Evidence map›Paper›PMID 39865693›Full record

Trial reportHuman vaccines & immunotherapeutics2025

Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial.

Siyue Jia, Chengwei Shao, Xin Cheng, Hongxing Pan, Zhijian Wang, Yu Xia, Jianfang Xu, Xuefen Huai, Danjing Leng, Jiarong Wang and 4 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. 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

14 authors.

Siyue JiaJiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.
Chengwei ShaoSchool of Public Health, Southeast University, Nanjing, China.
Xin ChengR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, China.
Hongxing PanJiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.
Zhijian WangDepartment of Acute Infectious Diseases and Immunization Program Management, Danyang Center for Disease Control and Prevention, Zhenjiang, China.
Yu XiaR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, China.
Jianfang XuDepartment of Acute Infectious Diseases and Immunization Program Management, Danyang Center for Disease Control and Prevention, Zhenjiang, China.
Xuefen HuaiR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, China.
Danjing LengDepartment of Acute Infectious Diseases and Immunization Program Management, Danyang Center for Disease Control and Prevention, Zhenjiang, China.
Jiarong WangR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, China.
Gan ZhaoR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, China.
Bin WangR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, China.
Jingxin LiJiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.
Fengcai ZhuJiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.ORCID 0000-0002-1644-0006

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INO-4800 represents a DNA-based vaccine encoding the spike protein of SARS-CoV-2. This phase 2 trial evaluated the immunogenicity and safety of INO-4800 as a primary vaccination series in adults. We conducted a randomized, observer-blind, placebo-controlled phase 2 trial of intradermal injection of INO-4800 in both healthy adults and elderly individuals. Eligible participants from each age group were enrolled and randomly assigned in a 3:3:2 ratio to receive two doses of INO-4800 (1.0 mg or 2.0 mg) or placebo, followed by electroporation on day 0 and day 28. The primary immunogenicity endpoints focused on determining the geometric mean titers (GMTs) of spike-binding antibodies and live SARS-CoV-2 neutralizing antibody at day 30 after the second dose. The primary endpoint for safety was the occurrence of adverse events within 30 days after vaccination. A total of 781 volunteers were recruited and screened for eligibility, with 320 eligible young adults (≥18 to <60 years old) and 320 elderly (≥60 to ≤85 years old) were randomly assigned to receive the low-dose (1.0 mg,

Indexed as

COVID-19COVID-19 VaccinesImmunogenicity, VaccineSARS-CoV-2Vaccines, DNAAdolescentAdultAgedAged, 80 and overAntibodies, NeutralizingAntibodies, ViralFemaleHealthy VolunteersHumansMaleMiddle AgedAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines, DNACOVID-19DNA vaccineimmunogenicityprimary immunizationsafety

Identifiers

PMID39865693
PMCPMC11776483

What OpenQuestion holds

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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.