Rhesus Rotavirus candidate vaccine: clinical trial in children vaccinated between 2 and 5 months of age

Article Abstract:

Rotaviruses, a group of viruses, are a major cause of acute gastrointestinal disturbances in infants and small children. A vaccine, rhesus Rotavirus vaccine (RRV-1), has been developed using an attenuated (inactivated) virus strain. The vaccine is administered orally. The results of a two-year trial which involved 200 infants, ranging in age from two to five months, are described. A bovine (from cattle) Rotavirus vaccine and a placebo were used in this study which assessed the vaccine's effectiveness and safety. The vaccine produced only partial protection in the children; a fourfold rise in antibodies against Rotavirus was observed in 62 percent of the infants. Twenty-six percent of the children who received the Rotavirus vaccine developed a fever reaction which lasted between three and four days. A total of 26 cases of Rotavirus diarrhea were confirmed; 16 cases occurred in the placebo group and 10 in the group given the vaccine. Based on these results, a 38 percent vaccine protection rate was determined. The children who received the vaccine experienced milder episodes of Rotavirus diarrhea. When the clinical severity of the diarrhea was assessed, 13 severe cases occurred in the placebo group, compared with 5 in the vaccinated group. Although some degree of protection was afforded by the vaccine, it was not effective enough to indicate general use. Experimentation with factors such as different serotypes, dosage variations, and age of immunization should be considered in order to modify the Rotavirus vaccine and increase its effectiveness. Further clinical trials are recommended to determine the optimal combination of factors for maximum protection. (Consumer Summary produced by Reliance Medical Information, Inc.)

Research, Children, Vaccination of children, Vaccination

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An efficacy trial of the rhesus rotavirus vaccine in Maryland

Article Abstract:

Rotaviruses are a major cause of acute gastrointestinal illness in infants and young children. Much effort has been expended in recent years to develop an effective vaccine against rotavirus. One virus that has been investigated for use in a vaccine is the rhesus rotavirus strain MMU 18006 (RRV). A study was conducted with 114 infants in Maryland to assess the efficacy of RRV. The RRV was administered orally and compared with a placebo (inert substance); 64 children received the vaccine and 50 children were given the placebo. Four subjects dropped out of the trial. The results indicated that the RRV was effective in producing immunity in the children. A four-fold or larger rise was observed in antibody response, which indicated immunity, in 83 percent of the subjects given this vaccine. A side effect of the vaccine was the development of a fever. During the week following vaccination, 34 percent of the vaccinees, compared with four percent of the control group, had a fever. The fevers were more prevalent among the older children than younger subjects. However, these fevers were generally mild and were not considered to be a cause for concern. The duration of the immunological effects of this vaccine is not known. During the two years after vaccination, 17 percent of the vaccinated group and 24 percent of the control group were diagnosed with rotavirus-positive diarrhea. It was concluded that the RRV provided protection, but that the duration of the protection may be variable. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Efficacy of the Rhesus rotavirus-based quadrivalent vaccine in infants and young children in Venezuela

Article Abstract:

The Rhesus-based quadrivalent vaccine against rotavirus appears to be effective in preventing this serious cause of childhood diarrhea in developing countries. Researchers randomly assigned 2,207 Venezuelan infants to receive three doses of the vaccine or a placebo during their first four months of age. The vaccine protected 88% of the children from rotavirus-induced diarrhea and reduced the rate of hospitalization by 70%. Fifteen percent of the children who received the vaccine developed a fever shortly after, compared to 7% of those who received the placebo.

Health aspects, Venezuela, Diarrhea in children, Childhood diarrhea

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