The Lancet
Oct 10, 2015 Volume 386 Number 10002 p1419-1508 e17
http://www.thelancet.com/journals/lancet/issue/current

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Comment
At last, vaccine-induced protection against Helicobacter pylori
Philip Sutton
Published Online: 30 June 2015
DOI: http://dx.doi.org/10.1016/S0140-6736(15)60579-7
Summary
For a quarter of a century, countless attempts have been made to produce an effective vaccine against Helicobacter pylori, a major cause of peptic ulcer disease and gastric adenocarcinoma.1 An effective vaccine against H pylori is needed most for prevention of gastric adenocarcinoma, the third leading cause of cancer-related death worldwide.2 However, efforts to produce such a vaccine have so far failed, and H pylori vaccine research has slowed in the past few years. The main reason for this might have been disillusionment, arising from the inability to produce a vaccine that completely protects against the infection.

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Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial
Ming Zeng, Xu-Hu Mao, Jing-Xin Li, Wen-De Tong, Bin Wang, Yi-Ju Zhang, Gang Guo, Zhi-Jing Zhao, Liang Li, De-Lin Wu, Dong-Shui Lu, Zhong-Ming Tan, Hao-Yu Liang, Chao Wu, Da-Han Li, Ping Luo, Hao Zeng, Wei-Jun Zhang, Jin-Yu Zhang, Bo-Tao Guo, Feng-Cai Zhu, Quan-Ming Zou
1457
Summary
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.