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Cho, Kim, Bae, and Cha: Current status of registry of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov, database of US National Institutes of Health
Original Article
Clinical and Experimental Vaccine Research

Clinical and Experimental Vaccine Research 2013; 2(1): 46-52.

Published online: 15 January 2013

DOI: https://doi.org/10.7774/cevr.2013.2.1.46

Current status of registry of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov, database of US National Institutes of Health

Jahyang Cho, Bo Bae Kim, Chong-Woo Bae, Sung-Ho Cha

Department of Pediatrics, Kyung Hee University School of Medicine, Seoul, Korea.

Corresponding author: Chong-Woo Bae, MD. Department of Pediatrics, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892 Dongnam-ro, Gangdong-gu, Seoul 134-727, Korea. Tel: +82-2-440-6130, Fax: +82-2-440-7175, baecw@khnmc.or.kr

Received 7 November 2012       Revised 22 November 2012       Accepted 27 November 2012

© Korean Vaccine Society.

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

PubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov.

Materials and Methods

As of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators.

Results

Total 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group.

Conclusion

Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.

Keywords: Vaccines, Clinical trial, Database, ClinicalTrials.gov, US National Institutes of Health

Introduction

KoreaMed is the largest medical journal database that is used in Korea. As of October 2012, there were 40 articles found under vaccine, Korea and clinical trials and 84 articles under vaccine, Korea, clinical study refer to the key words, respectively [1]. However in PubMed, the largest medical journal database used worldwide, there were 109 articles and 171 articles referring to the same key words [2]. PubMed has a separate registration system for clinical trials, known as ClinicalTrials.gov, under the supervision of US National Institutes of Health [3]. The aims and scope of ClinicalTrials.gov are as follows: "ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world" [3].
We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial. gov for the understanding the current status of Korean research on vaccine clinical trials at the international level.

Materials and Methods

As of October 2012, there are 72 trials found on the registry of vaccine clinical trials conducted by Korean investigators in the database of ClinicalTrial.gov [3]. This represents about 1.6% of 4,480 vaccine clinical trials, the total trials on vaccine clinical trials all over the world, registered in ClinicalTrial.gov (Table 1) [3]. These Korean-led trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators.

Results

Classification by conditions of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov (October 2012)

As of October 2012, 72 trials of vaccine clinical trials conducted by Korean investigators were classified by groups of infection, cancer, and others. The distributions under these categories are shown in Table 2 [3]. Infection group shown are as follows: 10 trials of poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b; 9 trials of seasonal influenza; 8 trials of human papillomavirus infection and associated cervical neoplasia; 6 trials of pneumococcal vaccine and disease; 4 trials of herpes zoster; 4 trials of smallpox; 4 trials of hepatitis B; 3 trials of Haemophilus influenzae type b; 3 trials of varicella, rubella, mumps and measles; 2 trials of meningococcal disease; 2 trials of Japanese encephalitis; 1 trial of each in anthrax, cholera, and hepatitis A. One trial of each in non-small cell lung cancer, breast cancer, prostate cancer, and advanced colorectal cancer are shown in cancer group. One trial of each in Crohn's disease and inflammatory bowel diseases, ulcerative colitis, hepatitis A, renal failure, and rheumatoid arthritis are shown in other group.

Used biologicals or drugs in vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov (October 2012)

The formulation of ingredients or preparation name of vaccine biological or drugs used in 72 clinical trials are listed in Table 3 [3].

Status of proceeding of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov (October 2012)

The progress of clinical trials as of October 2012, are shown in Table 4 [3]. There are 37 trials of completed clinical trials, 17 trials recruiting, 11 trials non-recruiting, 2 trials not yet recruiting, 1 trial enrolling by invitation, 1 terminated trial, and 3 trials of unknown progress. This means that out of 72 clinical trials reported only 37 trials were completed and rest are still ongoing, of which 1 trial was terminated and progression of 3 trials are unknown. Among the completed trials, 13 trails have reports of final results.

List of sponsor and collaborators of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gov (October 2012)

List of sponsors and collaborators in 72 vaccine clinical trials are shown in Table 5 [3].

