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NCT03966040

A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

Completed Phase 1 Last updated 30 March 2021
What this trial tests

Phase 1 trial testing Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7 in Staphylococcus Aureus Infection in 144 participants. Completed in 16 May 2020.

Timeline
16 May 2019
Primary endpoint
16 December 2019
16 May 2020

Quick facts

Lead sponsorJiangsu Province Centers for Disease Control and Prevention
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment144
Start date16 May 2019
Primary completion16 December 2019
Estimated completion16 May 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu Province Centers for Disease Control and Prevention — full company profile →

Who can join

Adults 18 to 70, any sex, with Staphylococcus Aureus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center, open-label phase1b clinical trial. The study will evaluate the safety and immunogenicity of an experimental recombinant staphylococcus aureus vaccine with different immunization schedules in healthy adults aged 18-70 years, including day 0-3-7, day 0/0-3-7, day 0/0-7 and day 0/0-7-14.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. <i>Staphylococcus aureus</i> Vaccine Research and Development: The Past, Present and Future, Including Novel Therapeutic Strategies.
    Clegg J, Soldaini E, McLoughlin RM, Rittenhouse S, et al · · 2021 · cited 118× · PMID 34305945 · DOI 10.3389/fimmu.2021.705360
  2. Evaluation of a recombinant five-antigen Staphylococcus aureus vaccine: The randomized, single-centre phase 1a/1b clinical trials.
    Zhu FC, Zeng H, Li JX, Wang B, et al · · 2022 · cited 19× · PMID 35473663 · DOI 10.1016/j.vaccine.2022.04.034
  3. mRNA-based platform for preventing and treating <i>Staphylococcus aureus</i> by targeted staphylococcal enterotoxin B.
    Luo F, Xu C, Zhang C, Tan A, et al · · 2024 · cited 13× · PMID 39640268 · DOI 10.3389/fimmu.2024.1490044
  4. Identification and application of a neutralizing epitope within alpha-hemolysin using human serum antibodies elicited by vaccination.
    Wei J, Cheng X, Zhang Y, Gao C, et al · · 2021 · cited 6× · PMID 33873093 · DOI 10.1016/j.molimm.2021.03.028
  5. Identification of cross-reactive vaccine antigen candidates in Gram-positive ESKAPE pathogens through subtractive proteome analysis using opsonic sera.
    Sadones O, Kramarska E, Sainz-Mejías M, Berisio R, et al · · 2025 · cited 3× · PMID 40138269 · DOI 10.1371/journal.pone.0319933
  6. Taming Superbugs: Current Progress and Challenges in Combating ESKAPE Pathogens.
    Hetta HF, Khalaf FR, Kotb AA, Alatawi MN, et al · · 2025 · cited 1× · PMID 41599011 · DOI 10.3390/pathogens15010028
  7. A promising &lt;i&gt;Staphylococcus aureus&lt;/i&gt; vaccine adjuvant candidate to overcome &lt;i&gt;Staphylococcal&lt;/i&gt; infection based on innate immunity.
    Mao X, Söderhäll T, Choi GS, Kang JH, et al · · 2025 · cited 1× · PMID 40741061 · DOI 10.7774/cevr.2025.14.e27
  8. Potent human antibodies against SpA5 identified by high-throughput single-cell sequencing of phase I clinical volunteers' B cells.
    Wang W, Li X, Ou Y, Zhou J, et al · · 2025 · cited 1× · PMID 39834865 · DOI 10.1016/j.isci.2024.111627

Verify or expand the search:

Other recruiting trials for Staphylococcus Aureus Infection

Currently open trials in the same condition.

Other Jiangsu Province Centers for Disease Control and Prevention trials

Trials by the same sponsor.

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Data sources for this page

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