Evidence map›Paper›PMID 38633263›Full record

Trial reportFrontiers in immunology2024

Boosting the immunogenicity of the CoronaVac SARS-CoV-2 inactivated vaccine with Huoxiang Suling Shuanghua Decoction: a randomized, double-blind, placebo-controlled study.

Ruying Tang, Linyuan Wang, Jianjun Zhang, Wenting Fei, Rui Zhang, Jinlian Liu, Meiyu Lv, Mengyao Wang, Ruilin Lv, Haipeng Nan and 5 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 2 institutions in 1 country.

Ruying TangSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Linyuan WangSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Jianjun ZhangSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Wenting FeiSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Rui ZhangSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Jinlian LiuSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Meiyu LvSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Mengyao WangSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Ruilin LvSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Haipeng NanSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Ran TaoSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Yawen ChenSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Yan ChenSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Yanxin JiangSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Hui ZhangSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Beijing University of Chinese Medicine · CNChinese Academy of Medical Sciences & Peking Union Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: In light of the public health burden of the COVID-19 pandemic, boosting the safety and immunogenicity of COVID-19 vaccines is of great concern. Numerous Traditional Chinese medicine (TCM) preparations have shown to beneficially modulate immunity. Based on pilot experiments in mice that showed that supplementation with Huoxiang Suling Shuanghua Decoction (HSSD) significantly enhances serum anti-RBD IgG titers after inoculation with recombinant SARS-CoV-2 S-RBD protein, we conducted this randomized, double-blind, placebo-controlled clinical trial aimed to evaluate the potential immunogenicity boosting effect of oral HSSD after a third homologous immunization with Sinovac's CoronaVac SARS-CoV-2 (CVS) inactivated vaccine. Methods: A total of 70 participants were randomly assigned (1:1 ratio) to receive a third dose of CVS vaccination and either oral placebo or oral HSSD for 7 days. Safety aspects were assessed by recording local and systemic adverse events, and by blood and urine biochemistry and liver and kidney function tests. Main outcomes evaluated included serum anti-RBD IgG titer, T lymphocyte subsets, serum IgG and IgM levels, complement components (C3 and C4), and serum cytokines (IL-6 and IFN-γ). In addition, metabolomics technology was used to analyze differential metabolite expression after supplementation with HSSD. Results: Following a third CVS vaccination, significantly increased serum anti-RBD IgG titer, reduced serum IL-6 levels, increased serum IgG, IgM, and C3 and C4 levels, and improved cellular immunity, evidenced by reduce balance deviations in the distribution of lymphocyte subsets, was observed in the HSSD group compared with the placebo group. No serious adverse events were recorded in either group. Serum metabolomics results suggested that the mechanisms by which HSSD boosted the immunogenicity of the CVS vaccine are related to differential regulation of purine metabolism, vitamin B6 metabolism, folate biosynthesis, arginine and proline metabolism, and steroid hormone biosynthesis. Conclusion: Oral HSSD boosts the immunogenicity of the CVS vaccine in young and adult individuals. This trial provides clinical reference for evaluation of TCM immunomodulators to improve the immune response to COVID-19 vaccines.

Indexed as

COVID-19COVID-19 VaccinesDrugs, Chinese HerbalVaccines, InactivatedAdultAnimalsHumansImmunoglobulin GImmunoglobulin MInterleukin-6MicePandemicsSARS-CoV-2COVID-19 VaccinesDrugs, Chinese HerbalImmunoglobulin GImmunoglobulin MInterleukin-6SARS-CoV-2 inactivated vaccinesshuanghuasinovac COVID-19 vaccineVaccines, Inactivatedclinic trialCoronaVac SARS-CoV-2 inactivated vaccineHuoxiang Suling Shuanghua Decoctionimmunogenicitymetabolomics

Identifiers

PMID38633263
PMCPMC11021573
OpenAlexW4393867203

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.