ArticleEClinicalMedicine2021
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18 years or older: A randomized, double-blind, placebo-controlled, phase 1/2 trial.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 5 of them syntheses that pooled 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.
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.
Who cites it
22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- A systematic review and meta-analysis of the effectiveness and safety of COVID-19 vaccination in older adults.Frontiers in immunology · 2023Pooled it
- Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022Pooled it
- Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis.BMC medicine · 2022Pooled it
- Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis.The journal of headache and pain · 2022Pooled it
- Efficacy, immunogenicity and safety of COVID-19 vaccines in older adults: a systematic review and meta-analysis.Frontiers in immunology · 2022Pooled it
- Trial
- Early assessment of the safety and immunogenicity of a third dose (booster) of COVID-19 immunization in Chinese adults.Frontiers of medicine · 2022Trial
- Safety and Immunogenicity of the Inactivated COVID-19 Vaccine Booster in People Living with HIV in China.Vaccines · 2023Article
- Safety and immunogenicity of a third-dose homologous BBIBP-CorV boosting vaccination: interim results from a prospective open-label study.Emerging microbes & infections · 2022Article
- Correlation of gut microbiota and metabolic functions with the antibody response to the BBIBP-CorV vaccine.Cell reports. Medicine · 2022Article
- Cost-Effectiveness of COVID-19 Sequential Vaccination Strategies in Inactivated Vaccinated Individuals in China.Vaccines · 2022Article
- Article
- Coronavirus disease 2019 (COVID-19) vaccine platforms: how novel platforms can prepare us for future pandemics: a narrative review.Journal of Yeungnam medical science · 2022Article
- Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike RBD protein vaccine: A randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study).EClinicalMedicine · 2022Article
- Review
- A Perspective on the Roles of Adjuvants in Developing Highly Potent COVID-19 Vaccines.Viruses · 2022Article
- Article
- COVID-19 Vaccines' Protection Over Time and the Need for Booster Doses; a Systematic Review.Archives of academic emergency medicine · 2022Review
- Safety and Adverse Events Related to Inactivated COVID-19 Vaccines and Novavax;a Systematic Review.Archives of academic emergency medicine · 2022Review
- The impact of CoronaVac on the neutralization breadth and magnitude of the antibody response to SARS-CoV-2 viruses.Frontiers in immunology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
38 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe aimed to assess the safety and immunogenicity of an inactivated vaccine against COVID-19 in Chinese adults aged ≥18 years.
methodsThis is an ongoing randomized, double-blind, placebo-controlled, phase 1/2 clinical trial among healthy adults aged ≥18 years in Henan Province, China. Participants (
findingsThe 7-day adverse reactions occurred in 4·8% to 32·1% of the participants in various groups, and most adverse reactions were mild, transient, and self-limiting. Twenty participants reported 68 serious adverse events which were judged to be unrelated to the vaccine. The 90-day post-injection geometric mean titres of neutralizing antibody ranged between 87 (95% CI: 61-125) and 129 (99-169) for three-dose schedule among younger and older adults; 20 (14-27), 53 (38-75), and 44 (32-61) in 5 µg days 0 and 14/21/28 groups, respectively, and 7 (6-9) in one-dose 10 µg group. There were no detectable antibody responses in all placebo groups.
interpretationThe inactivated vaccine against COVID-19 was well tolerated and immunogenic in both younger and older adults. The two-dose schedule of 5 µg on days 0 and 21/28 and three-dose schedules on days 0, 28, and 56 could be further evaluated for long-term safety and efficacy in the phase 3 trials.
Identifiers
What OpenQuestion holds
Registered trials
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.