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Comparison of reactogenicity and antigenicity of M37 rotavirus vaccine and rhesus-rotavirus-based quadrivalent
J Flores1, I Perez-Schael, M Blanco
1Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892.
Insights
The M37 rotavirus vaccine showed a lower IgA antibody response in infants compared to quadrivalent vaccines. However, it induced significant neutralizing antibody responses against M37 and some human rotavirus strains.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- Rotavirus is a leading cause of severe diarrheal disease in infants globally.
- Development of effective rotavirus vaccines is crucial for public health.
- Evaluating novel vaccine candidates and their immunogenicity is essential.
Purpose of the Study:
- To assess the safety and immunogenicity of the M37 rotavirus vaccine in Venezuelan infants.
- To compare the M37 vaccine's immune response with a quadrivalent rotavirus vaccine and a balanced quadrivalent vaccine.
Main Methods:
- A randomized trial involving 90 infants aged 10-20 weeks.
- Infants were assigned to receive M37 vaccine, quadrivalent vaccine, balanced quadrivalent vaccine, or placebo.
- Serum rotavirus IgA and neutralizing antibody responses were measured.
Main Results:
- Transient febrile responses were observed in 20-30% of vaccine recipients, with placebo showing 9%.
- M37 vaccine elicited a 50% rotavirus IgA response, lower than quadrivalent vaccines (74-86%).
- M37 vaccine induced neutralizing antibodies against itself (64%) and some human strains, while quadrivalent vaccines showed broader responses.
Conclusions:
- The M37 vaccine is generally well-tolerated but shows lower IgA induction compared to other rotavirus vaccines.
- Further studies are needed to determine the protective efficacy of the M37 vaccine.
- The M37 vaccine demonstrates potential for inducing neutralizing antibodies against specific rotavirus strains.
Abstract:
90 Venezuelan infants aged 10-20 weeks were randomly allocated to four groups which received one of the following: the M37 vaccine (1 x 10(4) pfu [plaque-forming units]); quadrivalent rotavirus vaccine (1 x 10(4) pfu each of serotype 3 rhesus rotavirus [RRV] and human rotavirus-RRV reassortants of serotypes 1, 2, and 4); balanced quadrivalent vaccine consisting of 1 x 10(4) pfu of serotype 1 and 3 components but 5 x 10(4) pfu of serotype 2 and 4 components; or placebo. The frequencies of transient febrile responses in these four groups were 20%, 27%, 30%, and 9%. 50% of 22 infants tested who received M37 vaccine showed a serum rotavirus IgA antibody response, compared with 74% of the 23 quadrivalent and 86% of the 22 balanced-quadrivalent recipients. 64% of the M37 recipients showed a neutralising antibody response to M37; 27% showed such responses to human serotype 1 Wa strain and 27% to serotype 4 neonatal strain ST3. 17-39% of the quadrivalent recipients and 27-41% of the balanced-quadrivalent recipients showed neutralising antibody responses to serotypes 1-4. 70-73% of the quadrivalent and balanced quadrivalent groups also showed neutralising antibody responses to RRV.