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NCT03966040
A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
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.
16 December 2019
Quick facts
| Lead sponsor | Jiangsu Province Centers for Disease Control and Prevention |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 144 |
| Start date | 16 May 2019 |
| Primary completion | 16 December 2019 |
| Estimated completion | 16 May 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7 — full drug profile →
- Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7 — full drug profile →
- Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7 — full drug profile →
- Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14 — full drug profile →
Conditions studied
- Staphylococcus Aureus Infection — all drugs for Staphylococcus Aureus Infection →
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):
-
<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 -
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 -
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 -
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 -
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 -
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 -
A promising <i>Staphylococcus aureus</i> vaccine adjuvant candidate to overcome <i>Staphylococcal</i> 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 -
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:
- PubMed search for NCT03966040
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Jiangsu Province Centers for Disease Control and Prevention trials
Trials by the same sponsor.
- NCT07530679 — Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential 9-Valent HPV Vacc · NA · not yet recruiting
- NCT07232745 — Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine · Phase 4 · active not recruiting
- NCT06609811 — The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuat · Phase 4 · completed
- NCT07035054 — Phase Ⅱ Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · Phase 2 · completed
- NCT07025876 — PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine · EARLY_PHASE1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03966040 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Province Centers for Disease Control and Prevention
- Last refreshed: 30 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03966040.
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