologic response rate to the vaccine at the two higher doses was somewhat better (24 of 28, 86%) in formula-fed infants than in breast-fed infants (37 of 52, 71%). However, the response rate of the breast-fed infants can also be considered satisfactory. Thus the current recommendation for use of the RIT 4237 vaccine would be administration of a dose of at least 10(8) TCID50 after feeding with either formula or breast milk.