NCT03813940 is a Phase 1 clinical trial of HPV Vaccine,135μg/0.5ml in Condylomata Acuminata, sponsored by Xiamen University.

Who is sponsoring NCT03813940?

NCT03813940 is sponsored by Xiamen University.

What drugs are being tested in NCT03813940?

Interventions in NCT03813940: HPV Vaccine,135μg/0.5ml, HPV Vaccine,270μg/1.0ml.

What condition does NCT03813940 study?

NCT03813940 studies Condylomata Acuminata, Cervical Cancer.

Is NCT03813940 still recruiting?

NCT03813940 is currently completed. Last updated 8 April 2021.

Last reviewed 2021-04-08 · How we verify

NCT03813940

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

Completed Phase 1 Last updated 8 April 2021

What this trial tests

Phase 1 trial testing HPV Vaccine,135μg/0.5ml in Condylomata Acuminata in 24 participants. Completed in 1 April 2021.

Timeline

3 January 2019

Primary endpoint
18 August 2019

1 April 2021

Quick facts

Lead sponsor	Xiamen University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	3 January 2019
Primary completion	18 August 2019
Estimated completion	1 April 2021
Sites	1 location across China

Drugs / interventions tested

HPV Vaccine,135μg/0.5ml — full drug profile →
HPV Vaccine,270μg/1.0ml — full drug profile →

Conditions studied

Condylomata Acuminata — all drugs for Condylomata Acuminata →
Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

Xiamen University

Who can join

Adults 18 to 45, any sex, with Condylomata Acuminata or Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I clinical study was designed to evaluate the safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Publications & conference data

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

Opportunities and challenges for human papillomavirus vaccination in China.
Zhao C, Zhao Y, Li J, Li M, et al · · 2024 · cited 30× · PMID 38575524 · DOI 10.1080/21645515.2024.2329450
Safety and immunogenicity of an <i>Escherichia coli</i>-produced 9-valent human papillomavirus L1 virus-like particle vaccine (types 6/11/16/18/31/33/45/52/58) in healthy adults: an open-label, dose-escalation phase 1 clinical trial.
Chu K, Bi ZF, Huang WJ, Li YF, et al · · 2023 · cited 6× · PMID 37283969 · DOI 10.1016/j.lanwpc.2023.100731
Evaluation of the safety and immunogenicity of a 9-valent human papillomavirus vaccine produced in <i>Saccharomyces cerevisiae</i> using a heating-chilling process for virus-like particle antigen assembly: a double-blind, randomized, placebo-controlled phase 1 clinica
Kim JH, Lee YK, Cho HB, Choi JW, et al · · 2025 · PMID 41048471 · DOI 10.1016/j.lanwpc.2025.101686

Verify or expand the search:

Other recruiting trials for Condylomata Acuminata

Currently open trials in the same condition.

NCT06197802 — Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women · active not recruiting
NCT05056402 — An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old · Phase 3 · active not recruiting
NCT04537156 — Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E. · Phase 3 · active not recruiting

Other Xiamen University trials

Trials by the same sponsor.

NCT07525245 — Effectiveness of Large Language Model-Based Chatbot Among Parents of Junior High School Girls in Improving Human Papillo · NA · not yet recruiting
NCT07351604 — Effectiveness of Large Language Model-Based Chatbot Among Female University Stdents in Improving HPV Vaccine Awareness, · NA · not yet recruiting
NCT06866574 — A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Ty · Phase 3 · active not recruiting
NCT06243666 — Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls · active not recruiting
NCT06197802 — Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03813940 (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 Xiamen University
Last refreshed: 8 April 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/NCT03813940.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing