Related Experiment Videos
Characterization of multivalent pneumococcal conjugate vaccines
1Wyeth-Lederle Vaccines, Pearl River, NY 10965, USA.
Insights
A new heptavalent pneumococcal conjugate vaccine demonstrated safety and efficacy in infants. Preclinical and clinical data support its use for preventing pneumococcal disease, paving the way for licensure.
Area of Science:
- Immunology
- Vaccinology
- Pharmaceutical Sciences
Background:
- Pneumococcal conjugate vaccines are crucial for preventing invasive pneumococcal disease.
- A heptavalent vaccine targeting specific serotypes (4, 6B, 9V, 14, 18C, 19F, 23F) was developed.
- Formulation challenges included low antigen levels and the presence of aluminium phosphate adjuvant.
Purpose of the Study:
- To evaluate the immunogenicity and antigenicity of a novel heptavalent pneumococcal conjugate vaccine.
- To assess the safety and efficacy of the vaccine in a large clinical trial.
- To support the licensure of the heptavalent pneumococcal vaccine.
Main Methods:
- Type-specific analyses using ELISA (immunogenicity) and rate nephelometry (antigenicity) in rabbits.
- Non-serotype specific assays including Anthrone assay (saccharide) and Lowry assay (protein).
- A large, randomized, double-blinded, multiethnic clinical trial in infants.
Main Results:
- Preclinical analyses provided data supporting vaccine use in infants.
- The clinical trial demonstrated that the heptavalent pneumococcal conjugate vaccine is safe and efficacious.
- Successful scale-up of the formulation process to manufacturing level was achieved.
Conclusions:
- The heptavalent pneumococcal conjugate vaccine is safe and effective in infants.
- The comprehensive preclinical and clinical data support vaccine licensure.
- The study highlights successful manufacturing scale-up for the vaccine.
Abstract:
A new heptavalent pneumococcal conjugate vaccine, designed to protect against disease due to serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, was formulated with aluminium phosphate adjuvant and analysed before testing in infants. Analyses were complicated by the presence of the adjuvant, and by the low level of each antigen; for example, all serotypes were formulated at 2 microg of saccharide /dose (except 6B which was formulated at 4 microg). Type specific analyses were performed on the formulated vaccine, and included determination of immunogenicity and antigenicity; the former was measured by ELISA following immunization of rabbits, the latter was measured by rate nephelometry. Non serotype specific information was also collected, and included total and adsorbed saccharide (by Anthrone assay), and total and adsorbed protein (by Lowry assay). These preclinical data supported the use of the vaccine in infants in a large randomized double-blinded clinical trial in a multiethnic population. The results of this trial show that the vaccine is safe and efficacious. Collectively, the data will be used to support licensure of the heptavalent vaccine, and documents successful scale-up of the formulation process to manufacturing level.