Evidence map›Paper›PMID 37243103›Full record

ArticleVaccines2023

A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18-45 Years of Age.

Xin Cheng, Gan Zhao, Aihua Dong, Zhonghuai He, Jiarong Wang, Brian Jiang, Bo Wang, Miaomiao Wang, Xuefen Huai, Shijie Zhang and 3 more

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 3% 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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
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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

13 authors at 1 institution in 1 country.

Xin ChengAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Gan ZhaoAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Aihua DongAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Zhonghuai HeAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Jiarong WangAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Brian JiangAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Bo WangAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Miaomiao WangAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Xuefen HuaiAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Shijie ZhangAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Shuangshuang FengAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Hong QinAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.
Bin WangAdvaccine Biopharmaceuticals Suzhou Co., Ltd., Suzhou 215000, China.ORCID 0000-0002-9945-1818
Fudan University · CN

Funding

National Major Scientific and Technological Special Project for "Program of Significant New Drug Developments" 2013ZX09102041National Natural Science Foundation of China 81991492National Natural Science Foundation of China 82041039
6 · The paper itself

Abstract

backgroundWith the enormous morbidity and mortality caused by respiratory syncytial virus (RSV) infections among infants and the elderly, vaccines against RSV infections are in large market demand.

methodsWe conducted a first-in-human (FIH), randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety and immunogenicity response of the rRSV vaccine (BARS13) in healthy adults aged 18-45. A total of 60 eligible participants were randomly assigned to receive one of four dose levels or vaccination regimens of BARS13 or placebo at a 4:1 ratio.

resultsThe mean age was 27.40, and 23.3% (14/60) were men. No treatment-emergent adverse events (TEAEs) led to study withdrawal within 30 days after each vaccination. No serious adverse event (SAE) was reported. Most of the treatment-emergent adverse events (TEAEs) recorded were classified as mild. The high-dose repeat group had a serum-specific antibody GMC of 885.74 IU/mL (95% CI: 406.25-1931.17) 30 days after the first dose and 1482.12 IU/mL (706.56-3108.99) 30 days after the second dose, both higher than the GMC in the low-dose repeat group (885.74 IU/mL [406.25-1931.17] and 1187.10 IU/ mL [610.01-2310.13]).

conclusionsBARS13 had a generally good safety and tolerability profile, and no significant difference in terms of adverse reaction severity or frequency was observed between different dose groups. The immune response in repeat-dose recipients shows more potential in further study and has guiding significance for the dose selection of subsequent studies.

Indexed as

immunogenicityrespiratory syncytial virussafetyvaccine

Identifiers

PMID37243103
PMCPMC10221330
OpenAlexW4377020216

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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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 OpenQuestion graph.