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Phase I and II Clinical Trials on Recombinant H. pylori Vaccine
Author(s) -
Zou QuanMing,
Zeng Ming,
Zhu Fengcai,
Mao XuHu,
Tong Wende,
Guo Gang,
Lu DongShui
Publication year - 2008
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.22.1_supplement.859.11
Subject(s) - seroconversion , medicine , placebo , adjuvant , immunization , saliva , recombinant dna , antibody , clinical trial , vaccination , immunology , gastroenterology , vaccine trial , biology , pathology , biochemistry , alternative medicine , gene
Backgrounds: Phase I and II clinical trials on oral recombinant Hp vaccine were conducted from August 2003 to March 2004, in Yangzhong, Jiangsu. It is a recombinant Hp intramolecular adjuvant vaccine. Methods: 653 healthy volunteers between age 6 and 15 that do not have Hp infection or Hp infection history were selected. All volunteers were clearly notified, and the experiment was random, double‐blinded, and controled. The volunteers were divided into 4 groups, which were given placebo, 15 mg, 30 mg, or 45 mg of vaccine per uptake. The vaccine and the placebo were taken orally on day 0, 14, and 28. Instant reaction was observed 30 min after each uptake. Thirty days of follow‐up visit were carried out, and abnormal reactions were monitored. At the same time, the levels of specific serum IgG, and total specific Ig of serum, along with specific sIgA of saliva and feces were detected before immunization, 14 days after the second immunization, 30 days, and 60 days after the third immunization. Results: The vaccine is safe at all three doses, and no toxicity is observed. The levels of specific IgG, total specific Ig developed in serum were high in all three groups of subjects for a long period of time, and remained high 2 months after the last immunization. The antibody's positive seroconversion rates of the three groups of subjects, 15 mg, 30 mg, and 45 mg per uptake, were 95.6%, 97.8%, 92.3% respectively. However, the placebo group is only 3.8%. Conclusions: This vaccine is safe and has strong immunogenicity. The effect of the vaccine is better after three immunizations than two immunizations.