Tags

Type your tag names separated by a space and hit enter

Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial.
Lancet 2015; 386(10002):1457-64Lct

Abstract

BACKGROUND

Helicobacter pylori is one of the most common gastric pathogens, affecting at least half the world's population, and is strongly associated with gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma. We aimed to assess the efficacy, safety, and immunogenicity of a three-dose oral recombinant H pylori vaccine in children in China.

METHODS

We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6-15 years without past or present H pylori infection were randomly assigned (1:1), via computer-generated randomisation codes in blocks of ten, to receive the H pylori vaccine or placebo. Participants, their guardians, and study investigators were masked to treatment allocation. The primary efficacy endpoint was the occurrence of H pylori infection within 1 year after vaccination. We did analysis in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT02302170.

FINDINGS

Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis. We extended follow-up to 3 years. We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), resulting in a vaccine efficacy of 71·8% (95% CI 48·2-85·6). 157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. Serious adverse events were reported in five (<1%) participants in the vaccine group and seven (<1%) participants in the placebo group, but none was considered to be vaccination related.

INTERPRETATION

The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori-naive children. This vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori-associated diseases.

FUNDING

Chongqing Kangwei Biological Technology.

Authors+Show Affiliations

National Institute for Food and Drug Control, Beijing, China.College of Pharmacy, Third Military Medical University, Chongqing, China.Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China.Kangwei Biological Technology, Chongqing, China.National Institute for Food and Drug Control, Beijing, China.Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China.College of Pharmacy, Third Military Medical University, Chongqing, China.National Institute for Food and Drug Control, Beijing, China.Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China.Ganyu County Center for Disease Control and Prevention, Lianyungang, Jiangsu Province, China.College of Pharmacy, Third Military Medical University, Chongqing, China.Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China.National Institute for Food and Drug Control, Beijing, China.College of Pharmacy, Third Military Medical University, Chongqing, China.Ganyu County Center for Disease Control and Prevention, Lianyungang, Jiangsu Province, China.College of Pharmacy, Third Military Medical University, Chongqing, China.College of Pharmacy, Third Military Medical University, Chongqing, China.College of Pharmacy, Third Military Medical University, Chongqing, China.College of Pharmacy, Third Military Medical University, Chongqing, China.College of Pharmacy, Third Military Medical University, Chongqing, China.Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China. Electronic address: jszfc@vip.sina.com.College of Pharmacy, Third Military Medical University, Chongqing, China. Electronic address: qmzou2007@163.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26142048

Citation

Zeng, Ming, et al. "Efficacy, Safety, and Immunogenicity of an Oral Recombinant Helicobacter Pylori Vaccine in Children in China: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial." Lancet (London, England), vol. 386, no. 10002, 2015, pp. 1457-64.
Zeng M, Mao XH, Li JX, et al. Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386(10002):1457-64.
Zeng, M., Mao, X. H., Li, J. X., Tong, W. D., Wang, B., Zhang, Y. J., ... Zou, Q. M. (2015). Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet (London, England), 386(10002), pp. 1457-64. doi:10.1016/S0140-6736(15)60310-5.
Zeng M, et al. Efficacy, Safety, and Immunogenicity of an Oral Recombinant Helicobacter Pylori Vaccine in Children in China: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial. Lancet. 2015 Oct 10;386(10002):1457-64. PubMed PMID: 26142048.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial. AU - Zeng,Ming, AU - Mao,Xu-Hu, AU - Li,Jing-Xin, AU - Tong,Wen-De, AU - Wang,Bin, AU - Zhang,Yi-Ju, AU - Guo,Gang, AU - Zhao,Zhi-Jing, AU - Li,Liang, AU - Wu,De-Lin, AU - Lu,Dong-Shui, AU - Tan,Zhong-Ming, AU - Liang,Hao-Yu, AU - Wu,Chao, AU - Li,Da-Han, AU - Luo,Ping, AU - Zeng,Hao, AU - Zhang,Wei-Jun, AU - Zhang,Jin-Yu, AU - Guo,Bo-Tao, AU - Zhu,Feng-Cai, AU - Zou,Quan-Ming, Y1 - 2015/06/30/ PY - 2015/7/5/entrez PY - 2015/7/5/pubmed PY - 2016/4/27/medline SP - 1457 EP - 64 JF - Lancet (London, England) JO - Lancet VL - 386 IS - 10002 N2 - BACKGROUND: Helicobacter pylori is one of the most common gastric pathogens, affecting at least half the world's population, and is strongly associated with gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma. We aimed to assess the efficacy, safety, and immunogenicity of a three-dose oral recombinant H pylori vaccine in children in China. METHODS: We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6-15 years without past or present H pylori infection were randomly assigned (1:1), via computer-generated randomisation codes in blocks of ten, to receive the H pylori vaccine or placebo. Participants, their guardians, and study investigators were masked to treatment allocation. The primary efficacy endpoint was the occurrence of H pylori infection within 1 year after vaccination. We did analysis in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT02302170. FINDINGS: Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis. We extended follow-up to 3 years. We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), resulting in a vaccine efficacy of 71·8% (95% CI 48·2-85·6). 157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. Serious adverse events were reported in five (<1%) participants in the vaccine group and seven (<1%) participants in the placebo group, but none was considered to be vaccination related. INTERPRETATION: The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori-naive children. This vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori-associated diseases. FUNDING: Chongqing Kangwei Biological Technology. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/26142048/Efficacy_safety_and_immunogenicity_of_an_oral_recombinant_Helicobacter_pylori_vaccine_in_children_in_China:_a_randomised_double_blind_placebo_controlled_phase_3_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(15)60310-5 DB - PRIME DP - Unbound Medicine ER -