Discussion

The 72 clinical trials conducted by Korean investigators represents about 1.6% of 4,480 vaccine clinical trials, the total vaccine clinical trials all over the world registered in ClinicalTrial.gov. This is a very low percentage, something that Korea will have to improve in the future.
Considering these trials by the goal of vaccine, prevention of infection was 90.0% (64 trials), cancer 5.5% (4 trials), others 5.5% (4 trials), in which the prevention of infection was the predominant goal. The categories of infection can be divided into poliomyelitis, pertussis, diphtheria, tetanus and Haemophilus influenzae type b (10 trials), seasonal influenza (9), human papillomavirus infection and associated cervical neoplasia (8), pneumococcal vaccine and disease (6), of herpes zoster (4), smallpox (4), hepatitis B (4), Haemophilus influenzae type b (3), varicella, rubella, mumps and measles (3), meningococcal disease (2), Japanese encephalitis (2), anthrax (1), cholera (1), and hepatitis A (1). Cancers can be categorized into trials on non-small cell lung cancer (1), breast cancer (1), prostate cancer (1), and advanced colorectal cancer (1). Others included Crohn's disease (1), inflammatory bowel disease, ulcerative colitis and hepatitis A (1), renal failure (1), and rheumatoid arthritis (1).
The 72 clinical trials can be divided by disease category of PubMed, there are some overlap (number of trials): arbovirus infections (2), arthritis (1), arthritis, rheumatoid (1), autoimmune diseases (1), bacterial infections (15), bacterial meningitis (1), brain diseases (2), breast diseases (1), breast neoplasms (1), bronchial neoplasms (2), calcium metabolism disorders (5), carcinoma (4), carcinoma in situ (2), carcinoma, bronchogenic (2), carcinoma, non-small-cell lung (2), central nervous system diseases (11), central nervous system infections (11), cervical intraepithelial neoplasia (2), chickenpox (2), cholera (1), chronic disease (1), Clostridium infections (9), colitis (1), colitis, ulcerative (1), colonic diseases (2), colorectal neoplasms (1), connective tissue diseases (1), cough (8), Crohn's disease (2), digestive system diseases (13), digestive system neoplasms (1), diphtheria (11), DNA virus infections (15), encephalitis (2), encephalitis, Japanese (2), enterovirus infection (13), flavivirus infections (2), gastroenteritis (7), gastrointestinal diseases (8), gastrointestinal neoplasms (1), genital diseases, female (1), genital diseases, male (1), genital neoplasms, male (1), Gram-negative bacterial infections (12), Gram-positive bacterial infections (11), haemophilus infections (1), Haemophilus influenzae (5), hepadnaviridae infections (4), hepatitis (6), hepatitis A (6), hepatitis B (4), hepatitis B, chronic (2), hepatitis, chronic (2), hepatitis, viral, human (6), herpes zoster (6), herpesviridae infections (6), hypocalcemia (5), inflammatory bowel diseases (2), influenza in birds (2), influenza, human (14), intestinal diseases (3) intestinal neoplasms (1), Japanese encephalitis (2), joint diseases (1), kidney diseases (1), kidney failure, chronic (1), liver diseases (6), lung diseases (4), lung neoplasms (2), measles (3), meningitis (2), meningitis, bacterial (1), meningitis, meningococcal (1), meningococcal infections (2), menopause (1), metabolic diseases (5), mouth diseases (3), mumps (3), musculoskeletal diseases (1), myelitis (7), Neisseria meningitidis infection (2), neisseriaceae infections (2), neoplasms, glandular and epithelial (2), neurologic manifestations (5), neuromuscular diseases (7), non-small cell lung cancer (2), orthomyxoviridae infections (14), papilloma (2), papillomavirus infections (1), paramyxoviridae infections (3), parotitis (3), cicornaviridae infections (13), pneumococcal infections (1), pneumonia (2), poliomyelitis (7), poxviridae infections (4), precancerous conditions (1), prostatic diseases (1), prostatic neoplasms (1), rectal diseases (1), renal insufficiency (1), renal insufficiency, chronic (1), respiratory tract diseases (23), respiratory tract infections (21), respiratory tract neoplasms (2), rheumatic diseases (1), RNA virus infections (31), rotavirus infections (1), rubella (3), salivary gland diseases (3), sialadenitis (3), skin diseases (1), smallpox (4), spinal cord diseases (7), stomatognathic diseases (3), streptococcal infections (1), tetanus (12), tetany (12), thoracic neoplasms (2), tumor virus infections (1), ulcer (1), urogenital neoplasms (1), urologic diseases (1), uterine cervical diseases (1), uterine cervical dysplasia (1), uterine cervical neoplasms (3), uterine diseases (1), vaccina (1), vibrio infections (1), virus diseases (41), and whooping cough (9).
The types of vaccines are also analyzed in Table 3. There were mostly studies of new products for licensure as well as some established products for efficacy studies. The centers in which the studies took place had a wide distribution from hospitals to pharmaceutical companies.
Looking at the current status of the studies, trials were completed, 31 were still in progress (sum of recruiting, active, not recruiting, not yet recruiting, and enrolling by invitation), 1 was terminated, and 3 were unknown. Among the completed trials, 13 trails have reports of final results. This data shows that the studies need continuing observation of study process for final results.
Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov, an internationally acknowledged databases, reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea [3].

Figures and Tables

Table 1
Number of papers and clinical trials of vaccine related key words of vaccine, Korea, and clinical trials in PubMed database of US National Library of Medicine and ClinicalTrials.gova) database of US National Institutes of Health (October 2012)
cevr-2-46-i001

a)http://clinicaltrials.gov/ [3].

Table 2
Classification by conditions of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gova)
cevr-2-46-i002

HPV, human papillomavirus.

a)http://clinicaltrials.gov/ [3].

Table 3
Biologicals or drugs in vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gova)
cevr-2-46-i003

JE, Japanese encephalitis; HPV, human papillomavirus; DTPa-IPV, diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine; PRP-T, polysaccharide conjugated to tetanus toxoid.

a)http://clinicaltrials.gov [3].

Table 4
Status of vaccine clinical trials conducted by Korean investigators in ClinicalTrials.gova)
cevr-2-46-i004

a)http://clinicaltrials.gov/ [3].

Table 5
Sponsors and collaborators in seventy two vaccine clinical trials in ClinicalTrials.gova)
cevr-2-46-i005

a)http://clinicaltrials.gov/ [3].

Notes

No potential conflict of interest relevant to this article was reported.

References

1. Korean Association of Medical Journals Editor. KoreaMed [Internet]. c2012. cited 2012 Oct 30. Seoul: Korean Association of Medical Journal Editors;Available from: http://www.koreamed.org.
2. US National Library of Medicine. PubMed [Internet]. c2012. cited 2012 Oct 30. Bethesda: US National Library of Medicine;Available from: http://www.ncbi.nlm.nih.gov/sites/entrez/.
3. US National Institutes of Health. ClinicalTrials.gov [Internet]. c2012. cited 2012 Oct 30. Bethesda: US National Institutes of Health;Available from: http://clinicaltrials.gov/.
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