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PubMed · 6922094

Pneumococcal immunization: policy development and implementation from the ACIP perspective.

H B Dull
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Abstract

The Advisory Committee on Immunization Practices (ACIP) of the U.S. Public Health Service is responsible for making recommendations on the use of new vaccines and periodically revising those for established vaccines. Recommendations for pneumococcal vaccine were first issued in 1978 and revised in 1981. The changes which appear in the revision reflect the continuing maturation of the Committee's judgment on the vaccine and are a good example of the process by which the ACIP develops its recommendations on national immunization practices.

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Bacterial VaccinesHealth PolicyHumansPneumonia, PneumococcalStreptococcus pneumoniaeUnited StatesUnited States Public Health ServiceVaccinationJournal Article

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H B Dull. Pneumococcal immunization: policy development and implementation from the ACIP perspective.. https://doi.org/10.1017/s019594170005640x

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PubMed1995

Stabilization of tetanus and diphtheria toxoids against moisture-induced aggregation.

The progress toward single-dose vaccines has been limited by the poor solid-state stability of vaccine antigens within controlled-release polymers, such as poly(lactide-co-glycolide). For example, herein we report that lyophilized tetanus toxoid aggregates during incubation at 37 degrees C and elevated humidity--i.e., conditions relevant to its release from such systems. The mechanism and extent of this aggregation are dependent on the moisture level in the solid protein, with maximum aggregation observed at intermediate moisture contents. The main aggregation pathway is consistent with formaldehyde-mediated cross-linking, where reactive electrophiles created and stored in the vaccine upon formalinization (exposure to formaldehyde during vaccine preparation) react with nucleophiles of a second vaccine molecule to form intermolecular cross-links. This process is inhibited by the following: (i) succinylating the vaccine to block reactive amino groups; (ii) treating the vaccine with sodium cyanoborohydride, which presumably reduces Schiff bases and some other electrophiles created upon formalinization; and (iii) addition of low-molecular-weight excipients, particularly sorbitol. The moisture-induced aggregation of another formalinized vaccine, diphtheria toxoid, is also retarded by succinylation, suggesting the generality of this mechanism for formalinized vaccines. Hence, mechanistic stability studies of the type described herein may be important for the development of effective single-dose vaccines.

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