Simplified Chinese
The quadrivalent vaccine is an ideal alternative to the DPT vaccine.
Release date:
2018-03-26
Author:
Excerpt: Weikang Vaccine
Source:
Abstract
Why is the quadrivalent vaccine an ideal alternative to the DPT vaccine? The reasons are as follows:
1. As shown in the figure, a comparison of AEFI surveillance data indicates that the incidence of adverse reactions following DPT vaccination is higher than that following DPT–Hib vaccination.
II. The four‑component formulation employs a globally unique particle‑size technology, offering enhanced safety.
The impact of aluminum hydroxide adjuvant particle size on vaccine antigens and post‑vaccination reactions in the DTP vaccine.
Aluminum hydroxide is the only human vaccine adjuvant approved for use by the U.S. FDA. [Functions and Applications] The production and application of aluminum adjuvants primarily involve two environments: first, the environment in which the adjuvant adsorbs antigens; second, the interstitial fluid environment following injection. With respect to its adsorption of antigens, aluminum hydroxide relies mainly on electrostatic forces.
In the figure above, the blue color represents the particle size of conventional aluminum adjuvants, while the red color denotes the particle size of the world’s only next‑generation aluminum adjuvant developed by Meilian Jitai. The small blue dots indicate the antigen.
[Effect on Antigen Load] As shown in the figure, under identical aluminum adjuvant mass conditions, the novel‑technology aluminum adjuvant features a greater number of particles, enabling it to adsorb more blue‑labeled antigen. Consequently, each unit of vaccine adjuvant binds a larger amount of antigen, resulting in a higher seroconversion rate and providing children with higher‑quality protection.
[Protective Efficacy and Impact on Adverse Reactions] The small particle size of the new technology results in narrower inter‑particle spaces. Following administration to humans, the body establishes a tightly packed “antigen reservoir” that releases antigens gradually, thereby significantly prolonging antigen exposure. Moreover, the reduced inter‑particle spacing minimizes extravasation of tissue fluid, thus decreasing local adverse reactions such as erythema, edema, and induration.
3. The antigen extraction methods differ; the quadrivalent formulation employs a separate extraction approach, resulting in higher antigen purity.
Diphtheria–tetanus–pertussis (DTP) vaccine: Mixed antigen extraction technique: PT and FHA are co‑extracted from the culture medium.
Drawbacks: low antigen purity, difficulty in controlling antigen ratios, and significant batch-to-batch variability.
Quadrivalent vaccine: Antigen extraction methods: PT and FHA are separately extracted from the culture medium and then mixed in a specified ratio.
Advantages: High antigen purity, ability to be mixed in precise ratios, and easy control of antigen content.
4. Different manufacturing processes: As shown in the figure, the ultrafiltration process used for Siliang is superior to the dialysis process employed in the DPT vaccine of the planned immunization program. This approach shortens processing time, allows the feed solution to be handled in a closed system—minimizing exposure and reducing risks—and thereby enhances safety.
The Chinese Journal of Biological Products states that
1 The titer of the raw solution obtained by ultrafiltration (11.166 IU/mL) is higher than that of the dialysis-purified raw solution (9.211 IU/mL).
2 Ultrafiltration is more efficient at removing pigments from the detoxifying agent (it can be completed within 3 hours, whereas dialysis requires 5–7 days).
3 Ultrafiltration can enhance the efficiency of subsequent ultrasonic homogenization, thereby indirectly increasing the product titer.
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